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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.
ID
References
Nanomedicine
Relevance
Product Name or ID
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
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
Confirmed
Doxil
OrthoBiotech
Drug
Kaposi Sarcoma
Doxurubicin
Liposome
87
Approved
Nov-95
050718
Intravenous
Passive
In Vivo
Soft
Confirmed
DaunoXome
Gilead Sciences
Drug
Kaposi Sarcoma
Daunorubicin Citrate
Liposome
45
Approved
Apr-96
050704
Intravenous
Passive
In Vivo
Soft
Confirmed
Amphotec
Drug
Aspergillosis
Amphotericn B
Lipid Nanoparticle
115
Approved
Nov-96
050729
Subcutaneous
NA
In Vivo
Soft
Confirmed
AmBisome
Gilead Sciences
Drug
Fungal Infections
Amphotericn B
Liposome
45-80
Approved
Aug-97
050740
Intravenous
Passive
In Vivo
Soft
Confirmed
Visudyne
QLT / Novartis
Drug
PDT Sensitizer
Verteporfin
Liposome
100
Approved
Apr-02
021119
Intravenous
Passive
In Vivo
Soft
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
11
NCT00769093, Li
Confirmed
Ferumoxytol
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
Drug
Palmitate Alprostadil
Emulsion
209
Foreign Approval
Nov-88
Japan
Intravenous
NA
In Vivo
Soft
13
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
Drug
Ovarian Cancer
Doxurubicin
Liposome
150
Foreign Approval
2000
European Union
Intravenous
Passive
In Vivo
Soft
16
NCT01003288, Fox
Confirmed
Pandemrix
GlaxoSmithKline Biologicals
Biological
Pandemrix
Emulsion
150-155
Foreign Approval
Sep-09
European Union
Intravenous
NA
In Vivo
Soft
17
NCT00364676, Talon
Confirmed
Alocrest
Drug
Solid Tumors
Vinorelbine
Liposome
100
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
18
NCT01041235, AzayaTherapeutics
Confirmed
ATI-1123
Drug
Solid Tumors
Docetaxel
Liposome
60-80
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
19
Confirmed
Atu027
Silence Therapeutics
Drug
Solid Tumors
siRNA
Liposome
120
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
20
NCT00765973, Talon
Confirmed
Brakiva
Drug
Solid Tumors
Topotecan
Liposome
100
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
21
Confirmed
CALAA-01
Calando Pharmaceuticals
Drug
Solid Tumors
siRNA
Polymeric Nanoparticle
50-80
Investigational
Phase I
Intravenous
Transferrin
In Vivo
Biodegradable
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
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
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
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
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
28
Confirmed
Lipotecan
Drug
Solid Tumors
Camptothecin
Liposome
180-200
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
29
NCT01052142, Herringson
Confirmed
Lipovaxin-MM
Biological
Melanoma
Vaccine
Liposome
240
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
30
Confirmed
MCC-465
Drug
Stomache Cancer
Doxorubicin
Liposome
143
Investigational
Phase I
Intravenous
GAH Antibody
In Vivo
Soft
31
NanoCarrier, Ino
Confirmed
NC-4016
Drug
Solid Tumors
Oxaliplatin
Micelle
50
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
32
Confirmed
PEV2
Biological
Chronic Hepatitis C
Vaccine
Virosome
100-200
Investigational
Phase I
Intravenous
NA
In Vivo
Soft
33
Pevion, Huckriede
Confirmed
PEV6
Biological
Breast Cancer
Vaccine
Virosome
100-200
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
34
Confirmed
PEV7
Biological
Vaccine
Virosome
100-200
Investigational
Phase I
Intravenous
NA
In Vivo
Soft
35
Confirmed
PK2
Drug
Liver Cancer
Doxorubicin
Polymeric Nanoparticle
8.4
Investigational
Phase I
Intravenous
Galactose
In Vivo
Biodegradable
36
NCT01191775, Sheikhnejad
Confirmed
PNT2258
Drug
Cancer
Oligonucleotide
Liposome
100
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
37
Confirmed
RVCLUV
Drug
Anesthetic
Ropivacaine
Liposome
130
Investigational
Phase I
Intravenous
NA
In Vivo
Soft
38
Confirmed
SN2310
OncoGenex
Drug
Solid Tumors
SN-38
Emulsion
<200
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
39
NCT00927459, Rossi
Confirmed
TKM-ApoB
Drug
Hypercholesterolemia
siRNA
Liposome
120
Investigational
Phase I
Intravenous
NA
In Vivo
Soft
40
NCT01519128, US Patent
20090176813
Confirmed
TMC278
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
Confirmed
CRLX101
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
Confirmed
MBP-426
Drug
Solid Tumors
Oxaliplatin
Liposome
180
Investigational
Phase I/II
Intravenous
Transferrin
In Vivo
Soft
ID
References
Nanomedicine
Relevance
Product Name or ID
FDA Classification
Condition / Application
Therapeutic
Identified Nanostructure
Nanoscale
Dimension (nm)
Status
Approval Date or
Phase
46
Confirmed
Nanoplatin
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
Confirmed
Aurimmune (CYT-6091)
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
Confirmed
55
NCT00646230, Okuda
56
57
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
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
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
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
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
Alendronate
Liposome
148-180
Investigational
Phase II
Intravenous
Passive
In Vivo
Soft
62
Confirmed
Liprostin
Endovasc, Inc.
