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 2 indications, with its most advanced program in Phase 2.[1]

Zurzuvae is one of 60 small molecule programs targeting Postpartum Depression. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Postpartum DepressionActive, not recruiting

StrokeRecruiting

Postpartum DepressionPreclinical

Active, not recruiting

StrokePhase 2

Recruiting

Competition

Competitive Landscape

150 competitors in Stroke

#DrugCompanyPhaseTrials

Zurzuvae

Biogen

Phase 2

1 2

Zometa

Pfizer

Preclinical

1 3

Savella

AbbVie

Preclinical

1 4

Proamatine

Repatha

Zantac 150

1 7

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 8

Alka-Seltzer

AAbbott

Preclinical

1 9

Haldol

DDePuy Orthopaedics

Preclinical

1 10

Inderal

Mylan Pharmaceuticals Inc

Preclinical

—

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

Timeline

Expected Milestones

Q1 2027

Recruiting

Postpartum Depression

NCT07398469

Q2 2027

Phase 2Recruiting

Stroke

NCT06759558

Clinical

Trials by Indication[1]

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

Depression, Postpartum1 trial

Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting

Completed· Biogen logo

Biogen··NCT07047820·305 enrolled

Postpartum Depression1 trial

A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use

Recruiting· Biogen logo

Biogen··NCT07398469·300 enrolled

Stroke1 trial

Allopregnanolone (Zuranolone) in Post-stroke Depression

Recruiting·DDuke University·Phase 2·NCT06759558·6 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 4, 2023

ZURZUVAE

NDA NDA217369

Oct 31, 2023

ZURZUVAE

NDA NDA217369

Jul 31, 2024

ZURZUVAE

NDA NDA217369

Apr 20, 2026

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

Q1 2027

Q2 2027

Trials by Indication[1]

Major Depressive Disorder1 trial

Depression, Postpartum1 trial

Postpartum Depression1 trial

Stroke1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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