Pfizer said its drug Litfulo met primary goals in two large late-stage studies, positioning it as a potential new oral treatment for nonsegmental vitiligo, the most common form of the skin-pigmentation disorder.
The U.S. drugmaker was testing Litfulo in adults with nonsegmental vitiligo, a condition that causes patches of skin to lose pigment. Pfizer said both studies showed significantly more patients on the drug achieved at least a 75% improvement in facial repigmentation and at least a 50% improvement in total-body repigmentation after 52 weeks compared with those given placebo.
“Litfulo could become a new oral systemic treatment option for adults living with NSV, significantly improving and potentially maintaining facial and total body repigmentation,” Michael Vincent, Pfizer’s chief inflammation and immunology officer, said in a statement.
The trials enrolled a combined 2,174 patients across 50 mg and 100 mg once-daily doses. Pfizer called them the largest late-stage programs to evaluate an oral treatment for nonsegmental vitiligo.
Litfulo works by blocking specific proteins inside immune cells — JAK3 and TEC family kinases — which helps stop the immune system from attacking pigment-producing cells in the skin. The drug is already approved in several countries, including the United States, for severe alopecia areata, an autoimmune disorder that causes hair loss.
Pfizer said the safety profile in vitiligo patients was consistent with that seen in alopecia studies, with no new safety signals identified. The company plans to submit the data to health regulators globally to seek approval for the treatment in adults with nonsegmental vitiligo.
LITFULO was approved in 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Pfizer plans to initiate a pivotal study evaluating LITFULO for the treatment of moderate alopecia areata in 2026.\
About LITFULO (ritlecitinib)
LITFULO is an oral inhibitor of Janus kinase 3 (JAK3) and the TEC family kinases which is being investigated for the treatment of nonsegmental vitiligo. By targeting key immune signaling pathways involved in the disease, LITFULO is thought to modulate the activity of immune cells that contribute to melanocyte destruction. LITFULO is currently approved for the treatment of severe alopecia areata in adults and adolescents 12 years and older, where it targets the underlying immune mechanisms that drive hair follicle damage and hair loss. Through its dual mechanism, LITFULO has demonstrated the potential to address immune-mediated pathology underlying both alopecia areata and nonsegmental vitiligo.
It is approved for the treatment of severe alopecia areata in adults and adolescents 12 years and older in the United States, European Union, Canada, Japan, China, and United Kingdom.
The LITFULO development program spans multiple immune‑mediated dermatologic conditions, including alopecia areata, nonsegmental vitiligo, chronic spontaneous urticaria, and hidradenitis suppurativa, supporting a focused development approach in dermatology.