Drug
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
Drug
Solid Tumors
Vincristine
Liposome
100
Investigational
Phase II
Intravenous
Passive
In Vivo
Soft
64
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
Drug
Colon Cancer
Vinorelbine
Liposome
95.2
Investigational
Phase II
Intravenous
Passive
In Vivo
Soft
67
Confirmed
NB-001
NanoBio Corporation
Drug
Herpes
Multiple Formulations
Emulsion
180
Investigational
Phase II
Topical
NA
In Vivo
Soft
68
Koizumi, Zamboni
Confirmed
NK012
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
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
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
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
Confirmed
PEV3
Biological
Falciparum Malaria
Vaccine
Virosome
100-200
Investigational
Phase II
Intravenous
NA
In Vivo
Soft
75
Confirmed
Pharmos NE Cream
Pharmos Corporation.
Drug
Osteoarthritis
Diclofenac
Emulsion
100-200
Investigational
Phase II
Topical
NA
In Vivo
Soft
76
Confirmed
PK1
University of Glasgow
Drug
Breast Cancer
Doxorubicin
Polymeric Nanoparticle
Investigational
Phase II
Intravenous
Passive
In Vivo
Biodegradable
77
Confirmed
ProLindac
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
FMP2.1/AS02A
Liposome
20
Investigational
Phase II
Intramuscular
NA
In Vivo
Soft
79
Confirmed
SP1049C
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
Drug
Bronchiolitis Obliterans
Cyclosporine
Liposome
40-50
Investigational
Phase II/III
Inhalation
NA
In Vivo
Soft
81
NCT00004083, Newman
Confirmed
SPI-77
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
85
Debbage, Shaffer
Confirmed
Opaxio
86
87
Dobrovolskaia
Confirmed
Auritol (CYT-21001)
Flamel
Confirmed
hGH
Flamel Technologies
Drug
Solid Tumors
Paclitaxel
Polymeric Nanoparticle
Biological
Solid Tumors
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
Other
Atherosclerosis
Radionuclides
Perfluorocarbon NP
200-300
Investigational
Preclinical
90
Pevion, Huckriede
Confirmed
PEV4
Biological
RSV
Vaccine
Virosome
100-200
Investigational
Preclinical
91
Canelas, Liquidia
Confirmed
Liquidia Technologies
Drug
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
In Vivo
Soft
In Vivo
Biodegradable
ID
References
Nanomedicine
Relevance
Product Name or ID
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
Confirmed
SapC-DOPS
Biological
Solid Tumors
Saposin C
Liposome
190
Investigational
Preclinical
Intravenous
Saposin C
In Vivo
Soft
93
Supratek
Confirmed
SP1060C-O
Drug
Solid Tumors
Topotecan
Micelle
10-100
Investigational
Preclinical
Oral
Passive
In Vivo
Soft
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.
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
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
Drug
Solid Tumors
Nystatin
Liposome
110-135
Terminated
Phase III
In Vivo
Soft
99
Likely
Adagen
Enzon
Drug
Immunodeficiency
Pegademase Bovine
Polymeric Nanoparticle
Approved
Mar-90
019818
Intramuscular
NA
In Vivo
Biodegradable
100
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
Denileukin Diftitox
Protein Nanoparticle
Approved
Feb-99
103767
Intravenous
IL-2 Protein
In Vivo
Soft
103
Likely
DepoCyt
SkyePharma
Drug
Lymphomatous Meningitis
Cytarabine
Liposome
Approved
Apr-99
021041
Intravenous
Passive
In Vivo
Soft
104
Wagner, Bawa
Likely
Renagel
Genzyme
Drug
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
Likely
Neulasta
Amgen
Drug
Fibrile Neutopenia
Pegfilgrastim
Polymeric Nanoparticle
Approved
Jan-02
125031
Subcutaneous
NA
In Vivo
Biodegradable
107
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
Cyclosporine
Emulsion
Approved
Oct-03
021023
Topical
NA
In Vivo
Soft
110
Likely
Macugen
Drug
Macular Degeneration
Pegaptanib Sodium
Polymeric Nanoparticle
Approved
Dec-04
021756
Intravenous
Passive
In Vivo
Biodegradable
111
TLC
Likely
Lipo-Dox
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
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
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
118
NCT00004806
Likely
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
121
122
NCT01556217
Likely
JNJ-39393406
123
Likely
124
Shah, NanoBio
125
Biological
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
Drug
Schizophrenia
Nanosuspension
Investigational
Phase I
Oral
NA
In Vivo
Soft
MAG-CPT
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
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
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
Likely
PICN
Drug
Solid Tumors
Paclitaxel
Nanosuspension
Investigational
Phase I
Intravenous
Passive
In Vivo
Soft
131
Copernicus
Likely
PLASmin
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.
ID
References
Nanomedicine
Relevance
Product Name or ID
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
132
Bawa
Likely
SGT-53
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
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
dHER2
Liposome
Investigational
Phase I/II
Intravenous
dHER2 Antibody
In Vivo
Soft
135
Alexis, Soepenberg
Likely
DE-310
Drug
Solid Tumors
Camptothecin
Polymeric Nanoparticle
Investigational
Phase I/II
Intravenous
Passive
In Vivo
Biodegradable
136
NCT00005969, Manconi
Likely
Atragen
Drug
Solid Tumors
Tretinoin
Liposome
Investigational
Phase II
Intravenous
Passive
In Vivo
Soft
137
Matsumura (2007)
Likely
CT-2106
Drug
Colorectal Cancer
Camptothecin
Polymeric Nanoparticle
Investigational
Phase II
Intravenous
Passive
In Vivo
Biodegradable
138
NCT00004104
Likely
IL-2 LIPO
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
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
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
Camptothecin
Polymeric Nanoparticle
Investigational
Phase II
Intravenous
Passive
In Vivo
Biodegradable
143
Alexis, Izzo
Likely
ADI-SS PEG
Drug
Arginine Deaminase
Polymeric Nanoparticle
Investigational
Phase III
Intravenous
Passive
In Vivo
Biodegradable
144
TLC
Likely
AmBiL
Drug
Fungal Infections
Amphotericin B
Liposome
Investigational
Phase III
Intravenous
Passive
In Vivo
Soft
145
NCT00175877
Likely
UCB, Inc.
Biological
Crohn's Disease
Monoclonal Antibody
Polymeric Nanoparticle
Investigational
Phase III
Subcutaneous
NA
In Vivo
Biodegradable
146
TLC
Likely
Doxisome
Drug
Solid Tumors
Doxorubicin
Liposome
Investigational
Phase III
ANDA
Intravenous
Passive
In Vivo
Soft
147
148
TLC
NCT00814515
Likely
Likely
ProFlow
Vekacia
Drug
Drug
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
Drug
Solid Tumors
Polymeric Nanoparticle
Investigational
Preclinical
Intravenous
Passive
In Vivo
Biodegradable
150
Sun Pharma
Likely
DICN
Drug
Solid Tumors
Docetaxel
Nanosuspension
Investigational
Preclinical
Intravenous
Passive
In Vivo
Soft
151
Mebiopharm
Likely
MBP-Y003
Drug
Lymphoma
Methotrexate
Liposome
Investigational
Preclinical
Intravenous
Transferrin
In Vivo
Soft
152
Mebiopharm
Likely
MBP-Y004
Drug
Solid Tumors
Docetaxel
Liposome
Investigational
Preclinical
Intravenous
Transferrin
In Vivo
Soft
153
Mebiopharm
Likely
MBP-Y005
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
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
Drug
Solid Tumors
Doxorubicin
Polymeric Nanoparticle
Terminated
Phase I
160
Zamboni
Likely
CNF1010
Biogen Idec
Drug
17-AAG
Emulsion
Terminated
Phase I
161
162
Alexis, Terwogt
Debbage, Satchi-Fainaro
Likely
Likely
PNU 166945
Caplostatin (TNP-470)
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
Drug
Solid Tumors
Methotrexate
Dendrimer
165
NCT00666328
Potential
Cleviprex
Drug
Cardiac Hypertension
Clevidipine Butyrate
166
Eurand
Potential
Mesulid Fast
Torrinomedica
Drug
Pain Relief
Nimesulide
167
Eurand
Potential
Biorise
Eurand
Drug
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
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
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
University of Virginia
Drug
Melanoma
Cancer Vaccine
Emulsion
Investigational
Phase I
Intravenous
Passive
In Vivo
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.
