Nanomedicine and Clinical Research List

CD Bioparticles, a leading provider of nanoparticle-based drug development services, has compiled a relatively complete list of FDA and EMA-approved nano-drugs for use as reference in new drug development. The list includes the most recent approvals and covers a wide range of therapeutic areas, from cancer to infectious diseases. By providing this valuable resource, CD Bioparticles aims to facilitate the development of new and innovative nano-drugs that can meet the needs of patients and healthcare providers worldwide.

Clinical Trials Nanomedicine Approved

Name	Material description	Nanoparticle advantage	Indication(s)	Year approved	Type
List of FDA‑approved nanotechnology‑based products and clinical trials
Adagen^®/pegademase bovine (Sigma‑Tau Pharmaceuticals)	PEGylated adenosine deaminase enzyme	Improve circulation time and decreased immuno‑ genicity	Severe combined immunodefi‑ ciency disease (SCID)	1990	Polymer nanoparticles
Cimzia^®/certolizumab pegol (UCB)	PEGylated antibody fragment (Certoli‑ zumab)	Improved circulation time and greater stability in vivo	Crohn’s disease; Rheumatoid arthritis; Psoriatic Arthritis; Ankylosing Spondylitis	2008	Polymer nanoparticles
				2009	Polymer nanoparticles
				2013	Polymer nanoparticles
				2013	Polymer nanoparticles
Copaxone^®/Glatopa (Teva)	Random copolymer of l‑glutamate, l	Large amino‑acid based polymer with controlled molecular weight and clearance characteristics	Multiple sclerosis (MS)	1996	Polymer nanoparticles
Copaxone^®/Glatopa (Teva)	alanine, l‑lysine and l‑tyrosine		Multiple sclerosis (MS)	1996	Polymer nanoparticles
Eligard^® (Tolmar)	Leuprolide acetate and polymer (PLGH (poly (dl‑lactide‑coglycolide))	Controlled delivery of payload with longer circula‑ tion time	Prostate cancer	2002	Polymer nanoparticles
Macugen^®/Pegaptanib (Bausch & Lomb)	PEGylated anti‑VEGF aptamer (vascular endothelial growth factor) aptamer	Improved stability of aptamer as a result of PEGylation	Macular degeneration, neovascular age‑related	2004	Polymer nanoparticles
Mircera^®/Methoxy polyethylene glycol‑ epoetin beta (Hoffman‑La Roche)	Chemically synthesized ESA (erythropoiesis‑ stimulating agent)	Improved stability of aptamer as a result of PEGylation	Anemia associated with chronic kidney disease	2007	Polymer nanoparticles
Neulasta^®/pegfilgrastim (Amgen)	PEGylated GCSF protein	Improved stability of protein through PEGylation	Neutropenia, chemotherapy induced	2002	Polymer nanoparticles
Pegasys^® (Genentech)	PEGylated IFN alpha‑2a protein	Improved stability of protein through PEGylation	Hepatitis B; Hepatitis C	2002	Polymer nanoparticles
PegIntron^® (Merck)	PEGylated IFN alpha‑2a protein	Improved stability of protein through PEGylation	Hepatitis C	2001	Polymer nanoparticles
Renagel^®[sevelamer hydrochloride]/Renagel^®[sevelamer carbonate] (Sanofi)	Poly(allylamine hydrochloride)	Increase circulation and therapeutic delivery	Chronic kidney disease	2000	Polymer nanoparticles
Somavert^®/pegvisomant (Pfizer)	PEGylated HGH receptor antagonist	Improved stability of protein through PEGylation	Acromegaly	2003	Polymer nanoparticles
Oncaspar^®/pegaspargase (Enzon pharma‑ ceuticals)	Polymer–protein conjugate (PEGylated l‑asparaginase)	Improved stability of protein through PEGylation	Acute lymphoblastic leukemia	1994	Polymer nanoparticles
Krystexxa^®/pegloticase (Horizon)	Polymer–protein conjugate (PEGylated porcine‑like uricase)	Improved stability of protein through PEGylation; introduction of unique mammalian protein	Chronic gout	2010	Polymer nanoparticles
Plegridy^® (Biogen)	Polymer–protein conjugate (PEGylated IFN beta‑1a)	Improved stability of protein through PEGylation	Multiple Sclerosis	2014	Polymer nanoparticles
ADYNOVATE (Baxalta)	Polymer–protein conjugate (PEGylated factor VIII)	Improved stability of protein through PEGylation	Hemophilia	2015	Polymer nanoparticles
Zilretta	Triamcinolone acetonide with a poly lactic‑co‑glycolic acid (PLGA) matrix microspheres	Extended pain relief over 12 weeks	Osteoarthritis (OA) of the knee	2017	Polymer nanoparticles
Rebinyn	Coagulation fator IX (Recombinant) Glyco‑ PEGylated	Effective control in 95% of bleeding episodes; 98% of bleeds were treated with 1–2 infusions	Control and prevention of bleeding episodes and prevention of bleed‑ ing in the perioperative setting for haemophilia B patients	2017	Polymer nanoparticles
DaunoXome^® (Galen)	Liposomal daunorubicin	Increased delivery to tumour site; lower systemic toxicity arising from side‑effects	Karposi’s sarcoma	1995	Liposome
DepoCyt© (Sigma‑Tau)	Liposomal cytarabine	Increased delivery to tumour site; lower systemic toxicity arising from side‑effects	Lymphomatous meningitis	1996	Liposome
Marqibo^® (Onco TCS)	Liposomal vincristine	Increased delivery to tumour site; lower systemic toxicity arising from side‑effects	Acute lymphoblastic leukemia	2012	Liposome
