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Table 1 List of FDA-approved nanotechnology-based products and clinical trials.

From: Nano based drug delivery systems: recent developments and future prospects

Polymer nanoparticles-synthetic polymer particles combined with drugs or biologics
 Name Material description Nanoparticle advantage Indication(s) Year approved
 Adagen®/pegademase bovine (Sigma-Tau Pharmaceuticals) PEGylated adenosine deaminase enzyme Improve circulation time and decreased immunogenicity Severe combined immunodeficiency disease (SCID) 1990
 Cimzia®/certolizumab pegol (UCB) PEGylated antibody fragment (Certolizumab) Improved circulation time and greater stability in vivo Crohn’s disease; Rheumatoid arthritis; Psoriatic Arthritis; Ankylosing Spondylitis 2008; 2009; 2013; 2013
 Copaxone®/Glatopa (Teva) Random copolymer of l-glutamate, l alanine, l-lysine and l-tyrosine Large amino-acid based polymer with controlled molecular weight and clearance characteristics Multiple sclerosis (MS) 1996
 Eligard® (Tolmar) Leuprolide acetate and polymer (PLGH (poly (dl-lactide-coglycolide)) Controlled delivery of payload with longer circulation time Prostate cancer 2002
 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
 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
 Neulasta®/pegfilgrastim (Amgen) PEGylated GCSF protein Improved stability of protein through PEGylation Neutropenia, chemotherapy induced 2002
 Pegasys® (Genentech) PEGylated IFN alpha-2a protein Improved stability of protein through PEGylation Hepatitis B; Hepatitis C 2002
 PegIntron® (Merck) PEGylated IFN alpha-2a protein Improved stability of protein through PEGylation Hepatitis C 2001
 Renagel®[sevelamer hydrochloride]/Renagel®[sevelamer carbonate] (Sanofi) Poly(allylamine hydrochloride) Increase circulation and therapeutic delivery Chronic kidney disease 2000
 Somavert®/pegvisomant (Pfizer) PEGylated HGH receptor antagonist Improved stability of protein through PEGylation Acromegaly 2003
 Oncaspar®/pegaspargase (Enzon pharmaceuticals) Polymer–protein conjugate (PEGylated l-asparaginase) Improved stability of protein through PEGylation Acute lymphoblastic leukemia 1994
 Krystexxa®/pegloticase (Horizon) Polymer–protein conjugate (PEGylated porcine-like uricase) Improved stability of protein through PEGylation; introduction of unique mammalian protein Chronic gout 2010
 Plegridy® (Biogen) Polymer–protein conjugate (PEGylated IFN beta-1a) Improved stability of protein through PEGylation Multiple Sclerosis 2014
 ADYNOVATE (Baxalta) Polymer–protein conjugate (PEGylated factor VIII) Improved stability of protein through PEGylation Hemophilia 2015
 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
 Rebinyn Coagulation fator IX (Recombinant) GlycoPEGylated 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 bleeding in the perioperative setting for haemophilia B patients 2017
Liposome formulations combined with drugs or biologics
 DaunoXome® (Galen) Liposomal daunorubicin Increased delivery to tumour site; lower systemic toxicity arising from side-effects Karposi’s sarcoma 1995
 DepoCyt© (Sigma-Tau) Liposomal cytarabine Increased delivery to tumour site; lower systemic toxicity arising from side-effects Lymphomatous meningitis 1996
 Marqibo® (Onco TCS) Liposomal vincristine Increased delivery to tumour site; lower systemic toxicity arising from side-effects Acute lymphoblastic leukemia 2012
 Onivyde® (Merrimack) Liposomal irinotecan Increased delivery to tumour site; lower systemic toxicity arising from side-effects Pancreatic cancer 2015
 AmBisome® (Gilead Sciences) Liposomal amphotericin B Reduced nephrotoxicity Fungal/protozoal infections 1997
 DepoDur® (Pacira Pharmaceuticals) Liposomal morphine sulphate Extended release Analgesia (post-operative) 2004
 Visudyne® (Bausch and Lomb) Liposomal verteporfin Increased delivery to site of diseased vessels; photosensitive release Macular degeneration, wet age-related; myopia; ocular histoplasmosis 2000
 Doxil®/Caelyx™ (Janssen) Liposomal doxorubicin Improved delivery to site of disease; decrease in systemic toxicity of free drug Karposi’s sarcoma; Ovarian cancer; multiple myeloma 1995; 2005; 2008
 Abelcet® (Sigma-tau) Liposomal amphotericin B lipid complex Reduced toxicity Fungal infections 1995
 Curosurf®/Poractant alpha (Chiesei farmaceutic Liposome–proteins SP-B and SP-C Increased delivery for smaller volume; reduced toxicity Pulmonary surfactant for respiratory distress syndrome 1999
 Vyxeos (Jazz Pharma) Lipossomal combination of daunorubicin and cytarabine Sustained release of the molecules and co-loaded two molecules with synergistic anti-tumor activity Acute myeloid leukemia (AML) or AMLA with myelodysplasia-related changes (AML-MRC) 2017
Micellar nanoparticles combined with drugs or biologics
 Estrasorb™ (Novavax) Micellar estradiol Controlled delivery of therapeutic Menopausal therapy 2003
Protein nanoparticles combined with drugs or biologics
 Abraxane®/ABI-007 (Celgene) Albumin-bound paclitaxel nanoparticles Improved solubility; improved delivery to tumor Breast cancer; NSCLC; Pancreatic cancer 2005; 2012; 2013
 Ontak® (Eisai Inc) Engineered protein combining IL-2 and diphtheria toxin Targeted T cell specificity; lysosomal escape Cutaneous T-cell lymphoma 1999
Nanocrystals
 Emend® (Merck) Aprepitant Surface area allows faster absorption and increases bioavailability Antiemetic 2003
 Tricor® (Lupin Atlantis) Fenofibrate Increases bioavailability simplifies administration Hyperlipidemia 2004
 Rapamune® (Wyeth Pharmaceuticals) Sirolimus Increased bioavailability Immunosuppressant 2000
 Megace ES® (Par Pharmaceuticals) Megestrol acetate Reduced dosing Anti-anorexic 2001
 Avinza® (Pfizer) Morphine sulphate Increased drug loading and bioavailability; extended release Psychostimulant 2002 (2015)
 Focalin XR® (Novartis) Dexmethylphenidate HCl Increased drug loading and bioavailability Psychostimulant 2005
 Ritalin LA® (Novartis) Methylphenidate HCl Increased drug loading and bioavailability Psychostimulant 2002
 Zanaflex® (Acorda) Tizanidine HCl Increased drug loading and bioavailability Muscle relaxant 2002
 Vitoss® (Stryker) Calcium phosphate Mimics bone structure allowing cell adhesion and growth Bone substitute 2003
 Ostim® (Heraseus Kulzer) Hydroxyapatite Mimics bone structure allowing cell adhesion and growth Bone substitute 2004
 OsSatura® (IsoTis Orthobiologics) Hydroxyapatite Mimics bone structure allowing cell adhesion and growth Bone substitute 2003
 NanOss® (Rti surgical) Hydroxyapatite Mimics bone structure allowing cell adhesion and growth Bone substitute 2005
 EquivaBone® (Zimmer Biomet) Hydroxyapatite Mimics bone structure Bone substitute 2009
 Invega® Sustenna® (Janssen Pharms) Paliperidone palmitate Allows slow release of injectable low solubility drug Schizophrenia; Schizoaffective disorder 2009; 2014
 Ryanodex® (Eagle Pharmaceuticals) Dantrolene sodium Faster administration at higher doses Malignant hypothermia 2014
 Inorganic and metallic nanoparticles Nanotherm® (MagForce) Iron oxide Allows cell uptake and introduces superparamagnetism Glioblastoma 2010
 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
 Venofer® (Luitpold pharmaceuticals) Iron sucrose Allows increased dose Iron deficiency in chronic kidney disease (CKD) 2000
 Ferrlecit® (Sanofi Avertis) Sodium ferric gluconate Allows increased dose Iron deficiency in chronic kidney disease (CKD) 1999
 INFeD® (Sanofi Avertis) Iron dextran (low MW) Allows increased dose Iron deficiency in chronic kidney disease (CKD) 1957
 DexIron®/Dexferrum® (Sanofi Avertis) Iron dextran (low MW) Allows increased dose Iron deficiency in chronic kidney disease (CKD) 1957
 Feridex®/Endorem® (AMAG pharmaceuticals) SPION coated with dextran Superparamagnetic character Imaging agent 1996 (2008)
 GastroMARK™; umirem® (AMAG pharmaceuticals) SPION coated with silicone Superparamagnetic character Imaging agent 2001 (2009)
  1. Data from 2016–2018 has been collected from various literature [204, 256,257,258,259,260,261]