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) |