Onivyde^® (Merrimack)	Liposomal irinotecan	Increased delivery to tumour site; lower systemic toxicity arising from side‑effects	Pancreatic cancer	2015	Liposome
AmBisome^® (Gilead Sciences)	Liposomal amphotericin B	Reduced nephrotoxicity	Fungal/protozoal infections	1997	Liposome
DepoDur^® (Pacira Pharmaceuticals)	Liposomal morphine sulphate	Extended release	Analgesia (post‑operative)	2004	Liposome
Visudyne^® (Bausch and Lomb)	Liposomal verteporfin	Increased delivery to site of diseased vessels; photosensitive release	Macular degeneration, wet agerelated; myopia; ocular histoplasmosis	2000	Liposome
Doxil^®/Caelyx™ (Janssen)	Liposomal doxorubicin	Improved delivery to site of disease; decrease in systemic toxicity of free drug	Karposi’s sarcoma;	1995	Liposome
			Ovarian cancer;	2005	Liposome
			multiple myeloma	2008	Liposome
Abelcet^® (Sigma-tau)	Liposomal amphotericin B lipid complex	Reduced toxicity	Fungal infections	1995	Liposome
Curosurf^®/Poractant alpha (Chiesei farmaceutic				1999	Liposome
Curosurf^®/Poractant alpha (Chiesei farmaceutic				2017	Liposome
Estrasorb™ (Novavax)	Micellar estradiol	Controlled delivery of therapeutic	Menopausal therapy	2003	Micellar nanoparticles
Abraxane^®/ABI-007 (Celgene)	Albumin-bound paclitaxel nanoparticles	Improved solubility; improved delivery to tumor	Breast cancer;	2005	Protein nanoparticles
			NSCLC;	2012	Protein nanoparticles
			Pancreatic cancer	2013	Protein nanoparticles
Ontak^® (Eisai Inc)	Engineered protein combining IL-2 and diphtheria toxin	Targeted T cell specificity; lysosomal escape	Cutaneous T-cell lymphoma	1999	Protein nanoparticles
Emend^® (Merck)	Aprepitant	Surface area allows faster absorption and increases bioavailability	Antiemetic	2003	Nanocrystals
Tricor^® (Lupin Atlantis)	Fenofibrate	Increases bioavailability simplifies administration	Hyperlipidemia	2004	Nanocrystals
Rapamune^® (Wyeth Pharmaceuticals)	Sirolimus	Increased bioavailability	Immunosuppressant	2000	Nanocrystals
Megace ES ^® (Par Pharmaceuticals)	Megestrol acetate	Reduced dosing	Anti-anorexic	2001	Nanocrystals
Avinza^® (Pfizer)	Morphine sulphate	Increased drug loading and bioavailability; extended release	Psychostimulant	2002 (2015)	Nanocrystals
Focalin XR ^® (Novartis)	Dexmethylphenidate HCl	Increased drug loading and bioavailability	Psychostimulant	2005	Nanocrystals
Ritalin LA ^® (Novartis)	Methylphenidate HCl	Increased drug loading and bioavailability	Psychostimulant	2002	Nanocrystals
Zanaflex^® (Acorda)	Tizanidine HCl	Increased drug loading and bioavailability	Muscle relaxant	2002	Nanocrystals
Vitoss^® (Stryker)	Calcium phosphate	Mimics bone structure allowing cell adhesion and growth	Bone substitute	2003	Nanocrystals
Ostim^® (Heraseus Kulzer)	Hydroxyapatite	Mimics bone structure allowing cell adhesion and growth	Bone substitute	2004	Nanocrystals
OsSatura^® (IsoTis Orthobiologics)	Hydroxyapatite	Mimics bone structure allowing cell adhesion and growth	Bone substitute	2003	Nanocrystals
NanOss^® (Rti surgical)	Hydroxyapatite	Mimics bone structure allowing cell adhesion and growth	Bone substitute	2005	Nanocrystals
EquivaBone^® (Zimmer Biomet)	Hydroxyapatite	Mimics bone structure	Bone substitute	2009	Nanocrystals
Invega^® Sustenna ^® (Janssen Pharms)	Paliperidone palmitate	Allows slow release of injectable low solubility drug	Schizophrenia;	2009	Nanocrystals
Invega^® Sustenna ^® (Janssen Pharms)	Paliperidone palmitate	Allows slow release of injectable low solubility drug	Schizoaffective disorder	2014	Nanocrystals
Ryanodex^® (Eagle Pharmaceuticals)	Dantrolene sodium	Faster administration at higher doses	Malignant hypothermia	2014	Nanocrystals
Inorganic and metallic nanoparticles Nanotherm ^® (MagForce)	Iron oxide	Allows cell uptake and introduces superparamagnetism	Glioblastoma	2010	Nanocrystals
Feraheme™/ferumoxytol (AMAG pharmaceuticals)	Ferumoxytol SPION with polyglucose sorbitol carboxymethylether	Magnetite suspension allows for prolonged steady release, decreasing number of doses	Deficiency anemia iron deficiency in chronic kidney disease (CKD)	2009	Nanocrystals
Venofer^® (Luitpold pharmaceuticals)	Iron sucrose	Allows increased dose	Iron deficiency in chronic kidney disease (CKD)	2000	Nanocrystals
Ferrlecit^® (Sanofi Avertis)	Sodium ferric gluconate	Allows increased dose	Iron deficiency in chronic kidney disease (CKD)	1999	Nanocrystals
INFeD^® (Sanofi Avertis)	Iron dextran (low MW)	Allows increased dose	Iron deficiency in chronic kidney disease (CKD)	1957	Nanocrystals
DexIron^®/Dexferrum^® (Sanofi Avertis)	Iron dextran (low MW)	Allows increased dose	Iron deficiency in chronic kidney disease (CKD)	1957	Nanocrystals
Feridex^®/Endorem^® (AMAG pharmaceuticals)	SPION coated with dextran	Superparamagnetic character	Imaging agent	1996 (2008)	Nanocrystals
GastroMARK™; umirem^® (AMAG pharmaceuticals)	SPION coated with silicone	Superparamagnetic character	Imaging agent	2001 (2009)	Nanocrystals

