Pfizer announced on Thursday that its oral hair loss medication, Litfulo, has met key objectives in two late-stage trials for nonsegmental vitiligo, a chronic condition involving pigment loss.
The Phase 3 studies for Litfulo reached their co-primary endpoints, according to Pfizer. In patients with active and stable nonsegmental vitiligo spanning a broad range of disease severity, both the 50 mg and 100 mg once-daily doses showed significant improvements in facial and overall repigmentation compared to a placebo at the 52-week mark.
Based on these results, the New York-based pharmaceutical company plans to file for regulatory approval worldwide, aiming to position Litfulo as a potential new oral systemic therapy for adults with nonsegmental vitiligo. The U.S. Food and Drug Administration (FDA) had already approved Litfulo in 2023 for treating severe alopecia areata in individuals aged 12 and older. Pfizer also indicated it intends to launch a pivotal study this year evaluating Litfulo for moderate alopecia areata.