Study achieved primary endpoint of complete resolution of injected wart without recurrence over 12 weeks as well as key secondary endpoints
First successfully completed, randomized, placebo-controlled prospective Phase 3 study for condition
FDA submission expected in the second half of 2026
SAN DIEGO–(BUSINESS WIRE)–Nielsen BioSciences, Inc. (“Nielsen”), a privately-held, San Diego-based biopharmaceutical company, today announced that its recently completed Phase 3 clinical trial of CANDIN® (Purified Candida albicans Antigen), the Company’s investigational immunotherapeutic therapy for the treatment and resolution of common warts (Verruca vulgaris) met its primary endpoint as well as key secondary endpoints.
The topline results of the trial were presented earlier this month at the Society of Investigative Dermatology Annual Conference in a late-breaking poster session [Link]
The study analyzed patients 12 years of age and older following treatment with CANDIN or saline injection as placebo, analyzing a total of 325 patients in the US and Japan. The study successfully met its primary endpoint of the complete resolution of the treated wart without recurrence through 12 weeks post-injection. Secondary endpoints, including the number of injections to achieve clearance of the injected wart and clearance of all or greater than 50% of measured warts beyond the injected wart were also met, providing evidence of CANDIN’s systemic effect. The study also assessed scarring and skin discoloration, which are key concerns of patients and dermatologists when treating warts with traditional methods.
“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, one of the co-authors of the study and a member of the Board of Directors at Nielsen Biosciences. “We extend our gratitude to both patients and investigators across the U.S. and Japan, whose time and commitment made this trial possible.”
“Our strategy to combine the US and Japan in one Phase 3 clinical trial was a success and we extend our deepest thanks to Maruho, our Japanese partner, for their confidence, efforts and support,” said David P. Burney, PhD, MBA, President and Chief Operating Officer at Nielsen BioSciences. “These positive Phase 3 trial results provide a compelling foundation for CANDIN to become the first approved therapeutic for the treatment of HPV-driven skin infections, and we look forward to continuing our advancement of this groundbreaking new treatment.”
Nielsen is currently completing the analysis of the full data set from the Phase 3 trial and its Clinical Study Report. The Company expects to file for approval with the U.S. Food and Drug Administration (FDA) in the second half of 2026. Nielsen is partnering with Maruho Co. Ltd, a leading dermatology-focused pharmaceutical company headquartered in Japan and exclusive licensee for the commercialization of CANDIN in Japan as well as development and commercialization in China and other key growth markets across Asia.
About Nielsen BioSciences
Nielsen BioSciences, Inc. is a privately-held, San Diego-based biopharmaceutical company focused on developing and commercializing biological products with wide-ranging applications in cell-mediated immune responses. For more information, please visit www.nielsenbio.com
About Maruho
Maruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,632 employees (as of the end of September 2025), and net sales were approximately 78.92 billion yen in its fiscal year ended September 30, 2025. With the mission “More smiles, brighter life for you.”, Maruho aims to help realize a society where everyone can live with a smile.
For more information, please visit https://www.maruho.co.jp/english/
About CANDIN
CANDIN (Candida albicans Skin Test Antigen for Cellular Hypersensitivity) is currently licensed in the United States for its U.S. Food and Drug Administration-approved use as a skin test antigen for the assessment of cellular hypersensitivity to Candida albicans. CANDIN is not currently approved in the United States or Japan for the treatment of common warts (Verruca vulgaris) or any other indications. Nielsen recently completed a Phase 3 safety and efficacy study of CANDIN for the treatment of common warts. The study recruited patients in both Japan and the U.S., making it the first multi-national randomized clinical trial for the treatment of common warts.