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Supplementary Material Complete Listing of Results:

Tables SM.1 and SM.2 include complete listings of all the potential nanomedicine
products identified through the described research methods. Also included are the specific
details gathered for each of these products. Blank cells indicate that the information was not
available or not applicable. These databases served as the basis for the categorical analyses
described in this study.

Table SM.1. Potential nanomedicine therapeutic products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Therapeutic

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

FDA Application Number or


Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Hard / Soft
Nanoparticle

Bawa, Han

Confirmed

Diprivan

Zeneca Pharma

Drug

Anesthetic

Propofol

Emulsion

150-200

Approved

Oct-89

019627

Intravenous

NA

In Vivo

Soft

NCT00332462, Garca-Gallont

Confirmed

Neoral

Novartis Pharmaceuticals

Drug

Liver Transplantation

Cyclosporine

Emulsion

10-150

Approved

Jul-95

050716

Oral

NA

In Vivo

Soft

Wagner, Project, Bawa, Faraji,


Papahadjopoulos, Bao

Confirmed

Doxil

OrthoBiotech

Drug

Kaposi Sarcoma

Doxurubicin

Liposome

87

Approved

Nov-95

050718

Intravenous

Passive

In Vivo

Soft

Wagner, Bawa, Griese

Confirmed

DaunoXome

Gilead Sciences

Drug

Kaposi Sarcoma

Daunorubicin Citrate

Liposome

45

Approved

Apr-96

050704

Intravenous

Passive

In Vivo

Soft

Wagner, Bawa, Faraji

Confirmed

Amphotec

SEQUUS Pharmaceuticals Inc.

Drug

Aspergillosis

Amphotericn B

Lipid Nanoparticle

115

Approved

Nov-96

050729

Subcutaneous

NA

In Vivo

Soft

Wagner, Bawa, Faraji

Confirmed

AmBisome

Gilead Sciences

Drug

Fungal Infections

Amphotericn B

Liposome

45-80

Approved

Aug-97

050740

Intravenous

Passive

In Vivo

Soft

Wagner, Faraji, NCT00556946,


Ichikawa

Confirmed

Visudyne

QLT / Novartis

Drug

PDT Sensitizer

Verteporfin

Liposome

100

Approved

Apr-02

021119

Intravenous

Passive

In Vivo

Soft

Wagner, Project, Bawa, Faraji,


Wiedenmann

Confirmed

Abraxane

Abraxis BioScience

Drug

Breast Cancer

Paclitaxel

Protein Nanoparticle

130

Approved

Jan-05

021660

Intravenous

Passive

In Vivo

Biodegradable

9
10

NCT00912574, O'Hagan
NCT00406341

Confirmed
Confirmed

Focetria
Durezol

Novartis Pharmaceuticals
Sirion Therapeutics, Inc.

Biological
Drug

Vaccine Adjuvant
Anterior Uveitis

Vaccine
Difluprednate

Emulsion
Emulsion

165
110

Approved
Approved

May-07
Jun-08

European Union
022212

Intravenous
Topical

NA
NA

In Vivo
In Vivo

Soft
Soft

Influenza A (H1N1) pandemic vaccine suspension. Administered intravenously.


Difuprednate ophthalmic emulsion. Topically administered anti-inflammatory.

11

NCT00769093, Li

Confirmed

Ferumoxytol

AMAG Pharmaceuticals, Inc.

Drug

Anemia

Iron Supplement

Nanoparticle

30

Approved

Jun-09

022180

Intravenous

NA

In Vivo

Hard

Iron oxide nanoparticle coated with a carbohydrate shell. Intravenous injection for the treatment of
iron-deficiency anemia in adult patients with chronic kidney disease

12

Shah, Hayashi

Confirmed

Liple

Mitsubishi Tanabe Pharma Corporation

Drug

Peripheral Vascular Disease

Palmitate Alprostadil

Emulsion

209

Foreign Approval

Nov-88

Japan

Intravenous

NA

In Vivo

Soft

13

Wagner, Bawa, Glck

Confirmed

Epaxal

Berna Biotech

Biological

Hepatitis A

Vaccine

Virosome

150

Foreign Approval

1993

40 Countries

Intramuscular

NA

In Vivo

Soft

14

Wagner, Mischler

Confirmed

Inflexal V Berna

Berna Biotech

Biological

Influenza

Vaccine

Virosome

175

Foreign Approval

1997

43 Countries

Intramuscular

NA

In Vivo

Soft

15

Faraji, Muggia

Confirmed

Evacet

The Liposome Company, Inc.

Drug

Ovarian Cancer

Doxurubicin

Liposome

150

Foreign Approval

2000

European Union

Intravenous

Passive

In Vivo

Soft

16

NCT01003288, Fox

Confirmed

Pandemrix

GlaxoSmithKline Biologicals

Biological

Swine-Origin Influenza A H1N1 Virus

Pandemrix

Emulsion

150-155

Foreign Approval

Sep-09

European Union

Intravenous

NA

In Vivo

Soft

17

NCT00364676, Talon

Confirmed

Alocrest

Hana Biosciences, Inc

Drug

Solid Tumors

Vinorelbine

Liposome

100

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

18

NCT01041235, AzayaTherapeutics

Confirmed

ATI-1123

Azaya Therapeutics, Inc.

Drug

Solid Tumors

Docetaxel

Liposome

60-80

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

19

Aleku, Li L, Silence Therapeutics

Confirmed

Atu027

Silence Therapeutics

Drug

Solid Tumors

siRNA

Liposome

120

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

20

NCT00765973, Talon

Confirmed

Brakiva

Hana Biosciences, Inc

Drug

Solid Tumors

Topotecan

Liposome

100

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

21

Bawa, NCT00689065, Heidel

Confirmed

CALAA-01

Calando Pharmaceuticals

Drug

Solid Tumors

siRNA

Polymeric Nanoparticle

50-80

Investigational

Phase I

Intravenous

Transferrin

In Vivo

Biodegradable

Cyclodextrin-containing siRNA delivery nanoparticles based on Calando's RNAi/Oligonucleotide


Nanoparticle Delivery (RONDEL) technology. Nanoparticle binds to transferrin receptors. Small
interfering RNA (siRNA) disrupts cancer gene expression. Intravenous delivery.

22

Flamel

Confirmed

FT-105

Flamel Technologies

Drug

Diabetes

Insulin

Polymeric Nanoparticle

20-50

Investigational

Phase I

Intravenous

NA

In Vivo

Biodegradable

FT-105 is Flamel's next generation basal insulin. Phase I results suggest that FT-105 has the
potential to offer substantially better glucose control than currently-marketed long-acting insulins.

23

Pevion, Huckriede

Confirmed

HIV Vaccine

Mymetics / Pevion Biotech Ltd

Biological

HIV

Vaccine

Virosome

100-200

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

HIV vaccine based on the same virosome technology platform as Berna Biotech. Administered
intravenously. One of six virosome-based vaccines in clinical development for Pevion Biotech Ltd.

24

Flamel

Confirmed

IFN alpha-2b XL

Flamel Technologies

Biological

Hepatitis B/C, Cancer

Interferon Alpha-2b

Polymeric Nanoparticle

20-50

Investigational

Phase I

Intravenous

NA

In Vivo

Biodegradable

IFN alpha-2b XL is a long-acting native interferon alpha-2b for the treatment of Hepatitis B and C
and some cancers.

25

NCT00364143

Confirmed

IHL-305

Yakult Honsha Co., LTD

Drug

Solid Tumors

Irinotecan

Liposome

100

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

Liposomal irinotecan and floxuridine. Licensing CPX-1 from Celator Pharmeceuticals (see below).

26

NCT00860522, Chang

Confirmed

JVRS-100

Juvaris BioTherapeutics, Inc.

Drug

Leukemia

Immunostimulatory DNA

Liposome

120

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

Lipid-DNA complex that is being developed as a therapeutic and an adjuvant to treat multiple
diseases. When combined with disease-specific antigens, JVRS-100 is capable of activating
substantial antibody- and cell-mediated immune responses. Intravenous injection.

27

NCT00024492, Neopharm

Confirmed

LE-M

NeoPharm, Inc.

Drug

Solid Tumors

Mitoxantrone

Liposome

<200

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

Liposomal mitoxantrone HCL (Novantrone). Based on NeoPharm's proprietary NeoLipid liposomal


formulation. Intravenously injected anti-cancer chemotherapy agent.

28

NCT00747474, Huang, TLC

Confirmed

Lipotecan

Taiwan Liposome Company

Drug

Solid Tumors

Camptothecin

Liposome

180-200

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

29

NCT01052142, Herringson

Confirmed

Lipovaxin-MM

Lipotek Pty Ltd

Biological

Melanoma

Vaccine

Liposome

240

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

30

Hamaguchi, Matsumura (2005),


Matsumura (2007)

Confirmed

MCC-465

Mitsubishi Tanabe Pharma Corporation

Drug

Stomache Cancer

Doxorubicin

Liposome

143

Investigational

Phase I

Intravenous

GAH Antibody

In Vivo

Soft

31

NanoCarrier, Ino

Confirmed

NC-4016

NanoCarrier Co., Ltd.

Drug

Solid Tumors

Oxaliplatin

Micelle

50

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

32

NCT00445419, Pevion, Huckriede

Confirmed

PEV2

Pevion Biotech Ltd

Biological

Chronic Hepatitis C

Vaccine

Virosome

100-200

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

33

Pevion, Huckriede

Confirmed

PEV6

Pevion Biotech Ltd

Biological

Breast Cancer

Vaccine

Virosome

100-200

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

34

NCT01067131, Pevion, Huckriede

Confirmed

PEV7

Pevion Biotech Ltd

Biological

Recurrent Vulvovaginal Candidiasis

Vaccine

Virosome

100-200

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

35

Matsumura (2007), Seymour

Confirmed

PK2

Pharmacia & Upjohn Inc.

Drug

Liver Cancer

Doxorubicin

Polymeric Nanoparticle

8.4

Investigational

Phase I

Intravenous

Galactose

In Vivo

Biodegradable

36

NCT01191775, Sheikhnejad

Confirmed

PNT2258

ProNAi Therapeutics Inc.

Drug

Cancer

Oligonucleotide

Liposome

100

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

37

NCT01054547, Ribeiro de Araujo

Confirmed

RVCLUV

University of Campinas, Brazil

Drug

Anesthetic

Ropivacaine

Liposome

130

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

38

NCT00385177, US Patent 7223770

Confirmed

SN2310

OncoGenex

Drug

Solid Tumors

SN-38

Emulsion

<200

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

39

NCT00927459, Rossi

Confirmed

TKM-ApoB

Tekmira Pharmaceuticals Corporation

Drug

Hypercholesterolemia

siRNA

Liposome

120

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

Stable-Nucleic-Acid-Lipid-Particles (SNALPs). Pegylated, liposomal delivery of small interefering RNA


(siRNA) for gene suppression in treatment of high cholesterol. Intravenously injected. Was PRO040201, but was renamed after initial studies were terminated.

40

NCT01519128, US Patent
20090176813

Confirmed

TMC278

Tibotec Pharmaceuticals Ltd

Drug

HIV

Nanosuspension

130

Investigational

Phase I

Intravenous

NA

In Vivo

Soft

Colloidal solutions containing non nucleoside reverse transcriptase inhibitors (NNRTIs), targeting
HIV-1 virus.

41

Bawa, NCT00455052,
Constantinides

Confirmed

XMT-1001

Mersana Therapeutics

Drug

Solid Tumors

Camptothecin

Polymeric Nanoparticle

5-10

Investigational

Phase I

Intravenous

Passive

In Vivo

Biodegradable

42

Debbage, Dobrovolskaia, Schluep

Confirmed

CRLX101

Cerulean Pharma, Inc.

Drug

Solid Tumors

Camptothecin

Polymeric Nanoparticle

78

Investigational

Phase I/II

Intravenous

Passive

In Vivo

Biodegradable

43
44

Flamel
NCT00271063, Booser

Confirmed
Confirmed

IL-2 XL
L-Annamycin

Flamel Technologies
Callisto Pharmaceuticals

Biological
Drug

Solid Tumors
Acute Lymphocytic Leukemia

Interleukin-2
Annamycin

Polymeric Nanoparticle
Liposome

20-50
150

Investigational
Investigational

Phase I/II
Phase I/II

Intravenous
Intravenous

Passive
Passive

In Vivo
In Vivo

Biodegradable
Soft

45

NCT00964080, Matsumura (2007),


Mebiopharm, Sankhala

Confirmed

MBP-426

Mebiopharm Co., Ltd

Drug

Solid Tumors

Oxaliplatin

Liposome

180

Investigational

Phase I/II

Intravenous

Transferrin

In Vivo

Soft

Description / Additional Details


Liposomal propofol. General anesthetic administered intraveneously.
Cyclosporine nanoemulsion. Administered through oral solution or gel capsule. It is an
immunosuppressant used to prevent organ rejection in people who have received a liver, kidney, or
heart transplant.
Pegylated, liposomal doxorubicin. Anti-cancer chemotherapy drug administered through
intravenous injection. Used to treat AIDS-related Kaposi's sarcoma, breast cancer, ovarian cancer,
and other solid tumors.
Liposome encapsulated aqueous solution of citrate salt of daunorubicin. Anti-cancer chemotherapy
drug administered through intravenous injection. Used to treat solid tumors.
Colloidal suspension of lipid-based amphotericin B. Subcutaneous delivery. Used to treat severe and
potentially life-threatening fungal infections.
Unilaminar, liposomal amphotericin B. Intravenous injection. Used to treat severe and potentially
life-threatening fungal infections.
Liposomal verteporfin. Photodynamic sensitizing agent. Drug is administered by intravenous
injection and collects in the abnormal vasculature in the back of the eye created by macular
degeneration. Drug is activated by short laser treatment, to destroy the abnormal vasculature.
Nanoparticle-albumin-bound paclitaxel (nab paclitaxel). Albumin is a human protein used to form
the nanoparticles. Anti-breast-cancer chemotherapy agent delivered through intravenous injection.

Palmitate alprostadil nanoemulsion intravenously injected for treatment of peripheral vascular


disease (PVD). Approved for use in Japan.
Hepatitis A vaccine adjuvanted with immunopotentiating reconstituted influenze virosomes (IRIV).
Intramuscular delivery. Licensed in over 40 countries.
Influenza vaccine adjuvanted with immunopotentiating reconstituted influenze virosomes (IRIV).
Intramuscular delivery. Licensed in over 43 countries.
Generic Doxil (see above).
Influenza A (H1N1) pandemic vaccine suspension. Administered intravenously. Approved by the
European Union.
Liposomal vinorelbine. Anti-cancer drug that inhibits mitosis at metaphase through its disruption of
microtubule assembly. Proprietary sphingomyelin/cholesterol liposome (OPTISOME) encapsulated
formulation. Intravenous injeciton.
Docetaxel in proprietary Protein Stabilized Nanoparticle (PSN) formulation. Anti-cancer
chemotherapy drug. Intravenous injection.
Silences lead internal RNAi therapeutic candidate, Atu027, is currently in a Phase I clinical trial.
Atu027 is a liposomal siRNA formulation targeting PKN3 for the treatment of advanced solid cancer.
Based on AtuPLEX platform.
Liposomal topotecan . Anti-cancer drug for treatment of refractory ovarian, small cell lung (SCLC),
and cervical cancers. Proprietary sphingomyelin/cholesterol liposome (OPTISOME) encapsulated
formulation. Intravenous injeciton.

Liposomal camptothecin. Intravenously injected anti-cancer chemotherapy drug.


Liposomal formulation to deliver cancer antigens which produce an immunoresponse against the
cancer cells. Intravenously injected.
Targeted. MCC-465 is an immunoliposome-encapsulated doxorubicin (DXR). The liposome is tagged
with polyethylene glycol (PEG) and the F(ab)2 fragment of human monoclonal antibody GAH, which
positively reacts to >90% of cancerous stomach tissues, but negatively to all normal tissues. In
preclinical studies, MCC-465 showed superior cytotoxic activity against several human stomach
cancer cells compared with DXR or DXR-incorporated PEG liposomes
Micellar oxaliplatin.
Hepatitis C vaccine based on the same virosome technology platform as Berna Biotech.
Administered intravenously. One of six virosome-based vaccines in clinical development for Pevion
Biotech Ltd.
Breast cancer vaccine based on the same virosome technology platform as Berna Biotech.
Administered intravenously. One of six virosome-based vaccines in clinical development for Pevion
Biotech Ltd.
Vulvovaginal candidiasis vaccine based on the same virosome technology platform as Berna
Biotech. Administered intravenously. One of six virosome-based vaccines in clinical development for
Pevion Biotech Ltd.
Doxorubicin was linked via a lysosomally degradable tetrapeptide sequence to N-(2hydroxypropyl)methacrylamide copolymers bearing galactosamine. Targeting, toxicity, and efficacy
were evaluated in 31 patients with primary (n 25) or metastatic (n 6) liver cancer.
No additional details are readily available.
Ropivacaine (RVC) large unilaminar vesicles (LUV). Liposomal ropivacaine intravenously injected as
general anesthetic.
Nanoemulsion derivative of SN-38 (SN2310). Intravenously injected anti-cancer chemotherapy
agent.

