Arcutis' Zoryve cream reduces itch in infants with atopic dermatitis in trial
ARQT•Arcutis Biotherapeutics presented results from a 101-infant trial of Zoryve cream 0.05%, reporting reduced itching and improved eczema symptoms and quality of life. An application to expand use to infants aged 3-24 months is under FDA review, with a decision target of February 23, 2027.
1. Infant trial results
Arcutis Biotherapeutics presented INTEGUMENT-INFANT results for Zoryve cream 0.05% on Nov. 13, 2026. Caregivers reported reduced itching, improved eczema symptoms and better quality of life among infants with mild to moderate atopic dermatitis. The trial enrolled 101 infants; treatment was well tolerated, with no serious or severe treatment-emergent adverse events reported.
2. FDA review
An application to expand Zoryve cream use to infants aged 3-24 months is under FDA review, with a February 23, 2027, decision target. The cream is already approved in the U.S. for mild to moderate atopic dermatitis in children aged 2-5 years.
