Treats acne vulgaris. Sold as Winlevi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Clascoterone (sold as Winlevi), first approved Aug 26, 2020, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Winlevi | Part D | $1.3M | +12% | 838 |
| Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne VulgarisAcne Vulgaris · Pak Emirates Military Hospital | Not applicable | Recruiting | Oct 20, 2026 |
| Clascoterone Versus Clindamycin Added to Adapalene/Benzoyl Peroxide for Moderate Facial AcneAcne Vulgaris · Allied Hospital Faisalabad | Phase 4 | Not yet recruiting | Oct 19, 2026 |
| Comparison of Topical Clascoterone and Adapalene for Mild Acne VulgarisAcne Vulgaris · Khyber Teaching Hospital | Early phase 1 | Not yet recruiting | Jun 29, 2026 |
| 1% Clascoterone Cream for the Treatment Acne VulgarisAcne Vulgaris · Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Phase 3 | Not yet recruiting | Mar 9, 2026 |
| Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform RosaceaPapular-pustular Rosacea, Papulopustular Rosacea (PPR) · Narrows Institute for Biomedical Research | Phase 2 | Recruiting | May 1, 2025 |
| A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne PatientsAcne Vulgaris · Sun Pharmaceutical Industries Limited | Phase 4 | Active, not recruiting | May 23, 2024 |
| Efficacy and Safety of Clascoterone Cream 1% in Facial Acne VulgarisAcne Vulgaris · Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Phase 3 | Recruiting | May 8, 2024 |
| Topical Anti-Androgens in Pilonidal Sinus DiseasePilonidal Disease, Pilonidal Disease of Natal Cleft · University of Pennsylvania | Phase 2 | Recruiting | Feb 29, 2024 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA