Shionogi & Co. and its Tokyo-based affiliate Torii Pharmaceutical have won Japanese approval to sell Vtama Cream 0.5% (tapinarof) for atopic dermatitis in children under 12. The clearance extends a drug the two companies already co-promote in a stronger 1% formulation for adults and children 12 and older with atopic dermatitis, and for adults with psoriasis, under a 2024 approval.
Tapinarof is a non-steroidal, small-molecule modulator of the aryl hydrocarbon receptor. The companies say the mechanism suppresses inflammatory cytokine production while inducing genes linked to skin-barrier repair and antioxidant activity.
The approval rests on a Japanese Phase 3 trial enrolling patients aged 2 to under 12. Once-daily dosing for eight weeks beat plain vehicle cream on the trial's primary endpoint, and long-term safety data collected over as long as 60 weeks showed good tolerability, according to Shionogi.
Rights to tapinarof trace back to a 2020 licensing agreement between Japan Tobacco, whose pharmaceutical business Shionogi later absorbed, and Dermavant Sciences (now owned by Organon & Co.). Shionogi holds the manufacturing and marketing authorization in Japan; Torii distributes the product under a co-promotion arrangement between the two companies.
Shionogi says the new pediatric indication will have only a minor effect on its consolidated results for the year ending March 2027, framing this as a franchise-building step rather than a near-term earnings driver. The disclosure does not include pricing, reimbursement terms or a launch date for the newly approved age group.