Brexanolone Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Brexanolone comprises 12 peer-reviewed publications across 10 journals, 2 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Stress Disorders, Post-Traumatic, Tinnitus, and Depression, Postpartum. Most recent publication: Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression., J Clin Psychiatry, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. An open-label, proof-of-mechanism trial evaluating a neuroactive steroid GABA modulator in tinnitus.
    Watson LS, O'Donnell P, Bankole K, et al. · Front Neurol · 2025
    PubMed: PMID 41341514 · NCT05645432 · Tinnitus
  2. Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression.
    Kozik R, Patterson R, Andersen E, et al. · J Clin Psychiatry · 2026
    PubMed: PMID 41871269 · NCT05543746 (BRX-PPD) · Depression, Postpartum
  3. Brexanolone: First Global Approval.
    Scott LJ · Drugs · 2019
    PubMed: PMID 31006078 · NCT05314153
  4. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials.
    Meltzer-Brody S, Colquhoun H, Riesenberg R, et al. · Lancet · 2018
    PubMed: PMID 30177236 · NCT05314153
  5. Psychometric evaluation of the Stanford Sleepiness Scale.
    MacLean AW, Fekken GC, Saskin P, et al. · J Sleep Res · 2019
    PubMed: PMID 10607023 · NCT05254405 · Stress Disorders, Post-Traumatic
  6. Open-label, proof-of-concept study of brexanolone in the treatment of severe postpartum depression.
    Kanes SJ, Colquhoun H, Doherty J, et al. · Hum Psychopharmacol · 2017
    PubMed: PMID 28370307 · NCT05314153
  7. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.
    Kanes S, Colquhoun H, Gunduz-Bruce H, et al. · Lancet · 2018
    PubMed: PMID 28619476 · NCT05314153
  8. Assessing Treatment-Resistant Posttraumatic Stress Disorder: The Emory Treatment Resistance Interview for PTSD (E-TRIP).
    Dunlop BW, Kaye JL, Youngner C, et al. · Behav Sci (Basel) · 2022
    PubMed: PMID 25494488 · NCT05254405 · Stress Disorders, Post-Traumatic

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT03665038Depression, PostpartumNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)
From first dose of study drug up to end of follow-up period (up to Day 30)
Double-Blind Phase: Brexanolone3 Participants
Double-Blind Phase: Placebo4 Participants
Open-Label Phase: Brexanolone5 Participants
NCT04537806COVID-19Percentage of Participants Who Are Alive and Free of Respiratory Failure at Day 28
Day 28
Brexanolone23.1 percentage of participants
Placebo23.1 percentage of participants

Publications by year

1978–2026: 12 publications.

1978
1
1999
1
2012
1
2014
1
2017
1
2018
2
2019
2
2022
1
2025
1
2026
1

Publications by indication

Stress Disorders, Post-Traumatic (6)

  • Assessing Treatment-Resistant Posttraumatic Stress Disorder: The Emory Treatment Resistance Interview for PTSD (E-TRIP).
    Behav Sci (Basel) · 2022 · PMID 25494488 · NCT05254405
  • Psychometric evaluation of the Stanford Sleepiness Scale.
    J Sleep Res · 2019 · PMID 10607023 · NCT05254405
  • Pulse oximetry: fundamentals and technology update.
    Med Devices (Auckl) · 2014 · PMID 25031547 · NCT05254405
  • The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.
    Am J Psychiatry · 2012 · PMID 22193671 · NCT05254405
  • The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10.
    J Clin Psychiatry · 1999 · PMID 9881538 · NCT05254405

Tinnitus (1)

  • An open-label, proof-of-mechanism trial evaluating a neuroactive steroid GABA modulator in tinnitus.
    Front Neurol · 2025 · PMID 41341514 · NCT05645432

Depression, Postpartum (1)

  • Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression.
    J Clin Psychiatry · 2026 · PMID 41871269 · NCT05543746

Publications by journal

Trial-results highlights

For individuals with Postpartum Depression, a study (NCT03665038) investigated the number of participants experiencing treatment-emergent adverse events (TEAEs) from the first dose up to Day 30. In the double-blind phase of this study, the Brexanolone arm reported TEAEs in 3 participants, while the placebo arm reported TEAEs in 4 participants. In the open-label phase of the same study, the Brexanolone arm reported TEAEs in 5 participants.