Camptothecin conjugated with Mersana's proprietary Fleximer technology. Fleximer is a


biodegradable and bio-inert polymer that can be chemically linked to small molecules, biologics and
nucleic acids. Intravenously injected anti-cancer chemotherapy drug.
CRLX101 (formerly named IT-101) is a conjugate of camptothecin (CPT) and a linear, cyclodextrinbased polymer. IT-101 is designed to increase the exposure of tumor cells to the chemotherapeutic
drug while minimizing the toxic side effects.
IL-2 XL, is a second-generation long-acting interleukin-2.
Liposomal annamycin. Intravenously injected anti-cancer chemotherapy agent.
Transferrin targeted. MBP-426 is a novel oxaliplatin-encapsulated transferrin (Tf) -conjugated Nglutaryl phosphatidylethanolamine (NGPE)-liposome. MBP-426 demonstrated potent anticancer
preclinical activity and has recently entered clinical trials. Direct drug binding to Tf receptor (TfR)
was demonstrated in human cancer cells in vitro; the drug delivery is thought to be enhanced via
uptake by TfR.

Table SM.1. Potential nanomedicine therapeutic products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Therapeutic

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

46

Matsumura (2009), NanoCarrier

Confirmed

Nanoplatin

NanoCarrier Co., Ltd.

Drug

Solid Tumors

Cisplatin

Micelle

20

Investigational

47

EpeiusBiotechnologies

Confirmed

Reximmune-C

Epeius Biotechnologies

Genetic

Solid Tumors

GM-CSF Gene

Nanoparticle

100

48

NCT00505713, EpeiusBiotech,
Morse

Confirmed

Rexin-G

Epeius Biotechnologies

Genetic

Solid Tumors

Rexin-G

Nanoparticle

49

Bawa, Starpharma

Confirmed

Vivagel

StarPharma Holdings

Drug

STD Prevention

SPL7013

50

Bawa, NCT00356980, Paciotti

Confirmed

Aurimmune (CYT-6091)

CytImmune Sciences, Inc.

Biological

Solid Tumors

51

NCT00245297, Powell

Confirmed

BAY 79-4980

Bayer

Drug

52

NCT00361842, Mayer

Confirmed

CPX-1

Celator Pharmaceuticals

53

NCT00875693, Mayer

Confirmed

CPX-351

54

Matsumura (2007), Thurston

Confirmed

55

NCT00646230, Okuda

56
57

FDA Application Number or


Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Hard / Soft
Nanoparticle

Phase I/II

Intravenous

Passive

In Vivo

Soft

Investigational

Phase I/II

Intravenous

von Willebrand
factor
(Collagen-Binding)

In Vivo

Biodegradable

Combines Epeius proprietary targeted delivery system with a powerful immune-stimulating gene
that recruits and activates a patients own immune cells at the site(s) of residual metastatic
diseasewhich is the source of cancer recurrence.

100

Investigational

Phase I/II

Intravenous

von Willebrand
factor
(Collagen-Binding)

In Vivo

Biodegradable

Nanoparticle construct consisting of envelope, matrix, capsid, enzymes, and genetic therapeutic.
Preferentially targets the collagen of the tumor matrix and delivers gene therapy to the tumor site.
Intravenously injected.

Dendrimer

Investigational

Phase I/II

Topical

NA

In Vivo

Soft

Dendrimer gel for delivery of SPL7013. Dendrimers are small repeatedly branching polymeric
molecules. Topically administered vaginal microbicide for STD prevention (HIV and herpes).

TNF-alpha

Colloidal Gold

30

Investigational

Phase II

Intravenous

TNF-

In Vivo

Hard

Pegylated colloidal gold nanoparticles with surface bound tumor necrosis factor (TNF). TNF binds to
and activates tumor cell TNF receptors, which results in an increase in tumor cell apoptosis.

Haemophilia A

Kogenate FS

Liposome

80-110

Investigational

Phase II

Intravenous

NA

In Vivo

Soft

Liposomal formulation of Recombinant Factor VIII, a antihaemophilic factor synthesized through


recombinant DNA technology. Intravenously injected for Haemophilia treatments.

Drug

Solid Tumors

Irinotecan

Liposome

100

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Liposomal irinotecan and floxuridine. Combination of approved anti-cancer drugs, for enhanced
synergistic effects. Treatment of cancer, particularly GI tumors. Intravenous delivery.

Celator Pharmaceuticals

Drug

Acute Myeloid Leukemia

Cytarabine and Daunorubicin

Liposome

100

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Liposomal cytarabine and daunorubicin. Combination of approved anti-cancer drugs, for enhanced
synergistic effects. Treatment of cancer, particularly leukemia. Intravenous delivery.

EndoTAG-1

Medigene AG

Drug

Solid Tumors

Paclitaxel

Liposome

180-200

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

EndoTAG-1 is a combination of positively charged liposomes with the therapeutic substance


paclitaxel embedded therein. The EndoTAG-1 concept is expected to provide a wide range of
applications. Principally, it could be suited for the treatment of all types of solid tumors which have
their own vascularization.

Confirmed

Fenretinide

CerRx Inc.

Drug

Neuroblastoma

Fenretinide

Emulsion

176

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

NCT01276548, Shimada

Confirmed

Genexol-PM

Samyang Pharmeceuticals

Drug

Solid Tumors

Paclitaxel

Micelle

10-200

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

NCT00492141, Knight

Confirmed

L9NC

University of New Mexico

Drug

Solid Tumors

L9NC

Liposome

100-300

Investigational

Phase II

Aerosol

Passive

In Vivo

Soft

58

Jamil, NeoPharm

Confirmed

LE-DT

NeoPharm, Inc.

Drug

Solid Tumors

Docetaxel

Liposome

<200

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

59

NCT01190982, Zhang

Confirmed

LEP-ETU

NeoPharm, Inc.

Drug

Solid Tumors

Paclitaxel

Liposome

150

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

60

NCT00104754, Zhang

Confirmed

LE-SN38

NeoPharm, Inc.

Drug

Solid Tumors

SN-38

Liposome

150-200

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Liposomal SN38 (active agent in irinotecan). Based on NeoPharm's proprietary NeoLipid liposomal
formulation. Intravenously injected anti-cancer chemotherapy agent.

61

NCT00739466

Confirmed

Liposomal Alendronate

Biorest Ltd.

Drug

Coronary Artery Stenosis

Alendronate

Liposome

148-180

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Liposomal alendronate. Intravenously injected for treatment of coronary artery stenosis.

62

NCT00053716, US Patent 5980551

Confirmed

Liprostin

Endovasc, Inc.

Drug

Peripheral Vascular Disease

Prostaglandin

Liposome

100-200

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Liposomal prostaglandin. Intravenously injected for treatment of peripheral vascular disease (PVD).

63

NCT00144963, Talon

Confirmed

Marqibo

Hana Biosciences, Inc

Drug

Solid Tumors

Vincristine

Liposome

100

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

64

Wagner, Bawa, Park

Confirmed

Myocet

Elan Corporation

Drug

Breast Cancer

Doxorubicin Citrate

Liposome

190

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

65

NCT01039103

Confirmed

Nanocort

Enceladus Pharmeceuticals BV

Drug

Rheumatoid Arthritis

Prednisolone

Liposome

<150

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

66

Chow, TLC

Confirmed

NanoVNB

Taiwan Liposome Company

Drug

Colon Cancer

Vinorelbine

Liposome

95.2

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

67

Bawa, Shah, Pannu, NanoBio

Confirmed

NB-001

NanoBio Corporation

Drug

Herpes

Multiple Formulations

Emulsion

180

Investigational

Phase II

Topical

NA

In Vivo

Soft

68

Koizumi, Zamboni

Confirmed

NK012

Nippon Kayaku Co. Ltd.

Drug

Solid Tumors

SN-38

Micelle

20

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

69
70

NanoCarrier, Negishi
Alexis, Matsumura (2004)

Confirmed
Confirmed

NK105
NK911

Nippon Kayaku Co. Ltd.


Nippon Kayaku Co. Ltd.

Drug
Drug

Stomache Cancer
Solid Tumors

Paclitaxel
Doxorubicin

Micelle
Micelle

85
30-50

Investigational
Investigational

Phase II
Phase II

Intravenous
Intravenous

Passive
Passive

In Vivo
In Vivo

Soft
Soft

71

NCT00038207, Gelmon

Confirmed

ONCO-TCS

Inex Pharmaceuticals

Drug

Solid Tumors

Vincristine

Liposome

120

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Description / Additional Details


Micellar cisplatin.

Fenretinide emulsion for intravenous injection. Anti-cancer chemotherapy agent for treatment of
Neuroblastoma.
Micellar formulation of paclitaxel. Intravenously injected anti-cancer chemotherapy agent for
treatment of a variety of forms of cancer.
Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC). Anti-cancer chemotherapy agent.
Aerosolized for potential inhalation delivery.
Liposomal docetaxel. Based on NeoPharm's proprietary NeoLipid liposomal formulation.
Intravenously injected anti-cancer chemotherapy agent.
Liposomal paclitaxel. Based on NeoPharm's proprietary NeoLipid liposomal formulation.
Intravenously injected anti-cancer chemotherapy agent.

Liposomal vincristine sulfate. Anti-cancer drug that inhibits cell division by binding to tubulin in
mitotic spindles. Proprietary sphingomyelin/cholesterol liposome (OPTISOME) encapsulated
formulation. Intravenous injeciton.
Liposomal doxorubicin. Intravenously injected anti-cancer chemotherapy agent. International
tradename is Caelyx.
Liposomal prednisolone. Intravenously injected to elicit anti-inflammatory response for treatment
of rheumatoid arthritis.
Pegylated liposome.
Nanoemulsion droplets based on proprietary NanoStat technology. Multiple drug formulations are
under clinical investigation. Treatment will be topically administered.
Micellar formulation of SN38 (active agent in irinotecan). Intravenously injected anti-cancer
chemotherapy agent for treatment of various cancers.
Micellar paclitaxel.
Micellar doxorubicin.
Liposomal vincristine. Intravenously injected anti-cancer chemotherapy agent for treatment of
various cancers.
Liposomal Lurtotecan. Intravenously injected anti-cancer chemotherapy agent for treatment of
various cancers.
Licensing CPX-1 from Celator Pharmeceuticals (see above).

72

NCT00046787

Confirmed

OSI-211

OSI Pharmaceuticals, Inc.

Drug

Solid Tumors

Lurtotecan

Liposome

100-200

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

73

NCT00940758

Confirmed

PEP02

PharmaEngine

Drug

Solid Tumors

Irinotecan

Liposome

100

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

74

NCT00408668, Pevion, Huckriede

Confirmed

PEV3

Mymetics / Pevion Biotech Ltd

Biological

Falciparum Malaria

Vaccine

Virosome

100-200

Investigational

Phase II

Intravenous

NA

In Vivo

Soft

75

Wagner, NCT00484120, Pharmos

Confirmed

Pharmos NE Cream

Pharmos Corporation.

Drug

Osteoarthritis

Diclofenac

Emulsion

100-200

Investigational

Phase II

Topical

NA

In Vivo

Soft

76

Matsumura (2007), Paul

Confirmed

PK1

University of Glasgow

Drug

Breast Cancer

Doxorubicin

Polymeric Nanoparticle

Investigational

Phase II

Intravenous

Passive

In Vivo

Biodegradable

77

Davis, Alexis, Access Pharm

Confirmed

ProLindac

Access Pharmaceuticals, Inc.

Drug

Ovarian Cancer

DACH Platinum

Polymeric Nanoparticle

6-15

Investigational

Phase II

Intravenous

Passive

In Vivo

Biodegradable

78

Wagner, NCT00460525,
MedicalNewsToday

Confirmed

RTS S/AS02

GlaxoSmithKline Biologicals

Biological

Plasmodium Falciparum Malaria

FMP2.1/AS02A

Liposome

20

Investigational

Phase II

Intramuscular

NA

In Vivo

Soft

Liposome delivered, genetic malarial vaccine.

79

Alakhov, Matsumura (2007),


Supratek

Confirmed

SP1049C

Supratek Pharma, Inc.

Drug

Solid Tumors

Doxorubicin

Micelle

30

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

Proprietary intravenous doxorubicin formulation developed for the treatment of cancers that are
otherwise resistant to doxorubicin. SP1049C is active in chemoresistant and metastatic cancers.
Potential opportunity exists for the treatment of metastatic adenocarcinoma of the upper
gastrointestinal tract as well as other chemo resistant indications including refractory colon, breast
and non-small cell lung cancers and leukemia.

Malaria vaccine based on the same virosome technology platform as Berna Biotech. Administered
intravenously. One of six virosome-based vaccines in clinical development for Pevion Biotech Ltd.
Diclofenac nanoemulsion delivered topically in a cream. Intended to provide anti-inflammatory
action for treatment of arthritis.
No additional details are readily available.
ProLindacTM is a prodrug of DACH platinum in which the cytotoxic agent is bound to a watersoluble
biocompatible copolymer backbone, called hydroxypropylmethacrylamide (HPMA).

Aerosolised L-CsA should suppress T-cell activation in the lung tissue and subsequently BOS
development.
STEALH liposomal cisplatin. Intravenously injected anti-cancer chemotherapy agent for treatment of
various cancers.

80

NCT01334892, Behr

Confirmed

L-CsA

PARI Pharma GmbH

Drug

Bronchiolitis Obliterans

Cyclosporine

Liposome

40-50

Investigational

Phase II/III

Inhalation

NA

In Vivo

Soft

81

NCT00004083, Newman

Confirmed

SPI-77

SEQUUS Pharmaceuticals Inc.

Drug

Solid Tumors

Cisplatin

Liposome

110

Investigational

Phase II/III

Intravenous

Passive

In Vivo

Soft

82

NCT00617981, Lindner

Confirmed

ThermoDox

Celsion Corporation

Drug

Solid Tumors

Doxorubicin, Lyso-Thermosensitive

Liposome

175

Investigational

Phase II/III

Intravenous

Thermosensitive

In Vivo

Soft

83

NCT00089180, Cafardi

Confirmed

Dimericine

Applied Genetics

Drug

Precancerous Condition

T4N5

Liposome

200

Investigational

Phase III

Topical

NA

In Vivo

Soft

Liposomal gene therapy intended to repair damaged DNA caused by UV overexposure on the skin.
Topical lotion is applied to the skin.

84

NCT00328692, Hosokawa

Confirmed

KW-3902

NovaCardia, Inc.

Drug

Heart Failure

Rolofylline

Emulsion

130

Investigational

Phase III

Intravenous

NA

In Vivo

Soft

Rolofylline emulsion intravenously injected for prevention of congestive heart failure.

85

Debbage, Shaffer

Confirmed

Opaxio

Cell Therapeutics, Inc.

86
87

Dobrovolskaia

Confirmed

Auritol (CYT-21001)

CytImmune Sciences, Inc.

Flamel

Confirmed

hGH

Flamel Technologies

Drug

Solid Tumors

Paclitaxel

Polymeric Nanoparticle

Biological

Solid Tumors

Taxol and TNF-a

Colloidal Gold

Biological

Growth Disorders

HGH

Polymeric Nanoparticle

5-100

Investigational

Phase III

Intravenous

Enzyme-Activated

In Vivo

26

Investigational

20-50

Investigational

Preclinical

Intravenous

TNF-

In Vivo

Hard

Preclinical

Intravenous

NA

In Vivo

Biodegradable

Intravenous

NA

88

Flamel

Confirmed

IFN beta XL

Flamel Technologies

Biological

Multiple Sclerosis

Interferon Beta

Polymeric Nanoparticle

20-50

Investigational

Preclinical

89

Caruthers, Roszek

Confirmed

Perfluorocarbon Nanoparticle

Philips Medical Systems

Other

Atherosclerosis

Radionuclides

Perfluorocarbon NP

200-300

Investigational

Preclinical

90

Pevion, Huckriede

Confirmed

PEV4

Pevion Biotech Ltd

Biological

RSV

Vaccine

Virosome

100-200

Investigational

Preclinical

91

Canelas, Liquidia

Confirmed

PRINT

Liquidia Technologies

Drug

Drug Delivery Platform

Polymeric Nanoparticle

200

Investigational

Preclinical

Intravenous

NA

Biodegradable

Thermally sensitive liposomal doxurubicin. Used in combination with radio frequency ablation
(RFA). Liposomes are delivered to the tumor site through intravenous injection. RFA destroys a
majority of the tumor site through thermal ablation, while the heat causes release of doxurubicin,
killing any remaining cancer cells.

Xyotax, CT-2103. OPAXIO was designed to deliver paclitaxel preferentially to tumor tissue. By
linking paclitaxel to a biodegradable amino acid carrier, the conjugated chemotherapeutic agent is
inactive in the bloodstream, sparing normal tissues the toxic side effects of chemotherapy. Once
inside tumor tissue the conjugated chemotherapeutic agent is activated and released by the action
of an enzyme called cathepsin B. The activity of this enzyme and thus the rate of release of paclitaxel
poliglumex is increased in the presence of estrogen.
Pegylated colloidal gold nanoparticles bound with TNF and paclitaxel.
hGH, a long-acting native human Growth Hormone for the treatment of growth disorders, and,

In Vivo

Biodegradable

IFN beta XL, a long-acting interferon beta for the treatment of multiple sclerosis.

In Vivo

Biodegradable

Radionuclides attached to perfluorocarbon nanoparticles.


Respiratory syncytial virus (RSV) vaccine based on the same virosome technology platform as Berna
Biotech. Administered intravenously. One of six virosome-based vaccines in clinical development for
Pevion Biotech Ltd.
Early phase development for delivery nanoparticles with variable size ranges.

In Vivo

Soft

In Vivo

Biodegradable

Table SM.1. Potential nanomedicine therapeutic products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Therapeutic

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

Administration Route

In Vivo Targeting

In Vivo
Use

Hard / Soft
Nanoparticle

92

Bexion, Qi, Chu

Confirmed

SapC-DOPS

Bexion Pharmaceuticals, Inc.

Biological

Solid Tumors

Saposin C

Liposome

190

Investigational

Preclinical

FDA Application Number or


Foreign Country

Intravenous

Saposin C

In Vivo

Soft

No additional details are readily available.

93

Supratek

Confirmed

SP1060C-O

Supratek Pharma, Inc.

Drug

Solid Tumors

Topotecan

Micelle

10-100

Investigational

Preclinical

Oral

Passive

In Vivo

Soft

SP1060C-O is a proprietary orally bioavailable formulation of topotecan and a Biotransport carrier


that increases the bioavailability of the active (lactone) form of the drug. The product prototype is a
free flowing powder that is water-soluble and compressible into tablets.

94

Constantinides, Mersana

Confirmed

XMT-1107

Mersana Therapeutics

Drug

Solid Tumors

Fumagillin

Fleximer

5-10

Investigational

Preclinical

Intravenous

Passive

In Vivo

Soft

Fumagillin conjugated with Mersana's proprietary Fleximer technology. Fumagillin is an antiangiogenic agent. Fleximer is a biodegradable and bio-inert polymer that can be chemically linked to
small molecules, biologics and nucleic acids. Intravenously injected, intended for cancer treatment.

Description / Additional Details

95

Dobrovolskaia

Confirmed

Basulin

Flamel Technologies

Drug

Type I Diabetes

Insulin

Polymeric Nanoparticle

20-50

Terminated

Phase II

In Vivo

Biodegradable

Improved insulin delivery with the use of the proprietary Medusa nanoparticle system.

96

NCT00055133

Confirmed

Paxceed

Angiotech Pharmaceuticals

Drug

Solid Tumors

Paclitaxel

Micelle

<200

Terminated

Phase II

Intravenous

Passive

In Vivo

Soft

Micellar formulation of paclitaxel. Intravenously injected for arthritis treatment. Clinical


investigations were terminated due to lack of demonstrated efficacy.

97

NCT00096668, Constantinides

Confirmed

TOCOSOL

OncoGenex

Drug

Solid Tumors

Paclitaxel

Emulsion

40-80

Terminated

Phase II

Intravenous

Passive

In Vivo

Soft

Paclitaxel emulsion for intravenous injection. Anti-cancer chemotherapy agent for treatment of
various cancers. Terminated in Phase III because the new formulation was not able to demonstrate
increased efficacy over straight Taxol injections.

98

NCT00002742, Moribe

Confirmed

Nyotran

Aronex Pharmaceuticals, Inc

Drug

Solid Tumors

Nystatin

Liposome

110-135

Terminated

Phase III

In Vivo

Soft

Liposomal nystatin. Discontinued for unknown reasons.

99

Wagner, Bawa, Faraji

Likely

Adagen

Enzon

Drug

Immunodeficiency

Pegademase Bovine

Polymeric Nanoparticle

Approved

Mar-90

019818

Intramuscular

NA

In Vivo

Biodegradable

Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the enzyme


adenosine deaminase (ADA). Enzyme is derived from bovine intestine. Intramuscular injection for
treatment of severe combined immunodeficiency disease (SCID).

100

Wagner, Bawa, Faraji

Likely

Oncaspar-IV

Enzon

Drug

Leukemia

Pegaspargase

Polymeric Nanoparticle

Approved

Feb-94

103411

Intravenous

Passive

In Vivo

Biodegradable

Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the enzyme Lasparaginase. Enzyme is derived from E coli. Intravenous injection for treatment of leukemia.

101

Wagner, Project

Likely

Copaxone

TEVA

Drug

Multiple Sclerosis

Glatiramer Acetate

Polymeric Nanoparticle

Approved

Dec-96

020622

Subcutaneous

NA

In Vivo

Biodegradable

Polymeric complex of glatiramer acetate (copolymer of L-glutamic acid, L-alanine, L-tyrosine, and Llysine). Subcutaneous injection to reduce the frequency of relapse with multiple sclerosis.

102

Faraji, Kanaoka

Likely

Ontak

Seragen, Inc.

Biological

Cutaneous T-cell lymphoma

Denileukin Diftitox

Protein Nanoparticle

Approved

Feb-99

103767

Intravenous

IL-2 Protein

In Vivo

Soft

103

Wagner, Bawa, Faraji

Likely

DepoCyt

SkyePharma

Drug

Lymphomatous Meningitis

Cytarabine

Liposome

Approved

Apr-99

021041

Intravenous

Passive

In Vivo

Soft

104

Wagner, Bawa

Likely

Renagel

Genzyme

Drug

Chronic Kidney Disease

Sevelamer HCl

Polymeric Nanoparticle

Approved

Jul-00

021179

Oral

NA

In Vivo

Biodegradable

105

Wagner, Bawa

Likely

Peg-Intron

Schering

Biological

Hepatisis C

Peginterferon Alpha-2B

Polymeric Nanoparticle

Approved

Jan-01

103949

Subcutaneous

NA

In Vivo

Biodegradable

106

Wagner, Bawa, Faraji

Likely

Neulasta

Amgen

Drug

Fibrile Neutopenia

Pegfilgrastim

Polymeric Nanoparticle

Approved

Jan-02

125031

Subcutaneous

NA

In Vivo

Biodegradable

107

Wagner, Bawa, Faraji

Likely

Pegasys

Enzon

Biological

Hepatisis C

Peginterferon Alpha-2A

Polymeric Nanoparticle

Approved

Oct-02

103964

Subcutaneous

NA

In Vivo

Biodegradable

108

Wagner, Bawa

Likely

Somavert

Nektar Therapeutics

Drug

Acromegaly

Pegvisomant

Polymeric Nanoparticle

Approved

Mar-03

021106

Subcutaneous

NA

In Vivo

Biodegradable

109

NCT00611403

Likely

RESTASIS

Allergan

Drug

Dry Eye Disease

Cyclosporine

Emulsion

Approved

Oct-03

021023

Topical

NA

In Vivo

Soft

110

Wagner, Bawa, Faraji

Likely

Macugen

OSI Pharmaceuticals, Inc.

Drug

Macular Degeneration

Pegaptanib Sodium

Polymeric Nanoparticle

Approved

Dec-04

021756

Intravenous

Passive

In Vivo

Biodegradable

111

TLC

Likely

Lipo-Dox

Taiwan Liposome Company

Drug

Solid Tumors

Doxorubicin

Liposome

Foreign Approval

2001

Taiwan

Intravenous

Passive

In Vivo

Soft

112
113
114
115

Emerich
Emerich, Nyman
Emerich
Emerich

Likely
Likely
Likely
Likely

Diazepam-Lipuro
Etomidate-Lipuro
Konakion MM
Valium MM

B. Braun Medical Inc.


B. Braun Medical Inc.
Roche
Roche

Drug
Drug
Drug
Drug

Tranquilizer
Anaesthetic
Nutrional Supplement
Tranquilizer

Diazepam
Etomidate
Phytomenadione
Diazepam

Emulsion
Emulsion
Micelle
Micelle

Foreign Approval
Foreign Approval
Foreign Approval
Foreign Approval

Intramuscular
Intravenous
Intramuscular
Intramuscular

NA
NA
NA
NA

In Vivo
In Vivo
In Vivo
In Vivo

Soft
Soft
Soft
Soft

National Cancer Institute

Other

Leukemia

Radioactive Actinium-225

Nanoparticle

Investigational

Phase I

Intravenous

HuM195 Antibody

In Vivo

Macromolecule

Interleukin 2-diptheria toxin fusion protein complex. Recombinant DNA-derived from E coli.
Intravenous injection for treatment of persistent or recurrent cutaneous T-cell lymphoma.
Liposomal cytarabine. Intravenously injected chemotherapy agent for treatment of lymphomatous
meningitis.
Poly (allylamine-co-N,N'-diallyl- 1,3-diamino-2-hydroxypropane) hydrochloride cross-linked drug
complex. Tablets are taken orally for controlling serum phosphorus in patients with chronic kidney
disease (CKD) on dialysis.
Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the protein alfa-2b
interferon. Recombinant DNA-derived from Escherichia coli. Subcutaneous injection for treatment
of chronic hepatitis C.
Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the protein
methionyl human G-CSF (Filgrastim). Recombinant DNA-derived from Escherichia coli.
Subcutaneous injection for treatment of febrile neutropenia (infection).
Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the protein alfa-2a
interferon. Recombinant DNA-derived from Escherichia coli. Subcutaneous injection for treatment
of chronic hepatitis C.
Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the protein
pegvisomant (analog of human growth hormone). Derived from Escherichia coli. Subcutaneous
injection for treatment of acromegaly.
0.05% cyclosporine ophthalmic emulsion. Topical administered anti-inflammatory for treatment of
dry eyes.
Monomethoxypolyethylene glycol (PEG) polymeric complex covalently bound to the oligonucleotide,
pegaptanib sodium. Intravitreous injection into the eye for treatment of neovascular (wet) agerelated macular degeneration.
Generic form of Doxil. TLC NanoX platform claims capability to produce liposomes in the 85-130nm
size range.
No additional details are readily available.
No additional details are readily available.
No additional details are readily available.
No additional details are readily available.
Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal
Antibody HuM195). The antibody HuM195 will be used to deliver actinium-225 directly to leukemia
cells throughout the body. Once actinium-225 reaches these cells, it gives off four alpha particles,
killing the leukemia cells. Experiments show that actinium-225-HuM195 should be about 1,000
times more potent than bismuth-213-HuM195. Actinium-225-HuM195 was safe when it was given
to mice and monkeys. Structure is likely on the order of several nanometers based on the
description.

116

NCT00672165

Likely

ACTINIUM-225-LABELED HUMANIZED
ANTI-CD33 MONOCLONAL ANTIBODY
HuM195

117

NCT00664170, Zamboni

Likely

ANX-514

Adventrx Pharmaceuticals

Drug

Solid Tumors

Docetaxel

Emulsion

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

Docetaxel emulsion formulation. Docetaxel is a chemotherapy drug approved for treatment of


breast, non-small cell lung, prostate, gastric and head and neck cancers. Investigational
intravenous injection for treatment of various cancers.

118

NCT00004806

Likely

CFTR Gene Liposome

National Institute of Diabetes and Digestive


and Kidney Diseases (NIDDK)

Genetic

Cystic Fibrosis

CFTR Gene

Liposome

Investigational

Phase I

Nasal

NA

In Vivo

Soft

Liposome-mediated cystic fibrosis transport regulator (CFTR) gene transfer therapy for treatment of
cystic fibrosis. Administered to the nasal epithelium.

119

NCT01048008, Morgan

Likely

DM-CHOC-PEN

DEKK-TEC, Inc.

Drug

Brain Neoplasms

DM-CHOC-PEN

Emulsion

Investigational

Phase I

Intravenous

Penetrate
Blood-BrainBarrier

In Vivo

Soft

120

NCT00009841

Likely

Soft

NCT01278095

Likely

EGFR Antisense DNA And DC-Chol


Liposomes
GLPG0555

EGFR Antisense DNA And DC-Chol

121
122

NCT01556217

Likely

JNJ-39393406

123

Bissett, Matsumura (2007),


Schluep

Likely

124

Shah, NanoBio

125

National Cancer Institute

Biological

Head and Neck Cancer

Liposome

Investigational

Phase I

Interstitial

Passive

In Vivo

Galapagos NV / GlaxoKlineSmith
Janssen Pharmaceutica NV / Johnson &
Johnson

Drug

Autoimmune Disorder

Nanosuspension

Investigational

Phase I

Oral

NA

In Vivo

Soft

4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) drug emulsion. Intravenous


injection for cancer treatment. Has demonstrated ability to cross the blood-brain barrier to target
localized cancers.
Liposome-mediated gene therapy for cancer treatment. Early stages of development and limited
information is available.
No additional details are readily available.

Drug

Schizophrenia

Nanosuspension

Investigational

Phase I

Oral

NA

In Vivo

Soft

No additional details are readily available.

MAG-CPT

Pharmacia & Upjohn Inc.

Drug

Solid Tumors

Camptothecin

Polymeric Nanoparticle

Investigational

Phase I

Intravenous

Passive

In Vivo

Biodegradable

MAGCPT comprises the topoisomerase I inhibitor camptothecin linked to a water soluble polymeric
backbone methacryloylglycynamide (average molecular weight 18 kDa, 10% CPT by weight).

Likely

NanoStat

Nanobio Corporation

Biological

Molluscum Contagiosum

Vaccine

Emulsion

150-400

Investigational

Phase I

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
clinical investigation. Treatment will be topically administered.

Shah, NanoBio

Likely

NanoStat

Nanobio Corporation

Biological

Tinea Capitis

Vaccine

Emulsion

150-400

Investigational

Phase I

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
clinical investigation. Treatment will be topically administered.

126

Shah, NanoBio

Likely

NanoStat

Nanobio Corporation

Biological

Influenza

Vaccine

Emulsion

150-400

Investigational

Phase I

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
clinical investigation. Treatment will be topically administered.

127

Shah, Pannu, NanoBio

Likely

NB-003

Nanobio Corporation

Drug

Acne

Antibiotic

Emulsion

150-400

Investigational

Phase I

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antibiotic drug formulations are
under clinical investigation. Treatment will be topically administered.

128

Nektar

Likely

NKTR-105

Nektar Therapeutics

Drug

Solid Tumors

Docetaxel

Polymeric Nanoparticle

Investigational

Phase I

Intravenous

Passive

In Vivo

Biodegradable

129

NCT00004471

Likely

pGT-1 Gene Liposome

National Institute of Diabetes and Digestive


and Kidney Diseases (NIDDK)

Genetic

Cystic Fibrosis

pGT-1 Gene

Liposome

Investigational

Phase I

Nasal

NA

In Vivo

Soft

Liposome-mediated cystic fibrosis gene (pGT-1) gene transfer therapy for treatment of cystic
fibrosis. Administered to the nasal epithelium.

130

NCT01305512, Sun Pharma

Likely

PICN

Sun Pharma Advanced Research Company


Ltd.

Drug

Solid Tumors

Paclitaxel

Nanosuspension

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

No additional details are readily available.

131

Copernicus

Likely

PLASmin

Copernicus Therapeutics, Inc.

Genetic

Cystic Fibrosis

DNA

DNA NP

Investigational

Phase I

Aerosol

NA

In Vivo

Soft

Using compacted DNA (non-viral) to introduce normal copies of the gene into CF airways. A Phase
1a trial demonstrated chloride current changes in the noses of CF patients, but no evidence of gene
expression. The gene therapy product is being reformulated prior to additional clinical trials in an
attempt to improve the amount and duration of gene expression.

NKTR-105 is a novel form of the anti-mitotic agent, docetaxel, and was designed using Nektar's
advanced polymer conjugate technology. Expected to improve the pharmacokinetic profile of the
drug, resulting in prolonged exposure of the tumor to docetaxel and an improved timeconcentration profile.

Table SM.1. Potential nanomedicine therapeutic products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Therapeutic

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

FDA Application Number or


Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Hard / Soft
Nanoparticle

Description / Additional Details

132

Bawa

Likely

SGT-53

SynerGene Therapeutics, Inc.

