Pfizer reports positive Phase 3 LITFULO results in vitiligo

Pfizer presented positive Phase 3 results on October 2, 2026, evaluating LITFULO (ritlecitinib) as a once-daily oral treatment for nonsegmental vitiligo across two pivotal trials, TRANQUILLO 2 and TRANQUILLO. The company plans to submit the findings to global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The trials evaluated 2,174 patients across 271 sites globally. In TRANQUILLO 2, testing a 100 mg dose in 1,567 adults, 21.86% of patients on LITFULO achieved at least 75% facial repigmentation (F-VASI75) at Week 52 compared to 2.40% on placebo. Additionally, 13.02% reached at least 50% total body repigmentation (T-VASI50) versus 2.40% on placebo.

In the TRANQUILLO study evaluating a 50 mg dose in 607 patients aged 12 and older, 12.47% reached F-VASI75 compared to 2.48% on placebo, while 8.98% achieved T-VASI50 versus 1.98% on placebo. Improvements began as early as Week 24 and expanded through Week 36 and Week 52.

Treatment-emergent adverse events were reported in 67.7% of patients on 100 mg LITFULO versus 62.0% on placebo in TRANQUILLO 2, and in 81.0% on 50 mg LITFULO versus 77.1% on placebo in TRANQUILLO. Serious adverse events remained low, occurring in 3.4% of patients in both arms of TRANQUILLO 2, and in 2.0% on LITFULO versus 2.5% on placebo in TRANQUILLO.