NEW YORK, July 30, 2026
Pfizer Inc. announced positive topline Phase 3 results for LITFULO™ (ritlecitinib) in patients with nonsegmental vitiligo (NSV), with both pivotal TRANQUILLO and TRANQUILLO 2 studies successfully meeting their co-primary endpoints. The once-daily oral therapy demonstrated statistically significant and clinically meaningful improvements in both facial repigmentation (F-VASI75) and total body repigmentation (T-VASI50) compared with placebo after 52 weeks of treatment. The Phase 3 program, which enrolled 2,174 patients across 271 sites worldwide, represents the largest clinical development program to date for an oral systemic therapy in nonsegmental vitiligo. Based on these findings, Pfizer plans to submit global regulatory filings seeking approval of LITFULO as a new oral systemic treatment option for adults with nonsegmental vitiligo.
Largest Phase 3 Program Demonstrates Significant Repigmentation Benefits
The TRANQUILLO clinical development program evaluated LITFULO in patients with both active and stable nonsegmental vitiligo across a broad range of disease severity. TRANQUILLO enrolled 607 adults and adolescents aged 12 years and older, while TRANQUILLO 2 included 1,567 adult patients. Across both studies, 50 mg and 100 mg doses of LITFULO achieved significant improvements over placebo in the proportion of patients reaching at least 75% improvement in Facial Vitiligo Area Scoring Index (F-VASI75) and at least 50% improvement in Total Vitiligo Area Scoring Index (T-VASI50) at Week 52. These findings highlight the therapy’s potential to restore pigmentation in patients living with a chronic autoimmune disease that currently has limited systemic treatment options.
Safety Profile Remains Consistent With Previous Clinical Experience
Pfizer reported that the safety profile of LITFULO in patients with nonsegmental vitiligo was consistent with its established safety profile observed in severe alopecia areata, with no new safety signals identified during the Phase 3 studies. The overall incidence of treatment-emergent adverse events (TEAEs) was similar across all treatment groups, supporting the therapy’s favorable benefit-risk profile. According to Dr. Michael Vincent, Chief Inflammation & Immunology Officer at Pfizer, the results build on the company’s dermatology expertise and strengthen confidence that LITFULO, if approved, could become a new oral systemic treatment capable of delivering meaningful and sustained facial and total body repigmentation for adults living with nonsegmental vitiligo.
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Regulatory Filings Planned as Pfizer Expands Dermatology Portfolio
The positive Phase 3 results further strengthen Pfizer’s dermatology pipeline, with the company planning to submit global regulatory applications seeking approval of LITFULO for nonsegmental vitiligo in adults. LITFULO, an oral JAK3 and TEC family kinase inhibitor, is already approved in multiple countries for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older. Beyond vitiligo, the medicine is also being investigated for chronic spontaneous urticaria and hidradenitis suppurativa, while Pfizer plans to launch a pivotal study in moderate alopecia areata later in 2026. If approved for nonsegmental vitiligo, LITFULO could become an important systemic treatment option for patients whose disease extends beyond the scope of localized therapies.
Source: Pfizer press release
