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Zuranolone

FDA-approved product (capsule, oral), marketed as Zurzuvae.

Registered studies
17
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Zuranolone
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
FDA pharmacologic class
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA47.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli43.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae39.3% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis42.5% AI-predicted activityAt or above 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

17registered 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)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

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

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

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 Zuranolone 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.

  • Allopregnanolone (Zuranolone) in Post-stroke Depression

    NCT06759558 · start 2026-01-30

    Registered record
    Registry ID
    NCT06759558
    Conditions
    Post Stroke Depression
    Interventions
    Zuranolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-01-30
    Completion
    2027-06-30
    Enrolment
    6

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

    ConditionPost Stroke Depression
    InterventionZuranolone
    PhasePhase 2
    Registry statusRecruiting
  • A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone

    NCT07398469 · start 2025-12-22

    Registered record
    Registry ID
    NCT07398469
    Conditions
    Postpartum Depression
    Interventions
    Zuranolone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-12-22
    Completion
    2027-03-29
    Enrolment
    300

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

    ConditionPostpartum Depression
    InterventionZuranolone
    PhaseNot recorded
    Registry statusRecruiting
  • A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy

    NCT07047820 · start 2025-06-30

    Registered record
    Registry ID
    NCT07047820
    Conditions
    Depression, Postpartum
    Interventions
    Zuranolone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2025-06-30
    Completion
    2026-08-02
    Enrolment
    305

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

    ConditionDepression, Postpartum
    InterventionZuranolone
    PhaseNot recorded
    Registry statusCompleted
  • Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

    NCT05655507 · start 2023-04-19

    Registered record
    Registry ID
    NCT05655507
    Conditions
    Major Depressive Disorder
    Interventions
    Zuranolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2023-04-19
    Completion
    2024-10-18
    Enrolment
    19

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

    ConditionMajor Depressive Disorder
    InterventionZuranolone
    PhasePhase 1
    Registry statusCompleted
  • A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

    NCT04476030 · start 2020-11-09

    Registered record
    Registry ID
    NCT04476030
    Conditions
    Depressive Disorder, Major
    Interventions
    SAGE-217; Matching Placebo; Sertraline; Escitalopram; Citalopram; Duloxetine; Desvenlafaxine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-11-09
    Completion
    2021-12-22
    Enrolment
    440

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

    ConditionDepressive Disorder, Major
    InterventionSAGE-217; Matching Placebo; Sertraline; Escitalopram +3 more
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

    NCT04442503 · start 2020-06-08

    Registered record
    Registry ID
    NCT04442503
    Conditions
    Depression, Postpartum
    Interventions
    SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-06-08
    Completion
    2022-04-12
    Enrolment
    200

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

    ConditionDepression, Postpartum
    InterventionSAGE-217; Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

    NCT04442490 · start 2020-05-12

    Registered record
    Registry ID
    NCT04442490
    Conditions
    Depressive Disorder, Major
    Interventions
    SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-05-12
    Completion
    2021-04-21
    Enrolment
    543

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

    ConditionDepressive Disorder, Major
    InterventionSAGE-217; Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

    NCT04007367 · start 2019-08-06

    Registered record
    Registry ID
    NCT04007367
    Conditions
    Major Depressive Disorder
    Interventions
    SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2019-08-06
    Completion
    2020-01-06
    Enrolment
    53

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

    ConditionMajor Depressive Disorder
    InterventionSAGE-217; Placebo
    PhasePhase 3
    Registry statusTerminated
  • A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

    NCT03864614 · start 2019-02-27

    Registered record
    Registry ID
    NCT03864614
    Conditions
    Major Depressive Disorder
    Interventions
    SAGE-217
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-02-27
    Completion
    2023-06-22
    Enrolment
    1,515

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

    ConditionMajor Depressive Disorder
    InterventionSAGE-217
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia

    NCT03771664 · start 2019-02-04

    Registered record
    Registry ID
    NCT03771664
    Conditions
    Major Depressive Disorder; Insomnia
    Interventions
    SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2019-02-04
    Completion
    2020-01-17
    Enrolment
    87

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

    ConditionMajor Depressive Disorder; Insomnia
    InterventionSAGE-217; Placebo
    PhasePhase 3
    Registry statusTerminated
  • A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

    NCT03672175 · start 2018-11-19

    Registered record
    Registry ID
    NCT03672175
    Conditions
    Major Depressive Disorder
    Interventions
    SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-11-19
    Completion
    2020-03-17
    Enrolment
    581

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

    ConditionMajor Depressive Disorder
    InterventionSAGE-217; Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode

    NCT03692910 · start 2018-08-23

    Registered record
    Registry ID
    NCT03692910
    Conditions
    Bipolar Disorder I; Bipolar Disorder II; Major Depressive Episode
    Interventions
    SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2018-08-23
    Completion
    2019-05-21
    Enrolment
    35

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

    ConditionBipolar Disorder I; Bipolar Disorder II; Major Depressive Episode
    InterventionSAGE-217; Placebo
    PhasePhase 2
    Registry statusCompleted
  • A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

    NCT03284931 · start 2017-09-14

    Registered record
    Registry ID
    NCT03284931
    Conditions
    Healthy
    Interventions
    SAGE-217 high dose; Placebo; SAGE-217 low dose
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2017-09-14
    Completion
    2017-12-18
    Enrolment
    45

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

    ConditionHealthy
    InterventionSAGE-217 high dose; Placebo; SAGE-217 low dose
    PhasePhase 1
    Registry statusCompleted
  • A Study to Evaluate SAGE-217 in Participants With Essential Tremor

    NCT02978781 · start 2017-03-24

    Registered record
    Registry ID
    NCT02978781
    Conditions
    Essential Tremor
    Interventions
    SAGE-217; SAGE-217; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-03-24
    Completion
    2017-12-05
    Enrolment
    34

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

    ConditionEssential Tremor
    InterventionSAGE-217; SAGE-217; Placebo
    PhasePhase 2
    Registry statusCompleted
  • A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

    NCT02978326 · start 2017-01-04

    Registered record
    Registry ID
    NCT02978326
    Conditions
    Postpartum Depression
    Interventions
    SAGE-217 15/20 mg Oral Solution; Placebo; SAGE 217 30 mg Capsules
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-01-04
    Completion
    2018-12-11
    Enrolment
    276

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

    ConditionPostpartum Depression
    InterventionSAGE-217 15/20 mg Oral Solution; Placebo; SAGE 217 30 mg Capsules
    PhasePhase 3
    Registry statusCompleted