• July 2022

The U.S. Food and Drug Administration has approved topical ruxolitinib (Opzelura) for the treatment of nonsegmental vitiligo in patients 12 years of age and older.

The Janus kinase 1/JAK2 inhibitor, formulated as a cream had been approved for the treatment of mild to moderate atopic dermatitis in September 2021.

The approval was based on the results of two phase 3 studies (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years and older. At 24 weeks, about 30% of patients on treatment applied twice daily had achieved at least 75% improvement in facial vitiligo, compared with about 8% and 13% among those in the vehicle groups in the two trials. At 52 weeks, about 50 percent of patients treated with topical ruxolitinib achieved 75 percent repigmentation.


One tube of Opzelura (ruxolitinib) cream 1.5% officially costs in the U.S. $1,950.00