Clascoterone (Winlevi)
First topical antiandrogen targeting root cause of acne & hair loss
About This Treatment
Clascoterone (Winlevi) is the world's first FDA-approved topical androgen receptor inhibitor. It directly blocks androgens from stimulating sebaceous glands at the skin surface. Unlike symptom-management acne treatments, it addresses the hormonal root cause.
EMA approved in 2025. Phase III hair loss trials show 5.39× hair count improvement vs placebo.
Mechanism of Action
Clascoterone is a steroidal androgen receptor antagonist that competitively inhibits DHT binding at the skin level. Blocks DHT signaling in sebaceous glands, suppressing sebum production and inflammatory cytokines. Minimal systemic absorption avoids side effects of oral antiandrogens (sexual dysfunction, etc.).
Indications
Expected Results
FDA approved (August 2020) for mild-moderate acne. December 2025 Phase III hair trial: 5.39× (Study 1) and 1.68× (Study 2) relative improvement in hair count vs placebo. Minimal systemic side effects.
Clinical Evidence
Risks & Side Effects
Mild irritation/dryness at application site. Contact dermatitis (rare). Extremely low systemic absorption but long-term hormonal effects still monitored. Hair loss formulation still investigational (as of Dec 2025). Prescription required.
Interested in this treatment?
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