NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Zulresso (brexanolone) is an intravenous neuroactive steroid approved for postpartum depression in women. It is administered as a 60-hour IV infusion and represents the first FDA-approved therapy specifically indicated for this condition. The drug works through modulation of GABA-A receptors to restore neurochemical balance disrupted during pregnancy and postpartum period.
Peak10.5 years to LOE
Product is in peak commercial phase with stable market position; brand and market access teams likely at optimal staffing levels.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
10 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.