Zurzuvae

(Zuranolone)

Phase 2Small molecule

Zurzuvae is a small molecule that works as a GABA-a Receptor Positive Allosteric Modulator.[2] It is being investigated across 3 indications, with its most advanced program in Phase 2.[1]

Zurzuvae is one of 99 small molecule programs targeting Stroke. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

StrokeActive, not recruiting

Postpartum DepressionActive, not recruiting

Major Depressive DisorderActive, not recruiting

StrokePhase 2

Active, not recruiting

Postpartum DepressionPreclinical

Active, not recruiting

Major Depressive DisorderPhase 1

Active, not recruiting

Competition

Competitive Landscape

461 competitors in Stroke

#DrugCompanyPhaseTrials

Activase

Roche

Preclinical

19 2

Zurzuvae

Biogen

Phase 2

1 3

Zometa

Pfizer

Preclinical

1 4

Folvite

Eli Lilly

Preclinical

1 5

Proamatine

Pradaxa

3 7

Zantac 150

CChattem

Preclinical

1 8

Alka-Seltzer

AAbbott

Preclinical

1 9

Anticoagulant

Bayer

Preclinical

1 10

Inderal

Mylan Pharmaceuticals Inc

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Postpartum Depression

NCT07047820

Q1 2027

Recruiting

Postpartum Depression

NCT07398469

Clinical

Trials by Indication[1]

Postpartum Depression2 trials

A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone

Recruiting· Biogen logo

Biogen··NCT07398469·200 enrolled

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

Recruiting· Biogen logo

Biogen··NCT07047820·200 enrolled

Major Depressive Disorder1 trial

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

Completed· Biogen logo

Biogen·Phase 1·NCT05655507·19 enrolled

Stroke1 trial

Allopregnanolone (Zuranolone) in Post-stroke Depression

Recruiting·—·Phase 2·NCT06759558·6 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 31, 2023

ZURZUVAE

NDA NDA217369

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Zuranolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zuranolone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zuranolone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217369). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zurzuvae. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Zuranolone. U.S. National Library of Medicine.
[7]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor Positive Allosteric Modulator[2]
Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Biogen

Patent Landscape[5]

Patent Cliff

Apr 17, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10342810Apr 17, 2034

10172871Apr 17, 2034

9512165Apr 17, 2034

11884696Aug 23, 2037

11236121Aug 23, 2037

Key Publications[6]

Zuranolone in Major Depressive Disorder: CORAL Phase 3

JAMA PsychiatryJun 7, 2023DOI: 10.1001/jamapsychiatry.2023.1472

Zurzuvae

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Trials by Indication[1]

Postpartum Depression2 trials

Major Depressive Disorder1 trial

Stroke1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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