Sold as Zulresso. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Brexanolone (sold as Zulresso), first approved Mar 19, 2019, with 1 new use approved and 0 published complete response letters.
| Brexanolone Lifting Outcomes Of MomsDepression, Postpartum, Postpartum Depression (PPD) · Lipocine Inc. | Phase 3 | Recruiting | Sep 16, 2026 |
| Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.Post Traumatic Stress Disorder · Massachusetts General Hospital | Phase 2 | Recruiting | Jul 23, 2025 |
| Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding StudyAlcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD) · Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Phase 2 | Not yet recruiting | Aug 30, 2024 |
| Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress DisorderPTSD, Alcohol Use Disorder · Yale University | Phase 1 | Active, not recruiting | Feb 4, 2022 |
| National Pregnancy Registry for Psychiatric MedicationsPregnant Women, Psychotropic Drugs · Massachusetts General Hospital | — | Recruiting | Nov 23, 2010 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 19, 2019 | ZulressoNDA 211371 · New molecular entity | Sage Therap Supernus | 8 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
