Pfizer (NYSE: PFE) reported positive topline Phase III results for ritlecitinib (Litfulo) in nonsegmental vitiligo (NSV), positioning the drug to become the first approved oral systemic therapy for the condition in the US. The data arrive as AbbVie's Rinvoq (upadacitinib) secured EU approval for NSV on July 29, 2026 — one day earlier — making the competitive race for systemic dominance in this indication immediate.
Two pivotal trials, TRANQUILLO and TRANQUILLO 2, enrolled a combined 2,174 adults and adolescents across 271 sites globally. TRANQUILLO evaluated ritlecitinib 50 mg once daily in 607 patients aged 12 and older; TRANQUILLO 2 evaluated 50 mg and 100 mg once daily in 1,567 adults. Both trials met their co-primary US endpoints at Week 52: the proportion of patients achieving F-VASI75 (≥75% improvement in facial Vitiligo Area Scoring Index (VASI)) and T-VASI50 (≥50% improvement in total body VASI). Specific response rates were not disclosed in the topline release. The safety profile was consistent with ritlecitinib's established profile in alopecia areata, with no new signals and treatment-emergent adverse event rates similar across treatment groups.
Ritlecitinib is an oral, covalent inhibitor of JAK3 and the TEC family kinases. By blocking these immune signaling pathways, it modulates the cytolytic activity of immune cells that destroy melanocytes — the pigment-producing cells whose loss drives NSV. The drug was approved by the US FDA in 2023 for severe alopecia areata in adults and adolescents aged 12 and older, and holds approval across the US, EU, Canada, Japan, China, and the UK for that indication.
The NSV data carry commercial weight beyond the vitiligo indication itself. The only approved topical therapy for NSV repigmentation is Incyte's Opzelura (ruxolitinib) cream, a JAK1/JAK2 inhibitor approved by the FDA in July 2022 for patients aged 12 and older. Ruxolitinib cream addresses localized disease but is limited by application burden and lower efficacy on acral and non-facial areas. No oral systemic therapy is currently FDA-approved for NSV, leaving patients with extensive or rapidly progressive disease without a targeted systemic option. Upadacitinib, a selective JAK1 inhibitor, received EU approval for NSV on July 29, 2026, with an FDA application submitted in February 2026 and a decision pending.