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. 2021 Jul 23;12(3):500–525. doi: 10.1007/s13346-021-01024-2

Table 1.

FDA- and EMA-approved nanomedicines since 2015, updated from Sainz et al. [13]

Tradename Nanoplatform and active agent Application Approval (date) Company
Adynovate®/Adynovi® PEGylated recombinant anti-hemophilic factor Hemophilia FDA (2015) EMA (2017) Takeda
Aristada® Aripiprazole lauroxil nanocrystals Schizophrenia FDA (2015) Alkermes
Glatopa® (Generic of Copaxone) Random copolymer of L-glutamate, L-alanine, L-lysine, and L-tyrosine Multiple sclerosis FDA (2015) Novartis
Invega Trinza®/Trevicta® Paliperidone palmitate nanocrystals Schizophrenia FDA (2015) EMA (2016) Janssen
Inveltys® Loteprednol etabonate nanosuspension Post-operative ophthalmic inflammation FDA (2018) KALA pharmaceuticals
Mircera® PEGylated epoetin beta Anemia in chronic renal diseases for pediatric patients FDA (2018) EMA (2019) Vifor
mRNA-1273 Lipid nanoparticle of full-length, prefusion stabilized spike protein mRNA Prevention of COVID-19 FDA (2020) EMA (2021) Moderna
Onpattro® (Patisiran) Lipid nanoparticle for siRNA targeting TTR protein TTR-mediated amyloidosis FDA and EMA (2018) Alnylam Pharmaceuticals
Onivyde® PEGylated liposomal irinotecan Metastatic pancreatic cancer FDA (2015) EMA (2016) Merrimack
Rebinyn®/Refixia® PEGylated glyco-protein drug Hemophilia FDA and EMA (2017) NovoNordisk
Sublocade® Buprenorphine-loaded PLGA nanoparticles Opioid use disorder FDA (2017) Indivior
Tozinameran® Lipid nanoparticle of full spike mRNA Prevention of COVID-19 FDA and EMA (2020) BioNTech SE and Pfizer
Vyxeos® Liposomal formulation of cytarabine: daunorubicin (5:1 M ratio) Acute myeloid leukemia FDA (2017) EMA (2018) Jazz Pharmaceuticals
Zilretta® PLGA hydrogel of triamcinolone acetonide Knee osteoarthritis FDA (2017) Flexion Therapeutics

FDA Food and Drugs Administration, EMA European Medicines Agency, TTR transthyretin, PLGA poly(lactic-co-glycolic acid), PEG polyethylene glycol, COVID-19 coronavirus disease 2019