Japan NDA Filed for Verrica’s TO-208

Verrica Pharmaceuticals, a dermatology therapeutics company, announced that its partner, Torii Pharmaceutical, has submitted a New Drug Application (NDA) in Japan for TO-208 (VP-102/YCANTH®). This marks a critical step toward introducing the first approved treatment for molluscum contagiosum in Japan, where the condition affects an estimated 1.6 million individuals.

TO-208 contains cantharidin as its active ingredient. In Phase 3 clinical trials in Japan, the drug demonstrated superior efficacy compared to a placebo, with a safety profile consistent with previous U.S. studies and no issues of tolerability.

Torii secured exclusive rights to develop and commercialize TO-208 for molluscum and common warts in Japan through a 2021 agreement with Verrica. In the U.S., the drug received approval in July 2023 and has been marketed under the brand name YCANTH® since August. Verrica is also exploring its use in other dermatological conditions such as common and external genital warts.