First Patient Dosed in Phase 3 VP-102 Common Warts Program

Verrica Pharmaceuticals Inc recently announced the initiation of a global phase 3 clinical development program evaluating VP-102 for the treatment of common warts, with the first patient dosed in December 2025. This milestone represents an expansion of the clinical development strategy for VP-102 beyond its currently approved indication for molluscum contagiosum and reflects ongoing efforts to address unmet therapeutic needs in dermatology.¹

Background and Unmet Need

Common warts (verruca vulgaris) are benign epidermal proliferations caused by human papillomavirus (HPV) infection. They are highly prevalent, with an estimated 22 million affected individuals in the United States alone. Children represent a substantial proportion of patients seeking care, accounting for approximately half of treated cases. Despite their prevalence, there are currently no therapies approved by the US FDA specifically for the treatment of common warts. Management typically relies on off-label or destructive approaches such as cryotherapy, salicylic acid preparations, curettage, or immunomodulatory techniques, which can be painful, require multiple visits, and yield variable outcomes.²

The absence of standardized, approved pharmacologic therapies underscores the clinical need for treatments that are both effective and suitable for pediatric and adult populations.

Phase 2 Data

The phase 3 program in common warts is informed by results from the phase 2 COVE-1 clinical trial. COVE-1 was an open-label study evaluating the safety and efficacy of VP-102 in patients with up to 6 common warts. The trial included 2 cohorts, with the primary efficacy analysis conducted at day 84 and extended follow-up through day 147.

Topline results from cohort 2 showed that 51% of treated subjects (18 of 35) achieved complete clearance of all treatable warts at day 84. Assessments were conducted across study visits over a 12-week treatment period. Reported adverse events were primarily localized cutaneous reactions, which are consistent with the known pharmacologic effects of cantharidin. No serious adverse events were observed in the study.

While the open-label design and relatively small sample size limit definitive conclusions, the observed clearance rates provided the rationale for advancing to a larger, controlled phase 3 program.

Phase 3 Program Design and Collaboration

The newly initiated global phase 3 program will further evaluate the safety and efficacy of VP-102 in patients with common warts. The study is being conducted in collaboration with Torii Pharmaceutical, Verrica’s partner in Japan. Under the terms of the collaboration, Torii will share development costs on a 50/50 basis and fund the first $40 million of trial expenses, representing approximately 90% of the current projected trial budget. Verrica’s portion of costs is expected to be offset through future milestones and royalties related to VP-102 in Japan.

This cost-sharing arrangement reduces near-term financial risk for Verrica while supporting a development program intended to support potential regulatory submissions in multiple regions, including the United States, Japan, and potentially the European Union.

VP-102

VP-102 is a proprietary drug-device combination product containing a pharmaceutical-grade, GMP-controlled formulation of cantharidin, delivered through a single-use applicator designed to allow precise topical dosing and targeted lesion application. Cantharidin has a long history of use in dermatology but, until recently, had not been available as an FDA-approved, standardized product.

VP-102 is currently approved in the United States for the treatment of molluscum contagiosum in adult and pediatric patients aged 2 years and older. Approval was based on 2 phase 3 randomized clinical trials involving approximately 500 patients, which demonstrated safety and efficacy for complete lesion clearance. The product is administered by health care professionals and is widely covered by insurance plans in the US, with patient assistance programs available for eligible individuals.

Clinical and Commercial Implications

If successful, VP-102 could become the first therapy approved in both the US and Japan specifically for the treatment of common warts. From a clinical perspective, an approved, standardized, health care professional–administered therapy could offer a more predictable and potentially less burdensome treatment option compared with existing off-label approaches.

From a market standpoint, Verrica estimates that the prevalence of common warts and the absence of approved therapies represent a significant commercial opportunity. The company has noted potential synergies with its existing VP-102 commercial infrastructure for molluscum contagiosum, given overlapping prescriber bases and patient populations, particularly in pediatric dermatology.

Conclusion

The dosing of the first patient in the global phase 3 program marks a significant step in the clinical development of VP-102 for common warts. While further data from larger, controlled trials will be required to confirm efficacy and safety, the phase 2 results provide preliminary evidence supporting continued investigation. The program reflects broader efforts within dermatology to move beyond empiric and destructive treatments toward standardized, evidence-based therapies for highly prevalent skin conditions.

References

1. Verrica Pharmaceuticals announces first patient dosed in phase 3 program evaluating YCANTH® (VP-102) for the treatment of common warts. News release. Published January 7, 2026. Accessed January 7, 2026. https://www.globenewswire.com/news-release/2026/01/07/3214452/0/en/Verrica-Pharmaceuticals-Announces-First-Patient-Dosed-in-Phase-3-Program-Evaluating-YCANTH-VP-102-for-the-Treatment-of-Common-Warts.html
2. Zhu P, Qi RQ, Yang Y, et al. Clinical guideline for the diagnosis and treatment of cutaneous warts (2022). J Evid Based Med. 2022. doi: 10.1111/jebm.12494.