ID
References
Nanomedicine
Relevance
175
NCT00117429
Potential
176
NCT00001512
177
NCT00000847
178
Product Name or ID
FDA Classification
Condition / Application
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
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
Drug
188
Bawa
Questionable
Verelan
Elan Corporation
Drug
189
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
Questionable
Emend
196
Questionable
Estrasorb
Novavax
197
Questionable
TriCor
198
Bawa
Questionable
Focalin XR
199
Wagner, Bawa
Questionable
Triglide
SkyePharma
Drug
200
Questionable
Megace ES
Drug
201
Bawa, Chu
Questionable
Elestrin
Biosante Pharmaceuticals
Drug
Menopausal Symptoms
202
Wagner
Questionable
Invega Sustenna
Drug
Schizophrenia
Therapeutic
Identified Nanostructure
Nanoscale
Dimension (nm)
Status
Approval Date or
Phase
Administration Route
In Vivo Targeting
In Vivo
Use
Intramuscular
NA
In Vivo
Intravenous
Idiotype Determinants
In Vivo
Hard / Soft
Nanoparticle
Biological
HIV
gp120/NefTat/AS02A
Emulsion
Investigational
Phase I
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
Drug
Angina
Diltiazem HCl
NanoCrystal Dispersion
<2000
Foreign Approval
1974
Japan / Asia
Oral
NA
In Vivo
In Vivo
206
NCT01050777
Questionable
Liposomal Glucantime
Drug
Cutaneous Leishmaniasis
Glucantime
Liposome
400
Investigational
Phase 0
Topical
NA
207
NCT01050777, Schettini
Questionable
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
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
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
Questionable
INGN-401
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
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
Investigational
Phase I/II
Aerosol
NA
In Vivo
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
Lidocaine
Nanoneedle
Investigational
Drug
Dental Anesthesia
Prilocaine
Liposome
400
Drug
Cystic Fibrosis
Amikacin
Liposome
375
Nanotherapeutics, Inc.
Drug
Doxycycline Monohydrate
Liposome
200-350
EntreMed
Drug
Solid Tumors
2-Methoxyestradiol
Nanocrystal Dispersion
Stimuvax
Oncothyreon
Biological
Solid Tumors
BLP25 Vaccine
Nanocapsules
Capsulation
Drug
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.
ID
References
Nanomedicine
Relevance
Product Name or ID
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
223
NCT00308711
Unlikely
Cervidil/Propess
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
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
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
Biological
bFGF
Hydrogel
227
NCT00631631, Jain
Unlikely
L-MTP-PE
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
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
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
Drug
Labor Induction
Misoprostol
Hydrogel
Investigational
Phase III
Vaginal
NA
In Vivo
232
NCT00481884
Unlikely
RadiaPlexRx
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.
ID
References
Nanomedicine
Relevance
Product Name or ID
FDA Classification
Condition / Application
Identified Nanostructure
Nanoscale
Dimension (nm)
Status
Approval Date or
Phase
Administration Route
In Vivo Targeting
In Vivo
Use
Soft / Hard
Nanoparticle
Active
Nanotechnology
Confirmed
Feridex IV
Advanced Magnetics
Drug
In Vivo Imaging
SPIO
100-250
Approved
Aug-96
020416
Intravenous
Passive
In Vivo
Hard
Active
Confirmed
Gastromark
Advanced Magnetics
Drug
In Vivo Imaging
SPIO
300
Approved
Dec-96
020410
Oral
Passive
In Vivo
Hard
Active
Confirmed
Resovist
Schering
Drug
In Vivo Imaging
SPIO
60
Approved
Mar-01
Intravenous
Passive
In Vivo
Hard
Active
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
Device
Micelle
5-50
Approved
Feb-04
In Vivo
Soft
NA
Project
Confirmed
TiMESH
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
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
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
Confirmed
Filtek
3M Company
Device
Dental Composite
Nanocomposite
5-75
Approved
Dec-08
K083610
Dental
NA
In Vivo
Hard
NA
14
Bao
Confirmed
Multiple
Drug
In Vivo Imaging
Nanocolloid
<30 nm
Approved
Multiple
Multiple
Intravenous
Passive
In Vivo
Molecular
NA
15
NCT00291603, Helixone
Confirmed
NephroCare
Device
Dialysis Filter
Nanoporous Material
3.3
Approved
Phase IV
K970700
In Vitro
NA
In Vitro
Nanostructured
Material
NA
16
Confirmed
ULURU, Inc.
Device
Medical Dressing
Hydrogel
28-78
Commercial
Jun-08
Wound Care
NA
Ex Vivo
Soft
NA
17
Debiotech, Roszek
Confirmed
JR Nanotech PLC
Device
Healthcare Textile
Nanosilver
25-250
Commercial
External
NA
Ex Vivo
Hard
NA
18
Luebbe
Confirmed
Pharmacia
Device
Drug Delivery
Nanoparticle
100
Discontinued
Phase I
Intravenous
Magnetic
In Vivo
Hard
Active
19
Spies
Confirmed
Biobon
Device
Bone Substitute
Nanocomposite
20-50
Foreign Approval
Nov-98
Implant
NA
In Vivo
Nanocrystal HA
NA
20
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
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
24
Roszek
Confirmed
Diamaze
Device
Surgical
Nanostructured Surface
Foreign Approval
Surgical
NA
In Vivo
Nanostructured
Material
NA
25
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
28
NCT01206023, Peng
Confirmed
NA-NOSE
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
Confirmed
nanoXRay
Nanobiotix
Device
Solid Tumors
Nanoparticle
70
Investigational
Phase I
In Vivo
Hard
Active
ID
References
Nanomedicine
Relevance
Product Name or ID
FDA Classification
Condition / Application
Identified Nanostructure
Nanoscale
Dimension (nm)
Status
Approval Date or
Phase
30
NCT00299598
Confirmed
Device
Dental Composite
Nanoparticle
<100
Investigational
31
NCT01007240
Confirmed
Antibacterial Liner
Device
Healthcare Textile
Nanoparticle
<100
33
Confirmed
Combidex (Ferumoxtran-10)
Advanced Magnetics
Drug
In Vivo Imaging
SPIO
34
NCT00659204, Rai
Confirmed
SilvaSorb (SilvaGard)
AcryMed, Inc.
Device
35
Confirmed
Sinerem
Guebert
Drug
36
Confirmed
Supravist
Schering
Device
37
Blue Membrane
Confirmed
Device
Administration Route
In Vivo Targeting
In Vivo
Use
Soft / Hard
Nanoparticle
Active
Nanotechnology
Phase II
Dental
NA
In Vivo
Soft
NA
Investigational
Phase II
External
NA
Ex Vivo
Soft
NA
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
Nanoporous Material
39
Confirmed
Ligand-Targeted Emulsion
Kereos, Inc.
Drug
In Vivo Imaging
Emulsion
40
Confirmed
TRIMETASPHERE
Device
In Vivo Imaging
Fullerene
2.5+
50-80
270
0.8
Investigational
Preclinical
Implant
NA
Platypus
Confirmed
Implant
NA
In Vivo
Nanostructured
Material
NA
Investigational
Preclinical
Intravenous
Ligand
In Vivo
Soft
NA
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
Miltenyi Biotec
chemicell
Preclinical
In Vitro Diagnostic
Platypus Technologies
Investigational
42
47
Confirmed
In Vivo
41
48
Invitrogen
Confirmed
FluoSpheres
Invitrogen
Exempt
In Vitro Diagnostic
Nanoparticle
20
Research Use
In Vitro
NA
In Vitro
Hard
NA
49
Nanoco
Confirmed
Nanodots
Device
In Vitro Diagnostic
Quantum Dot
< 10
Research Use
In Vitro
NA
In Vitro
Hard
Active
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
51
Wang, MR-TechIP
Confirmed
Clariscan
Nycomed
Drug
In Vivo Imaging
SPIO
20
Terminated
Intravenous
Passive
In Vivo
Hard
Active
52
Confirmed
Implant Coatings
Inframat Inc.