Genetic

Solid Tumors

p53 Gene

Liposome

Investigational

Phase I

Intravenous

Transferrin

In Vivo

Soft

Liposome-mediated p53 gene transfer therapy for treatment of solid tumor cancers. p53 gene is a
vital tumor suppressor gene in humans. Delivered through intravenous infusion.

133

Tekmira

Likely

TKM-PLK1

Tekmira Pharmaceuticals Corporation

Drug

Solid Tumors

siRNA

Liposome

Investigational

Phase I

Intravenous

Passive

In Vivo

Soft

Tekmira has taken advantage of this passive targeting effect to develop a LNP formulation directed
against PLK1 (polo-like kinase 1), a protein involved in tumour cell proliferation. Inhibition of PLK1
prevents the tumour cell from completing cell division, resulting in cell cycle arrest and cell death.
Uses same proprietary lipid nanoparticle (LNP) technology as TKM-ApoB platform.

134

NCT00952692

Likely

AS15

GlaxoSmithKline Biologicals

Biological

Metastatic Breast Cancer

dHER2

Liposome

Investigational

Phase I/II

Intravenous

dHER2 Antibody

In Vivo

Soft

The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a


recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a
protein that is commonly overexpressed in breast cancer. This protein is combined with the
immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal
formulation containing three immunostimulatory components.

135

Alexis, Soepenberg

Likely

DE-310

Daiichi Pharmaceutical Co. Ltd

Drug

Solid Tumors

Camptothecin

Polymeric Nanoparticle

Investigational

Phase I/II

Intravenous

Passive

In Vivo

Biodegradable

136

NCT00005969, Manconi

Likely

Atragen

Aronex Pharmaceuticals, Inc

Drug

Solid Tumors

Tretinoin

Liposome

Investigational

Phase II

Intravenous

Passive

In Vivo

Soft

137

Matsumura (2007)

Likely

CT-2106

Cell Therapeutics, Inc.

Drug

Colorectal Cancer

Camptothecin

Polymeric Nanoparticle

Investigational

Phase II

Intravenous

Passive

In Vivo

Biodegradable

CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors


designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal
tissues.

138

NCT00004104

Likely

IL-2 LIPO

National Cancer Institute

Biological

Melanoma

Interleukin-2

Liposome

Investigational

Phase II

Subcutaneous

Passive

In Vivo

Soft

Liposomal formulation of Interleukin-2 for treatment of cancers. Phase II study was terminated for
treatment of solid tumors, but Phase II study is progressing for skin melanoma.

139

Shah, Pannu, NanoBio

Likely

NB-002

Nanobio Corporation

Drug

Onychomycosis

Antibiotic

Emulsion

Investigational

Phase II

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antibiotic drug formulations are
under clinical investigation. Treatment will be topically administered.

140

Nektar

Likely

NKTR-102

Nektar Therapeutics

Drug

Solid Tumors

Irinotecan

Polymeric Nanoparticle

Investigational

Phase II

Intravenous

Passive

In Vivo

Biodegradable

NKTR-102 is a topoisomerase I inhibitor-polymer conjugate with a unique pharmacokinetics profile


that provides a continuous concentration of active drug with reduced peak concentrations. Polymer
conjugate technology platform and is the first oncology product candidate to leverage Nektar's
releasable polymer technology platform.

141

NCT00533637, Orexo

Likely

OX-NLA

Orexo AB

Drug

Allergic Rhinitis

Cetirizine HCl

Liposome

Investigational

Phase II

Nasal

NA

In Vivo

Soft

142

Debbage, Khemtong

Likely

PEG-SN38

Enzon

Drug

Metastatic Breast Cancer

Camptothecin

Polymeric Nanoparticle

Investigational

Phase II

Intravenous

Passive

In Vivo

Biodegradable

143

Alexis, Izzo

Likely

ADI-SS PEG

Pheonix Pharmacologics, Inc.

Drug

Unresectable Hepatocellular Carcinoma

Arginine Deaminase

Polymeric Nanoparticle

Investigational

Phase III

Intravenous

Passive

In Vivo

Biodegradable

144

TLC

Likely

AmBiL

Taiwan Liposome Company

Drug

Fungal Infections

Amphotericin B

Liposome

Investigational

Phase III

Intravenous

Passive

In Vivo

Soft

145

NCT00175877

Likely

CDP870 (Certolizumab Pegol)

UCB, Inc.

Biological

Crohn's Disease

Monoclonal Antibody

Polymeric Nanoparticle

Investigational

Phase III

Subcutaneous

NA

In Vivo

Biodegradable

146

TLC

Likely

Doxisome

Taiwan Liposome Company

Drug

Solid Tumors

Doxorubicin

Liposome

Investigational

Phase III

ANDA

Intravenous

Passive

In Vivo

Soft

147
148

TLC
NCT00814515

Likely
Likely

ProFlow
Vekacia

Taiwan Liposome Company


Novagali Pharma

Drug
Drug

Peripheral Vascular Disease


Dry Eye Disease

Palmitate Alprostadil
Cyclosporine

Emulsion
Emulsion

Investigational
Investigational

Phase III
Phase III

ANDA

Intravenous
Opthalmic

Passive
NA

In Vivo
In Vivo

Soft
Soft

149

Cerulean Pharma

Likely

CRLX228

Cerulean Pharma, Inc.

Drug

Solid Tumors

Polymeric Nanoparticle

Investigational

Preclinical

Intravenous

Passive

In Vivo

Biodegradable

150

Sun Pharma

Likely

DICN

Sun Pharma Advanced Research Company


Ltd.

Drug

Solid Tumors

Docetaxel

Nanosuspension

Investigational

Preclinical

Intravenous

Passive

In Vivo

Soft

No additional details are readily available.

151

Mebiopharm

Likely

MBP-Y003

Mebiopharm Co., Ltd

Drug

Lymphoma

Methotrexate

Liposome

Investigational

Preclinical

Intravenous

Transferrin

In Vivo

Soft

MBP-Y003 is a transferrin-conjugated nano particle formulation of methotrexate(MTX) for the


indication of Lymphoma and other cancers. Has potential antitumor activity against various tumor
cell lines such as prostate cancers and lymphomas.

152

Mebiopharm

Likely

MBP-Y004

Mebiopharm Co., Ltd

Drug

Solid Tumors

Docetaxel

Liposome

Investigational

Preclinical

Intravenous

Transferrin

In Vivo

Soft

153

Mebiopharm

Likely

MBP-Y005

Mebiopharm Co., Ltd

Drug

Solid Tumors

Gemsitabine

Liposome

Investigational

Preclinical

Intravenous

Transferrin

In Vivo

Soft

154

Shah, NanoBio

Likely

NanoStat

Nanobio Corporation

Biological

Hepatitis B

Vaccine

Emulsion

150-400

Investigational

Preclinical

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
preclinical investigation. Treatment will be topically administered.

155

Shah, NanoBio

Likely

NanoStat

Nanobio Corporation

Biological

Anthrax

Vaccine

Emulsion

150-400

Investigational

Preclinical

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
preclinical investigation. Treatment will be topically administered.

156

Shah, NanoBio

Likely

NanoStat

Nanobio Corporation

Biological

Anthrax/Plague/Botulinum

Vaccine

Emulsion

150-400

Investigational

Preclinical

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
preclinical investigation. Treatment will be topically administered.

157

Shah, NanoBio

Likely

NanoStat

Nanobio Corporation

Biological

Small Pox

Vaccine

Emulsion

150-400

Investigational

Preclinical

Topical

NA

In Vivo

Soft

Nanoemulsion droplets based on proprietary NanoStat technology. Antiviral formulations are under
preclinical investigation. Treatment will be topically administered.

158

Tekmira

Likely

TKM-Ebola

Tekmira Pharmaceuticals Corporation

Drug

Ebola

siRNA

Liposome

Investigational

Preclinical

Intravenous

NA

In Vivo

Soft

Novel anti-viral drug in the treatment of Ebola infection. Tekmira conducted a series of studies
demonstrating the ability of an RNAi therapeutic utilizing Tekmiras lipid nanoparticle (LNP)
technology to protect nonhuman primates from Ebola virus. Uses same proprietary lipid
nanoparticle (LNP) technology as TKM-ApoB platform.

Intravenous

Passive

150-400

159

Alexis, Danhauser-Riedl

Likely

AD-70

Alpha Therapeutic GmbH

Drug

Solid Tumors

Doxorubicin

Polymeric Nanoparticle

Terminated

Phase I

160

Zamboni

Likely

CNF1010

Biogen Idec

Drug

Chronic Lymphocytic Leukemia

17-AAG

Emulsion

Terminated

Phase I

161
162

Alexis, Terwogt
Debbage, Satchi-Fainaro

Likely
Likely

PNU 166945
Caplostatin (TNP-470)

Pharmacia & Upjohn


Children's Medical Center Corporation

Drug
Drug

Cancer
Solid Tumors

Paclitaxel
TNP-470

Polymeric Nanoparticle
Polymeric Nanoparticle

Terminated
Terminated

Phase I
Phase II

163

Wagner, BioWorldToday

Likely

Propofol IDD-D

SkyePharma

Drug

Anesthetic

Propofol

Polymeric Nanoparticle

Terminated

164

Roszek

Likely

Avidimer

Avidimer Therapeutics, Inc. (was NanoCure)

Drug

Solid Tumors

Methotrexate

Dendrimer

165

NCT00666328

Potential

Cleviprex

The Medicines Company

Drug

Cardiac Hypertension

Clevidipine Butyrate

166

Eurand

Potential

Mesulid Fast

Torrinomedica

Drug

Pain Relief

Nimesulide

167

Eurand

Potential

Biorise

Eurand

Drug

Drug Delivery Platform

Nanocrystal

Foreign Approval

168

Shah

Potential

Ropion

Kaken Pharmeceuticals

Drug

Pain Relief

Fluriprofen Axetil

Emulsion

Foreign Approval

169

Acusphere

Potential

Al-850

Acusphere, Inc.

Drug

Solid Tumors

Paclitaxel

Nanoporous Material

Investigational

ANDA

In Vivo

Biodegradable

In Vivo

Soft

In Vivo
In Vivo

Biodegradable
Biodegradable

Phase III

In Vivo

Biodegradable

Terminated

Preclinical

In Vivo

Soft

Emulsion

Approved

Aug-08

Nanocrystal

Foreign Approval

Intravenous
Subcutaneous

Passive
NA

022156

Intravenous

NA

In Vivo

Italy

Oral

NA

In Vivo
In Vivo

Phase I

Intravenous

NA

In Vivo

Intravenous

NA

In Vivo

In Vivo

170

NCT00000847

Potential

ALVAC-HIV MN120TMG (vCP205)

National Institute of Allergy and Infectious


Diseases (NIAID)

Biological

HIV

Emulsion

Investigational

Phase I

Multiple

NA

171

NCT00432562

Potential

ANX-530

Adventrx Pharmaceuticals

Drug

Solid Tumors

Vinorelbine Tartrate

Emulsion

Investigational

Phase I

Intravenous

Passive

In Vivo

172
173

NCT01159028
NCT01095848

Potential
Potential

BP-100-1.01
DPX-0907

Bio-Path Holdings, Inc.


ImmunoVaccine Technologies, Inc.

Drug
Biological

Leukemia
Neoplasms

Grb-2
Cancer Vaccine

Liposome
Liposome

Investigational
Investigational

Phase I
Phase I

Intravenous
Subcutaneous

NA
NA

In Vivo
In Vivo

174

NCT00912574

Potential

GM-CSF Vaccine Emulsion

University of Virginia

Drug

Melanoma

Cancer Vaccine

Emulsion

Investigational

Phase I

Intravenous

Passive

In Vivo

No additional details are readily available.


Liposomal formulation of all-trans retinoic acidATRA for acute promyelocytic leukemia and other
hematologic malignancies, solid tumors. Intravenous injection. 2006 study indicates liposomal
tretinoin synthesis with average size capabilities ranging from 87 to 393 nm.

Liposomal formulation of cetirizine hydrochloride for treatment of hay fever. Administered through
a nasal spray.
(Pegamotecan, PEG-camptothecin, Prothecan) Liposomal formulation of comptothecin. Studies
have been terminated for unlisted reasons, but development has continued under various brand
and investigational names.
Structure has a molecular weight of 20,000.
First generic form of AmBisome. TLC NanoX platform claims capability to produce liposomes in the
85-130nm size range.
Engineered Human Anti-TNF PEG Conjugate.
Generic form of Doxil. TLC NanoX platform claims capability to produce liposomes in the 85-130nm
size range.
Generic form of Liple. Bioequivalency to Liple would require similar emulsion sizes.
Cyclosporine A opthalmic emulsion formulation for treatment of eye allergies.
RLX228, Ceruleans preclinical lead candidate from the PNP technology contains a widely used
oncology drug and is presently progressing into IND enabling studies. CRLX288 shows substantial
efficacy and safety improvement over parent drug in validated pre-clinical models and offers the
potential to dramatically improve the therapeutic index of the parent drug.

MBP-Y004 is a transferrin-conjugated nano particle formulation of Docetaxel, used for ovarian,


breast and non-small cell lung cancer.
MBP-Y005 is a transferrin-conjugated nano particle formulation of Gemsitabine, which is a
nucleoside used for cancer treatment such as non-small cell lung cancer, pancreatic cancer and
biliary cancer.

Dextran-conjugated doxorubicin. Discontinued due to severe hepatotoxicity.


Drug emulsion formulation for leukemia treatment. Study was terminated, but no indications are
listed as to why the program was terminated.
Discontinued due to severe neurotoxicity.
No additional details are readily available.
Propofol polymeric nanoparticle complex for anesthetic delivery. Study was terminated, but no
indications are listed as to why the program was terminated.
Avidimer Therapeutics develops and commercializes pharmaceuticals, called avidimers, based on
proprietary nanotechnology. Avidimers are "smart drugs, designed to maximize damage to disease
targets while minimizing collateral damage to healthy tissue." No recent information available.
Clevidipine butyrate emulsion formulation. Intravenous injection for rapidly reducing and
maintaining blood pressure.
Utilizes Biorise system (see below).
New Physical Entities (NPEs) are produced by breaking down the crystalline drug into nanocrystals
and/or amorphous (noncrystalline) drug that is stabilized in a carrier system to maintain the drug in
its activated form for the duration of its shelf life.
Fluriprofen axetil emulsion for pain relief. Intravenous injection.
Putting nanoparticles of paclitaxel into our sponge-like microspheres, creates a paclitaxel
formulation that is free of Cremophor and consists of paclitaxel nanoparticles in a porous,
hydrophilic matrix, composed primarily of a sugar that has been proven to be innocuous in other
injectable drugs.
Recombinant canarypox vaccine emulsion for HIV treatment. Investigating intramuscular,
intranasal, and intravaginal administration routes.
Vinorelbine tartrate emulsion formulation. Intravenous injection for treatment of various forms of
cancer.
No additional details are readily available.
No additional details are readily available.
Granulocyte-macrophage colony-stimulating factor (GM-CSF) emulsion. GM-CSF encourages white
blood cell development. Intravenous injection for combination treatment of various forms of
cancer.

Table SM.1. Potential nanomedicine therapeutic products.

ID

References

Nanomedicine
Relevance

175

NCT00117429

Potential

176

NCT00001512

177

NCT00000847

178

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

HIV gp120/NefTat/AS02A Vaccine

GlaxoSmithKline Biologicals

Potential

Id-KLH

Potential

Unknown

NCT00035867

Potential

Telintra

179

NCT00709254, YMBioSciences

Potential

AeroLEF

YM BioSciences

Drug

180
181
182

NCT00484120
NCT00915187
NCT01066988

Potential
Potential
Potential

Cannabinor
VaxiSome
ORB Ocular Emulsion

Pharmos Corporation.
NasVax Ltd
Alcon Research

Drug
Biological
Drug

183

NCT00143611

Potential

TAK-242

Takeda Global Research & Development


Center, Inc.

Drug

Sepsis

184
185
186

NCT00688519
Bio-Path
Bio-Path

Potential
Potential
Potential

U0267
BP-100-1.02
BP-100-2.01

GlaxoSmithKline Biologicals
Bio-Path Holdings, Inc.
Bio-Path Holdings, Inc.

Drug
Drug
Drug

Plaque Psoriasis
Lymphoma
Ovarian Cancer

187

NCT00059657

Potential

Circulase

Mitsubishi Tanabe Pharma Corporation

Drug

Peripheral Vascular Disease

188

Bawa

Questionable

Verelan

Elan Corporation

Drug

189

Wagner, Bawa, Faraji

Questionable

Abelcet

Enzon

Drug

190

Bawa

Questionable

Naprelan

STAT TRADE

Drug

191

Bawa

Questionable

Verelan PM

Elan Corporation

192

Wagner, Project

Questionable

Rapamune

Wyeth

193

Bawa

Questionable

Avinza

194

Bawa

Questionable

Ritalin LA

195

Wagner, Project, Bawa

Questionable

Emend

Merck & Co., Inc.

