Arcutis Introduces ZORYVE® (roflumilast) Cream 0.05% For Young Children With Mild To Moderate Atopic Dermatitis

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company specializing in innovations in immuno-dermatology, has announced the commercial launch of ZORYVE (roflumilast) cream 0.05% in the United States. The topical treatment is now available for children aged 2 to 5 years with mild to moderate atopic dermatitis (AD), following its recent approval by the U.S. Food and Drug Administration (FDA) on October 6, 2025.

ZORYVE cream 0.05% is a once-daily, steroid-free topical therapy designed to provide long-term disease control without any limitation on the duration of use. In clinical trials, the treatment showed strong efficacy across all measured endpoints, demonstrating significant improvement in the signs and symptoms of atopic dermatitis, including itch relief and skin clearance. With this launch, Arcutis is expanding its ZORYVE portfolio to serve a younger pediatric population, offering a new treatment option for children as young as two years old.

“Atopic dermatitis is one of the most common chronic skin conditions in young children, yet safe and effective long-term treatments have been limited—particularly for children between the ages of 2 and 5,” said Todd Edwards, Chief Commercial Officer at Arcutis. “With ZORYVE cream 0.05%, families now have access to a once-daily, steroid-free treatment that targets the root cause of inflammation in atopic dermatitis. It offers consistent control, can be used for any duration, and is suitable for application on any part of the body without surface area restrictions. We are proud to make this important therapy available to improve quality of life for children and their families.”

ZORYVE cream 0.05% will be available in U.S. pharmacies starting this week. The product is currently under review by commercial pharmacy benefit managers and insurance providers to ensure coverage consistent with the rest of the ZORYVE product line.

Dr. Latanya Benjamin, Associate Professor of Pediatric Dermatology at Florida Atlantic University’s Charles E. Schmidt College of Medicine, emphasized the importance of new treatment options for young patients. “In my practice, I often see how difficult atopic dermatitis can be for children. The itch and rash can disrupt daily routines and sleep, and parents are often concerned about using steroid-based treatments,” said Dr. Benjamin. “ZORYVE cream 0.05% offers a gentle, non-steroidal, and easy-to-apply solution that effectively addresses the inflammation associated with atopic dermatitis while supporting skin-barrier health. I look forward to offering this treatment to young patients who need better options.”

Arcutis has also reinforced its commitment to patient access and affordability with comprehensive support programs for the ZORYVE portfolio. The ZORYVE Direct Program helps patients navigate the insurance process, promotes adherence to therapy, and includes the ZORYVE Direct Savings Card Program, which helps eligible commercially insured patients lower out-of-pocket costs. For those who are uninsured or underinsured, the company continues to offer the Arcutis Cares Patient Assistance Program (PAP), which provides ZORYVE products at no cost to financially eligible patients.

With the launch of ZORYVE cream 0.05%, Arcutis Biotherapeutics continues to build on its mission to deliver safe, effective, and accessible dermatological treatments that address unmet needs in patient care. This milestone marks another step forward in the company’s ongoing efforts to redefine long-term management of chronic inflammatory skin conditions, especially in pediatric populations.