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Updated: Jul 12, 2025

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Zuranolone: First Approval
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.
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.
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