FDA Approves Ruxolitinib Cream for Patients as Young as 2 Years With Atopic Dermatitis

Ruxolitinib cream (Opzelura; Incyte), a topical Janus kinase inhibitor, was approved for moderate atopic dermatitis in non-immunocompromised patients aged 2 years and older.

The FDA approval was based on data from the phase 3 TRuE-AD3 (NCT04921969) clinical study, which evaluated the safety and efficacy of the ruxolitinib cream in children aged 2 to 12 years with atopic dermatitis. The study met its primary and secondary end points, with significantly more patients treated with ruxolitinib achieving Investigator’s Global Assessment-treatment success compared with patients on the placebo. Ruxolitinib cream also demonstrated a 75% improvement in the Eczema Area and Severity Index in patients at the end of the 8-week vehicle-controlled period. No new safety signals were identified, and no serious infections, major adverse cardiovascular events, malignancies, or thrombosis were reported.¹

In a press release, Incyte Chief Executive Officer Bill Meury said that the approval represents progress in the company’s mission to deliver innovative solutions to real-world challenges faced by people with chronic skin conditions.¹

“With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option with the potential to significantly improve the burdensome symptoms they experience every day,” Meury said in the press release.

The study enrolled over 300 participants between the ages of 2 and 12 years diagnosed with atopic dermatitis on 3% to 20% of their body surface area (excluding scalp) and an Investigator’s Global Assessment score of 2 to 3—a measure of disease severity—and randomized patients 2:2:1 to receive ruxolitinib cream 0.75% twice daily, ruxolitinib cream 1.5% twice daily, or vehicle (non-medicated cream) twice daily.²

The chronic immune-mediated skin disease affects an estimated 2 to 3 million children between the ages of 2 and 11 years old and more than 21 million people aged 12 and older, making it the most common type of eczema. Common signs and symptoms include irritated skin, which can cause red lesions that may ooze and/or crust. People with atopic dermatitis are also more susceptible to bacterial, viral, and fungal infections.¹

“Navigating a complex condition like atopic dermatitis can be very challenging for children, who currently have limited treatment options to meet their specific needs,” Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, said in the press release. “With this approval, we now have a new, non-steroidal topical option that expands how we care for kids with this chronic disease. This is a meaningful step forward and marks a significant advancement in our ability to better support our pediatric patients.”

This FDA approval will expand the reach of ruxolitinib cream specifically for patients aged 2 years and older with mild to moderate non-immunocompromised atopic dermatitis. Ruxolitinib cream had already been approved in September 2021 for topical short-term and non-continuous use for patients aged 12 years and older with mild to moderate non-immunocompromised atopic dermatitis.³ It received an additional approval in July 2022 for treating adults and patients 12 years and older with nonsegmental vitiligo.⁴

“While every child’s journey with [atopic dermatitis] is unique, for many, the skin redness and irritation can profoundly impact their well-being,” Korey Capozza, founder of Global Parents for Eczema Research, said in the press release. “When you’re managing a condition that can affect daily life, access to safe, effective, and age-appropriate options is critical. With limited, safe treatment options currently available, especially for younger children, the addition of new therapies that control symptoms is so important to meet the needs and goals for children with [atopic dermatitis] and their families.”

References

1. Incyte announces additional FDA approval of Opzelura® (ruxolitinib) cream in children ages 2-11 with atopic dermatitis. News release. Incyte. September 18, 2025. Accessed September 19, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib 

2. Ruxolitinib Cream Phase 3 TRuE-AD3 Study. ClinicalTrials.gov. Identifier: NCT04921969. Updated March 10, 2025. Accessed September 19, 2025. https://clinicaltrials.gov/study/NCT04921969

3. Gavidia M. FDA approves ruxolitinib cream as first repigmentation therapy for vitiligo. AJMC®. September 19, 2025. Accessed September 19, 2025. https://www.ajmc.com/view/fda-approves-ruxolitinib-cream-as-first-repigmentation-therapy-for-vitiligo

4. Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis (AD). Incyte. Accessed September 19, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream