Last reviewed 2026-04-20 · How we verify

Zulresso (BREXANOLONE)

Zulresso, also known as brexanolone, is a small molecule neuroactive steroid gamma-aminobutyric acid A receptor positive modulator developed by SAGE THERAPEUTICS and currently owned by Sage Therap. It targets the GABA-A receptor alpha-1/beta-2/gamma-2 subunit, modulating the activity of this receptor to treat postpartum depression. Zulresso was FDA approved in 2019 and is a patented medication with no generic manufacturers available. Key safety considerations include its potential effects on blood pressure and electrolyte levels. It is a modulator of the GABA-A receptor, which is a key component of the brain's inhibitory neurotransmission system.

At a glance

Approved indications

• Postpartum depression

Common side effects

No common side effects on file.

Key clinical trials

• A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD (PHASE3)
• Study on Allopregnanolone and Depression in Perimenopausal Women (PHASE4)
• Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD. (PHASE2)
• National Pregnancy Registry for Psychiatric Medications
• A Study With SAGE-547 for Super-Refractory Status Epilepticus (PHASE3)
• A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) (PHASE3)
• Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder (PHASE1)
• A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.