Last reviewed · How we verify
Winlevi (CLASCOTERONE)
Winlevi works by blocking the androgen receptor, a protein that helps regulate hormones in the body.
Winlevi (clascoterone) is a small molecule androgen receptor inhibitor developed by CASSIOPEA SPA and currently owned by Sun Pharm. It was FDA-approved in 2020 for the treatment of acne vulgaris by targeting the androgen receptor. Winlevi is a patented medication with no generic manufacturers available. Key safety considerations include its mechanism of action, which may affect hormone levels. As a relatively new medication, long-term safety data is limited.
At a glance
| Generic name | CLASCOTERONE |
|---|---|
| Sponsor | Sun Pharma |
| Drug class | Androgen Receptor Inhibitor [EPC] |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Clascoterone is an androgen receptor inhibitor. The mechanism of action of WINLEVI cream for the topical treatment of acne vulgaris is unknown.
Approved indications
- Acne vulgaris
Common side effects
- Erythema/redness
- Pruritus
- Scaling/dryness
- Edema
- Stinging/burning
- Skin atrophy
- Striae rubrae
- Telangiectasia
- Hyperkalemia
- Polycystic ovaries
- Amenorrhea
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (PHASE3)
- 1% Clascoterone Cream for the Treatment Acne Vulgaris (PHASE3)
- Topical Anti-Androgens in Pilonidal Sinus Disease (PHASE2)
- A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients (PHASE4)
- A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne (PHASE4)
- A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) (PHASE3)
- A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne (PHASE4)
- A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |