US biopharmaceutical company Pfizer Inc (NYSE:PFE) on Thursday announced positive topline results from two Phase 3 trials evaluating LITFULO (ritlecitinib) as a potential oral systemic therapy for patients with nonsegmental vitiligo (NSV).

The TRANQUILLO and TRANQUILLO 2 studies met their co-primary endpoints, demonstrating significant improvements in facial and total body repigmentation compared with placebo at Week 52.

Both 50 milligram and 100 milligram doses of LITFULO delivered clinically meaningful improvements in the facial and total body Vitiligo Area Scoring Index (VASI) measures across patients with active and stable disease. Pfizer said it plans to submit global regulatory filings for LITFULO as a potential treatment option for adults with NSV.

The safety profile of LITFULO in NSV was consistent with its established safety profile in alopecia areata, with no new safety signals observed.

LITFULO was approved by the US Food and Drug Administration (FDA) in 2023 for severe alopecia areata in adults and adolescents 12 years and older.