Brexanolone Clinical Trials (2026): 11 Studies for Postpartum Depression & Alcohol Use Disorder
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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11 Brexanolone clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 9 indications (including Postpartum Depression & Alcohol Use Disorder) and 164 total planned enrollment. 2 Phase 3 Brexanolone trials and 2 Phase 2, 3 Phase 4 are listed. 1 Brexanolone clinical trial is actively recruiting. Most recent activity: NCT06580444 (Mar 2027).
Brexanolone clinical trials at a glance: phase × recruitment status
| Phase | active not recruiting | completed | terminated | withdrawn | not yet recruiting | approved for marketing | Total |
|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | |||||
| P1 | 1 | 1 | |||||
| P2 | 1 | 1 | 2 | ||||
| P3 | 1 | 1 | 2 | ||||
| P4 | 2 | 1 | 3 | ||||
| N/A | 1 | 1 | 2 |
Recruiting Brexanolone clinical trials (1)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06580444 | Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study | P2 | Alcohol Use Disorder (AUD) | 40 | Jul 2025 |
Brexanolone clinical trials by indication
Postpartum Depression (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05543746 | BRX-PPD | N/A | completed | Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression |
| NCT04273191 | — | P4 | withdrawn | A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) |
| NCT03924492 | — | N/A | approved for marketing | Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression |
Alcohol Use Disorder (AUD) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06580444 | — | P2 | not yet recruiting | Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study |
PTSD (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05223829 | — | P1 | active not recruiting | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder |
Post-Traumatic Stress Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05254405 | — | P4 | terminated | An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder |
Tinnitus (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05645432 | — | P2 | completed | An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus |
Depression (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05329779 | — | P4 | terminated | Study on Allopregnanolone and Depression in Perimenopausal Women |
Postpartum Psychosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05314153 | — | Early P1 | completed | Effects Zulresso on Postpartum Psychosis |
Acute Respiratory Distress Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04537806 | ARDS | P3 | terminated | A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) |
Post Partum Depression (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03665038 | PPD | P3 | completed | A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) |
Brexanolone pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ARDS | NCT04537806 | P3 | terminated | Acute Respiratory Distress Syndrome | 29 | — |
| PPD | NCT03665038 | P3 | completed | Post Partum Depression | 28 | — |
Terminated and withdrawn Brexanolone trials (4)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05254405terminatedAn Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
- NCT05329779terminatedStudy on Allopregnanolone and Depression in Perimenopausal Women
- NCT04273191withdrawnA Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
- NCT04537806terminatedA Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
All Brexanolone trials (11)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06580444 | Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study | P2 | not yet recruiting | 40 | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Jul 2025 | |
| NCT05223829 | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder | P1 | active not recruiting | 25 | Yale University | Aug 2023 | |
| NCT05254405 | An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder | P4 | terminated | 10 | Donald Jeffrey Newport | Jun 2023 | |
| NCT05314153 | Effects Zulresso on Postpartum Psychosis | Early P1 | completed | 10 | University of North Carolina, Chapel Hill | Feb 2022 | |
| NCT05645432 | An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus | P2 | completed | 10 | Supernus Pharmaceuticals, Inc. | May 2023 | |
| NCT05543746 | BRX-PPD | Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression | — | completed | 10 | University of North Carolina, Chapel Hill | Aug 2022 |
| NCT05329779 | Study on Allopregnanolone and Depression in Perimenopausal Women | P4 | terminated | 2 | Brigham and Women's Hospital | Nov 2022 | |
| NCT04273191 | A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) | P4 | withdrawn | 0 | Sage Therapeutics | Feb 2020 | |
| NCT04537806 | ARDS | A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) | P3 | terminated | 29 | Sage Therapeutics | Dec 2020 |
| NCT03665038 | PPD | A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) | P3 | completed | 28 | Supernus Pharmaceuticals, Inc. | Sep 2018 |
| NCT03924492 | Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression | — | approved for marketing | 0 | Supernus Pharmaceuticals, Inc. | — |
Brexanolone clinical trials: frequently asked questions
- How many Brexanolone clinical trials are there?
- 11 Brexanolone clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 4 are marked completed.
- Are Brexanolone clinical trials recruiting in 2026?
- No active Brexanolone trials are recruiting on ClinicalTrials.gov as of the current AACT refresh. Trials may resume; this page is updated daily.
- What conditions is Brexanolone being studied for?
- Brexanolone is being studied for Postpartum Depression, Alcohol Use Disorder, Alcohol Use Disorder (AUD), COVID-19, Depression and 7 more. The trials are grouped by indication on this page.
- What phase is Brexanolone in?
- Brexanolone clinical trials span 3 Phase 4, 2 Phase 3, 2 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Brexanolone clinical trials?
- The lead sponsor across the most Brexanolone trials is Supernus Pharmaceuticals, Inc., with 6 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Brexanoloneas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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