Name	Status	Active Ingredients	Indication(s)	Outcome	Type
Selected nanomedicines that are in phase III clinical trials
ThermoDox(Celsion)	completed	doxorubicin	hepatocellular carcinoma	Positive: ThermoDox increased intratumoral concentration of doxorubicin under external hyperthermia induction by 3.7 times compared with ThermoDox without hyperthermia induction	Lipid-based Nanoparticles
EndoTAG-1(SynCore Biotechnology)	ongoing	paclitaxel	breast cancer	-	Lipid-based Nanoparticles
EndoTAG-1(SynCore Biotechnology)	ongoing	paclitaxel	pancreatic adenocarcinoma	-	Lipid-based Nanoparticles
Tecemotide(Merk KGaA)	completed	MUC1 antigen	non-small-cell lung cancer	-	Lipid-based Nanoparticles
Allovectin-7^®(Vical)	completed	VCL-1005 plasmid	melanoma	Nothing has been mentioned	Lipid-based Nanoparticles
MAGE-A3 + AS15(GSK)	terminated	human melanoma-associated antigen A3 protein	melanoma	Negative: MAGE-A3 immunotherapeutic for use in melanoma has been stopped, as it was not efficacious	Lipid-based Nanoparticles
MAGE-A3 + AS15(GSK)	terminated	human melanoma-associated antigen A3 protein	non-small-cell lung cancer	Negative: MAGE-A3 immunotherapeutic for use in NSCLC has been stopped because it did not increase disease-free survival compared with placebo	Lipid-based Nanoparticles
MM-302(Merricmack Pharmaceutical)	terminated	doxorubicinhydrochloride	breast cancer	Negative: MM-302 did not demonstrate benefits over the control	Lipid-based Nanoparticles
Taxoprexin(Luitpold Pharmaceuticals)	completed	paclitaxel	melanoma	Nothing has been mentioned	Lipid-based Nanoparticles
Taxoprexin(Luitpold Pharmaceuticals)	completed	paclitaxel	non-small-cell lung cancer	Nothing has been mentioned	Lipid-based Nanoparticles
Nanocort(Enceladus in collaboration with Sun Pharma Global)	terminated	prednisolone	rheumatoid arthritis	Nothing has been mentioned	Lipid-based Nanoparticles
Nanoplatin(NanoCarrier)	completed	cisplatin	advanced solid tumors, lung, biliary, bladder, or pancreatic cancers	Nothing has been mentioned	Polymer-based Nanoparticles
CRLX101(Cerulean)	completed	Cyclodextrin-Camptothecin	ovarian, renal cell, small cell lung, or rectal cancers	Nothing has been mentioned	Polymer-based Nanoparticles
NC-6004(NanoCarrier)	completed	cisplatin	pancreatic cancer	Nothing has been mentioned	Polymer-based Nanoparticles
NKTR-102(Nektar Therapeutics)	completed	irinotecan	breast cancer brain metastases (BCBM)	Positive: there was a significant improvement in survival of patients with BCBM	Polymer-based Nanoparticles
NK-105(NanoCarrier)	completed	paclitaxel	breast cancer	Negative: the progression-free survival, which was the primary outcome measure, was not met	Polymer-based Nanoparticles
CT-2103(CTI BioPharma)	ongoing	paclitaxel	ovarian, peritoneal, or fallopian tube cancer	-	Polymer-based Nanoparticles
NBTXR3(Nanobiotix)	ongoing	hafnium-oxide nanoparticle	sarcoma	-	Inorganic nanoparticles

