TheraRadar
Data updated: Mar 29, 2026

ZULRESSO

BREXANOLONE
Approved 2019-03-19
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
7
Years on Market

Details

Status
Discontinued
First Approved
2019-03-19
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

SAGE THERAP
Active Ingredient: BREXANOLONE

ZULRESSO Approval History

Loading approval history...

What ZULRESSO Treats

2 FDA approvals

Originally approved for its first indication in 2019 . Covers 2 distinct patient populations.

  • Other (2)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Pro

ZULRESSO Patents & Exclusivity

Latest Patent: Mar 2037

Patents (8 active)

US10940156 Expires Mar 8, 2037
US10251894 Expires Nov 27, 2033
US10322139 Expires Jan 23, 2033
US8410077 Expires Mar 13, 2029
US9200088 Expires Mar 13, 2029
US9750822 Expires Mar 13, 2029
US7635773 Expires Mar 13, 2029
US10117951 Expires Mar 13, 2029
Source: FDA Orange Book

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: NDA211371 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.