Pfizer has reported positive results from two Phase 3 trials, Tranquillo 2 and Tranquillo, evaluating Litfulo (ritlecitinib) as a once-daily oral treatment for Nonsegmental Vitiligo (NSV). The findings showed that Litfulo 100 mg and 50 mg significantly improved facial and total body repigmentation compared with placebo.

In Tranquillo 2, 21.86 percent of patients receiving 100 mg Litfulo achieved F-VASI75, compared with 2.40 percent on placebo, while 13.02 percent achieved T-VASI50 versus 2.40  percent with placebo. In Tranquillo, the corresponding results for 50 mg Litfulo were 12.47 percent versus 2.48  percent for F-VASI75 and 8.98  percent versus 1.98  percent or T-VASI50.

The studies also showed improvements in patient-reported disease severity, vitiligo noticeability and disease stabilisation. The safety profile was consistent with Litfulo’s established profile in alopecia areata, with no new safety signals identified.

The Phase 3 programme included 2,174 patients across 271 sites worldwide. Pfizer plans to submit the data to regulatory authorities, including the US FDA and European Medicines Agency, for review. Litfulo is currently approved for severe alopecia areata in adults and adolescents aged 12 years and older.

The results were presented at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria.