Arcutis says Phase 2 trial shows Zoryve cream 0.05% clears atopic dermatitis in infants ages 3 to under 24 months
ARQT•Arcutis said a Phase 2 study found its investigational Zoryve cream 0.05% was well tolerated in infants ages 3 to under 24 months, with rapid skin clearance and itch relief. FDA review of an application to expand use in infants is underway, with a Feb. 23, 2027 PDUFA date.
1. Clinical and regulatory update
Arcutis highlighted clinical and real-world research on Zoryve, including Phase 3 psoriasis analyses showing symptom improvements across the scalp and body and reported quality-of-life gains. A survey and literature review flagged persistent concerns about long-term topical steroid use.
