NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
ZULRESSO (brexanolone) by Sage Therapeutics. Approved for postpartum depression. First approved in 2019.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZULRESSO (brexanolone) is an intravenous solution approved in 2019 for postpartum depression, a severe perinatal mood disorder affecting women in the immediate postpartum period. It is a neuroactive steroid that acts as a positive allosteric modulator of GABA-A receptors, thereby modulating neuroinhibitory pathways implicated in depression. The drug represents a novel mechanistic approach to treating a historically underserved patient population with limited acute treatment options.
Peak10.8 years to LOE
Product is in peak commercial phase but faces emerging competitive pressures; commercial teams are likely stabilized in size with focus on market maintenance and payer strategy.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (11)
Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
Started Jul 2025
40 enrolled
Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
Started Aug 2023
25 enrolled
PTSDAlcohol Use Disorder
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Started Jun 2023
20 enrolled
Post-Traumatic Stress Disorder
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Started May 2023
10 enrolled
Tinnitus
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
Started Aug 2022
10 enrolled
Postpartum Depression
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.