Primary completion· ClinicalTrials.gov
Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
Brexanolone History and Updates
37 events · 2018 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
37
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-25Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Brexanolone since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (1)
2026
- Results postedBrexanolone Study for Perimenopausal Depression Terminated Early· Jan 22, 2026
Upcoming & expected milestones
Past events
2026
Results posted· ClinicalTrials.gov
Study on Allopregnanolone and Depression in Perimenopausal Women
2025
Primary completion· ClinicalTrials.gov
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
Primary completion· ClinicalTrials.gov
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Primary completion· ClinicalTrials.gov
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Trial started· ClinicalTrials.gov
Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
Results posted· ClinicalTrials.gov
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
2024
Results posted· ClinicalTrials.gov
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Trial registered· ClinicalTrials.gov
Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study
Primary completion· ClinicalTrials.gov
Effects Zulresso on Postpartum Psychosis
2023
Primary completion· ClinicalTrials.gov
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Primary completion· ClinicalTrials.gov
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
Trial started· ClinicalTrials.gov
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
Primary completion· ClinicalTrials.gov
Study on Allopregnanolone and Depression in Perimenopausal Women
Trial started· ClinicalTrials.gov
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Trial started· ClinicalTrials.gov
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
2022
Trial registered· ClinicalTrials.gov
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Trial started· ClinicalTrials.gov
Study on Allopregnanolone and Depression in Perimenopausal Women
Trial registered· ClinicalTrials.gov
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
Results posted· ClinicalTrials.gov
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Trial started· ClinicalTrials.gov
Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression
Results posted· ClinicalTrials.gov
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Trial registered· ClinicalTrials.gov
Study on Allopregnanolone and Depression in Perimenopausal Women
Trial registered· ClinicalTrials.gov
Effects Zulresso on Postpartum Psychosis
Trial registered· ClinicalTrials.gov
An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder
Trial started· ClinicalTrials.gov
Effects Zulresso on Postpartum Psychosis
Trial registered· ClinicalTrials.gov
Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder
2021
Primary completion· ClinicalTrials.gov
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
Primary completion· ClinicalTrials.gov
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Primary completion· ClinicalTrials.gov
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
2020
Trial started· ClinicalTrials.gov
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Trial registered· ClinicalTrials.gov
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Trial started· ClinicalTrials.gov
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
Trial registered· ClinicalTrials.gov
A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
2019
Trial registered· ClinicalTrials.gov
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
2018
Trial registered· ClinicalTrials.gov
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Trial started· ClinicalTrials.gov
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.