Zuranolone

Generic Name: Zuranolone

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₃₅N_₃O_₂

CAS Number: 1632051-40-1

Unique Ingredient Identifier: 7ZW49N180B

Background: Zuranolone is a neuroactive steroid that acts as a positive allosteric modulator of the GABA receptors. Unlike other more common GABA positive allosteric modulators on the market like benzodiazepines, zuranolone can modulate both synaptic and extrasynaptic GABA conductance due to binding to a non-benzodiazepine site on the receptor. Zuranolone was designed with a pharmacological profile of a neuroactive steroid in mind while also possessing a pharmacokinetics profile of an oral, once-daily dosing formulation.

Zuranolone was approved by the FDA on August 4th, 2023, and it is currently the only approved treatment for women with postpartum depression. This approval was based on favorable results from 2 phase 3 clinical trials.

Indication: Zuranolone is indicated for the treatment of postpartum depression (PPD) in adults.

Associated Conditions: Postpartum Depression

Clinical Trials

Allopregnanolone in Post-Stroke Depression

Phase 2

Not yet recruiting

Conditions: Post Stroke Depression

Interventions: Drug: Zuranolone

First Posted Date: 2025-01-06

Last Posted Date: 2025-03-10

Lead Sponsor: Duke University

Target Recruit Count: 6

Registration Number: NCT06759558

Locations: 🇺🇸
Duke South Neurology Clinic 1L, Durham, North Carolina, United States

Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

Phase 1

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Zuranolone

First Posted Date: 2022-12-19

Last Posted Date: 2025-03-26

Lead Sponsor: Biogen

Target Recruit Count: 19

Registration Number: NCT05655507

Locations: 🇺🇸
Sage Investigational Site, Cincinnati, Ohio, United States

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Phase 3

Completed

Conditions: Depressive Disorder, Major

Interventions: Drug: Matching Placebo
Drug: SAGE-217
Drug: Sertraline
Drug: Escitalopram
Drug: Citalopram
Drug: Duloxetine
Drug: Desvenlafaxine

First Posted Date: 2020-07-17

Last Posted Date: 2023-12-22

Lead Sponsor: Biogen

Target Recruit Count: 440

Registration Number: NCT04476030

Locations: 🇺🇸
Sage Investigational Site, Bellevue, Washington, United States

A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Phase 3

Completed

Conditions: Depression, Postpartum

Interventions: Drug: Placebo
Drug: SAGE-217

First Posted Date: 2020-06-22

Last Posted Date: 2023-11-30

Lead Sponsor: Biogen

Target Recruit Count: 200

Registration Number: NCT04442503

Locations: 🇬🇧
Sage Investigational Site, Maidstone, United Kingdom
🇺🇸
Sage Investigational SIte, North Canton, Ohio, United States
🇺🇸
Sage Investigational site, Charleston, South Carolina, United States

A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

Phase 3

Completed

Conditions: Depressive Disorder, Major

Interventions: Drug: Placebo
Drug: SAGE-217

First Posted Date: 2020-06-22

Last Posted Date: 2023-12-22

Lead Sponsor: Biogen

Target Recruit Count: 543

Registration Number: NCT04442490

Locations: 🇺🇸
Sage Investigational Site, Charlottesville, Virginia, United States

A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

Phase 3

Terminated

Conditions: Major Depressive Disorder

Interventions: Drug: SAGE-217
Drug: Placebo

First Posted Date: 2019-07-05

Last Posted Date: 2023-11-29

Lead Sponsor: Biogen

Target Recruit Count: 53

Registration Number: NCT04007367

Locations: 🇺🇸
Sage Investigational Site, Everett, Washington, United States

A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: SAGE-217

First Posted Date: 2019-03-06

Last Posted Date: 2024-08-27

Lead Sponsor: Biogen

Target Recruit Count: 1515

Registration Number: NCT03864614

Locations: 🇺🇸
Sage Investigational Site, Bellevue, Washington, United States
🇺🇸
Sage Investigational site, Cincinnati, Ohio, United States

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

Phase 3

Terminated

Conditions: Major Depressive Disorder
Insomnia

Interventions: Drug: Placebo
Drug: SAGE-217

First Posted Date: 2018-12-11

Last Posted Date: 2023-11-29

Lead Sponsor: Biogen

Target Recruit Count: 87

Registration Number: NCT03771664

Locations: 🇺🇸
Sage Investigational Site, Austin, Texas, United States

A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode

Phase 2

Completed

Conditions: Bipolar Disorder I
Bipolar Disorder II
Major Depressive Episode

Interventions: Drug: SAGE-217
Drug: Placebo

First Posted Date: 2018-10-02

Last Posted Date: 2023-12-13

Lead Sponsor: Biogen

Target Recruit Count: 35

Registration Number: NCT03692910

Locations: 🇺🇸
Sage Investigational Site, Richardson, Texas, United States

A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: SAGE-217
Drug: Placebo

First Posted Date: 2018-09-14

Last Posted Date: 2023-11-29

Lead Sponsor: Biogen

Target Recruit Count: 581

Registration Number: NCT03672175

Locations: 🇺🇸
Site Investigational Site, Decatur, Georgia, United States
🇺🇸
Sage Investigational Site, Charlottesville, Virginia, United States

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