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zuranolone

Generic: ZURANOLONE·Brand: ZURZUVAE, Zurzuvae

zuranolone: sourced relationships with 2 companies · 2 clinical trials tracked · 1 FDA decision.

zuranolone evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

More than one company relationship is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about zuranolone, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

Postpartum depression (PPD)Postpartum depression (PPD) in adultsDepression, Postpartum

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (2)
CompanyDated record stage
BIOGEN INC. (BIIB)
co_developer · Reported 2024-02-14 · Current development: unknownSource
Postpartum depression (PPD)
Approved
Sage Therapeutics, Inc. (SAGE)
developer · Reported 2024-02-14 · Current development: unknownSource
Postpartum depression (PPD) in adults
Approved
Clinical Trial Registry Records (2)

A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use

NCT07398469Registry updated 2026-09-08·BIIB
Recruiting

Primary endpoint: Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15

Observational300 targetStarted 2025-12Completion 2027-031 site · United StatesBiogen

Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting

NCT07047820Registry updated 2026-09-08·BIIB
Completed

Primary endpoint: Cohorts 1 and 2: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15

Observational305 enrolledStarted 2025-06Completion 2026-081 site · United StatesBiogen
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 )(BIIB)FDA ↗
NDA217369Type 1 - New Molecular EntityPriorityOralCapsule

Frequently asked questions

Which companies have sourced relationships with zuranolone?

zuranolone has dated SEC/FDA relationship records for BIOGEN INC., Sage Therapeutics, Inc..

How many clinical trials involve zuranolone?

BioSniper tracks 2 clinical trials involving zuranolone.

What is zuranolone's latest FDA decision?

The most recent tracked FDA decision for zuranolone is Approval for 1 INDICATIONS AND USAGE ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 ), dated August 4, 2023.