Zulresso

(Brexanolone)

ApprovedSmall molecule

PPresage Biosciences

Zulresso is one of 68 small molecule programs targeting Postpartum Depression. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Postpartum DepressionWithdrawn

Post-Traumatic Stress DisorderRecruiting

Postpartum DepressionApproved

Withdrawn

Post-Traumatic Stress DisorderApproved

Recruiting

Competition

Competitive Landscape

61 competitors in Post-Traumatic Stress Disorder

#DrugCompanyPhaseTrials

Lexapro

AbbVie

Approved

5 2

Minipress

Pfizer

Approved

4 3

Epidiolex

Jazz Pharmaceuticals

Approved

2 4

Revia

Teva

Approved

1 5

Marinol

Jazz Pharmaceuticals

Approved

1 6

Ritalin

Novartis

Approved

1 7

Namenda

AbbVie

Approved

1 8

Zoloft

VViatris Specialty LLC

Approved

7 9

Inderal

WWyeth-Lederle Vaccines

Approved

5 10

Estrace

Novo Nordisk

Approved

—

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 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Withdrawn· Biogen logo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

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

Post-Traumatic Stress Disorder2 trials

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

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

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

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

Menopausal Women1 trial

Study on Allopregnanolone and Depression in Perimenopausal Women

Terminated·—·Phase 4·NCT05329779·2 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 — Presage Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

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

Zulresso

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Postpartum Depression3 trials

Post-Traumatic Stress Disorder2 trials

Tinnitus1 trial

Acute Respiratory Distress Syndrome1 trial

Menopausal Women1 trial

Alcohol Use1 trial

Psychosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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