Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation in Patients with Nonsegmental Vitiligo

LITFULO significantly improved facial and total body repigmentation at Week 52 compared to placebo, with continuous improvement starting at Week 24, supporting planned regulatory filings for a potential new oral systemic therapy for adults with nonsegmental vitiligo

NEW YORK, October 02, 2026--Pfizer Inc. (NYSE: PFE) today presented results from two Phase 3 trials evaluating the efficacy and safety of LITFULO® (ritlecitinib) as a once-daily oral treatment across a wide range of disease extent.

In the two studies, TRANQUILLO 2 and TRANQUILLO, LITFULO 100 mg and 50 mg, respectively, significantly improved facial and total body repigmentation compared to placebo. These improvements were supported by patient-reported outcomes indicating reduced disease severity and meaningful change in facial and total body vitiligo, as well as greater disease stabilization compared to placebo. These results from the largest Phase 3 program to date evaluating an oral systemic therapy for nonsegmental vitiligo (NSV) were presented today in a late-breaking oral presentation at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria.

Pfizer intends to submit these data to regulatory authorities globally, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for review.

"LITFULO has dual selectivity for JAK3 and the TEC family kinases, signals that immune cells use to attack pigment-producing cells in the skin, so it addresses a root cause of nonsegmental vitiligo rather than its visible effects alone. Across the largest Phase 3 program to date evaluating an oral systemic therapy for nonsegmental vitiligo, both TRANQUILLO 2 and TRANQUILLO demonstrated strong and increasing improvements in facial and total body repigmentation over time and also improved patients' own perception of facial and overall disease severity. We look forward to discussing these results with regulators to bring this potential option to patients as soon as possible."

- Michael Vincent, M.D., Ph.D., Chief Inflammation & Immunology Officer, Pfizer

"Nonsegmental vitiligo is a disease that can have a substantial burden on patients' lives beyond the visible symptoms on their skin. 1,2,3 It is a chronic autoimmune disease, yet patients often face stigma because it is trivialized as a condition that affects only skin appearance. 2 It can progress unpredictably, often across highly visible areas, and for decades people living with vitiligo have relied on limited available treatment options. 2,3 Research has shown that LITFULO (ritlecitinib) not only significantly improved facial and total body repigmentation, but also resulted in greater disease stabilization compared to the placebo. The results solidify the potential of LITFULO to support a new treatment paradigm rooted in systemic treatment that can address underlying disease drivers for people living with nonsegmental vitiligo."