2019 Small Molecule Drug Approvals

2019 was another big year for drug discovery, with 29 FDA novel drug approvals for small molecules (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) and 3 for antibody-drug-conjugates so far. 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.

Here is a visual summary of the small molecules with their mechanism of action, indication, and dosing regimen listed (from respective FDA drug labels).

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

List of 2019 Small Molecule Drug Approvals

List of 2019 Approvals in Oncology (8)

  • Alpelisib (Piqray) – PI3Kα-sel. inhibitor
  • Erdafitinib (Balversa) – panFGFR inhibitor
  • Darolutamide (Nubeqa) – AR antagonist
  • Fedratinib (Inrebic – JAK2-selective inhibitor
  • Selinexor (Xpovio) – XPO1 inhibitor
  • Entrectinib (Rozlytrek) – ROS1/TRK/ALK inhibitor
  • Zanubrutinib (Brukinsa) – BTK-selective inhibitor
  • Pexidartinib (Turalio) – CSF1R inhibitor

List of 2019 Approvals in Neurology (9)

  • Lasmiditan (Reyvow) – 5-HT11F -selective agonist
  • Ubrogepant (Ulbrelvy) – CGRP receptor antagonist
  • Lumateperone (Caplyta) – D2/5 – HT2A antagonist
  • Pitolisant (Wakix) – H3-selective antagonist/inverse agonist
  • Brexanolone (Zulresso) – GABA AR positive modulator
  • Cenobamate (Xcopri) – unclear/GABAA-modulator
  • Siponimod (Mayzent) – S1PR1/5 modulator
  • Solriamfetol (Sunosi) – dopamine/norepinephrine reuptake inhibitor
  • Lemborexant (Dayvigo) – OX1R/OX2R dual antagonist

List of 2019 Approvals in Infectious Diseases (3) + Other Areas (4)

  • Lefamulin (Xenleta) – bacterial ribosome 50S inhibitor
  • Triclabendazole (Egaten) – Fasciola anthelmintic
  • Tafamidis (Vyndaqel) – specific transthyretin stabilizer
  • Voxelotor (Oxbryta) – HbS hemoglobin polymerization inhibitor
  • Pretomanid – mycolic acid biosynthesis inhibitor
  • Upadacitinib (Rinvoq) – JAK1 -selective inhibitor
  • Trifarotene (Aklief) – RARy-selective agonist

Explore drughunter.com for more.

Join the Drug Hunter mailing list

to get free content and resources weekly. Trusted by > 5,500 drug hunters worldwide. Unsubscribe anytime.

This field is for validation purposes and should be left unchanged.

Join Subscribers from

…and hundreds more!