Shionogi and Torii report positive interim Phase 3 results for tapinarof cream 0.5% in Japanese infants with atopic dermatitis, showing meaningful clinical improvement and consistent safety, supporting broader pediatric development.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Shionogi & Co., Ltd. and its wholly owned subsidiary Torii Pharmaceutical Co., Ltd. announced positive interim analysis results from a Phase 3 study evaluating tapinarof cream 0.5% in Japanese infants with atopic dermatitis. The trial enrolled patients aged 3 months to under 24 months and demonstrated clinically meaningful improvements in eczema severity based on investigator assessments.
The interim analysis, with a March 2026 data cutoff, confirmed a consistent safety profile throughout the treatment period, supporting long‑term tolerability in infants. No new safety signals were observed.
Tapinarof is an aryl hydrocarbon receptor (AhR) modulating agent that regulates immune signaling and improves skin barrier function. As a non‑steroidal topical therapy, it offers a potential long‑term treatment option for inflammatory dermatologic conditions including atopic dermatitis and plaque psoriasis.
Atopic dermatitis is a chronic inflammatory skin disease characterized by persistent itching, recurrent flares, and impaired barrier function. The condition frequently begins in infancy and can significantly affect sleep, quality of life, and caregiver burden.
The ongoing Phase 3 study is an open‑label, uncontrolled trial assessing the efficacy and safety of tapinarof cream 0.5% over 52 weeks in Japanese infants. While detailed efficacy metrics were not disclosed, the interim findings supported sustained clinical improvement alongside favorable long‑term safety.
The new infant data expand tapinarof’s pediatric development program in Japan. In June 2024, regulators approved VTAMA® Cream 1% for atopic dermatitis in patients aged 12 years and older and for plaque psoriasis in adults, with commercial launch in October 2024 co‑promoted by Shionogi and Torii.
Tapinarof is also approved in the United States as VTAMA® Cream 1% for adult plaque psoriasis. Development efforts continue in younger pediatric populations: in October 2025, Japan Tobacco submitted a manufacturing and marketing application for tapinarof cream 0.5% in children aged 2 to under 12 years with atopic dermatitis.
Together, the infant data and ongoing pediatric submissions support a stepwise expansion of tapinarof’s label into younger age groups in Japan, reinforcing its potential as a steroid‑free, long‑term therapy for chronic inflammatory skin disease beginning in infancy.
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