Announcement Regarding Torii Pharmaceutical’s Manufacturing and Marketing Approval of YCANTH® (Cantharidin) topical solution 0.71% for the Treatment of Molluscum Contagiosum in Japan

OSAKA, Japan, September 19, 2025 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) hereby announces that its group company, Torii Pharmaceutical Co., Ltd. (Head Office: Chuo-ku, Tokyo, Japan; President and Chief Executive Officer: Nobumasa Kondo), has issued a press release regarding the approval in Japan for the manufacture and marketing of YCANTH® topical Solution 0.71% for the treatment of molluscum contagiosum, a dermatological disease.

 

Below is the announcement released by Torii Pharmaceutical.

 

Torii Pharmaceutical Co., Ltd. (Torii) announced that Torii has today received manufacturing and marketing approval of YCANTH® (cantharidin) topical solution 0.71% for the treatment of Molluscum Contagiosum in Japan.

 

YCANTH® (cantharidin) topical solution 0.71% is a skin disease treatment drug containing cantharidin as an active ingredient. In the Phase 3 clinical study of YCANTH® (cantharidin) topical solution 0.71% in patients with molluscum contagiosum (≥2 years old) in Japan, the primary endpoint of efficacy has met superiority to the vehicle. Furthermore, the safety of YCANTH® (cantharidin) topical solution 0.71% was confirmed and there were no observed issues of tolerability for the application.

 

Torii expects YCANTH® (cantharidin) topical solution 0.71% to be a new option for the treatment of molluscum contagiosum patients (≥2 years old) in Japan.

 

Separately, Verrica received approval from the U.S. Food and Drug Administration in July 2023 for the topical treatment of molluscum contagiosum in adult and pediatric patients (≥2 years old) and launched YCANTH in the US in August 2023. Verrica and Torii are in process of further developing YCANTH® for additional indications, including a planned global clinical program in common warts, targeted to begin enrollment in the US by the end of 2025.

 

Product name

YCANTH® topical solution 0.71%

Japanese Accepted Name

Cantharidin

Indications

Molluscum Contagiosum

Dosage and
administration

For adults and pediatric patients (≥2 years old), apply an appropriate amount of solution to the affected area once every 3 weeks during treatment. 16 to 24 hours after application, washing affected area with soap.

ABOUT Molluscum Contagiosum

Molluscum contagiosum is a highly prevalent, contagious dermatologic disease that often occurs in children due to infection with the molluscum contagiosum virus, a member of the poxviridae family, and is commonly referred to as “water warts.” Many shiny papules with a diameter of 1 to 4 mm are seen on the trunk and extremities.

 

ABOUT Common Warts

Common warts (Verruca vulgaris) is a common dermatologic disease caused by infection with the human papillomavirus, and is commonly called “warts”. Keratinized raised lesions measuring several mm to 1 cm are seen mainly on the hands and feet.

 

 

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

 

For Further Information, Contact:

SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html

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