196

Wagner, Project, Bawa, Bandak

Questionable

Estrasorb

Novavax

197

Wagner, Project, Bawa

Questionable

TriCor

198

Bawa

Questionable

Focalin XR

199

Wagner, Bawa

Questionable

Triglide

SkyePharma

Drug

200

Wagner, Project, Bawa

Questionable

Megace ES

Par Pharmaceutical Companies, Inc. (USA)

Drug

201

Bawa, Chu

Questionable

Elestrin

Biosante Pharmaceuticals

Drug

Menopausal Symptoms

202

Wagner

Questionable

Invega Sustenna

Johnson & Johnson

Drug

Schizophrenia

Therapeutic

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

FDA Application Number or


Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Intramuscular

NA

In Vivo

Intravenous

Idiotype Determinants

In Vivo

Hard / Soft
Nanoparticle

Description / Additional Details


HIV gp120/NefTat/AS02A vaccine emulsion. Three recombinant HIV clade B viral antigens: the
envelope glycoprotein gp120 and two regulatory proteins, Nef and Tat.The antigens are formulated
in a proprietary adjuvant, AS02A, comprised of two immunostimulants in an oil-in-water emulsion
(produced by GlaxoSmithKline). Intramuscular injection.

Biological

HIV

gp120/NefTat/AS02A

Emulsion

Investigational

Phase I

National Cancer Institute

Biological

Lymphoma

Id-KLH Vaccine

Emulsion

Investigational

Phase I

Biocine

Biological

HIV

Emulsion

Investigational

Phase I

Telik, Inc.

Drug

Myelodysplastic Syndromes

TLK199 HCl

Liposome

Investigational

Phase I/II

Pain Relief

Fentanyl

Liposome

Investigational

Phase II

Aerosol

NA

In Vivo

Osteoarthritis
Influenza
Sjogren's Syndrome

CB2 Antagonist
Vaccine

Emulsion
Liposome
Emulsion

Investigational
Investigational
Investigational

Phase II
Phase II
Phase III

Intravenous
Intramuscular
Opthalmic

Passive
NA
NA

In Vivo
In Vivo
In Vivo

TLR4

Emulsion

Investigational

Phase III

Subcutaneous

NA

In Vivo

Calcipotriene
Bcl-2
siRNA

Emulsion
Liposome
Liposome

Investigational
Investigational
Investigational

Phase III
Preclinical
Preclinical

Topical
Intravenous
Intravenous

NA
NA
NA

In Vivo
In Vivo
In Vivo

Ecraprost

Emulsion

Terminated

Phase III

Intravenous

Passive

In Vivo

Ecrapost emulsion formulation for treatment of severe peripheral vascular disease (PVD). Study
was terminated, but no indications are listed as to why the program was terminated.

Hypertension

Verapamil Hydrochloride

NanoCrystal Dispersion

<2000

Approved

May-90

019614

Oral

NA

In Vivo

Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.

Fungal Infections

Amphotericn B

Liposome

1600-11000

Approved

Nov-95

050724

Intravenous

NA

In Vivo

Anti-Inflammatory

Naproxen Sodium

NanoCrystal Dispersion

<2000

Approved

Jan-96

020353

Oral

NA

In Vivo

Drug

Hypertension

Verapamil Hydrochloride

NanoCrystal Dispersion

<2000

Approved

Nov-98

020943

Oral

NA

In Vivo

Drug

Immunosuppressant

Sirolimus

NanoCrystal Dispersion

<2000

Approved

Sep-99

021083

Oral

NA

In Vivo

King Pharmeceuticals

Drug

Chronic Pain

Morphine Sulfate

NanoCrystal Dispersion

<2000

Approved

Mar-02

021260

Oral

NA

In Vivo

Novartis Pharmaceuticals

Drug

ADHD

Methylphenidate Hydrochloride

NanoCrystal Dispersion

<2000

Approved

Jun-02

021284

Oral

NA

In Vivo

Drug

Anti-Nausea

FOSAPREPITANT DIMEGLUMINE

NanoCrystal Dispersion

<2000

Approved

Mar-03

021549

Oral

NA

In Vivo

Drug

"Hot Flashes"

Estradiol Hemihydrate

Emulsion

10-1000

Approved

Oct-03

021371

Topical

NA

In Vivo

Abbott Laboratories

Drug

Cholesterol

Fenofibrate

NanoCrystal Dispersion

<2000

Approved

Nov-04

021656

Oral

NA

In Vivo

Novartis Pharmaceuticals

Drug

ADHD

Dexmethylphenidate Hydrochloride

NanoCrystal Dispersion

<2000

Approved

May-05

021802

Oral

NA

In Vivo

Lipid Regulation

Fenofibrate

NanoCrystal Dispersion

<2000

Approved

May-05

021350

Oral

NA

In Vivo

Appetite Stimulant

Megestrol Acetate

NanoCrystal Dispersion

<2000

Approved

Jul-05

021778

Oral

NA

In Vivo

Estradiol

Nanoparticle

70-1000

Approved

Dec-06

021813

Topical

NA

In Vivo

Paliperidone Palmitate

NanoCrystal Dispersion

<2000

Approved

Jul-09

022264

Intramuscular

NA

In Vivo
In Vivo

Terminated?

In Vivo

Oral

NA

In Vivo

203

Bandak

Questionable

Androsorb

Novavax

Drug

Testosterone

Emulsion

10-1000

Approved

Inactive

052065

Topical

NA

204

Bawa

Questionable

Theo-Dur

Key Pharmaceuticals

Drug

Asthma

Theophylline

NanoCrystal Dispersion

<2000

Discontinued

Jan-84

089131

Oral

NA

In Vivo

205

Bawa

Questionable

Herbesser

Tanabe Seiyaku Co., Ltd.

Drug

Angina

Diltiazem HCl

NanoCrystal Dispersion

<2000

Foreign Approval

1974

Japan / Asia

Oral

NA

In Vivo
In Vivo

Id-KLH vaccine emulsion for treatment of lymphoma.


Clinical trial for HIV vaccine emulsion, but detailed information was not provided. Study may have
been terminated.
Liposomal ezatiostat hydrochloride (TLK199) for treatment of myelodysplastic syndrome (MDS).
Inhibits the enzyme, glutathione S-transferase P1-1. GSTP1-1 is a key regulatory protein that can
signal the cell to either make more blood elements or if the cell is cancerous to die. Oral tablet.
Proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in
development for the treatment of moderate to severe acute pain.
Synthetic CB2-selective agonist emulsion for pain relief. Intravenous injection.
Liposomal adjuvant for influenza vaccine. Intramuscular injection.
Ocular emulsion for treatment of dry eyes.
TAK-242 emulsion for treatment of severe sepsis. TAK-242 is a small molecule suppressor of
pathogen-induced release of inflammatory cytokines and acts by inhibiting TLR-4 mediated
signaling. Subcutaneous injection.
Vaccine emulsion for treatment of skin disease. Topically administered.
No additional details are readily available.
No additional details are readily available.

Liposomal formulation of amphotericin B for treating fungal infections. Intravenous injection.


Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Estradiol hemihydrate micellar emulsion for treatment of hot flashes. Transdermal application.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Estradiol gel (0.06%) incorporating calcium phosphate nanoparticles. Transdermal delivery.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Testosterone micellar emulsion. Transdermal application. Product is approved, but does not list any
treated conditions and is not currently an active product.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.
Liposomal formulation of glucantime for treatment of skin infections (Leishmaniasis). Administered
topically.
Liposomal formulation of meglumine antimoniate for treatment of skin infections (Leishmaniasis).
Administered topically.
Biodegradable calcium phosphate (CaP), protein complex nanoparticles. Application as drug delivery
platform.
Biodegradable calcium phosphate (CaP), protein complex nanoparticles. Application as drug delivery
platform.
Biodegradable calcium phosphate (CaP), protein complex nanoparticles. Application as vaccine
adjuvant.

206

NCT01050777

Questionable

Liposomal Glucantime

Tehran University of Medical Sciences

Drug

Cutaneous Leishmaniasis

Glucantime

Liposome

400

Investigational

Phase 0

Topical

NA

207

NCT01050777, Schettini

Questionable

Liposomal Meglumine Antimoniate

Instituto de Ciencias Biologicas

Drug

Cutaneous Leishmaniasis

Meglumine Antimoniate

Liposome

400

Investigational

Phase 0

Topical

NA

In Vivo

208

Chu, BioSantePharma

Questionable

BioAir

Biosante Pharmaceuticals

Drug

Protein Adjuvant

Protein

Nanoparticle

70-1000

Investigational

Phase I

Inhalation

NA

In Vivo

209

Chu, BioSantePharma

Questionable

BioOral

Biosante Pharmaceuticals

Drug

Protein Adjuvant

Protein

Nanoparticle

70-1000

Investigational

Phase I

Oral

NA

In Vivo

210

Chu, BioSantePharma

Questionable

BioVant

Biosante Pharmaceuticals

Biological

Vaccine Adjuvant

Vaccine

Nanoparticle

70-1000

Investigational

Phase I

Intramuscular

NA

In Vivo

211

NCT00922363, Christensen

Questionable

CAF01

Statens Serum Institut

Biological

Tuberculosis

Vaccine

Liposome

450

Investigational

Phase I

Intramuscular

NA

In Vivo

Cationic liposomal adjuvant used for tuberculosis vaccine delivery. Intramuscular injection.

212

NCT00968604, Xie

Questionable

C-VISA BikDD

National Cancer Institute

Genetic

Pancreatic Cancer

BikDD

Liposome

405

Investigational

Phase I

Intravenous

VISA

In Vivo

C-VISA BikDD: liposome consists of a pancreatic-cancer-specific expression vector VISA (VP16GAL4-WPRE integrated systemic amplifier) and a pancreatic-cancer-specific promoter CCKAR
(cholecystokinin type A receptor) (CCKAR-VISA or C-VISA) which drives expression of the gene
BikDD. Intravenous injection for cancer treatment.

213

Bawa, NCT00059605, Ito

Questionable

INGN-401

Introgen Therapeutics, Inc.

Genetic

Lung Cancer

DOTAP:Chol-fus1

Liposome

375

Investigational

Phase I

Intravenous

Passive

In Vivo

Liposomal cholersterol FUS1 gene complex for treatment of lung cancer. Intravenous injection.
Experimental gene transfer. It is thought that the absence of the fus1 gene may be involved in the
development of lung cancer tumors.

214

NCT00024648, Rudin

Questionable

LE-rafAON

NeoPharm, Inc.

Drug

Neoplasms

LErafAON-ETU

Liposome

400

Investigational

Phase I

Intravenous

Passive

In Vivo

"Easy-to-use" liposomal formulation of an antisense oligonucleotide (AON) complementary to the craf mRNA sequence, which mediates tumor cell growth. This drug formulation utilizes the
Company's NeoPhectin(TM) transfection reagent which consists of a novel, positively charged,
synthetic cardiolipin (PCL-2). Intravenous injection.

215

NanoCyte

Questionable

NanoCyte

NanoCyte

216

NCT01073371, Saia Cereda

Questionable

PLCLUV

217

NCT00775138, Li

Questionable

Arikace

Transave

218

NCT00764361, Yu

Questionable

NanoDOX

219

NCT00400348

Questionable

220

NCT00157209, Elamanchili

Questionable

221

Capsulation, Roszek

Questionable

222

NCT00816829

Questionable

Phase I

Subcutaneous

NA

In Vivo

NanoCyte is leveraging a sophisticated natural injection system that evolved in sea life over the last
700 million years. The NanoCyte micro-injectors are harvested from sea-anemones, which are
cultivated in a closed, circulatory system at our facilities. The micro-injectors are composed of a
collagen-based capsule with an internal coiled microscopic nano-needle. Upon combination with the
active solution (drug or cosmeceutical), a high pressure of 150 atmospheres is developed within the
micro-injector, resulting in an unfolding of the long thin nano-needle out of the microcapsule at an
extremely high speed. During the penetration process, the active solution is pumped into, and
through the micro-injector, into the skin.

Investigational

Phase I

Interstitial

NA

In Vivo

Prilocaine-lidocaine cream liposomal unilaminar vesicle (PLCLUV). Interstitial injection.

Investigational

Phase I/II

Aerosol

NA

In Vivo

Sustained-release liposomal formulation of amikacin for treatment of lung infections. Dosage is


inhaled.

Investigational

Phase II

Topical

NA

In Vivo

1% doxycycline monohydrate hydrogel is a topical gel that is intended for direct contact with the
wound and is applied to the entire surface of the wound bed. A secondary dressing, such as gauze
or non-adhering dressing, is applied to cover. Anti-inflammatory to facilitate wound healing.

<2000

Investigational

Phase II

Oral

NA

In Vivo

Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.

Liposome

150-580

Investigational

Phase II/III

Intravenous

NA

In Vivo

Liposomal cancer vaccine designed to induce an immune response to cancer cells that express
MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many
cancers such as lung cancer, breast cancer, prostate cancer and colorectal cancer.

Investigational

Preclinical

Nanocrystal Dispersion

<2000

Terminated

Phase II

Oral

NA

Drug

Drug Delivery Platform

Lidocaine

Nanoneedle

Investigational

Drug

Dental Anesthesia

Prilocaine

Liposome

400

Drug

Cystic Fibrosis

Amikacin

Liposome

375

Nanotherapeutics, Inc.

Drug

Foot Ulcer, Diabetic

Doxycycline Monohydrate

Liposome

200-350

Panzem Nanocrystal Colloidal Dispersion


(NCD)

EntreMed

Drug

Solid Tumors

2-Methoxyestradiol

Nanocrystal Dispersion

Stimuvax

Oncothyreon

Biological

Solid Tumors

BLP25 Vaccine

Nanocapsules

Capsulation

Drug

Drug Delivery Platform

Fenobibrate Nanocrystal Colloidal


Dispersion (NCD)

Abbott Laboratories

Drug

Sleep Apnea

Fenofibrate

In Vivo
In Vivo

Capsule walls are generally comprised of 4 to 20 layers with a thickness of 8 - 50nm. Scaling would
suggest a total size on the order of microns.
Elan's NanoCrystal Technology drug formulation. Wet-milled to particle sizes <2000nm. Surfacecoated to prevent agglomeration.

Table SM.1. Potential nanomedicine therapeutic products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Therapeutic

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

FDA Application Number or


Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Hard / Soft
Nanoparticle

Description / Additional Details


Proprietary hydrogel polymer system, the vaginal insert is a sustained-release formulation of
dinoprostone, a synthetic prostaglandin E2 used when there is a medical need for cervical ripening,
i.e., preparing the cervix for labor.
Desonide hydrogel gel for the treatment of mild to moderate atopic dermatitis. Topically
administered.

223

NCT00308711

Unlikely

Cervidil/Propess

Cytokine PharmaSciences, Inc.

Drug

Pregnancy

Dinoprostone

Hydrogel

Approved

Mar-95

020411

Vaginal

NA

In Vivo

224

NCT00690833

Unlikely

Desonate

INTENDIS

Drug

Atopic Dermatitis

Desonide

Hydrogel

Approved

Oct-06

021844

Topical

NA

In Vivo

225

BioDelivery, Santangelo

Unlikely

Bioral

BioDelivery Sciences International, Inc.

Drug

Fungal Infections

Amphotericin B

Nanocochleate

Investigational

Phase I

Oral

NA

In Vivo

Bioral is a novel drug delivery system, based upon cochleate technology. Bioral encapsulates and
protects a drug without chemically bonding to it and may facilitate oral dosing of drugs that typically
need to be given by intravenous administration. Alternating layers of lipids spiral around a drug
molecule, encapsulating it and potentially protecting it from degradation by acid or digestive
enzymes in the stomach.

Investigational

Phase I

Implant

NA

In Vivo

No additional details are readily available.

Investigational

Phase I

Intravenous

NA

In Vivo

Liposomal muramyl tripeptide phosphatidyl ethanolamine (L-MTP-PE) for treatment of nonmetastatic osteosarcoma in children. Intravenous injection. Formerly known as known as Junovan.

407

226

NCT00981006

Unlikely

Implanted Hydrogel Drug Release

Japan National Cardiovascular Center

Biological

Congestive Heart Failure

bFGF

Hydrogel

227

NCT00631631, Jain

Unlikely

L-MTP-PE

Millennium Pharmaceuticals, Inc.

Drug

Osteosarcoma

L-MTP-PE

Liposome

228

Rainbow

Unlikely

Thymectacin

Newbiotics, Inc.

Drug

Colorectal Cancer

Brivudine Phosphoramidate

Polymeric Nanoparticle

Investigational

Phase I/II

Intravenous

NA

In Vivo

The particle appears to be microscale based on the descriptions.

229

NCT01051258

Unlikely

AeriSeal

Aeris Therapeutics

Biological

Pulmonary Emphysema

BLVR

Hydrogel

Investigational

Phase II

Aerosol

NA

In Vivo

Physician uses a bronchoscope to direct treatment to the most damaged areas of the patients
lungs. Using a catheter, the proprietary hydrogel sealant is administered to the small airways and
alveoli at the treatment site. The foam sealant is delivered as a liquid and polymerizes in situ to form
a soft, elastic, adhesive foam.

230

NCT01247818

Unlikely

PH-10

Provectus Pharmaceuticals

Drug

Plaque Psoriasis

Rose Bengal Disodium

Hydrogel

Investigational

Phase II

Topical

NA

In Vivo

Topical rose bengal disodium hyrdogel gel for the treatment of psoriasis and other skin conditions.

231

NCT00828711

Unlikely

Misodel / Misopess

Cytokine PharmaSciences, Inc.

Drug

Labor Induction

Misoprostol

Hydrogel

Investigational

Phase III

Vaginal

NA

In Vivo

232

NCT00481884

Unlikely

RadiaPlexRx

MPM Medical, Inc.

Other

Radiation Dermatitis

Sodium Hyaluronate

Hydrogel

Investigational

Phase III

Topical

NA

In Vivo

710

Uses the same vaginal delivery system as Cervidil/Propess, but with a different active ingredient:
misoprostol.
Sodium hyaluronate hydrogel gel for treatment of radiation reactions, pressure ulcers, minor burns,
cuts and abrasions.

Table SM.2. Potential nanomedicine device products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

FDA Application Number


or Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Soft / Hard
Nanoparticle

Active
Nanotechnology

Wagner, Wang, MR-TechIP,


Hayat

Confirmed

Feridex IV

Advanced Magnetics

Drug

In Vivo Imaging

SPIO

100-250

Approved

Aug-96

020416

Intravenous

Passive

In Vivo

Hard

Active

Wagner, Wang, MR-TechIP,


Hayat

Confirmed

Gastromark

Advanced Magnetics

Drug

In Vivo Imaging

SPIO

300

Approved

Dec-96

020410

Oral

Passive

In Vivo

Hard

Active

Wagner, Wang, MR-TechIP,


Hayat

Confirmed

Resovist

Schering

Drug

In Vivo Imaging

SPIO

60

Approved

Mar-01

Intravenous

Passive

In Vivo

Hard

Active

Wagner, Project, Wilson

Confirmed

CellTracks

Immunicon Corporation

Device

In Vitro Diagnostic

Nanoparticle

100

Approved

Nov-03

K030263

In Vitro

NA

In Vitro

Hard

Active

Wagner, Project

Confirmed

Vitoss

Orthovita

Device

Bone Substitute

Nanoscaffold

100

Approved

Dec-03

K032288

Implant

NA

In Vivo

Nanocrystal HA

NA

Project, Pagliaro

Confirmed

Neowater

Do-Coop Technologies Ltd.

Device

Drug Delivery Platform

Micelle

5-50

Approved

Feb-04

Drug Master File

In Vivo

Soft

NA

Project

Confirmed

TiMESH

GfE Medizintechnik GmbH

Device

Tissue Engineering

Nanocoating

30

Approved

Mar-04

K031225

Implant

NA

In Vivo

Nanostructured
Material

NA

Wagner, Spies

Confirmed

Ostim

Osartis

Device

Bone Substitute

Nanocomposite

20

Approved

Dec-04

K030052

Implant

NA

In Vivo

Nanocrystal HA

NA

Confirmed

Acticoat

Smith & Nephew, Inc.

Device

Medical Dressing

Nanosilver

15

Approved

Apr-05

K050030

Wound Care

NA

Ex Vivo

Hard

NA

Confirmed

Ceram X Duo

Dentspley

Device

Dental Composite

Nanocomposite

2-10

Approved

Aug-05

K052097

Dental

NA

In Vivo

Hard

NA

10

Wagner, Project, Hayman,


Trop, Lu
Wagner, CeramX

11

Hayman

Confirmed

ON-Q SilverSoaker

I-Flow Corporation

Device

Device Coating

Nanosilver

10

Approved

Dec-05

K051401

Surgical

NA

In Vivo

Hard

NA

12

Project, AcryMed

Confirmed

SilvaGard

AcryMed, Inc.

Device

Device Coating

Nanosilver

10

Approved

Dec-05

K051401

Implant

NA

In Vivo

Hard

NA

13

Wagner, Filtek, Schmid

Confirmed

Filtek

3M Company

Device

Dental Composite

Nanocomposite

5-75

Approved

Dec-08

K083610

Dental

NA

In Vivo

Hard

NA

14

Bao

Confirmed

Technetium Tc 99m Colloids

Multiple

Drug

In Vivo Imaging

Nanocolloid

<30 nm

Approved

Multiple

Multiple

Intravenous

Passive

In Vivo

Molecular

NA

15

NCT00291603, Helixone

Confirmed

Fresenius Polysulfone Helixone

NephroCare

Device

Dialysis Filter

Nanoporous Material

3.3

Approved

Phase IV

K970700

In Vitro

NA

In Vitro

Nanostructured
Material

NA

16

NCT01062204, St. John

Confirmed

Altrazeal Dressing (Nanoflex Technology)

ULURU, Inc.

Device

Medical Dressing

Hydrogel

28-78

Commercial

Jun-08

Wound Care

NA

Ex Vivo

Soft

NA

17

Debiotech, Roszek

Confirmed

Nanosilver Healthcare Textiles

JR Nanotech PLC

Device

Healthcare Textile

Nanosilver

25-250

Commercial

External

NA

Ex Vivo

Hard

NA

18

Luebbe

Confirmed

Magnetic Drug Targeting

Pharmacia

Device

Drug Delivery

Nanoparticle

100

Discontinued

Phase I

Intravenous

Magnetic

In Vivo

Hard

Active

19

Spies

Confirmed

Biobon

Merck Biomaterial GmbH

Device

Bone Substitute

Nanocomposite

20-50

Foreign Approval

Nov-98

Implant

NA

In Vivo

Nanocrystal HA

NA

20

Wang, MR-TechIP, Hayat

Confirmed

Endorem

Guebert

Drug

In Vivo Imaging

SPIO

80-150

Foreign Approval

<2000

Intravenous

Passive

In Vivo

Hard

Active

32

Rivera Gil

Confirmed

NanoTherm

MagForce Nanotechnologies AG

Device

Solid Tumors

SPIO

10-15

Foreign Approval

Feb-11

European Union

Interstitial

Passive

In Vivo

Hard

Active

21

Wagner, Rauschmanna

Confirmed

Perossal

aap impantate

Device

Bone Substitute

Nanocomposite

17

Foreign Approval

2003

European Union

Implant

NA

In Vivo

Nanocrystal HA

NA

22

NCT00337714, Guggenbichler

Confirmed

LogiCath AgTive

Smiths Medical International

Device

Device Coating

Nanosilver

10

Foreign Approval

2006

Phase IV

Surgical

NA

In Vivo

Hard

NA

23

PlasmaChem

Confirmed

BioDiamond Stents

Device Coating

Nanocoating

Foreign Approval

Implant

NA

In Vivo

Nanostructured
Material

NA

PlasmaChem

Device

European Union

Description / Additional Details


Superparamagnetic iron-oxide nanoparticles with dextran coating. Liverspecific contrast agent targeted through passive uptake. Prepared as
colloidal solution for intravenous injection.
Superparamagnetic iron-oxide nanoparticles with dextran coating. Bowelspecific contrast agent targeted through oral injestion and passage
through the gastrointestinal tract.
Superparamagnetic iron-oxide nanoparticles with dextran coating. Liverspecific contrast agent targeted through passive uptake. Prepared as
colloidal solution for intravenous injection.
Magnetic nanoparticles targeted to specific cell types with anitbodies.
Nanoparticles (and attached cells) are magnetically separated,
fluorescently marked, and imaged for detection.
Particles approximately 100 nm in size, making up highly porous, 3dimensional -TCP scaffolds with pores ranging from 1 to 1000 m in
size. Structure serves as implantable bone substitute.
Well-controlled micelles approved for drug-delivery applications. DoCoop has not yet partnered with anyone to produce an approved
pharmaceutic application.
Soft tissue reinforcement mesh implant. Excellent biocompatibility due
in part to a layer of titanium < 30 nm thick covalently bonded to the
surface.
Fully synthetic nanocrystalline hydroxyapatite paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Surgical dressing coated with silver nanocrystals, offering anti-microbial
and moisture control.
Nanoceramic dental composite.
Silver nanoparticle, anti-microbial coated catheter. First and only
approved device utilizing the SilvaGard brand nanoparticle coating.
Silver nanoparticle, anti-microbial coatings for medical devices. The IFlow Corporation ON-Q SilverSoaker intravenous catheter was approved
for use with SilvaGard in 2005, but no other devices have used the
SilvaGard coating.
Dental composite consisting of silica nanoparticles (75nm) with
zirconium nanoparticles (5-20nm).
Radioactive colloid used in scintillation scanning of the
reticuloendothelial system (RES). Intravenous injection collects
preferentially in liver, spleen, and bone marrow, for imaging. Has been a
standard imaging protocol for many years and kits are available from
many manufacturers.
Kidney dialysis system with specialized nanoporous membrane.
Helixone membrane is manufactured using a process involving Nano
Controlled Spinning (NCS) technology. It is possible to create the inner
membrane layer with a defined pore structure and pore distribution
profile according to the desired application.
Hydrogel powder is applied to an exuding wound by sprinkling the on
the open wound. The particles then hydrate and aggregate, becoming a
moist, flexible film over the surface of the open wound that provides an
ideal moist wound environment for healing.
Healthcare textiles embedded with nanosilver particles.
External magnetic fields were used to direct magnetic nanoparticles
conjugated to an anti-cancer drug, to the tumor site. It does not appear
the study progressed beyond Phase I, due to minimal increases in
efficacy.
Fully synthetic nanocomposite bone substitute paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Superparamagnetic iron-oxide nanoparticles with dextran coating. Liverspecific contrast agent targeted through passive uptake. Prepared as
colloidal solution for intravenous injection. Foreign brand of Feridex
(discontinued in US).
Magnetically heated iron-oxide nanoparticles for tumor ablation.
Colloidal solution is injected directly into the treatment site. Treatment
requires use of a special magnetic field applicator.
Combines the biodegradable nanocomposite, Ostim (listed above), with
delivery of antibiotics to the bone repair site.
Central venous catheter with silver nanoparticle, antimicrobial coating to
prevent infections.
Uniform coating of the inner and outer stainless steel surface with
Diamond-Like Carbon by a specially developed Plasma-Induced Cold
Deposition Technique. The coating is ultra-thin (50 nm), extremely
sturdy, smooth and flexible.
Cutting edge is coated with a pure diamond film which is sharpened with
a plasma sharpening process that can form an almost atomically sharp
cutting edge. Transmission electron microscopy investigations have
shown that with the radius of curvature at the cutting edge can be as
small as 3nm.

24

Roszek

Confirmed

Diamaze

Gesellschaft fr Diamantprodukte mbH


(GFD)

Device

Surgical

Nanostructured Surface

Foreign Approval

Surgical

NA

In Vivo

Nanostructured
Material

NA

25

Wang, MR-TechIP, Hayat

Confirmed

Lumirem

Guebert

Drug

In Vivo Imaging

SPIO

300

Foreign Approval

Oral

Passive

In Vivo

Hard

Active

Superparamagnetic iron-oxide nanoparticles with dextran coating. Bowelspecific contrast agent targeted through oral injestion and passage
through the gastrointestinal tract. Foregin brand of GastroMARK.

26

Bawa, Schwartz

Confirmed

AuroShell

Nanospectra Biosciences

Device

Solid Tumors

Nanoparticle

150

Investigational

Phase I

Intravenous

Passive

In Vivo

Hard

Active

Near infrared (NIR) laser excited gold nanoshells (with silica core) for
head and neck cancer tumor ablation. Systemic intravenous injection of
colloidal nanoparticle solution with passive, size-dependant targeting.
Once the nanoshells reach the tumor, they are excited (heated) with an
NIR laser. NIR radiation can penetrate tissue at shallow distances.

27

NCT00880802, Thaxton

Confirmed

nanoPSA

Nanosphere, Inc.

Device

In Vitro Diagnostic

Colloidal Gold

30

Investigational

Phase I

In Vitro

NA

In Vitro

Hard

NA

Colloidal gold nanoparticles used in in vitro testing.

28

NCT01206023, Peng

Confirmed

NA-NOSE

Israel Institute of Technology

Device

In Vitro Diagnostic

Nanostructured Surface

Investigational

Phase I

In Vitro

NA

In Vitro

Hard

NA

The discriminative power of a tailor-made Nanoscale Artificial Nose (NANOSE) based on an array of five gold nanoparticle sensors was tested.
The NA-NOSE signals were analysed to detect statistically significant
differences between sub-populations in clinical study.

29

Rivera Gil, Nanobiotix

Confirmed

nanoXRay

Nanobiotix

Device

Solid Tumors

Nanoparticle

70

Investigational

Phase I

In Vivo

Hard

Active

Nbtxr3 is a dense, biocompatible nanoparticle with an unknown coating,


designed to infiltrate only the targeted tumors cells. Once inside the
tumors cells, nbtxr3 nanoparticles have properties that convert
incoming, standard X-ray radiation into an efficient emission of electrons
responsible for the generation of free radicals.

Table SM.2. Potential nanomedicine device products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Identified Nanostructure

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

30

NCT00299598

Confirmed

Antibacterial Dental Composite

Hadassah Medical Organization

Device

Dental Composite

Nanoparticle

<100

Investigational

31

NCT01007240

Confirmed

Antibacterial Liner

Hadassah Medical Organization

Device

Healthcare Textile

Nanoparticle

<100

33

Wang, MR-TechIP, Hayat

Confirmed

Combidex (Ferumoxtran-10)

Advanced Magnetics

Drug

In Vivo Imaging

SPIO

34

NCT00659204, Rai

Confirmed

SilvaSorb (SilvaGard)

AcryMed, Inc.

Device

Creams and Gels

35

Wang, MR-TechIP, Hayat

Confirmed

Sinerem

Guebert

Drug

36

MR-TIP, Roszek, X. Zhang


(2001)

Confirmed

Supravist

Schering

Device

37

Blue Membrane

Confirmed

Blue Membrane Nano-Carbon Coatings

Blue Membranes GmbH

Device

Administration Route

In Vivo Targeting

In Vivo
Use

Soft / Hard
Nanoparticle

Active
Nanotechnology

Phase II

Dental

NA

In Vivo

Soft

NA

Antibacterial application of alkylated polyethylenimine nanoparticles


incorporated into flowable hybrid composite resin disks embedded in a
palatal removable appliance for dental restoration.

Investigational

Phase II

External

NA

Ex Vivo

Soft

NA

Anitbacterial application of crosslinked quaternary ammonium


polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a
commercial soft liner material.

20-40

Investigational

Phase III

Intravenous

Passive

In Vivo

Hard

Active

Nanosilver

2 to 20

Investigational

Phase III

External

NA

Ex Vivo

Hard

NA

In Vivo Imaging

SPIO

20-40

Investigational

Phase III

Intravenous

Passive

In Vivo

Hard

Active

In Vivo Imaging

SPIO

20

Investigational

Phase III

Intravenous

Passive

In Vivo

Hard

Active

In Vivo

Nanostructured
Material

NA

Device Coating

Nanoporous Material

38

Debiotech, Roszek

Confirmed

Debiostar

Debiotech SA

Device

Implantable Drug Delivery

Nanoporous Material

39

Kereos, Roszek, Schmieder

Confirmed

Ligand-Targeted Emulsion

Kereos, Inc.

Drug

In Vivo Imaging

Emulsion

40

Luna, Mraz, Roszek

Confirmed

TRIMETASPHERE

Luna Innovations, Inc.

Device

In Vivo Imaging

Fullerene

2.5+

50-80

270

0.8

Investigational

FDA Application Number


or Foreign Country

Preclinical

Implant

NA

Platypus

Confirmed

Implant

NA

In Vivo

Nanostructured
Material

NA

Investigational

Preclinical

Intravenous

Ligand

In Vivo

Soft

NA

Fibrin-targeted nanoparticles bound with gadolidium for enhanced MR


imaging contrast.

Investigational

Preclinical

Nanostructured Surface

55

Investigational

Quantum Dot

15-20

Research Use

Device

Qdot Nanocrystals

Invitrogen Corporation

Device

In Vitro Diagnostic

NA

In Vitro

NA

In Vitro

Nanostructured Material

NA

In Vitro

NA

In Vitro

Hard

Active

43

OceanNanotech

Confirmed

Affinity IOs

OceanNanotech, LLC.

Exempt

In Vitro Diagnostic

SPIO

10-30

Research Use

In Vitro

NA

In Vitro

Hard

NA

44
45

BBInternational
BBInternational

Confirmed
Confirmed

Bio-Conjugated Nanoparticles
Bio-Conjugated Nanoparticles

BBInternational
Nanoprobes, Inc.

Exempt
Exempt

In Vitro Diagnostic
In Vitro Diagnostic

Colloidal Gold
Colloidal Gold

2-250
1.8, 5, 10, 15

Research Use
Research Use

In Vitro
In Vitro

NA
NA

In Vitro
In Vitro

Hard
Hard

NA
NA

46

Miltenyi

Confirmed

FeraSpin

Exempt

In Vivo Imaging

SPIO

10-100

Research Use

In Vitro

NA

In Vitro

Hard

Active

Device

In Vitro Diagnostic

Nanoparticle

50-200

Research Use

In Vitro

NA

In Vitro

Hard

Active

Chemicell

Confirmed

fluidMAG-affinity

Nov-07

Hard

Project, Invitrogen, Qdot

Miltenyi Biotec
chemicell

Drug-eluting stent coatings.

Preclinical

In Vitro Diagnostic

Platypus Technologies

Silver nanoparticle antibacterial hand gel. Utilizes same silver


nanoparticle technology as SilvaGard medical device coatings.
Superparamagnetic iron-oxide nanoparticles with unknown coating. Can
assist in the differentiation of metastatic and non-metastatic lymph
nodes in patients with confirmed primary cancer. Foreign brand of
Combidex.
An ultrasmall superparamagnetic iron oxide under development as a
positive enhancing blood pool agent.

Investigational

42

47

Confirmed

Nano-Patterned Polyurethane Test Substrates

Superparamagnetic iron-oxide nanoparticles with unknown coating. Can


assist in the differentiation of metastatic and non-metastatic lymph
nodes in patients with confirmed primary cancer.

By use of a perfectly controlled nanoporous membrane, the drug can be


delivered from an implantable system over several weeks to several
months. The delivery profile can be tailored to specific pharmacokinetic
requirements by modification of the size as well as the thickness of the
membrane. Additional surface chemistry can be added to the membrane
in order to delay the delivery over a prolonged period of time.

In Vivo

41

Description / Additional Details

A class of novel fullerenes comprising 80 carbons (C80) forming a sphere


which encloses a complex of three metal atoms and one nitrogen atom.
Carbon nanomaterials have the potential for use in diagnostics as safe
imaging agents and in therapeutics targeting and treating diseases.
Polymeric substrates are optically transparent and possess an
anisotropic topography on tens of nanometer scales. The substrates are
also available with conformal coatings of gold. When combined with the
use of self-assembled monolayers formed from organosulfur
compounds, these gold-coated polymeric substrates offer control of the
chemical functionality and nanometer-scale topography of surfaces. This
characteristic makes these substrates potentially useful in investigating a
range of surface-dominated phenomena.
Cadmium/selenium/tellurium core with zinc-sulfide shell and polymer
coating. Quantum dots provide fluorescent excitation under specific
wavelengths of light. Biomolecular targeting options availabe for specific
cells types. Multiple product lines available. For in vitro testing
applicaitons only.
Iron oxide nanoparticles with antibody, protein, or streptavidin
conjugation.
Custom conjugation of colloidal gold nanoparticles.
Custom conjugation of colloidal gold nanoparticles.
FeraSpin R is a nanoparticulate superparamagnetic iron oxide contrast
agent specifically formulated for pre-clinical magnetic resonance
imaging (MRI). FeraSpin R accumulates particularly in the liver and
spleen and is degraded with its iron being transferred into the
physiological iron stores.
Bioaffine ligands are covalently bound to magnetic particles.
Available in sizes from 20nm to 4um. Molecular Probes FluoSpheres and
TransFluoSpheres beads are manufactured using high-quality, ultraclean
polystyrene microspheres. These imicrospheres are internally labeled
with Molecular Probes dyes, making them the brightest fluorescent
microspheres available . Used as injectable tracers.

48

Invitrogen

Confirmed

FluoSpheres

Invitrogen

Exempt

In Vitro Diagnostic

Nanoparticle

20

Research Use

In Vitro

NA

In Vitro

Hard

NA

49

Nanoco

Confirmed

Nanodots

Nanoco Group PLC

Device

In Vitro Diagnostic

Quantum Dot

< 10

Research Use

In Vitro

NA

In Vitro

Hard

Active

Quantum dots for research use.

50

Project, Crystalplex

Confirmed

TriLite Nanocrystals

Crystalplex Corporation

Device

In Vitro Diagnostic

Quantum Dot

5-10

Research Use

In Vitro

NA

In Vitro

Hard

Active

Cadmium/selenium/sulfur core with various options for surface


functionalization and coatings. Quantum dots provide fluorescent
excitation under specific wavelengths of light. No biomolecular
targeting. Multiple product lines. For in vitro testing applicaitons only.

51

Wang, MR-TechIP

Confirmed

Clariscan

Nycomed

Drug

In Vivo Imaging

SPIO

20

Terminated

Intravenous

Passive

In Vivo

Hard

Active

Superparamagnetic iron-oxide nanoparticles with unknown coating.


Passive targeting of liver and tumors. Development was discontinued for
unlisted reasons.

52

Roszek, Z. Zhang (2001)

Confirmed

Implant Coatings

Inframat Inc.

Device

Device Coating

Nanocoating

20-50

Unknown

Implant

NA

Unknown

Nanostructured
Material

NA

Inframat is a global leader in nano/superfine coatings using techniques


of thermal spray, solution plasma spray, and electrodeposition. Coating
types include wear resistance, anti-corrosion, anti-biofouling, and high
lubricity coatings in both ceramic and hardmetal composites.

53

Roszek, Sato

Confirmed

IonTite

Spire Biomedical Corporation

Device

Device Coating

Nanocoating

20

Unknown

Implant

NA

In Vivo

Nanocrystal CaP

NA

Calcium phosphate formulations, coatings are ideal for promoting


bone/implant interfacial bonding. These adherent coatings can be
applied to dental, joint replacement and fixation products made of
biomaterials such as Co-Cr, Ti, stainless steel and most metals.

54

Debiotech, Roszek

Confirmed

Nanocoating

Debiotech SA

Device

Device Coating

Nanocoating

100

Unknown

Implant

NA

In Vivo

Nanostructured
Material

NA

Nanocoatings are used in the fields of drug eluting stents (DES) and
orthopaedic Implants. This coating technology can produce ceramic
coatings with variable chemistries, controlled porosities, large specific
surface areas and high drug loading capacity.

55

Masse, Roszek

Confirmed

Spi-Argent

Spire Biomedical Corporation

Device

Device Coating

Nanosilver

50-150

Unknown

Implant

NA

In Vivo

Hard

NA

Spi-Argent is a nanocrystalline silver-based antimicrobial coating that


can be applied to polymeric, ceramic or metallic medical devices. This
minimally-leaching film reduces the potential for bacterial colonization
without the drawbacks of other antimicrobials and antibiotics.

56

NCT00971373, Wong

Likely

Vestex Textiles (NanoSphere)

Vestagen Technical Textiles, LLC


Schoeller Technologies

Exempt

Healthcare Textile

Nanostructured Surface

Approved

2000

External

NA

Ex Vivo

Nanostructured
Material

NA

57

Wagner, Nymox

Likely

NicAlert

Nymox

Device

In Vitro Diagnostic

Colloidal Gold

Approved

Oct-02

In Vitro

NA

In Vitro

Hard

NA

Phase III

K021688

Nanostructured impregnation involves a three-dimensional surface


structure with gel-forming additives which repel water and prevent dirt
particles from attaching themselves.
Colloidal gold bound to antibodies for specific protein detection. Urine
and saliva based assay. Detects cotinine, the principle metabolite of
nicotine.

Table SM.2. Potential nanomedicine device products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Identified Nanostructure

58

Roszek

Likely

Stratus CS

Dade Behring

Device

In Vitro Diagnostic

59

OsSatura, Roszek

Likely

OsSatura

Isotis Orthobiologics US

Device

60

Project

Likely

Zirconium Oxide

Altair Nanotechnologies, Inc.

61

Wagner, KerrDental

Likely

Premise

Sybron Dental Specialties

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

FDA Application Number


or Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Soft / Hard
Nanoparticle

Active
Nanotechnology

Dendrimer

Approved

Jan-03

K022976

In Vitro

NA

In Vitro

Soft

NA

Bone Substitute

Nanocomposite

Approved

May-03

K030131

Implant

NA

In Vivo

Nanocrystal HA

NA

Device

Dental Composite

Nanocomposite

Approved

Sep-03

Dental

NA

In Vivo

Hard

NA

Device

Dental Composite

Nanocomposite

Approved

Nov-03

Dental

NA

In Vivo

Hard

NA

K032921

62

Veridex

Likely

CellSearch Epithelial Cell Kit

Veridex, LLC (Johnson & Johnson)

Device

In Vitro Diagnostic

SPIO

Approved

Jun-04

K040898

In Vitro

NA

In Vitro

Hard

Active

63

Rivera Gil

Likely

NanOss

Angstrom Medica, Inc.

Device

Bone Substitute

Nanocomposite

Approved

Feb-05

K050025

Implant

NA

In Vivo

Nanocrystal HA

NA

64

Project, Greenberg

Likely

EnSeal Laparoscopic Vessel Fusion System

Ethicon Endo-Surgery, Inc.

Device

Device Coating

Nanoparticle Coating

Approved

Apr-05

K050671

Surgical

NA

In Vivo

Nanostructured Material

NA

65

Nano-Bond

Likely

Nano-Bond

Pentron Clinical Technologies, LLC

Device

Dental Composite

Nanocomposite

Approved

Implant

NA

In Vivo

Hard

NA

Aug-07

K071500

66

Dobson, Buxton

Likely

Verigene

67

BIOMET

Likely

NanoTite Implant

Nanosphere, Inc.

Device

In Vitro Diagnostic

Colloidal Gold

Approved

Sep-07

K070804

In Vitro

NA

In Vitro

Hard

NA

Device

Device Coating

Nanocomposite

Approved

Jan-08

K051461

Implant

NA

In Vivo

Nanocrystal CaP

NA

In Vitro Diagnostic

Nanoparticle

Approved

Mar-08

K073699

In Vitro

NA

In Vitro

Hard

NA

Biomet
68

Saladax

Likely

MyCare Assays

69

ETEX

Likely

70

ETEX

71

Saladax Biomedical

Device

Alpha-bsm

ETEX Corporation

Device

Bone Substitute

Nanocomposite

Approved

Nov-09

K091607

Implant

NA

In Vivo

Nanocrystal HA

NA

Likely

Beta-bsm

ETEX Corporation

Device

Bone Substitute

Nanocomposite

Approved

Nov-09

K091607

Implant

NA

In Vivo

Nanocrystal HA

NA

ETEX

Likely

EquivaBone

ETEX Corporation

Device

Bone Substitute

Nanocomposite

Approved

Nov-09

K091607

Implant

NA

In Vivo

Nanocrystal HA

NA

72

ETEX

Likely

Gamma-bsm

ETEX Corporation

Device

Bone Substitute

Nanocomposite

Approved

Nov-09

K091607

Implant

NA

In Vivo

Nanocrystal HA

NA

73

ETEX

Likely

CarriGen

ETEX Corporation

Device

Bone Substitute

Nanocomposite

Approved

Feb-10

K093447

Implant

NA

In Vivo

Nanocrystal HA

NA

74

Wagner

Likely

Mondial NanoPearls

Heraeus Kulzer

Device

Dental Composite

Nanocomposite

Approved

Dental

NA

In Vivo

Hard

NA

75

Roszek

Likely

Bioline 1RK91

Sandvik Materials Technology

Device

Surgical

Nanocomposite

Foreign Approval

Surgical

NA

In Vivo

Nanostructured
Material

NA

76

Hayman

Likely

Silverline

Spiegelberg KG

Device

Device Coating

Nanosilver

Foreign Approval

Surgical

NA

In Vivo

Hard

NA

77

Roszek

Likely

BrachySil

pSivida Ltd.

Device

Solid Tumors

Nanoporous Material

Investigational

Phase II

Interstitial

NA

In Vivo

Nanostructured
Material

NA

78

NCT00337714, Buxton

Likely

Corel-C Stent

Relysis Medicals

Device

Device Coating

Nanoparticle Coating

Investigational

Phase II

Implant

NA

In Vivo

Hard

NA

79

Roszek, Oncologic

Likely

Aspen Medisys, LLC (Formerly Targeted NanoTherapeuticsTM)

Triton BioSystems, Inc.

Device

Solid Tumors

SPIO

Investigational

Preclinical
In Vivo

Hard

Active

Description / Additional Details


The Stratus CS Analyzer for acute care diagnostics provides quantitative
cardiac assays for fast, cost-effective evaluation of patients presenting
with suspected myocardial ischemia. Utilizes dendrimer-linked
antibodies.
Ossatura is composed of approximately 80% hydroxyapatite (HA) and
20% -tricalcium phosphate (-T CP), similar to human bone in both
structure and chemical composition.
Nanoscale zirconium-oxide particles used in dental fillings. High strength
and good optical imaging qualities.
0.4 micron barium glass filler along with nanoparticles for enhanced
polishability and gloss. The addition of pre-polymerized filler particles
(PPF) gives physical properties equivalent to a hybrid.
The CellSearch Epithelial Cell Kit contains a ferrofluid-based capture
reagent and immunofluorescent staining reagents. The ferrofluid
reagent consists of nanoparticles with a magnetic core surrounded by a
polymeric layer coated with antibodies targeting the Epithelial Cell
Adhesion Molecule (EpCAM) antigen for capturing circulating tumor cells
(CTCs).
Nanocrystalline hydroxyapatite forming solution which is injected into a
bone voids or defects to provide filling. The fill resorbs and is replaced
with bone during the healing process.
Surgical tissue sealing instrument. The device employs an electrode with
nanometer-sized conductive particles embedded in a proprietary
temperature-sensitive polymer that maintains tissue temperature at
around 100C.
Unique, functional, nano-particle that strengthens the resin while it
infiltrates the etched surface and provides a strong interface.
Surface functionalized colloidal gold nanoparticles for detection of
nucleic acid and protein targets.
Nanometer-scale discrete crystalline deposition (DCD) of calcium
phosphate (CaP) creates a complex surface topography. This renders the
NanoTite implant a bone bonding surface by the interlocking of the
newly formed cement.
Tests that measure chemotherapy drug levels in blood using proprietary
monoclonal antibodies bound to nanoparticles.
Fully synthetic nanocrystalline hydroxyapatite paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Fully synthetic nanocrystalline hydroxyapatite paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Fully synthetic nanocrystalline hydroxyapatite paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Fully synthetic nanocrystalline hydroxyapatite paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Fully synthetic nanocrystalline hydroxyapatite paste which is injected
into a bone voids or defects. The fill resorbs and is replaced with bone
during the healing process.
Dental composite incorporating "nanopearls," but unable to locate more
specific information on the composite construction.
It is a stainless grade, UNS 46910, alloyed with Mo, Ti, Cu and Al which
form nano-size precipitates. It offers a combination of high tensile and
stiffnes and excellent ductility which cannot be found in any other
stainless steel.
Cranial drainage catheters with silver nanoparticle, antimicrobial
coating.
BrachySil, (32P-BioSilicon), is a novel brachytherapy product currently
in development for the treatment of solid tumors. BrachySil comprises
30 micron particles of highly pure BioSilicon encapsulating radioactive
phosphorous (32P) closely bonded within an internal silicon
microcrystalline structure.
Paclitaxel-eluting porous carbon-carbon nanoparticle coated,
nonpolymeric cobalt-chromium coronary stent.
Aduro Biosciences merged with Triton BioSystems and Aspen Medisys,
LLC., which has now spun off to pursue magnetic nanoparticle heating
applications.

80

Roszek

Likely

Gadomer-17

Schering

Device

In Vivo Imaging

Dendrimer

Investigational

Preclinical

Intravenous

Passive

In Vivo

Soft

NA

An intravascular macromolecular MRI contrast agent with positive


enhancement under development for MR angiography and tumor
differentiation. The synthetic dendrimer with large molecular weight
(17kD - limits agent to vascular space) is linked to Gadolinium. Stucture
is likely on the order of several nanometers.

81

Buxton, NanoScan

Likely

N1177

NanoScan Imaging, LLC.