Nanomedicine approved by FDA classified by type of carrier/material used in preparation of the formulation
Doxil^®/Caelyx™ (Janssen)	Doxorubicin	Liposomes	Karposi’s sarcoma; Ovarian can‑ cer; multiple myeloma	Increase site‑specific delivery (tumor) and decrease systemic toxicity	FDA(1995; 2005; 2008)
Abelcet^® (Sigma‑tau)	Amphotericin B lipid complex	Liposomes	Fungal infection	Decrease toxicity	FDA(1995)
DaunoXome^® (Galen)	Daunorubicin	Liposomes	Karposi’s sarcoma	Increase site‑specific delivery	FDA(1996)
DepoCyt© (Sigma‑Tau)	Cytarabine	Liposomes	Lymphomatous meningitis	Increase site‑specific delivery (tumor) and decrease toxicity	FDA(1996)
AmBisome^® (Gilead Sciences)	Amphotericin B	Liposomes	Fungal and/or protozoal infections	Reduced nephrotoxicity	FDA(1997)
Curosurf^®/Poractant alpha (Chie‑ sei farmaceutici)	Proteins SP-B and SP-C	Liposomes	Lung activator for stress disorder; pulmonary surfactant for respiratory distress syndrome	Decrease toxicity and increased delivery for smaller volume;	FDA(1999)
Visudyne^® (Bausch and Lomb)	Verteporfin	Liposomes	Ocular histoplasmosis, myopia, decreased vision	Increase site-specific delivery (lesion vessels) photosensitive release	FDA(2000)
DepoDur^® (Pacira Pharmaceuticals)	Morphine sulfate	Liposomes	Prolonged release	Loss of pain (post-operative)	FDA(2004)
Marqibo^® (Onco TCS)	Vincristine	Liposomes	Acute lymphoblastic leukemia	Increase site-specific delivery (tumor) and decrease toxicity	FDA(2012)
Onivyde^® (Merrimack)	Irinotecan	Liposomes	Pancreatic cancer	Increase site-specific delivery (tumor) and decrease toxicity	FDA(2015)
Adagen^® (Sigma-Tau Pharmaceuticals)	Pegademase bovine	PEGylated adenosine deaminase enzyme	Immunodeficiency disease	Improve circulation time in body and decrease immunogenicity	FDA(1990)
Oncaspar^® (Enzon Pharmaceuticals)	l-Asparaginase	PEGylated l-asparaginase	Acute lymphoblastic leukemia	Improved protein stability due PEGylation	FDA(1994)
Copaxone^® (Teva)	Glatopa	l-Glutamate, l-alanine, l-lysine and l-tyrosine random copolymer	Multiple sclerosis	Regulation of clearance and polymer with controlled molecular weight	FDA(1996)
Renagel^® (Sanofi)	Sevelamer hydrochloride or sevelamer carbonate	Poly(allylamine hydrochloride)	Chronic renal diseases	Increase site-specific delivery and increase in circulation time in body	FDA(2000)
PegIntron^® (Merck)	Interferon-alpha (IFN-α2b)	PEGylated IFN-α2b protein	Hepatitis C	Improved protein stability due PEGylation	FDA(2001)
Pegasys^® (Genentech)	Interferon-alpha (IFN-α2a)	PEGylated IFN-α2a protein	Hepatitis B and C	Improved protein stability due PEGylation	FDA(2002)
Eligard^® (Tolmar)	Leuprolide acetate	Polymer (PLGH (poly(dl-lactideco glycolide)	Prostate cancer	Prolonged drug delivery and circulation time in body	FDA(2002)
Neulasta^® (Amgen)	PEG-filgrastim	PEGylated granulocyte colonystimulating factor (GCSF) protein	Neutropenia induced by chemotherapy	Improved protein stability due PEGylation	FDA(2002)
Somavert^® (Pfizer)	PEG-visomant	PEGylated HGH receptor antagonist	Acromegaly	Improved protein stability due PEGylation	FDA(2003)
Macugen^® (Bausch & Lomb)	PEG-aptanib	PEGylated anti vascular endothelial growth factor aptamer	Macular degeneration; neovascular age-related (decreased vision)	Improved stability due PEGylation	FDA(2004)
Mircera^® (Hoffman-La Roche)	Methoxy polyethylene glycolepoetin beta	Chemically synthesized erythropoiesis- stimulating agent	Anemia associated with renal failure due to diseases	Improved stability due PEGylation	FDA(2007)
Cimzia^® (UCB)	Certolizumab pegol	PEGylated antibody fragment (Certolizumab)	Crohn’s disease; rheumatoid arthritis; psoriatic arthritis and ankylosing spondylitis	Increase stability and circulation time in body	FDA(2008; 2009; 2013; 2013)
Krystexxa^® (Horizon)	PEG-loticase	PEGylated porcine-like uricase	Chronic gout	Improved protein stability due to PEGylation	FDA(2010)
