Clascoterone

China [CN]

1. Core Uses

Approved Indication: Acne vulgaris in individuals aged 12 years and older (1% topical cream, Winlevi®, FDA approved in 2020, EMA approved in 2021)

Indications under development: Male androgenetic alopecia (AGA) (5% topical solution, Phase III clinical trials successful, significant improvement in hair count)

Mechanism: Competitively binds to androgen receptors (AR) in the pilosebaceous unit, blocking DHT-mediated sebum secretion and inflammation. Primarily acts locally with extremely low systemic absorption (blood concentration < 1 ng/mL), resulting in no systemic anti-androgen side effects.

2. Key Clinical Information

Dosage Form: 1% topical cream (acne), 5% topical solution (hair loss, under development)

Dosage and Administration: Acne: Apply thinly to the face twice daily; Hair loss: Apply to the scalp once daily

Core Advantages:

High selectivity: Only antagonizes AR, without progestogenic/estrogenic/glucocorticoid activity

Low systemic absorption: Avoids systemic side effects of oral anti-androgens (e.g., decreased libido, breast development)

Dual action: Reduces sebum secretion + anti-inflammatory effect, simultaneously improving inflammatory and non-inflammatory acne lesions