Verrica Completes Enrollment in Phase 3 YCANTH Common Warts Trial

Verrica Pharmaceuticals Inc has completed enrollment in COVE-2, the first pivotal phase 3 trial in its global program evaluating YCANTH (VP-102; Verrica Pharmaceuticals) for the treatment of common warts. A per-protocol interim statistical power analysis conducted by an independent statistician determined that no additional patients were recommended for full enrollment. COVE-3, the second pivotal phase 3 trial, has exceeded 50% of its current target enrollment.¹

Verrica expects topline data from COVE-2 in the first quarter of 2027, with remaining topline data from the phase 3 program anticipated by mid-2027.¹

Common Warts Represent Significant Unmet Need

Common warts affect an estimated 22 million patients in the United States, and there are currently no FDA-approved prescription drug therapies for the condition. YCANTH, a drug-device combination product containing cantharidin, is already FDA approved for the treatment of molluscum contagiosum in adult and pediatric patients aged 2 years and older. If the phase 3 program is successful, a common warts indication could make YCANTH the first FDA-approved prescription drug treatment for the condition.¹

COVE-2 and COVE-3 Trial Design

COVE-2 and COVE-3 are double-blind, randomized, vehicle-controlled studies evaluating the efficacy and safety of VP-102/TO-208 administered once every 21 days for up to 4 applications in patients aged 2 years and older with common warts. COVE-2 enrolled patients exclusively in the United States, whereas COVE-3 is enrolling patients in the United States and Japan.¹

The interim analysis was conducted by an independent statistician, and COVE-2 remains fully blinded to Verrica and the study team. Based on results from the phase 3 program, Verrica and its Japanese development partner, Torii Pharmaceutical Co, Ltd, a wholly owned subsidiary of Shionogi & Co, Ltd, intend to seek marketing approval in the United States and Japan, respectively.¹

The phase 3 program follows COVE-1, a phase 2 study that, according to Verrica, demonstrated clinically meaningful findings including reductions in the number of common warts, complete clearance among some patients, and durability of clearance.¹

Global YCANTH Development Program

In addition to the 2 pivotal trials, the global phase 3 program includes COVE-4, a supportive long-term follow-up study, and COVE-5, a pharmacokinetics study. Because COVE-2 remains blinded and COVE-3 is still enrolling, the current announcement does not include efficacy or safety results from either pivotal phase 3 trial.

Verrica and Torii Share Phase 3 Development Costs

Verrica and Torii will split costs of the global phase 3 program on a 50/50 basis. Torii will fund the first $40 million in trial costs, representing approximately 90% of the current trial budget. Verrica's portion is expected to be paid through future transfer price payments, milestones, and royalties arising from YCANTH sales in Japan.¹

YCANTH is also approved in Japan for molluscum contagiosum based on a separate phase 3 study involving approximately 300 patients.¹

Approximately 50% of US patients who seek treatment for common warts are children, according to Verrica.¹

Verrica Highlights Phase 3 Enrollment Progress

"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," Jayson Rieger, PhD, MBA, president and chief executive officer of Verrica, said in the announcement. "We have also achieved greater than 50% of the current targeted enrollment in the second pivotal trial, COVE-3, ahead of schedule."

Noah L. Rosenberg, MD, chief medical officer of Verrica, highlighted the lack of approved prescription options for patients with common warts.

"Patients often try minimally effective over-the-counter therapies, with limited success and frequent recurrence of warts," Rosenberg said. "If the Phase 3 program is successful, YCANTH has the potential to become the first FDA-approved prescription drug treatment for common warts, one of the largest unmet needs in dermatology."¹

Potential Commercial Expansion for YCANTH

If phase 3 results support a label expansion, Verrica plans to leverage its existing YCANTH sales and marketing infrastructure, clinician and key opinion leader relationships, and payor contacts established through the product's molluscum contagiosum indication.¹ Verrica estimates that the approximately 22-million-patient US common warts population could represent a multibillion-dollar commercial opportunity.¹

For clinicians, however, the current announcement represents an enrollment milestone rather than evidence of efficacy or safety in common warts. COVE-2 topline results expected in the first quarter of 2027 will provide the first phase 3 efficacy and safety readout from the pivotal program.

References

1. Verrica Pharmaceuticals announces completion of enrollment in first pivotal phase 3 trial (COVE-2) evaluating YCANTH for the treatment of common warts, with topline data expected Q1 2027. News release. Verrica Pharmaceuticals Inc. August 27, 2026. Accessed August 27, 2026. https://verrica.com/press_release/
2. Verrica Pharmaceuticals Inc. YCANTH (VP-102) prescribing information and corporate overview. Accessed August 27, 2026. https://www.verrica.com