The U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor developed by Incyte, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended. This approval, represents the third U.S. approval for Opzelura, which is now indicated to treat mild to moderate AD in patients ages 2 and up, and nonsegmental vitiligo in patients 12 years and older. Importantly, Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis, offering a much-needed steroid-free option for children and families.

DelRicht Research Contributions

DelRicht Research is proud to have supported this milestone approval through the work of two experienced investigators:

Dr. Deirdre Hooper at Audubon Dermatology, New Orleans, LA
Dr. Ira Thorla at Louisiana Dermatology Associates, Baton Rouge, LA

Together, Dr. Hooper and Dr. Thorla contributed to the pivotal research that informed FDA decision-making, helping to evaluate both the safety and efficacy of ruxolitinib cream in pediatric populations. Their leadership reflects the strength of DelRicht’s embedded, physician-led site model, which enables rapid enrollment and high-quality data collection across real-world patient populations.

Evidence From the TRuE-AD3 Study

The FDA’s approval was based on data from the Phase 3 TRuE-AD3 trial, which evaluated ruxolitinib cream in children aged 2 to under 12 years with atopic dermatitis. The study met its primary endpoint, with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success (IGA-TS) compared to vehicle (non-medicated cream).

A key secondary endpoint was also achieved: significantly more patients reached at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8. The overall safety profile of Opzelura in TRuE-AD3 was consistent with previous trials, with no new safety signals identified. The most common adverse event reported was upper respiratory tract infection, and no serious infections, malignancies, or thrombotic events were observed.

Addressing a Pressing Need

“This new approval for Opzelura in children ages 2–11 represents meaningful progress in a field with few approved treatments for young patients. Our investigators at DelRicht, including Dr. Hooper and Dr. Thorla, were integral in executing a high-quality trial. Their commitment and performance are examples of how strong site partnerships accelerate access to innovation,” said Marshall Morris, Partner at DelRicht Research.

For patients, families, and caregivers, this represents an important step forward. Pediatric atopic dermatitis is a chronic, immune-mediated disease that affects an estimated 2–3 million children ages 2–11 in the U.S. Symptoms such as redness, lesions, and itching can significantly impact daily life and well-being, with limited options available for this age group until now.

“This new approval for Opzelura in children ages 2–11 represents meaningful progress in a field with few approved treatments for young patients. Our investigators at DelRicht, including Dr. Hooper and Dr. Thorla, were integral in executing a high-quality trial. Their commitment and performance are examples of how strong site partnerships accelerate access to innovation,”

— Marshall Morris, Partner at DelRicht Research

A Continued Commitment in Dermatology

This approval builds on DelRicht Research’s growing track record of supporting pivotal dermatology therapies across indications, including atopic dermatitis, vitiligo, acne, and psoriasis. With more than 90 trials conducted by principal investigators Dr. Hooper and over 100 trials by Dr. Thorla, our dermatology network demonstrates both depth of expertise and consistent top-tier performance.

Moving Medicine Forward

The approval of Opzelura for pediatric atopic dermatitis highlights the power of collaboration between sponsors, investigators, and site networks in advancing therapeutic options for underserved patient populations. For families affected by AD, this represents meaningful progress. For sponsors and CROs, it underscores DelRicht’s role as a proven partner in dermatology research, delivering both operational excellence and patient access to accelerate trial success.

To learn more about Opzelura, visit www.opzelura.com or read the full press release from Incyte.

Congratulations to the team at Incyte, to our participating investigators, and to the many patients and families who made this approval possible.