Device

In Vivo Imaging

Nanoparticle

Investigational

Preclinical

Intravenous

Passive

In Vivo

Hard

NA

Emulsified suspension that is composed of crystalline iodinated particles


dispersed with surfactant, selectively accumulates in macrophage cells.

82

Biophan

Likely

Nanomagnetic Enhanced Drug Delivery

Biophan Technologies, Inc.

Device

Drug Delivery

Nanoparticle

Investigational

Preclinical

Intravenous

Magnetic

In Vivo

Hard

Active

Nanomagnetic carriers offer the possibility of improved drug efficacy


and reduced toxicity by delivering pharmaceuticals to the exact location
of need and releasing them at the appropriate time.

In Vivo

Nanostructured
Material

NA

83

Nanovis

Likely

Nanostructured Coatings

Device

Tissue Engineering

Nanocoating

84

DiagNano

Likely

NanoHC

85

Yang

Likely

86

Dobson

87

Wagner, Nymox

Investigational

Preclinical

Nanovis
DiagNano

Exempt

In Vitro Diagnostic

Alert Ticket

US Army Research Laboratory

Device

In Vitro Diagnostic

Likely

Sensation Technology

Nanomix, Inc.

Device

Likely

TobacAlert

Nymox

Exempt

Quantum Dot

Investigational

Research Use

In Vitro

NA

In Vitro

Hard

Active

Dendrimer

Investigational

In Vitro

NA

In Vitro

Soft

NA

In Vitro Diagnostic

Carbon Nanotube

Investigational

In Vitro

NA

In Vitro

Hard

NA

In Vitro Diagnostic

Colloidal Gold

Research Use

In Vitro

NA

In Vitro

Hard

NA

Sep-03

Implant

NA

Nanovis nanostructured biomaterials are designed to act as highly


effective tissue scaffolds with customizable resorption profiles and
capability for localized drug delivery. Currently developing
nanostructured biomaterials using novel nanostructured polymers and
nanoscale ceramics as well as novel self assembling helical rosette
nanotubes.
Quantum dots for research use.
Alert TicketTM (US Army Research Laboratory, Adelphi, MD) is an
anthrax-detection agent.
Carbon nanotubes with biomolecular targeted, chemical surface
treatments for electronic detection of biological molecules.
Colloidal gold bonded to antibodies for specific protein detection. Urine
and saliva based assay. Detects cotinine, the principle metabolite of
nicotine. Not approved for medical use.

Table SM.2. Potential nanomedicine device products.

ID

References

Nanomedicine
Relevance

Product Name or ID

Listed Company / Sponsor

FDA Classification

Condition / Application

Identified Nanostructure

88

Wagner, Nymox

Likely

AlzheimAlert

Nymox

Exempt

In Vitro Diagnostic

89

Wagner

Likely

AuroDye

GE Healthcare

Exempt

90

eBiosciences

Likely

eFluor Nanocrystals

91

Miltenyi

Likely

ExiTron

Nanoscale
Dimension (nm)

Status

Approval Date or
Phase

Colloidal Gold

Research Use

Jul-05

In Vitro Diagnostic

Colloidal Gold

Exempt

In Vitro Diagnostic

Exempt

FDA Application Number


or Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Soft / Hard
Nanoparticle

Active
Nanotechnology

In Vitro

NA

In Vitro

Hard

NA

Colloidal gold bound to antibodies for specific protein detection. Urine


based assay. Identifies neural thread protein (NTP), which is
overexpressed in patients with Alzheimer's disease.

Research Use

In Vitro

NA

In Vitro

Hard

NA

Colloidal gold reagent is a stabilized gold solution adjusted to a pH of


about 3. At this low pH, negatively charged gold particles bind very
selectively to proteins by hydrophobic and ionic interactions.

Quantum Dot

Research Use

In Vitro

NA

In Vitro

Hard

Active

In Vivo Imaging

Nanoparticle

Research Use

Intravenous

Passive

Animal

Hard

NA

Exempt

In Vitro Diagnostic

SPIO

Research Use

In Vitro

NA

In Vitro

Hard

Active

Exempt

In Vitro Diagnostic

Dendrimer

Research Use

In Vitro

NA

In Vitro

Soft

NA

Exempt

In Vitro Diagnostic

Dendrimer

In Vitro

NA

In Vitro

Soft

NA
NA

eBiosciences

Miltenyi Biotec
92

T2 Biosystems

Likely

NanoDX

93

EMD Chemicals

Likely

NanoJuice

94

Roszek

Likely

SuperFect

T2 Biosystems
EMD Chemicals Inc. (Dendritic
Nanotechnologies)
Qiagen

Research Use
95

ClinicalTrials.gov

Potential

ACUVUE

Johnson & Johnson

Device

Contact Lens

Hydrogel

Approved

Feb-00

K994324

Opthalmic

NA

In Vivo

Soft

96

ClinicalTrials.gov

Potential

Menicon Z

Menicon Co., Ltd.

Device

Contact Lens

Hydrogel

Approved

May-00

K000133

Opthalmic

NA

In Vivo

Soft

97

NCT01359046, CR Bard

Potential

Bardex IC Catheter

C. R. Bard, Inc.

Device

Device Coating

Hydrogel

Approved

Sep-02

K002612

Surgical

NA

Surgical

NA

98

Roszek, Deffenbaugh

Potential

Rheo Knee

Ossur

Device

External

NA

External

NA

Orthopedic

Nanoparticle

Approved

Jan-04

510k Exempt

100-1000

NA

99

ClinicalTrials.gov

Potential

PureVision

Bausch & Lomb

Device

Contact Lens

Hydrogel

Approved

May-05

K050948

Opthalmic

NA

In Vivo

Soft

NA

100

NCT00828412

Potential

EpiCeram Skin Barrier Emulsion

Promius Pharma, LLC

Device

Creams and Gels

Emulsion

Approved

Apr-06

K052643

Topical

NA

In Vivo

Soft

NA

101

Wagner

Potential

SYNOX

Biotronik

Device

Device Coating

Nanostructured Surface

Approved

Sep-08

K980869

Surgical

NA

Surgical

Jan-10

K093331

NA

102

NCT01188226

Potential

SR Phonares

Ivoclar Vivadent Inc.

Device

Dental Composite

Nanocomposite

Approved

Implant

NA

In Vivo

Hard

NA

103

ClinicalTrials.gov

Potential

ClearKone

SynergEyes, Inc.

Device

Contact Lens

Hydrogel

Approved

Opthalmic

NA

In Vivo

Soft

NA

104

ClinicalTrials.gov

Potential

OPTIX

Novartis Pharmaceuticals

Device

Contact Lens

Hydrogel

Approved

Opthalmic

NA

In Vivo

Soft

NA

105

ClinicalTrials.gov

Potential

VISA

Coopervision, Inc.

Device

Contact Lens

Hydrogel

Approved

Opthalmic

NA

In Vivo

Soft

NA

106

NCT00947726, CeraVe

Potential

CeraVe

CORIA Laboratories, Ltd.

Exempt

Creams and Gels

Emulsion

Commercial

Topical

NA

In Vivo

Soft

NA

107

Cinvention

Potential

cequence/celect/cimpact

Cinvention AG

Device

Device Coating

Nanocoating

Investigational

Preclinical

Implant

NA

In Vivo

Nanostructured
Material

NA

108

Roszek

Potential

NanoSpider Technology

HemCon Medical Technologies Inc.

Device

Wound Care

Nanofiber

Investigational

Preclinical

Wound Care

NA

External

109

Nanotope

Potential

Neural Tissue Regenerative Gel

Device

Tissue Engineering

Nanofiber

Investigational

Preclinical

Implant

NA

In Vivo

Biodegradable

NA

Preclinical

Implant

NA

In Vivo

Hard

NA

NA

Nanotope

Description / Additional Details

eFluor Nanocrystals are high quantum yield nanocrystals that possess a


core particle surrounded by a patented surface coating that reduces
background staining and artifacts.
Alkaline earth metal-based nanoparticulate contrast agent specifically
formulated for preclinical computed tomography (CT).
Nanoparticles composed of an iron oxide metal core covered with
dextran polymer. These are in turn functionalized with a detection
moiety, such as a an antibody recognizing a virus.
Priostar dendrimers along with a polycationic liposomal formulation.
Transfection reagent.
SuperFect Transfection Reagent is based on activated dendrimer
technology developed for DNA transfection into a broad range of cell
lines.
Soft contact lenses made from hydrogels. Unable to confirm the size of
hydrogels, but hydrogel structure could be nanoscale.
Soft contact lenses made from hydrogels. Unable to confirm the size of
hydrogels, but hydrogel structure could be nanoscale.
Unable to confirm size of hydrogel or nanoparticles, but "silver hydogel"
coating could be nanoscale.
Description provided by Roszek notes that use of 100-1000 nm iron
particles in magnetorheologic fluid that is used for damping in the
prosthetic joint. Unable to find description of nanoparticle fluid
elsewhere.
Soft contact lenses made from hydrogels. Unable to confirm the size of
hydrogels, but hydrogel structure could be nanoscale.
Emulsion-based skin cream for treatment of chronic skin conditions
characterized by dryness, itching, and inflammation.
"Fractal" nanostructured coating on electrodes provides improved
electrical performance. No information or structural dimensions
provided for fractal coating.
No additional details are readily available.
Soft contact lenses made from hydrogels. Unable to confirm the size of
hydrogels, but hydrogel structure could be nanoscale.
Soft contact lenses made from hydrogels. Unable to confirm the size of
hydrogels, but hydrogel structure could be nanoscale.
Soft contact lenses made from hydrogels. Unable to confirm the size of
hydrogels, but hydrogel structure could be nanoscale.
Emulsion-based skin cream for treatment of chronic skin conditions
characterized by dryness, itching, and inflammation.
Manufacturer website indicates "nano-structured" coatings, but no clear
references on details of nanoscale nature of coatings.
The NanoSpider technology allows multiple fibers to be created and
spun together in both simple or complex layering configurations for use
in medical products.
These nanofiber gels are capable of directing the rapid differentiation of
immature neuroprogenitor cells into neurons with significant neurite
outgrowth.
The core NMS technology is a silicon-based nanofabricated chip that
contains nanochannels which regulate and/or control the molecule-bymolecule release of a therapeutic agent stored within the implant.

110

NanoMedicalSystems

Potential

Personalized Molecular Drug-delivery System


(PMDS)

NanoMedical Systems

Device

Implantable Drug Delivery

Nanostructured Surface

Investigational

111

Dobson

Potential

BioDetect

Integrated Nano-Technologies

Device

In Vitro Diagnostic

Nanowire

Investigational

In Vitro

NA

In Vitro

NA

112

Chipman, Ambri, Prashar

Potential

Ion Channel Switch (ICS) Sensor

In Vitro Diagnostic

Nanomembrane

Investigational

In Vitro

NA

In Vitro

NA

Ambri

Device
Nanostructured Surface

Investigational

In Vitro

NA

In Vitro

NA

In Vivo

NA

Specific details on technology are not listed, but described as a sitespecific drug delivery system, which will allow for delivery of therapeutic
agents directly to specific cells within the body, such as tumors.

Nanoscale electrode wires are bridged by DNA segments, creating a


"DNA wire" for detection.
A self-assembling, synthetic, two molecular layer bio-membrane, the
ICS acts like a biological switch and is capable of detecting a range of
biological and chemical substances such as drugs, hormones, bacteria,
DNA, and ions, in any body fluid, including whole blood, urine, and
saliva. No approved applications.
Molecular surface modification for antimicrobial action, cell
attachement, drug-elution, immobilization, etc. No approved devices
utilizing technology are listed.

113

Hayman

Potential

Molecular Surface Modification Technologies

Chameleon Scientific

Device

Device Coating

114

Myshko

Potential

NanoSyringe

Integrated Nano-Technologies

Device

Drug Delivery Platform

115

Nanologix

Potential

BioNanoPore

Nanologix, Inc.

Exempt

In Vitro Diagnostic

Nanoporous Material

Research Use

In Vitro

NA

In Vitro

NA

Microbial detection system utilizing sandwiched-membrane petri dish


technology with nanoporous membrane for nutrient transfer.

116

Zuo

Potential

ViriChip

BioForce Nanosciences, Inc.

Exempt

In Vitro Diagnostic

Nanostructured Surface

Research Use

In Vitro

NA

In Vitro

NA

Nanopatterned array of biomolecular targets for biological detection


applications.

117

Wagner, Tetric EvoCeram

Questionable

Tetric EvoCeram

Ivoclar Vivadent

Device

Dental Composite

Nanocomposite

40-3000

Approved

Nov-04

K042819

Dental

NA

In Vivo

NA

Dental composite with filler particles ranging from nano to micro size.

118

Borg, Artimplant

Questionable

Artelon

Device

Tissue Engineering

Nanofiber

100+, 750

Approved

Sep-07

K071887

Implant

NA

In Vivo

NA

Electrospun scaffolds for tissue engineering. The diameter of the


electrospun fibers, studied by scanning electron microscopy, ranged
from 100 nm to a few lm, with an average diameter of 750 nm.

Device

In Vitro Diagnostic

NA

In Vitro

NA

In Vitro

NA

Oral

Passive

In Vivo

NA
In Vitro

NA
NA

NA
In Vitro

Wound Care
Wound Care
Wound Care
External

NA
NA
NA
NA

External
External
External
External

Investigational

Hard

Artimplant

119

Project

Questionable

Microarrays

CombiMatrix Corporation

120

Wang, MR-TechIP, Hayat

Questionable

Abdoscan

Nycomed

Drug

In Vivo Imaging

SPIO

121
122

Bawa,
Project, Dobson

Questionable
Questionable

Controlled Flow Cavitation Process


NanoChip Technology

Five Star Technologies


Nanogen Inc.

Device
Exempt

Manufacturing Process
In Vitro Diagnostic

NA
NA

123

NanoBiotech

Questionable

Novasome

IGI Laboratories, Inc.

Device

Drug Delivery Platform

Liposome

124
125
126
127

NCT00970697
NCT00971048
NCT00984022
NCT00562471

Unlikely
Unlikely
Unlikely
Unlikely

DuoDERM Hydrogel
Tegaderm
Aquacel
Adhibit

ConvaTec
3M Company
ConvaTec
Angiotech Pharmaceuticals

Device
Device
Device
Device

Medical Dressing
Medical Dressing
Medical Dressing
Creams and Gels

Hydrogel
Hydrogel
Hydrogel
Hydrogel

Approved

3500

Foreign Approval
Process
Research Use

500-700

2005
Jun-05

Unknown
Approved
Approved
Approved
Approved

In Vivo
Dec-97
Nov-04
Dec-09

K973689
K040890
K091034

Hard

NA
NA
NA

Soft

NA
NA
NA
NA
NA

Microarrays use a specially modified CMOS semiconductor to direct the


molecular assembly of a specific sequence of DNA bases in response to a
digital command. Each feature on the array (a microelectrode) is
digitally addressed to selectively generate acid, by means of an
electrochemical reaction.
Superparamagnetic iron-oxide nanoparticles with dextran coating. Bowelspecific contrast agent targeted through oral injestion and passage
through the gastrointestinal tract.
Uses a cavitation process to provide control at the "nanoscale."
Mirco-assay using DNA markers.
Novasome is a liposome adjuvant marketed for development of generic
drugs. No partnered applications are listed.
Hydrating hydrogel gel for wound care.
Transparent hydrogel wound dressing.
Hydrogel wound dressing.
Hydrogel based adhesion prevention gel.

Table SM.2. Potential nanomedicine device products.

ID

References

Nanomedicine
Relevance

Product Name or ID

128

NCT00234728

Unlikely

Hydrogel Patch

129

NCT01077765

Unlikely

Eutrophill

130

NCT01088685

Unlikely

Hydrogel Blister Patch

Johnson & Johnson

Listed Company / Sponsor

Nanoscale
Dimension (nm)

FDA Classification

Condition / Application

Identified Nanostructure

Status

Teikoku Pharma USA

Device

Medical Dressing

Hydrogel

Approved

Sanofi-Aventis US LLC

Device

Cosmetic

Hydrogel

Investigational

Device

Medical Dressing

Hydrogel

Investigational

Approval Date or
Phase

Phase III

FDA Application Number


or Foreign Country

Administration Route

In Vivo Targeting

In Vivo
Use

Soft / Hard
Nanoparticle

Active
Nanotechnology

Wound Care

NA

External

Subcutaneous

NA

In Vivo

Biodegradable

NA

NA

Wound Care

NA

In Vivo

Soft

NA

Description / Additional Details


Hydrogel occulative dressing.
Polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIVinfected patients.
Hydrogel blister dressing.

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NCT01007240. Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel
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NCT01039103. Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
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NCT01041235. Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid
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NCT01048008. Study of 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in
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NCT01066988. Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness
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NCT01067131. Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent
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NCT01088685. Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel
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