Verrica Pharmaceuticals Achieves First U.S. Patient Dosing in COVE-3 Phase 3 Trial for Common Warts

With the first U.S. patient dosed in COVE-3, Verrica Pharmaceuticals has activated the second of two pivotal studies required to support a potential NDA submission for YCANTH (VP-102), a cantharidin-based topical that, if approved, would be the first cleared therapy for common warts in the U.S. market. For CMC and regulatory affairs leads tracking the program, the dual-geography enrollment structure carries direct implications for Chemistry, Manufacturing, and Controls submissions across two regulatory jurisdictions simultaneously.

The COVE-3 study enrolls patients in both the U.S. and Japan, while the parallel COVE-2 trial remains U.S.-only. Both are double-blind, randomized, vehicle-controlled studies evaluating VP-102 applied once every 21 days for up to four applications in patients aged two years and older. Verrica's Japanese development partner, Torii Pharmaceutical, a wholly-owned subsidiary of Shionogi, dosed its first Japanese patient in COVE-3 last week, triggering concurrent regulatory timelines under the Pharmaceuticals and Medical Devices Agency (PMDA) alongside the FDA pathway.

The cost-sharing arrangement is structurally relevant to manufacturing investment planning: Torii funds the first $40 million of Phase 3 trial costs on a 50/50 split basis, representing approximately 90% of the current trial budget, with Verrica's portion expected to be offset against future milestones and royalties from Japanese sales. That structure limits Verrica's near-term cash exposure but ties scale-up capital decisions closely to enrollment velocity and interim data readouts.

Phase 2 COVE-1 data, which underpinned the Phase 3 program design, showed 51% complete wart clearance at Day 84 in Cohort 2 (18 of 35 subjects), with adverse events limited to local cutaneous reactions and no serious adverse events reported. The open-label design of COVE-1 means the randomized, vehicle-controlled COVE-2 and COVE-3 studies carry the full evidentiary weight for registration. COVE-2 enrollment has already exceeded 50% of its targeted patient count in the U.S., and a long-term follow-up study, COVE-4, is also enrolling U.S. patients concurrently.

For plant heads and QA directors, the simultaneous U.S./Japan approval strategy means process validation packages and batch release specifications will need to satisfy both 21 CFR Part 211 and Japanese GMP standards, a dual-compliance burden that typically surfaces during late-stage CMC alignment between partners. Verrica retains global rights to YCANTH for all indications and territories outside Japan, which concentrates manufacturing oversight responsibility on the U.S. side of the partnership.

The measurable checkpoint ahead is full enrollment completion across COVE-2 and COVE-3, after which topline efficacy data will determine whether the program supports concurrent NDA and JNDA filings.

Source: Verrica Pharmaceuticals Inc. via GlobeNewswire, June 22, 2026.