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Zulresso

(Brexanolone)

ApprovedSmall molecule

Zulresso is one of 172 small molecule programs targeting Tinnitus. It is currently in Approved.

5

Indications

10

Total Trials

3

Active Trials

171

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

4

Patents

Pipeline

Status by Indication[3][1]

Indication

TinnitusActive, not recruiting

Postpartum DepressionActive, not recruiting

Post-Traumatic Stress DisorderActive, not recruiting

PsychosisActive, not recruiting

Acute Respiratory Distress SyndromeActive, not recruiting

TinnitusPhase 2

Active, not recruiting

Postpartum DepressionApproved

Active, not recruiting

Post-Traumatic Stress DisorderApproved

Active, not recruiting

PsychosisPhase 1

Active, not recruiting

Acute Respiratory Distress SyndromePhase 3

Active, not recruiting

Competition

Competitive Landscape

146 competitors in Acute Respiratory Distress Syndrome

#DrugCompanyPhaseTrials

Zulresso

Medrol

Plaquenil

Alnylam Pharmaceuticals

Activase

Ultomiris

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Inomax

Vafseo

AAkebia Therapeutics

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Aurlumyn

BBTG International Inc.

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

Timeline

Expected Milestones

Q1 2027

Phase 2Not yet recruiting

Alcohol Use

NCT06580444

Clinical

Trials by Indication[1]

Postpartum Depression3 trials

A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

Completed· Supernus Pharmaceuticals, Inc. logo

Supernus Pharmaceuticals, Inc.·Phase 3·NCT03665038·28 enrolled

A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)

Withdrawn· Biogen logo

Biogen·Phase 4·NCT04273191

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

Completed·UUniversity of North Carolina, Chapel Hill··NCT05543746·10 enrolled

Post-Traumatic Stress Disorder2 trials

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

Active, not recruiting·YYale University·Phase 1·NCT05223829·25 enrolled

An Open Label Pilot Study of IV Brexanolone for the Treatment of Post-Traumatic Stress Disorder

Recruiting·DDonald Jeffrey Newport·Phase 4·NCT05254405·20 enrolled

Tinnitus1 trial

An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

Completed· Supernus Pharmaceuticals, Inc. logo

Supernus Pharmaceuticals, Inc.·Phase 2·NCT05645432·10 enrolled

Menopausal Women1 trial

Study on Allopregnanolone and Depression in Perimenopausal Women

Terminated·—·Phase 4·NCT05329779·2 enrolled

Acute Respiratory Distress Syndrome1 trial

A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

Terminated· Biogen logo

Biogen·Phase 3·NCT04537806·29 enrolled

2 more indications

Alcohol Use1 trial

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

Not yet recruiting·PPharmacotherapies for Alcohol and Substance Use Disorders Alliance·Phase 2·NCT06580444·40 enrolled

Psychosis1 trial

Effects Zulresso on Postpartum Psychosis

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT05314153·10 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 17, 2019

ZULRESSO

NDA NDA211371

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Brexanolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Brexanolone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Brexanolone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211371). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zulresso. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Biogen

Patent Landscape[5]

Patent Cliff

Mar 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8410077Mar 13, 2029

10322139Jan 23, 2033

10251894Nov 27, 2033

10940156Mar 8, 2037

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