Plegridy^® (Biogen)	Interferon-beta (IFN-β1a)	PEGylated IFN-β1a protein	Multiple sclerosis	Improved protein stability due to PEGylation	FDA(2015)
ADYNOVATE (Baxalta)	Factor VIII	PEGylated factor VIII	Hemophilia	Improved protein stability due to PEGylation	FDA(2015)
Rapamune^® (Wyeth Pharmaceuticals)	Sirolimus	Nanocrystals	Immunosuppressant	Increased bioavailability	FDA(2000)
Megace ES ^® (Par Pharmaceuticals)	Megestrol acetate	Nanocrystals	Anti-anorexic	Reduced posology	FDA(2001)
Avinza^® (Pfizer)	Morphine sulfate	Nanocrystals	Mental stimulant	Prolonged release and increased bioavailability	FDA(2002/2015)
Ritalin LA ^® (Novartis)	Methylphenidate HCl	Nanocrystals	Mental stimulant	Increased drug loading and bioavailability	FDA(2002)
Zanaflex^® (Acorda)	Tizanidine HCl	Nanocrystals	Muscle relaxant	Increased bioavailability and decreased posology	FDA(2002)
Emend^® (Merck)	Aprepitant	Nanocrystals	Antiemetic drug	Increased absorption and bioavailability	FDA(2003)
Vitoss^® (Stryker)	Calcium phosphate	Nanocrystals	Bone substitute	Mimics bone structure by cell adhesion and growth	FDA(2003)
OsSatura^® (IsoTis Orthobiologics)	Hydroxyapatite	Nanocrystals	Bone substitute	Mimics bone structure by cell adhesion and growth	FDA(2003)
Ostim^® (Heraseus Kulzer)	Hydroxyapatite	Nanocrystals	Bone substitute	Mimics bone structure by cell adhesion and growth	FDA(2004)
Tricor^® (Lupin Atlantis)	Fenofibrate	Nanocrystals	Hyperlipidemia	Increased bioavailability	FDA(2004)
Focalin XR ^® (Novartis)	Dexmethylphenidate HCl	Nanocrystals	Mental stimulant	Increased bioavailability	FDA(2005)
NanOss^® (Rti Surgical)	Hydroxypatite	Nanocrystals	Bone substitute	Mimics bone structure by cell adhesion and growth	FDA(2005)
EquivaBone^® (Zimmer Biomet)	Hydroxypatite	Nanocrystals	Bone substitute	Mimics bone structure	FDA(2009)
Invega^® Sustenna ^® (Janssen Pharms)	Paliperidone palmitate	Nanocrystals	Schizophrenia schizoaffective disorder	Decreased release of poor watersoluble drugs	FDA(2009/2014)
Ryanodex^® (Eagle Pharmaceuticals)	Dantrolene sodium	Nanocrystals	Malignant hypothermia	Allows higher administration at higher doses	FDA(2014)
Estrasorb™ (Novavax)	Estradiol	Micelles	Menopause hormone therapy	Sustained release	FDA(2003)
Abraxane^® (Celgene)	Paclitaxel (ABI-007)	Albumin-bound paclitaxel nanoparticles	Breast cancer; non-small cell lung cancer and pancreatic cancer	Increase site-specific delivery (tumor) and solubility	FDA(2005;2012;2013)
INFeD^® (Sanofi Avertis)	Iron	Iron dextran (low MW)	Chronic kidney failure with iron deficiency	Increased dose capacity	FDA(1957)
DexIron^®/Dexferrum^® (Sanofi Avertis)	Iron	Iron dextran (high MW)	Chronic kidney failure with iron deficiency	Increased dose capacity	FDA(1957)
Feridex^®/Endorem^® (AMAG pharmaceuticals)	Superparamagnetic iron oxide nanoparticles (SPION)	SPION coated with dextran	Imaging material	Superparamagnetic character	FDA(1996/2008)
Ferrlecit^® (Sanofi Avertis)	Sodium ferric	Sodium ferric gluconate	Chronic kidney failure with iron deficiency	Increased dose capacity	FDA(1999)
Venofer^® (Luitpold Pharmaceuticals)	Iron oxide	Iron sucrose	Chronic kidney failure with iron deficiency	Increased dose capacity	FDA(2000)
GastroMARK™; umirem ^® (AMAG pharmaceuticals)	Superparamagnetic iron oxide nanoparticles (SPION)	SPION coated with silicone	Imaging material	Superparamagnetic character	FDA(2001/2009)
Feraheme™ (AMAG pharmaceuticals)	Ferumoxytol-ultrasmall superparamagnetic iron oxide nanopartilces (SPION)	Ferumoxytol SPION with polyglucose sorbitol carboxymethylether	Chronic kidney failure with iron deficiency	Prolonged steady release and decreased number of doses	FDA(2009)
Nanotherm^® (MagForce)	Iron oxide	Aminosilane-coated Iron nanoparticles	Brain tumor	Thermotherapy for destroy tumor cells or sensitized for additional therapies	FDA(2010)

