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Regulatory applications for upadacitinib as a treatment for non-segmental vitiligo in adults and adolescents have been submitted to the FDA and the European Medicines Agency, the manufacturer, AbbVie, announced in a statement on February 3.
The applications for the expanded indication for the oral JAK inhibitor included data from the phase 3 Viti-Up studies in adults and adolescents aged 12 years or older with non-segmental vitiligo eligible for systemic therapy, according to the press release. In October 2025, the company announced results of the studies comparing 15 mg of upadacitinib once a day in 411 patients aged 12 years or older with non-segmental vitiligo and 203 on placebo. The co-primary endpoints were a 50% reduction in the Total Vitiligo Area Scoring Index (T-VASI 50) and a 75% reduction in the Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline to 48 weeks.
At 48 weeks in study 1, 19.4% of patients on treatment achieved T-VASI 50 and 25.2% achieved F-VASI 75 vs 5.9% of those on placebo in both studies. At 48 weeks in study 2, 21.5% of those on upadacitinib achieved T-VASI 50, and 23.4% achieved F-VASI 75 vs 5.9% and 6.9% of those on placebo, respectively.
In both studies, safety was “generally consistent with that observed in approved indications,” and no new safety signals were noted, according to the October press release.
If approved, upadacitinib would be the first systemic medication for treating vitiligo, the company noted in the February release.
Additional phase 3 trials are underway evaluating upadacitinib in patients with systemic lupus erythematosus, hidradenitis suppurativa, Takayasu arteritis, and alopecia areata, according to the press release. In the US, upadacitinib (Rinvoq) is currently approved for several indications, including psoriatic arthritis, atopic dermatitis, and rheumatoid arthritis in adults.
In 2022, topical ruxolitinib (Opzelura), a JAK inhibitor, was approved by the FDA for treating non-segmental vitiligo in people aged 12 years or older.
