In Phase 2 (COVE-1), YCANTH (VP-102) achieved complete clearance of all treatable common warts at Day 84 in 51% of subjects (18/35) in Cohort 2, with adverse events limited to expected local cutaneous reactions and no serious adverse events reported. Follow-up extended to Day 147.
Verrica has initiated a global Phase 3 program in common warts, dosing the first patient in December 2025. The program is backed by a cost-sharing arrangement with Torii, which will fund the first $40 million—about 90% of the current trial budget—and split overall costs 50/50. Verrica retains global rights to YCANTH outside Japan; Torii’s economics are tied to the Japanese market. YCANTH is already FDA-approved for molluscum contagiosum as a physician-administered cantharidin formulation delivered via a single-use applicator, and Verrica is positioning common warts as the next label expansion in a prevalent, largely pediatric setting where no FDA-approved prescription therapies exist.
Strategically, this is a scale and leverage play. Verrica is trying to extend an established procedural product into an adjacent, higher-volume indication that fits the same clinic workflow, sales call point, and reimbursement logic. The Torii structure de-risks trial financing and signals intent to coordinate dossier expectations across the U.S. and Japan without ceding ex-Japan upside. The tension is the evidentiary bar: the Phase 2 signal comes from an open-label design in a condition with spontaneous resolution and variable natural history. Phase 3 will need a rigorous vehicle-controlled design, blinded assessment, standardized lesion mapping, and clarity on durability to convert the signal into approvable evidence. Prior approval in molluscum helps with CMC and device-use familiarity, but it does not shortcut efficacy requirements in warts, where historical vehicle and procedural effects can be nontrivial.
For sites, this program aligns with routine dermatology operations: in-office application, predictable local AEs, and minimal equipment burden. Pediatric inclusion will drive recruitment volume but requires tight consent workflows and caregiver scheduling. Accurate lesion counting, photographic documentation, and consistent application technique are operational linchpins; sponsors and CROs should budget for robust rater training and centralized image review to mitigate assessment bias. Given the ubiquity of warts, enrollment should be tractable, but motivation can lag in a benign condition, making site engagement, visit flexibility, and modest stipends important. For CROs, this is a straightforward, geographically broad dermatology study with an emphasis on data quality over complex logistics; the main risks are heterogeneity in application practices and endpoint ascertainment.
Regulators will scrutinize complete clearance of all treatable warts versus target-lesion endpoints, time to clearance, recurrence post-clearance, and age-stratified efficacy. Safety expectations are well framed by molluscum experience, but blistering intensity, pain, and treatment discontinuation rates will be watched closely in children. On the commercial side, payer policy will weigh clinically adjudicated clearance and durability against inexpensive OTC options, office cryotherapy, and compounded cantharidin; demonstrating consistent outcomes and fewer visits could be pivotal.
Key upcoming markers include Phase 3 protocol specifics, especially control arm and blinded outcome assessment, recruitment cadence in pediatric cohorts, and any interim looks at durability. Readout timing will set the cadence for a potential supplemental filing. Execution risks center on effect-size erosion versus Phase 2, variability across regions and age groups, and operational drift in application technique. If Verrica delivers a clean, durable clearance signal with manageable tolerability, the company can credibly extend its procedural franchise while testing whether standardized, GMP cantharidin can displace entrenched, heterogenous office practices at scale.
