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.

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

Name Material description Nanoparticle advantage Indication(s) Year approved Type
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
alanine, l‑lysine and l‑tyrosine 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
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
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

Selected nanomedicines that are in phase III clinical trials

Name Status Active Ingredients Indication(s) Outcome Type
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
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
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
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

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.

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