Pfizer's LITFULO Meets Primary Endpoints in Phase 3 Trials for Nonsegmental Vitiligo Treatment

Pfizer announced positive topline results on July 30, 2026, from two Phase 3 trials of LITFULO (ritlecitinib) for nonsegmental vitiligo. Both the 50 mg and 100 mg daily doses met co-primary endpoints, showing significant facial and total body repigmentation at Week 52 compared to placebo. The trials evaluated 2,174 patients globally. While demonstrating efficacy, LITFULO carries warnings for serious infections, cardiovascular events, and blood clots.

LITFULO Phase 3 vitiligo trials

• ▪Pfizer announced on July 30, 2026, positive topline results from two Phase 3 trials evaluating LITFULO once daily in patients with nonsegmental vitiligo.
• ▪The safety profile of LITFULO in nonsegmental vitiligo trials was consistent with its established safety profile in alopecia areata, showing no new safety signals.
• ▪Both 50 milligram and 100 milligram doses of LITFULO demonstrated significant improvements over placebo in facial and total body repigmentation at Week 52.

Nonsegmental vitiligo disease background

• ▪Nonsegmental vitiligo is a chronic autoimmune disease where the immune system attacks melanin-producing cells, causing pigment loss and white patches on the skin.
• ▪Nonsegmental vitiligo can appear at any age and in all skin types, frequently affecting visible areas like the face, neck, and hands.

LITFULO JAK3 TEC mechanism

• ▪The U.S. Food and Drug Administration approved LITFULO in 2023 for treating severe alopecia areata in adults and adolescents aged 12 and older.
• ▪LITFULO is an oral inhibitor of Janus kinase 3 and TEC family kinases, designed to modulate immune cells contributing to melanocyte destruction.

TRANQUILLO clinical program design

• ▪The Phase 3 TRANQUILLO clinical development program evaluated 2,174 patients with nonsegmental vitiligo across 271 sites worldwide.
• ▪The TRANQUILLO trial evaluated 607 adults and adolescents, while the TRANQUILLO 2 trial evaluated 1,567 adults.

LITFULO serious infection risks

• ▪Healthcare providers must test patients for tuberculosis before starting LITFULO and monitor them for signs of tuberculosis during treatment.
• ▪LITFULO can lower the immune system's ability to fight infections, increasing the risk of serious infections like tuberculosis and shingles.

Cardiovascular events blood clots

• ▪LITFULO treatment can cause potentially life-threatening blood clots in the veins of the legs, lungs, or eyes.
• ▪Janus kinase inhibitors carry an increased risk of major cardiovascular events, including heart attack, stroke, or death, in patients aged 50 and older with cardiovascular risk factors.