A landmark Phase III clinical trial has demonstrated that China-based Thederma's 1% benvitimod cream, a first-in-class non-hormonal topical AhR modulator, achieves an EASI-90 response rate of 81.6% in infants aged 3–24 months with atopic dermatitis (AD). Presented at China's 31st National Congress of Dermatology, the data mark the first successful global Phase III trial of a topical therapy in this age group. The product also showed a 77% Investigator’s Global Assessment (IGA) success rate and a favourable safety profile, with only 7.3% mild-to-moderate local reactions.

Approved in November 2024 for children aged two and above, the therapy is now undergoing regulatory review for the infant indication. The drug acts through dual mechanisms: restoring skin barrier function and suppressing type 2 inflammation. Its commercialisation is being driven by a strategic partnership between Thederma and Jumpcan Pharmaceutical, leveraging Jumpcan’s paediatric and dermatology channel expertise to improve accessibility for families.

PharmCube's NextBiopharm® database shows that the medicine is undergoing Phase I trials in five additional indications. Click here to request a free trial for NextBiopharm®.