Disclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today's episode.
In this episode of Skinfluenced: The Skin Podcast, we review the brand new FDA approval of Opzelura® (ruxolitinib) cream 1.5% for children ages 2 and up with atopic dermatitis. This marks a major step forward in pediatric dermatology, offering the first topical JAK inhibitor option for younger patients with mild-to-moderate AD who need more than topical steroids or topical calcineurin inhibitors.
We’ll discuss the clinical trial data from the TRuE-AD program, safety considerations, and where ruxolitinib cream may fit into the evolving treatment landscape for pediatric eczema. Tune in to learn what this means for providers, patients, and families navigating chronic AD care.
#AtopicDermatitis #Eczema #PediatricDermatology #Opzelura #Ruxolitinib #JAKInhibitor #Dermatology #SkinHealth #NewTreatments #FDAApproved #TopicalTherapies #ClinicalGuidelines #FDAApproval #EczemaTreatment #ADUpdate #SkinScience #EvidenceBasedMedicine #ADManagement #DermUpdate #SkinScience #Dermatology #DermatologyProvider #Dermatologist #CosmeticDermatology #Aesthetics #PhysicianAssistant #PhysicianAssociate #NursePractitioner #SkinfluencedPodcast #DermatologyPodcast
Link to Source(s):
Business Wire. Incyte Announces U.S. FDA Approval of Opzelura (Ruxolitinib) Cream, a Topical JAK Inhibitor, for Treatment of Atopic Dermatitis (AD). Published September 21, 2021. Accessed September 20, 2025. https://www.businesswire.com/news/home/20210921006072/en/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD
Contemporary Pediatrics. FDA Approves Ruxolitinib for Pediatric Atopic Dermatitis. Published July 29, 2025. Accessed September 20, 2025. https://www.contemporarypediatrics.com/view/fda-approves-ruxolitinib-for-pediatric-atopic-dermatitis
Incyte. Incyte Announces FDA Approval of Opzelura (Ruxolitinib) Cream for Treatment of Vitiligo in Nonsegmental Patients 12 Years and Older. Published July 18, 2022. Accessed September 20, 2025. https://investor.incyte.com/node/23156/pdf
Incyte. Incyte Announces Positive Topline Results From Pivotal Phase 3 TRuE-AD Clinical Trial Program Evaluating Ruxolitinib Cream for Atopic Dermatitis. Published December 15, 2019. Accessed September 20, 2025. https://investor.incyte.com/node/23376/pdf
Incyte. Incyte Announces FDA Approval of Opzelura (Ruxolitinib) Cream for Treatment of Atopic Dermatitis in Pediatric Patients Ages ≥2 Years. Published July 29, 2025. Accessed September 20, 2025. https://investor.incyte.com/node/25636/pdf
Incyte. Incyte Announces FDA Approval of Opzelura (Ruxolitinib) Cream for Treatment of Nonsegmental Vitiligo in Patients 12 Years and Older. Published July 18, 2022. Accessed September 20, 2025. https://investor.incyte.com/node/25226/pdf
Pharmacy Times. FDA Approves 1.5% Ruxolitinib Cream for Pediatric Atopic Dermatitis. Published July 29, 2025. Accessed September 20, 2025. https://www.pharmacytimes.com/view/fda-approves-1-5-ruxolitinib-cream-for-pediatric-atopic-dermatitis
The American Journal of Managed Care (AJMC). FDA Approves Ruxolitinib Cream for Patients as Young as 2 Years With Atopic Dermatitis. Published July 29, 2025. Accessed September 20, 2025. https://www.ajmc.com/view/fda-approves-ruxolitinib-cream-for-patients-as-young-as-2-years-with-atopic-dermatitis