List of globally marketed nanomedicines approved by the FDA and the EMA
Emend^® (Merk & Co. Inc.)	aprepitant	Nanocrystal	antiemetic drug	FDA (2003)
Ivemend^® (Merk & Co. Inc.)	fosaprepitant dimeglumine (prodrug of aprepitant)	Nanocrystal	antiemetic drug	FDA, EMA (2008)
Ostim^® (Osartis GmbH & Co.)	calcium hydroxyapatite	Nanocrystal	bone-grafting material	FDA (2004)
Rapamune^® (Wyeth Pharmaceuticals Inc. (a subsidiary of Pfizer Inc.))	sirolimus (rapamycin)	Nanocrystal	prevents rejection of kidney transplants (immunosuppressant)	EMA (2001), FDA (2010)
Rapamune^® (Wyeth Pharmaceuticals Inc. (a subsidiary of Pfizer Inc.))	sirolimus (rapamycin)	Nanocrystal	a rare progressive lung disease (lymphangioleiomyomatosis)	FDA (2015)
Vitoss^® (Orthovita Inc.)	β-tricalcium phosphate	Nanocrystal	bone-grafting material	FDA (2003)
Ritalin LX^® (Novartis)	methylphenidate	Nanocrystal	attention deficit hyperactivity disorder (ADHD) in children	FDA (2002)
Avinza^® (Pfizer Pharmaceuticals)	morphine sulfate	Nanocrystal	psychostimulant	FDA (2002)
Focalin XR^® (Novartis)	dexamethylphenidate HCl	Nanocrystal	ADHD in children	FDA (2008)
Invega^® (Janssen Pharmaceuticals)	paliperidone	Nanocrystal	schizophrenia	FDA (2009)
Invega Sustenna^® (Janssen Pharmaceuticals)	paliperidone Palmitate	Nanocrystal	schizophrenia	FDA (2009)
Megace ES^® (Par Pharmaceuticals)	megestrol acetate	Nanocrystal	antianorexic	FDA (2005)
NanOss^® (RTI Surgical)	hydroxyapatite	Nanocrystal	bone substitute	FDA (2005)
EquivaBone^® (Zimmer Biomet)	hydroxyapatite	Nanocrystal	bone substitute	FDA (2009)
OsSatura^® (Isotis Othobiologics Inc.)	hydroxyapatite	Nanocrystal	bone substitute	FDA (2003)
Epaxal^® (Crucell Berna Biotech)	inactivated hepatitis A virus vaccine	Nanocrystal	prevents hepatitis A infection	EMA (1993)
Zanaflex^® (Acorda)	tizanidine HCl	Nanocrystal	muscle relaxant	FDA (2002)
Ryanodex^® (Eagle pharm)	dantrolene sodium	Nanocrystal	malignant hyperthermia	FDA (2014)
TriCor^® (Abbott Laboratories)	fenofibrate	Nanocrystal	antihyperlipidemia	FDA (2004)
Doxil^® (Johnson & Johnson)	doxorubicin (adriamycin)	Lipid-based Nanoparticles	metastatic ovarian cancer, HIV-associated Kaposi’s sarcoma (KS)	FDA (1995), EMA (1996)
Lipodox^® (Sun Pharma Global FZE)	doxorubicin hydrochloride	Lipid-based Nanoparticles	metastatic ovarian cancer, HIV-associated KS	FDA (2013)
DaunoXome^® (Galen Ltd.)	daunorubicin	Lipid-based Nanoparticles	cancers and HIV-associated KS	FDA, EMA (1996)
Onivyde^® (Merrimack Pharmaceuticals)	irinotecan	Lipid-based Nanoparticles	metastatic pancreatic cancer	FDA (2015)
DepoCyt^® (Pacira Pharmaceuticals)	cytarabine	Lipid-based Nanoparticles	lymphomatous meningitis	EMA (2002), FDA (2007)
Myocet^® (Teva Pharmaceutical Industries Ltd.)	doxorubicin hydrochloride	Lipid-based Nanoparticles	breast cancer	EMA (2000)
Caelyx^® (Janssen Pharmaceuticals)	doxorubicin	Lipid-based Nanoparticles	breast cancer, ovarian cancer, HIV-associated KS	EMA (1996)
Mepact^® (Takeda France SAS)	mifamurtide	Lipid-based Nanoparticles	osteogenic sarcoma	EMA (2009)
Marqibo^® (Talon Therapeutics)	vincristine	Lipid-based Nanoparticles	Philadelphia chromosome-negative chronic myelogenous leukemia in adult patients	FDA (2012)
Onpattro^® (Alnylam)	patisiran	Lipid-based Nanoparticles	hereditary transthyretin (TTR) mediated amyloidosis	FDA & EMA (2018)
Lipusu^® ()	paclitaxel	Lipid-based Nanoparticles	breast cancer, non-small-cell lung cancer (NSCLC)	FDA (2016)
