West Chester-based Verrica Pharmaceuticals has finished enrolling patients in its first pivotal Phase 3 trial of YCANTH for common warts.
No prescription drug is FDA-approved for the condition. Verrica estimates common warts affect about 22 million Americans, and about half of patients seeking treatment are children.
The drugmaker announced Thursday, Aug. 27 that enrollment in COVE-2, the U.S.-only trial, is complete. An independent statistician conducted an interim power analysis and confirmed no additional patients are needed. Verrica (Nasdaq: VRCA) said it expects topline results in the first quarter of 2027.
YCANTH is already FDA-approved for molluscum contagiosum, a viral skin condition, in patients ages 2 and older. The drug-device combination delivers a controlled dose of cantharidin through a single-use topical applicator.
"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," Chief Medical Officer Noah L. Rosenberg said in the announcement.
A second pivotal trial, COVE-3, has surpassed 50% of its target enrollment ahead of schedule, according to the company. That study is enrolling patients in both the U.S. and Japan, with topline data expected by mid-2027. The broader program also includes a long-term follow-up study and a pharmacokinetics study.
Verrica is running the Phase 3 program with Japan-based Torii Pharmaceutical Co. Ltd., a subsidiary of Shionogi & Co. Ltd. The two companies split costs evenly, but Torii is funding the first $40 million of trial expenses. Verrica said that covers roughly 90% of the program's current budget. If the trials succeed, Verrica plans to seek U.S. approval while Torii pursues approval in Japan.
The enrollment milestone comes weeks after Verrica reported a $13.2 million second-quarter loss on Aug. 13. Revenue fell to $5.9 million from $12.7 million a year earlier, largely because a one-time $8 million licensing payment from Torii in 2025 did not repeat. U.S. product revenue from YCANTH rose 12.3% to $5.1 million, and dispensed applicator units hit a record 19,626, up 46.1% year over year.
"Demand for YCANTH continues to accelerate," President and CEO Jayson Rieger said in August when the company reported those quarterly results.
Verrica also secured a credit line of up to $27.5 million on Aug. 6 from an entity controlled by Chairman Paul B. Manning. The company said the facility could extend its cash runway into 2028.







