ZULRESSO (brexanolone)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2019-03-19
- Patent Cliff
- 2037
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
ZULRESSO Approval History
What ZULRESSO Treats
2 FDA approvalsOriginally approved for its first indication in 2019 . Covers 2 distinct patient populations.
- Other (2)
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05329779 results posted | 2021P003137 | Ph 4 | terminated | Study on Allopregnanolone and Depression in Perimenopausal Women |
| NCT05223829 | 2000031354 U54AA027989 | Ph 1 | active not recruiting | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder |
| NCT05645432 results posted | 547-TRM-201 | Ph 2 | completed | An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus |
| NCT03665038 results posted | 547-PPD-304 2017-004356-34 | Ph 3 | completed | A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) |
| NCT06580444 | AS210006-A09 | Ph 2 | not yet recruiting | Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study |
| NCT04537806 results posted | 547-ARD-301 | Ph 3 | terminated | A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) |
| NCT04273191 | 547-EXM-401 | Ph 4 | withdrawn | A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZULRESSO FDA Label Details
ZULRESSO Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for ZULRESSO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 8 active patents
Trial Analysis
- • 8 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment