Research & Development at Nielsen Biosciences

Nielsen BioSciences’ R&D efforts are focused on exploring the potential of its purified candida antigen CANDIN for the treatment of human papilloma virus (HPV) – driven indications. Specifically, Nielsen is studying CANDIN for the treatment of verruca vulgaris or common warts. CANDIN is currently not approved for the treatment of common warts, but is approved as a skin test antigen for the assessment of cellular hypersensitivity to Candida albicans.

Nielsen BioSciences initiated a rigorous clinical program to investigate the potential of CANDIN in the treatment of common warts. Results of the Phase 2 research were highly encouraging and provided the foundation for the current Phase III program. The results of the Phase II study were peer-reviewed and published in Dermatology & Therapy. See Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens | Dermatology and Therapy

The consecutive Phase III clinical trial is fully recruited. The primary endpoint is assessing CANDIN’s potential to provide complete resolution of treated warts without recurrence. Several secondary endpoints are also being studied. Information on our ongoing clinical trials can be obtained at https://clinicaltrials.gov/search?term=NCT05889845. This Phase III multi-center randomized, double-blind, placebo-controlled study is currently the only Phase III clinical study program to investigate treatment of warts. The study is fully enrolled with patients in the US and Japan and projected to report results in Q4 2025.

In addition, based on the encouraging results of our clinical program and a significant body of peer reviewed publications, we plan to continue evaluating the Candin antigen active ingredient as a potential treatment for a variety of other viral dermatological conditions, including Molluscum Contagiosum, Plantar Warts, Periungual Warts, Flat Warts, Facial Warts, and Genital Warts

Pipeline

Nielsen products development pipeline chart

Diseases and Conditions

Common Warts – Common warts are caused by human papillomavirus (HPV) and affect several areas of the body, most commonly fingers and hands. Common warts can be transmitted by touch and can take as long as two to six months to develop after skin has been exposed to the virus. Lesions can cause pain, discomfort, itchiness and embarrassment for patients, which lead them to look for treatment. Common wart treatment today is dominated (70%+) by destructive therapies such as cryotherapy, salicylic acid, surgical removal and blistering agents which can painful and cause scarring.

warts

Plantar Warts – Hard, grainy growths that appear on the heels or balls of the feet. Plantar warts are caused by the human papillomavirus (HPV). These can become irritated and painful.

plantar warts

Genital Warts – Small, flesh-colored bumps or have a cauliflower-like appearance. In many cases, the warts are too small to be visible. This is one of the most common types of sexually transmitted infections. Also caused by the human papillomavirus (HPV).

Publications

Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens | Dermatology and Therapy
https://doi.org/10.1007/s13555-025-01387-1
Smith, S.R., Esch, R.E., Nielsen, H.S. et al. (2025)

Significance of interferon gamma in the prediction of successful therapy of common warts by intralesional injection of Candida antigen – https://pubmed.ncbi.nlm.nih.gov/28791682/
Ahmad Nofal, Ayman Marei, Amin Amer, Hanaa Amen (2017)

Immunotherapy with intralesional Candida albicans antigen in resistant or recurrent warts: a study –
https://pubmed.ncbi.nlm.nih.gov/24082180/
Imran Majid, Saher Imran (2013)

Pulsed-dye laser versus intralesional Candida albicans antigen injection in treatment of genital warts –
https://pubmed.ncbi.nlm.nih.gov/30901065/
Eman Hamed Elmaadawy, Shaimaa Saeed Shams, Doaa Salah Hegab, Raghda Ahmed Zaki (2019)

Research & Development at Nielsen Biosciences

Pipeline

Diseases and Conditions

Publications

Important Safety Information For CANDIN:

Indication and Usage:

Warning:

Contraindication:

Warnings and Precautions:

Adverse Reactions:

Drug Interactions:

Use in Specific Populations:

Important Safety Information For Spherusol: