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Brexanolone

FDA-approved product (solution, intravenous), marketed as Zulresso.

Registered studies
26
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

Chemical structure of Brexanolone
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Depressive disorder
  • Major depressive disorder
  • Postpartum depression

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other antidepressants
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA. It was surfaced computationally for further investigation; it is not an established treatment for this infection.

AI-predicted activity

AI prediction · nothing measured
  • MRSA55.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli10.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae24.9% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis23.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

26registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.7 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.6 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.0 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.5 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Brexanolone with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study

    NCT06580444 · start 2027-01-15

    Registered record
    Registry ID
    NCT06580444
    Conditions
    Alcohol Use Disorder (AUD); Post Traumatic Stress Disorder (PTSD)
    Interventions
    Brexanolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2027-01-15
    Completion
    2027-12-31
    Enrolment
    40

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAlcohol Use Disorder (AUD); Post Traumatic Stress Disorder (PTSD)
    InterventionBrexanolone
    PhasePhase 2
    Registry statusNot yet recruiting
  • Brexanolone Lifting Outcomes Of Moms

    NCT07822321 · start 2026-09

    Registered record
    Registry ID
    NCT07822321
    Conditions
    Depression, Postpartum; Postpartum Depression (PPD); Post-partum Depression; Postnatal Depression; Post-Natal Depression; Peripartum Depression
    Interventions
    LPCN 1154A; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2026-09
    Completion
    2027-09
    Enrolment
    120

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionDepression, Postpartum; Postpartum Depression (PPD); Post-partum Depression; Postnatal Depression +2 more
    InterventionLPCN 1154A; Placebo
    PhasePhase 3
    Registry statusRecruiting
  • Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.

    NCT07079761 · start 2025-08-04

    Registered record
    Registry ID
    NCT07079761
    Conditions
    Post Traumatic Stress Disorder
    Interventions
    Experiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigm; Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer.; Experiment 1. Three-day aversive conditioning, extinction, and extinction retention testing paradigm; Matching IV Placebo; Experiment 2. Three-day aversive conditioning, reconsolidation blockade, and testing paradigm; Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer.; Experiment 2. Three-day aversive conditioning, reconsolidation blockade, and testing paradigm; Matching IV Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-08-04
    Completion
    2027-04-30
    Enrolment
    96

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPost Traumatic Stress Disorder
    InterventionExperiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigm; Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer.; Experiment 1. Three-day aversive conditioning, extinction, and extinction retention testing paradigm; Matching IV Placebo +4 more
    PhasePhase 2
    Registry statusRecruiting
  • A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD

    NCT06979544 · start 2025-06-16

    Registered record
    Registry ID
    NCT06979544
    Conditions
    Depression, Postpartum; Depression, Post-Partum; Postpartum Depression (PPD); Post-Natal Depression; Peripartum Depression; Postnatal Depression
    Interventions
    LPCN 1154A; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2025-06-16
    Completion
    2026-02-17
    Enrolment
    90

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionDepression, Postpartum; Depression, Post-Partum; Postpartum Depression (PPD); Post-Natal Depression +2 more
    InterventionLPCN 1154A; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

    NCT05223829 · start 2023-08-01

    Registered record
    Registry ID
    NCT05223829
    Conditions
    PTSD; Alcohol Use Disorder
    Interventions
    Brexanolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2023-08-01
    Completion
    2025-12-31
    Enrolment
    25

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPTSD; Alcohol Use Disorder
    InterventionBrexanolone
    PhasePhase 1
    Registry statusActive not recruiting
  • An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder

    NCT05254405 · start 2023-06-01

    Registered record
    Registry ID
    NCT05254405
    Conditions
    Post-Traumatic Stress Disorder
    Interventions
    Brexanolone Injection [Zulresso]
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2023-06-01
    Completion
    2025-12-30
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPost-Traumatic Stress Disorder
    InterventionBrexanolone Injection [Zulresso]
    PhasePhase 4
    Registry statusTerminated
  • An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

    NCT05645432 · start 2023-05-10

    Registered record
    Registry ID
    NCT05645432
    Conditions
    Tinnitus
    Interventions
    Brexanolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-05-10
    Completion
    2023-11-21
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTinnitus
    InterventionBrexanolone
    PhasePhase 2
    Registry statusCompleted
  • Study on Allopregnanolone and Depression in Perimenopausal Women

    NCT05329779 · start 2022-11-04

    Registered record
    Registry ID
    NCT05329779
    Conditions
    Depression
    Interventions
    brexanolone; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2022-11-04
    Completion
    2023-07-18
    Enrolment
    2

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionDepression
    Interventionbrexanolone; placebo
    PhasePhase 4
    Registry statusTerminated
  • Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

    NCT05543746 · start 2022-08-05

    Registered record
    Registry ID
    NCT05543746
    Conditions
    Postpartum Depression
    Interventions
    Brexanolone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-08-05
    Completion
    2023-11-15
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPostpartum Depression
    InterventionBrexanolone
    PhaseNot recorded
    Registry statusCompleted
  • Pharmacokinetic Study for IV Allopregnanolone

    NCT04468360 · start 2022-03-04

    Registered record
    Registry ID
    NCT04468360
    Conditions
    Pharmacokinetic Study; Post Traumatic Stress Disorder
    Interventions
    PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis; PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2022-03-04
    Completion
    2025-04-29
    Enrolment
    11

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPharmacokinetic Study; Post Traumatic Stress Disorder
    InterventionPK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis; PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.
    PhasePhase 2
    Registry statusTerminated
  • Effects Zulresso on Postpartum Psychosis

    NCT05314153 · start 2022-02-23

    Registered record
    Registry ID
    NCT05314153
    Conditions
    Postpartum Psychosis
    Interventions
    Brexanolone
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2022-02-23
    Completion
    2024-06-01
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPostpartum Psychosis
    InterventionBrexanolone
    PhaseEarly phase 1
    Registry statusCompleted
  • A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

    NCT05059600 · start 2021-10-08

    Registered record
    Registry ID
    NCT05059600
    Conditions
    Postpartum Depression
    Interventions
    ZULRESSO®
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-10-08
    Completion
    2022-07-14
    Enrolment
    52

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPostpartum Depression
    InterventionZULRESSO®
    PhasePhase 4
    Registry statusCompleted
  • A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

    NCT04537806 · start 2020-12-18

    Registered record
    Registry ID
    NCT04537806
    Conditions
    Acute Respiratory Distress Syndrome; COVID-19
    Interventions
    Brexanolone; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2020-12-18
    Completion
    2021-07-01
    Enrolment
    29

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Respiratory Distress Syndrome; COVID-19
    InterventionBrexanolone; Placebo
    PhasePhase 3
    Registry statusTerminated
  • A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)

    NCT04273191 · start 2020-02

    Registered record
    Registry ID
    NCT04273191
    Conditions
    Postpartum Depression
    Interventions
    Brexanolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2020-02
    Completion
    2021-08
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPostpartum Depression
    InterventionBrexanolone
    PhasePhase 4
    Registry statusWithdrawn
  • A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

    NCT03665038 · start 2018-09-07

    Registered record
    Registry ID
    NCT03665038
    Conditions
    Post Partum Depression
    Interventions
    Brexanolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-09-07
    Completion
    2021-01-08
    Enrolment
    28

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPost Partum Depression
    InterventionBrexanolone
    PhasePhase 3
    Registry statusCompleted