Brexanolone Clinical Trials (2026): 11 Studies for Postpartum Depression & Alcohol Use Disorder

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

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

Phaseactive not recruitingcompletedterminatedwithdrawnnot yet recruitingapproved for marketingTotal
Early P111
P111
P2112
P3112
P4213
N/A112

Recruiting Brexanolone clinical trials (1)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT06580444Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding StudyP2Alcohol Use Disorder (AUD)40Jul 2025

Brexanolone clinical trials by indication

Postpartum Depression (3)

NCTAcronymPhaseStatusTitle
NCT05543746BRX-PPDN/AcompletedDynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
NCT04273191P4withdrawnA Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
NCT03924492N/Aapproved for marketingExpanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression

Alcohol Use Disorder (AUD) (1)

NCTAcronymPhaseStatusTitle
NCT06580444P2not yet recruitingBrexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study

PTSD (1)

NCTAcronymPhaseStatusTitle
NCT05223829P1active not recruitingUtility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

Post-Traumatic Stress Disorder (1)

NCTAcronymPhaseStatusTitle
NCT05254405P4terminatedAn Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder

Tinnitus (1)

NCTAcronymPhaseStatusTitle
NCT05645432P2completedAn Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

Depression (1)

NCTAcronymPhaseStatusTitle
NCT05329779P4terminatedStudy on Allopregnanolone and Depression in Perimenopausal Women

Postpartum Psychosis (1)

NCTAcronymPhaseStatusTitle
NCT05314153Early P1completedEffects Zulresso on Postpartum Psychosis

Acute Respiratory Distress Syndrome (1)

NCTAcronymPhaseStatusTitle
NCT04537806ARDSP3terminatedA Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

Post Partum Depression (1)

NCTAcronymPhaseStatusTitle
NCT03665038PPDP3completedA 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
ARDSNCT04537806P3terminatedAcute Respiratory Distress Syndrome29
PPDNCT03665038P3completedPost Partum Depression28

Terminated and withdrawn Brexanolone trials (4)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06580444Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding StudyP2not yet recruiting40Pharmacotherapies for Alcohol and Substance Use Disorders AllianceJul 2025
NCT05223829Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress DisorderP1active not recruiting25Yale UniversityAug 2023
NCT05254405An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress DisorderP4terminated10Donald Jeffrey NewportJun 2023
NCT05314153Effects Zulresso on Postpartum PsychosisEarly P1completed10University of North Carolina, Chapel HillFeb 2022
NCT05645432An Open-Label Study Evaluating Brexanolone in Adults With TinnitusP2completed10Supernus Pharmaceuticals, Inc.May 2023
NCT05543746BRX-PPDDynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depressioncompleted10University of North Carolina, Chapel HillAug 2022
NCT05329779Study on Allopregnanolone and Depression in Perimenopausal WomenP4terminated2Brigham and Women's HospitalNov 2022
NCT04273191A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)P4withdrawn0Sage TherapeuticsFeb 2020
NCT04537806ARDSA Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)P3terminated29Sage TherapeuticsDec 2020
NCT03665038PPDA Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)P3completed28Supernus Pharmaceuticals, Inc.Sep 2018
NCT03924492Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depressionapproved for marketing0Supernus 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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