LITFULO (ritlecitinib) - (TRANQUILLO)

July 30, 2026: Pfizer Inc. (NYSE: PFE) reported positive topline results from two Phase 3 pivotal trials (TRANQUILLO and TRANQUILLO 2) of once-daily LITFULO (ritlecitinib) in patients with active or stable nonsegmental vitiligo (NSV). In both studies, 50 mg and 100 mg doses showed statistically significant, clinically meaningful improvements versus placebo on the co-primary endpoints at Week 52: facial repigmentation (F‑VASI75; ≥75% improvement in Facial VASI) and total body repigmentation (T‑VASI50; ≥50% improvement in Total VASI). TRANQUILLO enrolled patients aged ≥12 years (607 treated with 50 mg), and TRANQUILLO 2 enrolled adults (1,567 treated with 50 or 100 mg; 50 mg comparisons described as exploratory/descriptive). Overall, 2,174 NSV patients were evaluated across 271 sites worldwide.

Safety in NSV was consistent with LITFULO’s established profile in alopecia areata, with no new safety signals and similar rates of treatment-emergent adverse events across groups.

Based on these results, Pfizer plans to submit global regulatory filings for LITFULO in adult NSV. Additional data will be presented at a future medical meeting. Pfizer also plans to initiate a pivotal study of LITFULO in moderate alopecia areata in 2026.