Device
Device Coating
Nanocoating
20-50
Unknown
Implant
NA
Unknown
Nanostructured
Material
NA
53
Roszek, Sato
Confirmed
IonTite
Device
Device Coating
Nanocoating
20
Unknown
Implant
NA
In Vivo
Nanocrystal CaP
NA
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
Device
Device Coating
Nanosilver
50-150
Unknown
Implant
NA
In Vivo
Hard
NA
56
NCT00971373, Wong
Likely
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
ID
References
Nanomedicine
Relevance
Product Name or ID
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
61
Wagner, KerrDental
Likely
Premise
Nanoscale
Dimension (nm)
Status
Approval Date or
Phase
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
Device
In Vitro Diagnostic
SPIO
Approved
Jun-04
K040898
In Vitro
NA
In Vitro
Hard
Active
63
Rivera Gil
Likely
NanOss
Device
Bone Substitute
Nanocomposite
Approved
Feb-05
K050025
Implant
NA
In Vivo
Nanocrystal HA
NA
64
Project, Greenberg
Likely
Device
Device Coating
Nanoparticle Coating
Approved
Apr-05
K050671
Surgical
NA
In Vivo
Nanostructured Material
NA
65
Nano-Bond
Likely
Nano-Bond
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
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
Device
Solid Tumors
SPIO
Investigational
Preclinical
In Vivo
Hard
Active
80
Roszek
Likely
Gadomer-17
Schering
Device
In Vivo Imaging
Dendrimer
Investigational
Preclinical
Intravenous
Passive
In Vivo
Soft
NA
81
Buxton, NanoScan
Likely
N1177
Device
In Vivo Imaging
Nanoparticle
Investigational
Preclinical
Intravenous
Passive
In Vivo
Hard
NA
82
Biophan
Likely
Device
Drug Delivery
Nanoparticle
Investigational
Preclinical
Intravenous
Magnetic
In Vivo
Hard
Active
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
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
ID
References
Nanomedicine
Relevance
Product Name or ID
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
Administration Route
In Vivo Targeting
In Vivo
Use
Soft / Hard
Nanoparticle
Active
Nanotechnology
In Vitro
NA
In Vitro
Hard
NA
Research Use
In Vitro
NA
In Vitro
Hard
NA
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
Device
Contact Lens
Hydrogel
Approved
Feb-00
K994324
Opthalmic
NA
In Vivo
Soft
96
ClinicalTrials.gov
Potential
Menicon Z
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
Device
Contact Lens
Hydrogel
Approved
May-05
K050948
Opthalmic
NA
In Vivo
Soft
NA
100
NCT00828412
Potential
Device
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
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
Exempt
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
Device
Wound Care
Nanofiber
Investigational
Preclinical
Wound Care
NA
External
109
Nanotope
Potential
Device
Tissue Engineering
Nanofiber
Investigational
Preclinical
Implant
NA
In Vivo
Biodegradable
NA
Preclinical
Implant
NA
In Vivo
Hard
NA
NA
Nanotope
110
NanoMedicalSystems
Potential
NanoMedical Systems
Device
Nanostructured Surface
Investigational
111
Dobson
Potential
BioDetect
Integrated Nano-Technologies
Device
In Vitro Diagnostic
Nanowire
Investigational
In Vitro
NA
In Vitro
NA
112
Potential
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.
113
Hayman
Potential
Chameleon Scientific
Device
Device Coating
114
Myshko
Potential
NanoSyringe
Integrated Nano-Technologies
Device
115
Nanologix
Potential
BioNanoPore
Nanologix, Inc.
Exempt
In Vitro Diagnostic
Nanoporous Material
Research Use
In Vitro
NA
In Vitro
NA
116
Zuo
Potential
ViriChip
Exempt
In Vitro Diagnostic
Nanostructured Surface
Research Use
In Vitro
NA
In Vitro
NA
117
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
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
Questionable
Abdoscan
Nycomed
Drug
In Vivo Imaging
SPIO
121
122
Bawa,
Project, Dobson
Questionable
Questionable
Device
Exempt
Manufacturing Process
In Vitro Diagnostic
NA
NA
123
NanoBiotech
Questionable
Novasome
Device
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
ID
References
Nanomedicine
Relevance
Product Name or ID
128
NCT00234728
Unlikely
Hydrogel Patch
129
NCT01077765
Unlikely
Eutrophill
130
NCT01088685
Unlikely
Nanoscale
Dimension (nm)
FDA Classification
Condition / Application
Identified Nanostructure
Status
Device
Medical Dressing
Hydrogel
Approved
Sanofi-Aventis US LLC
Device
Cosmetic
Hydrogel
Investigational
Device
Medical Dressing
Hydrogel
Investigational
Approval Date or
Phase
Phase III
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
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