In a study evaluating Brexanolone for COVID-19 (NCT04537806), a primary outcome measured the percentage of participants who were alive and free of respiratory failure at Day 28. In this study, the Brexanolone arm showed 23.1% of participants meeting this outcome, which was the same as the 23.1% reported in the placebo arm.

All values presented are sourced directly from primary registry reporting. For clinical decisions, individual published papers and detailed study reports should be consulted.

All Brexanolone publications (12)

2026 (1 paper)

  1. Temporal Dynamics of Antidepressant Response Following Brexanolone Treatment in Postpartum Depression.
    Kozik R, Patterson R, Andersen E, et al. · J Clin Psychiatry · 2026 · Derived
    PubMed: PMID 41871269 · NCT05543746 (BRX-PPD) · Depression, Postpartum

2025 (1 paper)

  1. An open-label, proof-of-mechanism trial evaluating a neuroactive steroid GABA modulator in tinnitus.
    Watson LS, O'Donnell P, Bankole K, et al. · Front Neurol · 2025 · Derived
    PubMed: PMID 41341514 · NCT05645432 · Tinnitus

2022 (1 paper)

  1. Assessing Treatment-Resistant Posttraumatic Stress Disorder: The Emory Treatment Resistance Interview for PTSD (E-TRIP).
    Dunlop BW, Kaye JL, Youngner C, et al. · Behav Sci (Basel) · 2022 · Background
    PubMed: PMID 25494488 · NCT05254405 · Stress Disorders, Post-Traumatic

2019 (2 papers)

  1. Brexanolone: First Global Approval.
    Scott LJ · Drugs · 2019 · Background
    PubMed: PMID 31006078 · NCT05314153
  2. Psychometric evaluation of the Stanford Sleepiness Scale.
    MacLean AW, Fekken GC, Saskin P, et al. · J Sleep Res · 2019 · Background
    PubMed: PMID 10607023 · NCT05254405 · Stress Disorders, Post-Traumatic

2018 (2 papers)

  1. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials.
    Meltzer-Brody S, Colquhoun H, Riesenberg R, et al. · Lancet · 2018 · Background
    PubMed: PMID 30177236 · NCT05314153
  2. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.
    Kanes S, Colquhoun H, Gunduz-Bruce H, et al. · Lancet · 2018 · Background
    PubMed: PMID 28619476 · NCT05314153

2017 (1 paper)

  1. Open-label, proof-of-concept study of brexanolone in the treatment of severe postpartum depression.
    Kanes SJ, Colquhoun H, Doherty J, et al. · Hum Psychopharmacol · 2017 · Background
    PubMed: PMID 28370307 · NCT05314153

2014 (1 paper)

  1. Pulse oximetry: fundamentals and technology update.
    Nitzan M, Romem A, Koppel R, et al. · Med Devices (Auckl) · 2014 · Background
    PubMed: PMID 25031547 · NCT05254405 · Stress Disorders, Post-Traumatic

2012 (1 paper)

  1. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.
    Posner K, Brown GK, Stanley B, et al. · Am J Psychiatry · 2012 · Background
    PubMed: PMID 22193671 · NCT05254405 · Stress Disorders, Post-Traumatic

1999 (1 paper)

  1. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10.
    Sheehan DV, Lecrubier Y, Sheehan KH, et al. · J Clin Psychiatry · 1999 · Background
    PubMed: PMID 9881538 · NCT05254405 · Stress Disorders, Post-Traumatic

1978 (1 paper)

  1. Assessing the impact of life changes: development of the Life Experiences Survey.
    Sarason IG, Johnson JH, Siegel JM, et al. · J Consult Clin Psychol · 1978 · Background
    PubMed: PMID 701572 · NCT05254405 · Stress Disorders, Post-Traumatic

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).