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Zuranolone · Zurzuvae, BIIB125

Small molecule · Modulator of GABA A receptor (GABRA1) · developed by Biogen

Approved FDA, Aug 2023

BIIB Developer

1 Registered trials

What is Zuranolone?

Zuranolone is a neuroactive steroid that acts as a positive allosteric modulator of GABA A receptors.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Zurzuvae, BIIB125, S-812217, SGE-797
Drug type: Small molecule
Targets: GABA A receptor (GABRA1)
Mechanism: Modulator of GABA A receptor (GABRA1)
Pathways: GABA signaling
Therapy area: Psychiatry
Developer: Biogen (BIIB)
FDA status: Approved as Zurzuvae (August 4, 2023), NDA217369 · FDA label
UNII: 7ZW49N180B

✅ FDA-approved uses

Postpartum depression

From the indications section of the FDA label (version of Jun 15, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07398469	N/A	Postpartum Depression	Recruiting	BIIB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Postpartum Depression

Other drugs acting on GABRA1

Midazolam FDA approved Remimazolam FDA approved

More from Biogen

Dimethyl Fumarate FDA approved Diroximel Fumarate FDA approved Interferon Beta-1A FDA approved Natalizumab FDA approved Nusinersen FDA approved Omaveloxolone FDA approved Tofersen FDA approved BIIB115 Phase 1 BIIB122 Phase 3 BIIB144 Phase 1 BIIB147 Phase 1/2 Diranersen Phase 2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BIIB page.

Follow BIIB, the company behind Zuranolone

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z