Roughly 22 million people in the U.S. have common warts, and not one of them has access to an FDA-approved prescription treatment. Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), based in West Chester, Pennsylvania, announced on August 27, 2026 that it has completed enrollment in COVE-2, the first of two pivotal Phase 3 trials evaluating whether YCANTH® (VP-102, cantharidin) can become that treatment, with topline data expected in the first quarter of 2027.
President and CEO Jayson Rieger, PhD, MBA, said: “I am very pleased to announce substantial progress in our global Phase 3 program seeking to expand the label for YCANTH® to include common warts. We have now completed enrollment in the first pivotal trial, COVE-2, after conducting a per-protocol interim analysis evaluating powering assumptions. The interim analysis confirms that no additional subjects are recommended. We have also achieved greater than 50% of the current targeted enrollment in the second pivotal trial, COVE-3, ahead of schedule. I would like to recognize the significant effort by all involved and especially our development partner for the program, Torii Pharmaceutical,” Dr. Rieger continued.
How the Torii Partnership Splits the Bill
The global Phase 3 program consists of two double-blind, randomized, vehicle-controlled studies, COVE-2 and COVE-3, evaluating YCANTH® when applied once every 21 days for up to four applications in patients age 2 and older with common warts. COVE-3 is enrolling patients in both the U.S. and Japan, has exceeded 50% of its target enrollment, and its data is expected by mid-2027. The trials are run under Verrica’s partnership with Torii Pharmaceutical Co., Ltd. (referred to in Japan as VP-102/TO-208), a subsidiary of Shionogi, which is splitting Phase 3 costs with Verrica on a 50/50 basis and funding the first $40 million of trial costs, roughly 90% of the current budget. Verrica’s share is expected to be repaid through future transfer price payments, milestones, and royalties from YCANTH® sales in Japan.
Why Common Warts Could Be a Multibillion-Dollar Opportunity
In the United States, approximately 50% of the patients who seek treatment for common warts are children, and with a prevalence of approximately 22 million patients in the U.S. alone and no FDA-approved prescription drug therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity.
Chief Medical Officer Noah L. Rosenberg, M.D., said: “Patients often try minimally effective over-the-counter therapies, with limited success and frequent recurrence of warts.” YCANTH is already FDA-approved to treat molluscum contagiosum in patients age 2 and older; a successful Phase 3 program would make it the first FDA-approved prescription drug treatment for common warts as well.’
YCANTH®’s Existing FDA Approval
YCANTH® (VP-102) is already FDA-approved for the treatment of molluscum contagiosum in adult and pediatric patients age two and older. The product is a proprietary drug-device combination containing a GMP-controlled formulation of cantharidin, delivered through a single-use applicator designed for precise topical dosing and targeted administration. It is the first and only healthcare professional-administered product approved by the FDA for molluscum contagiosum, a common and highly contagious skin disease affecting an estimated six million people in the United States, primarily children. YCANTH® is also approved for molluscum contagiosum in Japan, based on a separate Phase 3 trial of approximately 300 patients, and is now being studied in a global Phase 3 program across the U.S. and Japan for the treatment of common warts.
About Verrica Pharmaceuticals
Verrica is a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma ASA to develop and commercialize VP-315 (ruxotemitide, formerly known as LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com.
