Nielsen BioSciences Reports Successful Phase 3 Trial Results for CANDIN in Wart Treatment
Nielsen BioSciences Announces Positive Phase 3 Trial Results of CANDIN for the Treatment and Clearance of Common Warts
Businesswire
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Nielsen BioSciences has announced positive results from its Phase 3 trial of CANDIN, an investigational treatment for common warts, achieving complete wart resolution without recurrence in patients. The company plans to submit for FDA approval in late 2026.
- 01The Phase 3 trial involved 325 patients aged 12 and older in the U.S. and Japan.
- 02CANDIN met its primary endpoint of complete wart resolution without recurrence within 12 weeks.
- 03Secondary endpoints included successful clearance of all or over 50% of warts, demonstrating systemic effects.
- 04The trial is the first placebo-controlled, randomized study for treating HPV-driven skin conditions.
- 05Nielsen BioSciences plans to file for FDA approval in the second half of 2026.
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Nielsen BioSciences, a San Diego-based biopharmaceutical company, has announced that its Phase 3 clinical trial of CANDIN® (Purified Candida albicans Antigen) for treating common warts (Verruca vulgaris) has achieved significant results. The trial, which included 325 patients aged 12 and older across the U.S. and Japan, met its primary endpoint of complete resolution of the injected wart without recurrence over a 12-week period. Additionally, key secondary endpoints were also achieved, including the number of injections required for wart clearance and the clearance of all or over 50% of other measured warts, indicating a systemic effect of the treatment. The trial is notable for being the first placebo-controlled, randomized study for this HPV-driven condition. Nielsen BioSciences aims to submit its findings to the U.S. Food and Drug Administration (FDA) for approval in the latter half of 2026. The company is collaborating with Maruho Co. Ltd, a Japanese pharmaceutical firm, for the commercialization of CANDIN in Japan and other Asian markets.
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The successful results of the Phase 3 trial could lead to a new effective treatment option for common warts, which affects a significant number of patients.
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