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brexanolone

Generic: BREXANOLONE·Brand: ZULRESSO, Zulresso

brexanolone: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.

brexanolone evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect brexanolone to SAGE; that link alone does not prove the drug works.

What to watch

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

Prepared research question

How could brexanolone → SAGE affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

Postpartum depression (PPD) in individuals 15 years old and olderAlcohol Use DisorderAlcohol Use Disorder (AUD)PTSD

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Sage Therapeutics, Inc. (SAGE)
Postpartum depression (PPD) in individuals 15 years old and …
Approved
Clinical Trials (2)

Brexanolone to Target Concurrent Posttraumatic Stress Disorder (PTSD) and Stress Induced Alcohol Use in Veterans: A Dose Finding Study

NCT06580444·Phase 2
Not yet recruiting

Primary endpoint: Severity and numbers of treatment-emergent AEs

InterventionalRandomizedtriple40 targetStarted 2025-07Completion 2027-03Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

NCT05223829·Phase 1
Active, not recruiting

Primary endpoint: Treatment-emergent adverse events

Interventionalopen25 targetStarted 2023-08Completion 2025-121 site · United StatesYale University
FDA Decisions1 records
Approval(SAGE)FDA ↗
NDA211371Type 1 - New Molecular EntityPriorityIntravenousSolution

Frequently asked questions

Who is developing brexanolone?

brexanolone is being developed by Sage Therapeutics, Inc..

How many clinical trials involve brexanolone?

BioSniper tracks 2 clinical trials involving brexanolone.

What is brexanolone's latest FDA decision?

The most recent tracked FDA decision for brexanolone is Approval, dated March 19, 2019.