CANDIN Meets Primary Endpoint in Phase 3 Common Wart Trial
Key Takeaways
Nielsen BioSciences reported positive Phase 3 results for investigational immunotherapy CANDIN in common warts.
The randomized, placebo-controlled trial met its primary endpoint and several secondary endpoints, including clearance of untreated warts.
Nielsen plans to submit CANDIN to the FDA in the second half of 2026.
Nielsen BioSciences announced positive topline findings from its Phase 3 trial evaluating CANDIN (Purified Candida albicans Antigen) for the treatment of common warts (verruca vulgaris), marking what the company described as the first successfully completed randomized, placebo-controlled prospective Phase 3 study for the condition.
The multicenter study included 325 patients aged 12 years and older across sites in the United States and Japan. Participants received either intralesional CANDIN injections or saline placebo injections. According to the company, the trial achieved its primary endpoint of complete resolution of the treated wart without recurrence through 12 weeks post-injection.
Phase 3 Trial Supports Potential New Immunotherapy Option for Common Warts
Investigators also reported success across several key secondary endpoints, including fewer injections needed to achieve wart clearance and clearance of untreated warts beyond the injected lesion, findings that may support a systemic immune-mediated effect. The study additionally evaluated scarring and skin discoloration, common concerns associated with traditional wart treatments.
Topline results were presented earlier this month during a late-breaking poster session at the Society for Investigative Dermatology Annual Conference. Nielsen said it is finalizing the complete data analysis and Clinical Study Report, with plans to submit CANDIN to the FDA in the second half of 2026. If approved, the therapy could become one of the first FDA-approved immunotherapeutic options specifically indicated for HPV-driven cutaneous wart infections.
“The successful completion of this Phase 3 trial, the first ever placebo-controlled, randomized clinical trial for this HPV-driven skin condition, is a milestone for the company and for patients suffering from common warts who are in urgent need of new treatment options,” said Robert Esch, PhD, co-author of the study and member of Nielsen BioSciences’ Board of Directors, commented in the news release.
Source
Nielsen BioSciences news release. Nielsen BioSciences; May 27, 2026.