WINLEVI (clascoterone)
Winlevi is a topical cream that treats acne vulgaris in adults and adolescents 12 years of age and older. It helps patients with this skin condition by functioning as an androgen receptor inhibitor. This medication is used to manage common acne through direct application to the skin.
How WINLEVI Works
Clascoterone works by inhibiting androgen receptors. While the specific process by which this action improves acne is currently unknown, the drug functions as a localized androgen receptor inhibitor.
Details
- Status
- Prescription
- First Approved
- 2020-08-26
- Patent Cliff
- 2030
- Routes
- TOPICAL
- Dosage Forms
- CREAM
WINLEVI Approval History
What WINLEVI Treats
1 indicationsWINLEVI is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
WINLEVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to WINLEVI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06403501 | LWY23090C | Ph 3 | recruiting | Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris |
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.
WINLEVI FDA Label Details
Indications & Usage
FDA Label (PDF)WINLEVI is indicated for the treatment of Acne Vulgaris.
WINLEVI Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for WINLEVI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • 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.