Pfizer plans to ask regulators to approve its oral drug Litfulo for vitiligo, after two late-stage trials showed it helped restore skin pigment better than placebo.
Announced July 30, 2026, the company said it intends to submit global regulatory filings for Litfulo (ritlecitinib) as an oral systemic treatment for nonsegmental vitiligo (NSV) in adults. NSV is a chronic autoimmune disease in which the immune system attacks the melanin-producing cells that give skin its color, leaving white patches. There is currently no approved oral therapy specifically for it.
What the trials showed
The filing is backed by two Phase 3 studies, TRANQUILLO and TRANQUILLO 2. Both the 50 mg and 100 mg doses produced significant improvements over placebo on the co-primary endpoints. After 52 weeks, more patients on Litfulo reached F-VASI75 — at least a 75% improvement in facial pigmentation — and T-VASI50, at least a 50% improvement across the whole body, than those on placebo. TRANQUILLO enrolled patients aged 12 and up; TRANQUILLO 2 studied adults.
Building on an existing approval
Litfulo is not new: the FDA approved it in 2023 for severe alopecia areata, an autoimmune form of hair loss, in adults and adolescents 12 and older. Extending it to vitiligo would broaden its use into another visible, immune-driven skin condition where treatment options are limited.
What to watch
Pfizer did not give a precise regulatory timeline and said additional results will be presented at a future medical meeting. Approval decisions will rest with regulators reviewing the full data, not the topline results alone.