ZURZUVAE (zuranolone)
ZURZUVAE is indicated for the treatment of Postpartum Depression.
How ZURZUVAE Works
Zuranolone functions as a positive allosteric modulator of gamma-aminobutyric acid (GABA) A receptors. While the exact mechanism of action in treating postpartum depression is not fully understood, the drug is thought to achieve its therapeutic effect through this modulation. By acting on these specific biological targets, the medication influences the GABAergic system.
Details
- Status
- Prescription
- First Approved
- 2023-08-04
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ZURZUVAE Approval History
What ZURZUVAE Treats
1 indicationsZURZUVAE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postpartum Depression
ZURZUVAE Boxed Warning
IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of dr...
WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE [see Warnings and Precautions ( 5.1 )] . WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES See full prescribing information for complete boxed warning. ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects. Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration. Patients may not be able to assess their own driving competence or the degree of impairment caused by ZURZUVAE ( 5.1 , 5.2 ) .
ZURZUVAE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06759558 ALLO in PSD | Pro00118406 | Ph 2 | recruiting | Allopregnanolone (Zuranolone) in Post-stroke Depression |
| NCT05655507 | 217-CLP-118 NCT05655507 | Ph 1 | completed | Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD) |
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.
ZURZUVAE FDA Label Details
Indications & Usage
FDA Label (PDF)ZURZUVAE is indicated for the treatment of Postpartum Depression.
WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . Advise patients not to drive or engage in other potentially hazardous activi...
ZURZUVAE Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZURZUVAE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 45 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.