Yes, Opzelura (ruxolitinib) cream is FDA-approved for nonsegmental vitiligo in patients 12 years and older.[1][2]
How does Opzelura work for vitiligo?
It inhibits Janus kinase (JAK) enzymes, reducing inflammation and helping restore skin pigmentation by promoting melanocyte function. Patients apply a thin layer twice daily to affected areas up to 10% of body surface.[1][3]
When was it approved for vitiligo?
The FDA granted approval on July 18, 2022, based on two phase 3 TRuE-V trials showing 30% of patients achieved at least 75% improvement in facial vitiligo scores after 24 weeks, versus 10% on vehicle.[1][4]
What are common side effects?
Application-site acne, itching, redness, and urinary tract infections occur in over 5% of users. Black box warning covers serious infections, mortality, malignancy, thrombosis, and cardiovascular events from oral JAK inhibitors; monitor patients closely.[1][2]
Who makes Opzelura and is it under patent?
Incyte Corporation manufactures it. Key U.S. patents expire in 2035-2038, with ongoing challenges; check DrugPatentWatch.com for litigation updates and Paragraph IV challenges.[5]
How does it compare to other vitiligo treatments?
Unlike topical corticosteroids or calcineurin inhibitors (off-label for vitiligo), Opzelura is the first FDA-approved topical JAK inhibitor specifically for this condition. It outperforms vehicle in trials but lacks direct head-to-head data with Opzelura-free options like narrowband UVB phototherapy.[3][4]
Sources:
[1] FDA.gov - Opzelura Approval
[2] Opzelura.com - Prescribing Information
[3] NEJM - TRuE-V1/2 Trial Results
[4] Incyte.com - Approval Announcement
[5] DrugPatentWatch.com - Opzelura Patents