AmBisome^® (NeXstar Pharmaceuticals)	amphotericin B	Lipid-based Nanoparticles	antifungal drug	EMA (1990), FDA (1997)
Vyxeos^® (Jazz Pharmaceutics)	daunorubicin and cytarabine	Lipid-based Nanoparticles	acute myeloid leukemia	FDA (2017), EMA (2018)
Abelcet^® (Defiante Farmaceutica)	amphotericin B	Lipid-based Nanoparticles	antifungal drug	FDA (1995)
DepoDur^® (SkyePharma)	liposomal morphine sulphate	Lipid-based Nanoparticles	postoperative analgesia	FDA (2004), EMA (2006)
Curosurf^® (Chiesi)	poractant alfa	Lipid-based Nanoparticles	respiratory distress syndrome (RDS)	FDA (1999)
Zevalin^® (Bayer Pharma)	90Y-ibritumomab tiuxetan	Lipid-based Nanoparticles	lymphoma	FDA (2002) Disc. * EMA (2004)
Inflexal^® (Crucell Berna Biotech)	inactivated influenza virus vaccine	Lipid-based Nanoparticles	prevents influenza infection	EMA (1997)
Pfizer-BioNTech Vaccine (Pfizer Pharmaceuticals)	mRNA vaccine	Lipid-based Nanoparticles	prevents COVID-19 infection	FDA (2020)
Moderna COVID-19 Vaccine (ModernaTX Inc.)	mRNA vaccine	Lipid-based Nanoparticles	prevents COVID-19 infection	FDA (2020)
Visudyne^® (QLT Phototherapeutics)	photosensitizer (PS), benzoporphyrin	Lipid-based Nanoparticles	choroidal neovascularization caused by wet age-related macular degeneration	FDA & EMA (2000)
Cimzia^® (UCB)	IgG Fab’ fragment that specifically recognizes and binds to TNF-α	Polymer-based anoparticles	rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and ankylosing spondylitis	FDA (2008), EMA (2009)
Apealea^® (Oasmia Pharmaceutical AB)	paclitaxel	Polymer-based anoparticles	ovarian cancer, peritoneal cancer, fallopian tube cancer	EMA (2018)
Adagen^® (Enzon Pharmaceuticals Inc.)	adenosine deaminase (ADA)	Polymer-based anoparticles	adenosine deaminase (ADA)-severe combined immunodeficiency disorder	FDA (1990)
Neulasta^® (Amgen, Inc.)	filgrastim	Polymer-based anoparticles	febrile neutropenia, consequent infections arising due to lack of neutrophils	FDA (2002)
Oncaspar^® (Enzon Pharmaceuticals Inc.)	L-asparaginase	Polymer-based anoparticles	acute lymphoblastic leukemia, chronic myelogenous leukemia	FDA (1994), EMA (2016)
Genexol-PM^® (Lupin Ltd.)	paclitaxel	Polymer-based anoparticles	breast cancer	FDA (2007)
Pegasys^® (Genentech USA, Inc)	recombinant human alfa-2a interferon	Polymer-based anoparticles	hepatitis C, hepatitis B	FDA, EMA (2002)
Diprivan^® (Fresenius Kabi)	propofol	Polymer-based anoparticles	(sedative-hypnotic agent) used in surgeryto induce relaxation before and during general anesthesia	FDA (1989), EMA (2001)
Somavert^® (Pfizer Pharmaceuticals)	analog of human growth hormone (acts as an antagonist of GH receptors)	Polymer-based anoparticles	acromegaly	EMA (2002), FDA (2003)
Macugen^® (Pfizer Pharmaceuticals)	pegatinib sodium	Polymer-based anoparticles	choroidal neovascularization caused by wet age-related maculardegeneration	FDA (2004)
Mircera^® (Vifor)	epoetin β (EPO) (EPO is a genetically recombinant form of erythropoietin)	Polymer-based anoparticles	anemia	EMA (2007), FDA (2018)
PegIntron^® (Merk & Co. Inc.)	alpha interferon (INF) molecule	Polymer-based anoparticles	hepatitis C	EMA (2000), FDA (2001)
Krystexxa^® (Savient Pharmaceuticals)	pegloticase is a recombinant porcinelike uricase	Polymer-based anoparticles	refractory chronic gout	FDA (2010)
Plegridy^® (Biogene)	recombinant IFN-β	Polymer-based anoparticles	relapsing remitting multiple sclerosis (RRMS) in adult patients	FDA (2014)
Adynovate^® (Baxalta US Inc.)	coagulation factor VIII	Polymer-based anoparticles	hemophilia A	FDA (2015)
Copaxone^®/FOGA (Teva Pharmaceutical Industries Ltd.)	glatiramer acetate	Polymer-based anoparticles	multiple sclerosis (MS)	FDA (1996), EMA (2016)
Eligard^® (Tolmar Pharmaceuticals Inc.)	leuprolide acetate	Polymer-based anoparticles	prostate cancer	FDA (2002)
Renagel^® (Sanofi)	sevelamer carbonate	Polymer-based anoparticles	hyperphosphatemia caused by chronic kidney disease (CKD)	FDA (2000)
Renagel^®/Renvela^® (Genzyme)	sevelamer HCL	Polymer-based anoparticles	hyperphosphatemia caused by CKD	EMA (2007)
Restasis^® (Allergan)	cyclosporine	Polymer-based anoparticles	chronic dry eye	FDA (2003)
Rebinyn^® (NovoNordisk)	recombinant DNA-derived coagulation FIX	Polymer-based anoparticles	hemophilia B	FDA (2017)
Estrasorb™ (Novavax, Inc.)	estradiol (17β-estradiol) hemihydrate	Polymer-based anoparticles	moderate vasomotor symptoms due to menopause	FDA (2003)
Zilretta^® (Flexion Therapeutics)	triamcinolone acetonide	Polymer-based anoparticles	knee osteoarthritis	FDA (2017)
VivaGel^® BV (Starpharma)	astodrimer sodium	Dendrimer-based anoparticles	anti-infective for prevention of recurrent bacterial vaginosis (BV)	FDA (2015)
Abraxane^® (Celgene Pharmaceutical Co. Ltd.)	paclitaxel	Protein-based Nanoparticles	approved by the FDA for treatment of metastatic breast cancer (2005), lung cancer (2012), and metastatic pancreatic adenocarcinoma (2013)	FDA (2005, 2012, 2013), EMA (2008)
Ontak^® (Eisai)	diphtheria toxin	Protein-based Nanoparticles	leukemia, T-cell lymphoma	FDA (1999)
Feraheme™ (AMAG Pharmaceuticals)	ferumoxytol	Inorganic Nanoparticles	anemia	FDA (2009)
Venofer^® (Luitpold Pharm)	iron sucrose	Inorganic Nanoparticles	iron deficiency in CKD	FDA (2000)
Dexferrum^® (American Regent)	iron dextran	Inorganic Nanoparticles	iron deficiency in CKD	FDA (1996)
Ferinject^® (Vifor)	iron carboxymaltose colloid	Inorganic Nanoparticles	iron deficient anemia	FDA, EMA (2013)
Ferrlecit^® (Sanofi-Aventis)	sodium ferric gluconate	Inorganic Nanoparticles	iron deficiency in CKD	FDA (1999), EMA (2013)
Hensify^® (Nanobiotix)	hafnium oxide nanoparticles	Inorganic Nanoparticles	locally advanced squamous cell carcinoma	EMA (2019)
Infed^® (Actavis Pharma)	iron dextran	Inorganic Nanoparticles	iron deficiency in CKD	FDA (1992)
Feridex^®/Endorem^® (AMAG Pharma)	SPION-dex	Inorganic Nanoparticles	imaging agent	FDA (1996) Disc. * 2008
GastroMARK™/Umir (Mallinckrodt Inc.)	SPION-silicone	Inorganic Nanoparticles	imaging agent	FDA (2009)Disc. * 2012

References:
1. Patra, et al.; Nano based drug delivery systems: recent developments and future prospects. J Nanobiotechnol. 2018,16:71
2. Bobo D, et al.; Nanoparticle based medicines: a review of FDA-approved materials and clinical trials to date. Pharm Res. 2016, 33:2373–87.
3. Halwani AA. Development of Pharmaceutical Nanomedicines: From the Bench to the Market. Pharmaceutics. 2022 Jan 3;14(1):106.

Supports

Fill out the form below
to receive a quote

GET A QUOTE

Nanomedicine and Clinical Research List

List of FDA‑approved nanotechnology‑based products and clinical trials

Selected nanomedicines that are in phase III clinical trials

Nanomedicine approved by FDA classified by type of carrier/material used in preparation of the formulation

List of globally marketed nanomedicines approved by the FDA and the EMA