In August, Italian pharmaceutical company Cassiopea SpA submitted a New Drug Application to the FDA for marketing
approval of clascoterone cream 1% for acne treatment. If approved, the topical androgen receptor inhibitor would be the first new mechanism of action in acne in nearly four decades.
Clascoterone 1% cream is in late stage development for acne treatment and in a higher strength solution for androgenetic alopecia. Once applied to the skin’s surface, clascoterone penetrates the skin to reach the androgen receptors within the sebaceous glands and hair follicles, according to a Cassiopea news release announcing the New Drug Application on August 20, 2019.
“Clascoterone is an exciting new drug, as it is based on a novel mechanism of action for a topical agent, targeting androgen receptors,” says Lawrence Eichenfield, M.D., chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital — San Diego, and a clascoterone 1% cream study investigator.
“The cream is designed as a small molecule to target the sebaceous gland. We know that androgen receptors mediate dihydrotestosterone, which appears to be an important driver of acne.”
Clascoterone acts as a local, selective androgen inhibitor, limiting the acnegenic effects of androgens on sebum production and inflammation, according to Cassiopea SpA.
Dr. Eichenfield has consulting and/or research ties to Allergan, Almirall, Cassiopeia, Dr. Reddy, DS Laboratories, Galderma, LEO Pharma, Lilly, Novan, Otsuka Pharmaceutical Co., Pfizer, Sanofi-Regeneron, Ortho Dermatologics/Valeant, and Vyome