Sun Pharmaceutical Industries Limited announced that the Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for Winlevi (clascoterone cream 1%). Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Winlevi is approved for the topical treatment of acne vulgaris in people 12 years of age and older.

Although the exact mechanism of action for Winlevi is unknown, laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles1. Androgens are widely recognized as the most important of all hormones in terms of regulating sebum production2. Within the skin, androgens bind to androgen receptors, causing increased sebum production and inflammation 3. In particular, the skin of patients with acne vulgaris produces higher levels of the androgens testosterone and dihydrotestosterone (DHT) than the skin of healthy individuals4.

Winlevi binds to the androgen receptor competing with androgens such as DHT on cells within the sebaceous gland. Although its precise mechanism of action is unknown, studies suggest Winlevi inhibits androgen receptors5 in the skin and reduces production of sebum and inflammation. Additionally, Winlevi is rapidly metabolized in the skin, limiting systemic absorption.

Sun Pharma has received from Cosmo the exclusive right to develop and commercialize WINLEVI in US, Japan, Australia, New Zealand, Brazil, Mexico and Russia.