WEST CHESTER, PA — Verrica Pharmaceuticals (Nasdaq: VRCA) has dosed the first U.S. patient in a second Phase 3 clinical trial evaluating YCANTH for common warts, expanding a late-stage development program targeting a dermatology market with no FDA-approved treatments and an estimated 22 million affected patients in the United States.
The company announced that enrollment has begun in the COVE-3 trial, which is being conducted in the United States and Japan. The milestone follows the recent dosing of the first Japanese patient by Verrica’s development partner, Torii Pharmaceutical.
The study is the second pivotal trial in Verrica’s global Phase 3 program designed to support potential regulatory submissions in both countries.
“We are excited to get the COVE-3 clinical trial started with the enrollment of our first patient in the U.S. and would like to congratulate our development partner, Torii Pharmaceutical, for also reaching this important and exciting clinical milestone for YCANTH in Japan,” President and Chief Executive Officer Jayson Rieger stated.
Rieger noted that the company has already surpassed 50% of its targeted enrollment in the first Phase 3 study, COVE-2, while also enrolling patients in a long-term follow-up study known as COVE-4.
The Phase 3 program consists of two randomized, double-blind, vehicle-controlled studies evaluating YCANTH, also known as VP-102, in patients ages 2 and older with common warts. Participants receive treatment every 21 days for up to four applications.
Verrica and Torii plan to seek regulatory approval in the United States and Japan, respectively, if the studies are successful.
The program follows positive results from the Phase 2 COVE-1 trial. According to the company, 51% of participants in one treatment cohort achieved complete clearance of all treatable warts after 84 days. Reported adverse events were primarily localized skin reactions, and no serious adverse events were observed.
The financial structure of the partnership substantially reduces Verrica’s near-term development burden. Torii has agreed to split Phase 3 costs equally and fund the first $40 million of trial expenses, representing approximately 90% of the program’s current budget. Verrica expects its share of costs to be covered through future milestones and royalties tied to Japanese sales.
Common warts represent a significant commercial opportunity because no FDA-approved therapies currently exist despite the condition’s prevalence. Verrica estimates that roughly half of patients seeking treatment are children.
If approved, YCANTH would become the first FDA-approved therapy for common warts in the United States and could expand the commercial reach of a product already marketed for molluscum contagiosum.
YCANTH is currently the only FDA-approved, healthcare professional-administered treatment for molluscum contagiosum in adults and children age 2 and older. The product is also approved in Japan for molluscum and is being evaluated for expanded use in common warts through the ongoing global Phase 3 program.
The company estimates that approximately 250 million people in the United States are eligible to receive insurance-covered YCANTH treatment.
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