Oral therapy improves vitiligo repigmentation in phase 3 trials

Nonsegmental vitiligo is an autoimmune disease in which immune cells attack pigment-producing cells. Treatment options include topical medications and phototherapy. An effective oral therapy could expand choices for patients with extensive disease.

Litfulo (ritlecitinib), a once-daily oral medication FDA-approved for severe alopecia areata in adults and adolescents aged 12 years and older, improved facial and total body repigmentation versus placebo in two randomized, double-blind phase 3 trials presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress. Both alopecia areata and nonsegmental vitiligo involve immune attacks, targeting hair follicles in alopecia areata and pigment-producing cells in vitiligo. Ritlecitinib inhibits JAK3 and TEC-family kinases involved in those immune responses. Pfizer plans to seek FDA approval for treating adults with nonsegmental vitiligo.

The two trials enrolled patients with active or stable disease affecting 4%–60% of body surface area, including facial involvement. The TRANQUILLO trial evaluated ritlecitinib 50 mg daily in patients aged 12 years and older. TRANQUILLO 2 evaluated ritlecitinib 100 mg daily in adults.

At week 52, at least 75% improvement in the facial Vitiligo Area Scoring Index occurred in 12.5% of patients receiving 50 mg versus 2.5% receiving placebo in TRANQUILLO. In TRANQUILLO 2, corresponding rates were 21.9% with 100 mg versus 2.4% with placebo.

At least 50% improvement in the total body score occurred in 9.0% versus 2.0% in the 50 mg trial and 13.0% versus 2.4% in the 100 mg trial. Improvements emerged by week 24 and increased through week 52. More treated patients also reported improvement in facial and overall disease severity.

No new safety signals were identified. Reported adverse events included respiratory infections, headache, increased creatine phosphokinase, and decreased lymphocyte counts. Existing labeling includes boxed warnings for serious infections, malignancy, major cardiovascular events, thrombosis, and mortality.

“Living with nonsegmental vitiligo can have a profound impact on patients’ daily lives. Many patients experience frustration due to the unpredictable nature of nonsegmental vitiligo as well as the limitations of currently available treatments and are seeking additional options that can address the underlying disease,” said Iltefat Hamzavi, MD, of Henry Ford Health and Hamzavi Dermatology Specialists in an earlier press release. “In these trials, Litfulo (ritlecitinib) demonstrated significant improvements in both facial and total body repigmentation, with the findings reinforcing the potential of Litfulo to help support a new treatment paradigm with systemic therapies for patients for whom disease burden warrants more than localized treatment alone.”

Sources: Hamzavi IH, et al. (2026 Oct 2) EADV Congress 2026, Abstract. Efficacy and safety of ritlecitinib in patients with nonsegmental vitiligo (NSV): results from the Tranquillo 2 Part Ia and Tranquillo Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trials; Pfizer. (2026 Oct 2). Pfizer’s LITFULO significantly improved facial and total body repigmentation in patients with nonsegmental vitiligo