Arcutis Biotherapeutics released long‑term safety and efficacy data for its pediatric ZORYVE cream 0.05% in children ages 2‑5 with mild‑to‑moderate atopic dermatitis. The data were published in the journal Pediatric Dermatology on March 10, 2026.
The 56‑week open‑label extension, which followed the pivotal INTEGUMENT‑PED trial, enrolled 562 children and demonstrated that the cream remains safe and well‑tolerated. At week 56, 63.1% of participants achieved clear or almost clear skin, and 71.9% achieved a ≥75% reduction in the Eczema Area and Severity Index (EASI‑75).
These results confirm the safety profile established in the pivotal trial and provide evidence of durable efficacy over a full year of treatment.
The data reinforce the company’s strategy to expand pediatric indications, potentially increasing market penetration and strengthening its competitive position in the non‑steroidal topical segment. They also support the FDA approval granted in October 2025 and lay the groundwork for the upcoming sNDA for infants expected in Q2 2026.
Dr. Lawrence F. Eichenfield, lead author of the publication, said the data reinforce ZORYVE as a meaningful, long‑term treatment option for children. Chief medical officer Patrick Burnett highlighted that the publication underscores the strong safety profile and durable efficacy of ZORYVE and the company’s commitment to providing clinicians, families, and young children with treatment options that can be used confidently over time.
In addition to the pediatric data, Arcutis is advancing the INTEGUMENT‑INFANT Phase 2 trial for infants and has moved the ARQ‑234 program into Phase 1a/1b, positioning the company to broaden its portfolio beyond atopic dermatitis.
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