FDA Approves Ruxolitinib Cream for Atopic Dermatitis in Children 2 Years and Older
FDA approves ruxolitinib cream for children with atopic dermatitis, offering a new nonsteroidal treatment option for better symptom management.
The FDA approved ruxolitinib (Opzelura) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised children 2 years and older whose disease is inadequately controlled with topical therapies or when those therapies are not recommended.1
FDA approves ruxolitinib cream for children with atopic dermatitis, offering a new nonsteroidal treatment option for better symptom management. | Image Credit: Марина Терехова - stock.adobe.com
“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 a news release.1 “With this approval, we now have a new, nonsteroidal topical option that expands how we care for [children] with this chronic disease. This is a meaningful step forward and marks a significant advancement in our ability to better support our pediatric patients.”
The approval was based on data from the phase 2 TRuE-AD3 (NCT04921969) trial, which evaluated the efficacy and safety of the drug for children with AD. The study was a randomized, double-blind trial, with treatment being assigned 2:2:1 with ruxolitinib cream 0.75%, 1.5%, and the vehicle cream. At week 8, investigators evaluated the efficacy, and individuals who had no additional safety concerns continued into the 44-week long-term safety period, with patients who received the vehicle cream now receiving either the 0.75% or 1.5% strength.2
The primary outcome was the percentage of participants who achieved Investigator’s Global Assessment – Treatment Success (IGA-TS) at week 8. Secondary end points include the percentage of individuals with a 4-point or more improvement in Itch Numerical Rating Scale (NRS) score to week 8, the number of patients with any treatment-emergent adverse events (TEAE), and the number of individuals with any grade 3 or higher TEAE.2
Investigators reported that patients achieved the primary end point of IGA-TS at week 8, the efficacy period, at 36.6% with the 0.75% cream and 56.6% with the 1.5% cream compared with 10.8% for the vehicle. For patients aged 6 to 11 years, investigators found reductions in daily itch NRS scores, with 37.5% and 43.4%, respectively, achieving itch NRS4 at week 8 compared with 29.7% with the vehicle.3
Most TEARs were mild or moderate, with the most common being upper respiratory tract infection and nasopharyngitis, according to the study authors.3
“While every child’s journey with AD 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 news release.1 “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 AD and their families.”
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REFERENCES
1. Incyte announces additional FDA approval of Opzelura (ruxolitinib) cream in children ages 2 to 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. A study to assess the efficacy and safety of ruxolitinib cream in children with atopic dermatitis (TRuE-AD3). ClinicalTrials.gov identification: NCT04921969. Updated March 28, 2025. Accessed September 19, 2025. https://www.clinicaltrials.gov/study/NCT04921969
3. Eichenfield LF, Stein Gold LF, Simpson EL, et al. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. 2025;93(3):689-698. doi:10.1016/j.jaad.2025.05.1385
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