Arcutis Biotherapeutics introduced ZORYVE® cream 0.05% for mild to moderate atopic dermatitis in children ages 2‑5. The steroid‑free, once‑daily topical uses a selective phosphodiesterase‑4 inhibitor and is approved for long‑term use with no limits on duration or body surface area.
The product became available in U.S. pharmacies during the week of October 30, 2025, following FDA approval on October 6, 2025. The launch expands the ZORYVE franchise into a younger pediatric population, addressing an unmet need and opening a new revenue stream.
Arcutis reported a profitable third quarter of 2025, with net product revenue of $99.2 million, a 122 % year‑over‑year increase, and a net income of $7.4 million, a turnaround from a $41.5 million loss in Q3 2024. Guidance for 2026 full‑year net product sales is $455‑$470 million.
The pediatric atopic dermatitis market includes approximately 9.6 million U.S. children, representing a substantial addressable opportunity. ZORYVE is already the top‑prescribed branded topical therapy across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, and the steroid‑free formulation differentiates it from traditional topical steroids.
Arcutis continues to offer patient assistance programs, including a copay savings card and the Arcutis Cares™ program, to help patients navigate payer processes and reduce out‑of‑pocket costs. Coverage is under review by commercial pharmacy benefit managers, with expectations for comparable coverage to the existing ZORYVE portfolio.
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