2019 Small Molecule Drug Approvals

2019 was another big year for drug discovery, with 29 FDA novel drug approvals for small molecules[note]Including istradefylline which was first approved in Japan, but not including brilliant blue G, fluorodopa F18, Ga-68-DOTATOC, bremelanotide, afamelanotide, and ferric maltol, which could all be considered small molecules by some definitions: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019[/note] and 3 for antibody-drug-conjugates so far.[note]The ADC approvals include the anti-CD79b agent polatuzumab vedotin (Polivy), the anti-nectin-4 agent enfortumab vedotin (Padcev), and the anti-HER2 agent fam-trastuzumab deruxtecan (Enhertu), all for oncology.[/note]

Chris De Savi put together a great compilation of the molecules on LinkedIn recently, and here’s a “fast-follower” updated visual summary of the small molecules with their mechanism of action, indication, and dosing regimen listed.[note]From respective FDA drug labels.[/note] Happy new year, and looking forward to a great 2020! You can find a higher resolution PDF at the bottom of the page.

2019 Small Molecule Drug Approvals
Note: Istradefylline (Nourianz) not included since it was approved in Japan in 2013.

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