14 completed, 3 terminated, 1 active not recruiting, 1 approved for marketing. 7 Phase 2, 7 Phase 3, 4 Phase 4, 2 Phase 1, 1 Early Phase 1.
Follow brexanolone: new trials by email Literature Review of brexanolone trials Research Report on brexanolone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study Brexanolone - Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD) | Phase 2 | Not yet recruiting | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | 40 | 2027-01-15 | 2026-09-21 |
| Brexanolone Lifting Outcomes Of Moms LPCN 1154A, Placebo - Depression, Postpartum, Postpartum Depression (PPD) | Phase 3 | Recruiting | Lipocine Inc. | 120 | 2026-09-01 | 2026-09-16 |
| A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD LPCN 1154A, Placebo - Depression, Postpartum, Depression, Post-Partum | Phase 3 | Completed | Lipocine Inc. | 90 | 2025-06-16 | 2026-02-24 |
| Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder Brexanolone - PTSD, Alcohol Use Disorder | Phase 1 | Active not recruiting | Yale University | 25 | 2023-08-01 | 2025-10-14 |
| An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder Brexanolone Injection [Zulresso] - Post-Traumatic Stress Disorder | Phase 4 | Terminated | Donald Jeffrey Newport | 10 | 2023-06-01 | 2026-05-22 |
| An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus Brexanolone - Tinnitus | Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 10 | 2023-05-10 | 2025-09-15 |
| Study on Allopregnanolone and Depression in Perimenopausal Women brexanolone, placebo - Depression | Phase 4 | Terminated | Brigham and Women's Hospital | 2 | 2022-11-04 | 2026-01-22 |
| Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression Brexanolone - Postpartum Depression | Completed | University of North Carolina, Chapel Hill | 10 | 2022-08-05 | 2025-01-28 | |
| Effects Zulresso on Postpartum Psychosis Brexanolone - Postpartum Psychosis | Early Phase 1 | Completed | University of North Carolina, Chapel Hill | 10 | 2022-02-23 | 2024-08-26 |
| A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting ZULRESSO® - Postpartum Depression | Phase 4 | Completed | Supernus Pharmaceuticals, Inc. | 52 | 2021-10-08 | 2025-09-15 |
| A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) Brexanolone, Placebo - Acute Respiratory Distress Syndrome, COVID-19 | Phase 3 | Terminated | Sage Therapeutics | 29 | 2020-12-18 | 2022-08-19 |
| A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) Brexanolone - Postpartum Depression | Phase 4 | Withdrawn | Sage Therapeutics | 2020-02-01 | 2020-08-18 | |
| A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) Brexanolone - Post Partum Depression | Phase 3 | Completed | Supernus Pharmaceuticals, Inc. | 28 | 2018-09-07 | 2025-09-15 |
| A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) Placebo, SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h - Postpartum Depression | Phase 3 | Completed | Supernus Pharmaceuticals, Inc. | 138 | 2016-08-01 | 2025-10-14 |
| A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) Placebo, SAGE-547 90 μg/kg/h - Postpartum Depression | Phase 3 | Completed | Supernus Pharmaceuticals, Inc. | 108 | 2016-07-01 | 2025-09-15 |
| A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression SAGE-547, Placebo - Severe Postpartum Depression | Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 21 | 2015-12-15 | 2025-09-15 |
| Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone Allopregnanolone - Fragile X-associated Tremor/Ataxia Syndrome | Phase 2 | Completed | Randi J. Hagerman, MD | 6 | 2015-10-01 | 2018-12-06 |
| A Study With SAGE-547 for Super-Refractory Status Epilepticus SAGE-547, Placebo - Super-Refractory Status Epilepticus | Phase 3 | Completed | Supernus Pharmaceuticals, Inc. | 132 | 2015-06-01 | 2025-10-14 |
| Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression SAGE-547 - Postpartum Depression | Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 4 | 2015-01-07 | 2025-09-15 |
| Evaluate SAGE-547 in Participants With Essential Tremor SAGE-547, Placebo - Essential Tremor | Phase 2 | Completed | Sage Therapeutics | 25 | 2014-09-23 | 2022-06-29 |
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Depression, Postpartum (11) · Stress Disorders, Post-Traumatic (3) · Alcoholism (2) · Depression (2) · Alcohol Drinking (1) · COVID-19 (1) · Essential Tremor (1) · Fragile X Tremor Ataxia Syndrome (1) · Respiratory Distress Syndrome (1) · Status Epilepticus (1) · Tinnitus (1) · Wounds and Injuries (1)
Supernus Pharmaceuticals, Inc. (11) · Sage Therapeutics (3) · Lipocine Inc. (2) · University of North Carolina, Chapel Hill (2) · Brigham and Women's Hospital (1) · Donald Jeffrey Newport (1) · Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (1) · Randi J. Hagerman, MD (1) · Yale University (1)
United States (19) · Austria (1) · Canada (1) · Denmark (1) · Estonia (1) · Finland (1) · France (1) · Germany (1) · Hungary (1) · Israel (1) · Italy (1) · Netherlands (1) · Serbia (1) · Spain (1) · Sweden (1)
Helen Colquhoun, MD (2) · Robert Lasser, MD, MBA (2) · Stephen J Kanes, MD, PhD (2) · Donald J Newport, MD (1) · Eric Rosenthal, MD (1) · Henrikas Vaitkevicius, MD (1) · MacKenzie R Peltier, PhD (1) · MacKenzie R. Peltier, Ph.D. (1) · Mark Wainwright, MD, PhD (1) · Randi J Hagerman, MD (1) · Samantha Meltzer-Brody, MD, MPH (1) · Susan Girdler, PhD (1)
PMID 33181049, PMID 30177236, PMID 28619476, PMID 41341514, PMID 41871269
2017 (1), U54AA027989 (1)