Zuranolone: First Approval

Drugs. 2023 Nov;83(16):1559-1567. doi: 10.1007/s40265-023-01953-x.

Abstract

Zuranolone (ZURZUVAE™) is an oral neuroactive steroid and a positive allosteric modulator of the gamma aminobutyric acid A (GABAA) receptor being developed by Sage Therapeutics and Biogen for the treatment of mood disorders. In August 2023, zuranolone received its first approval in the USA for the treatment of adults with postpartum depression [pending scheduling by the US Drug Enforcement Administration (DEA)]. This article summarizes the milestones in the development of zuranolone leading to this first approval.

Publication types

  • Review

MeSH terms

  • Adult
  • Depression, Postpartum* / drug therapy
  • Female
  • Humans
  • Pregnanes* / therapeutic use
  • Pregnanolone / pharmacology
  • Pregnanolone / therapeutic use
  • Pyrazoles / therapeutic use

Substances

  • zuranolone
  • Pregnanes
  • Pyrazoles
  • Pregnanolone