Shionogi and Torii Win Japanese Approval for VTAMA Cream 0.5% in Pediatric Atopic Dermatitis
核心洞察
Shionogi and Torii Pharmaceutical (搜索) obtained Japanese manufacturing and marketing approval for VTAMA Cream (搜索) 0.5% (tapinarof) in atopic dermatitis (搜索) patients under 12 years of age.
The approval rests on a domestic Phase 3 trial in children aged 2 to under 12 in which once-daily tapinarof for 8 weeks beat vehicle cream on the primary endpoint.
Long-term safety was assessed for up to 60 weeks of treatment, with the companies reporting favorable tolerability in the pediatric population.
Shionogi & Co., Ltd. and Torii Pharmaceutical (搜索) Co., Ltd., a SHIONOGI Group company, announced on September 16, 2026 that they have obtained manufacturing and marketing approval in Japan for VTAMA® Cream 0.5% (generic name: tapinarof) for the treatment of atopic dermatitis (搜索) in pediatric patients under 12 years of age.
The approval extends the product's Japanese label, which previously covered atopic dermatitis (搜索) in adults and pediatric patients aged 12 years and older, as well as plaque psoriasis (搜索) in adults, under VTAMA® Cream 1%.
Mechanism and Formulation
Tapinarof is a nonsteroidal, small molecule therapeutic aryl hydrocarbon receptor (搜索) (AhR) modulating agent. According to Shionogi, the drug suppresses the production of inflammatory cytokines and induces gene expression of skin barrier function-related and antioxidant molecules through activation of AhR. The newly approved pediatric indication uses a 0.5% cream strength, distinct from the 1% formulation already marketed in Japan.
Phase 3 Evidence in Children Aged 2 to Under 12
The approval is based on a domestic Phase 3 clinical trial conducted in pediatric patients with atopic dermatitis (搜索) aged 2 to under 12 years (registered as jRCT2031230139). In the trial, the efficacy and safety of the drug administered once daily for 8 weeks were evaluated against vehicle cream, and long-term safety of administration for up to 60 weeks was also assessed.
The primary efficacy endpoint was met, with tapinarof demonstrating superiority over vehicle cream. Favorable tolerability was also confirmed with respect to long-term safety, the companies reported.
Positioning in Pediatric Atopic Dermatitis
Atopic dermatitis (搜索) is a chronic and pruritic inflammatory skin disease. Shionogi notes that it is thought to develop through exposure to various irritants or allergens in patients with a physiological abnormality of the skin, characterized by dry skin and abnormal skin barrier function. The disease frequently develops in childhood, and with this approval the drug is expected to become a new treatment option for pediatric patients.
Shionogi and Torii stated they will continue to work to deliver the drug as quickly as possible, with the aim of contributing to the treatment and quality of life (QOL) of pediatric patients with atopic dermatitis (搜索). The SHIONOGI Group has identified "Contributing to a healthier and enriched life" as one of its material issues.
Commercial and Development History
In 2020, Japan Tobacco (搜索) Inc. — whose pharmaceutical business has since been transferred to Shionogi — and Dermavant Sciences (搜索) GmbH, later acquired by Organon & Co., entered into an agreement for exclusive development and commercialization rights to tapinarof for dermatological diseases in Japan. Japan Tobacco and Torii Pharmaceutical (搜索) separately entered an agreement for co-development and marketing of the product in Japan. Tapinarof was approved in Japan in 2024 under the product name VTAMA® Cream 1%. Shionogi is currently the manufacturer and distributor, with Torii Pharmaceutical as distributor, and the two companies co-promote the product in Japan.
Financial Guidance
Shionogi stated that the impact of this approval on its consolidated financial results for the fiscal year ending March 2027 is expected to be minimal. The announcement includes forward-looking statements subject to risks and uncertainties, including those related to completion and discontinuation of clinical trials, obtaining regulatory approvals, claims and concerns about product safety and efficacy, and manufacturing and marketing risks.