Pfizer's LITFULO Clears Phase 3 Vitiligo Trials as AbbVie's Rinvoq Wins EU Approval

Pfizer (PFE) announced positive topline results from two Phase 3 trials of LITFULO (ritlecitinib) in nonsegmental vitiligo on July 30, with both the 50 mg and 100 mg once-daily doses meeting co-primary endpoints for facial and total body repigmentation versus placebo at Week 52. Pfizer plans to submit global regulatory filings for the drug as a potential oral systemic therapy for adults with the disease.

PFE closed at $25.15 on July 29. The stock was flat in premarket trading on July 30 following the announcement, consistent with a large-cap pharma where a single dermatology indication adds limited near-term revenue. Pfizer’s market cap sits near $143 billion.

TRANQUILLO enrolled 607 adults and adolescents aged 12 and older at 50 mg once daily. TRANQUILLO 2 enrolled 1,567 adults at either 50 mg or 100 mg once daily. Across both studies, significantly more patients on LITFULO achieved F-VASI75, a 75% improvement in the Facial Vitiligo Area Scoring Index, and T-VASI50, a 50% improvement in the Total Body Vitiligo Area Scoring Index, compared with placebo at Week 52. The safety profile was consistent with the established profile in alopecia areata, and no new safety signals emerged. Pfizer disclosed no specific response rates, with full data reserved for a future medical meeting.

LITFULO is an oral inhibitor of Janus kinase 3 (JAK3) and the TEC family kinases. By targeting key immune signaling pathways, it is thought to modulate the immune cells that destroy melanocytes in vitiligo. The FDA approved LITFULO for severe alopecia areata in adults and adolescents 12 and older in 2023, which de-risks the safety database ahead of the vitiligo filing. The JAK class carries a boxed warning for serious infections, malignancy, and thrombosis, a headwind for broader adoption in a non-life-threatening skin condition.

The competitive picture shifted the day before Pfizer’s readout. On July 29, 2026, the European Commission approved AbbVie’s (ABBV) Rinvoq (upadacitinib) for nonsegmental vitiligo in adults and adolescents 12 and older, making it the first and only systemic medication approved for vitiligo in the European Union. AbbVie had submitted FDA and EMA applications in February 2026 based on its Phase 3 Viti-Up program, which met the same co-primary endpoints of F-VASI75 and T-VASI50 at Week 48. The FDA decision is still pending, but the EU approval gives Rinvoq a meaningful head start.

Incyte’s (INCY) Opzelura (ruxolitinib cream), approved for topical vitiligo in 2022, set the efficacy bar. In the Phase 3 TRuE-V program, approximately 51% of patients who applied Opzelura from Day 1 achieved F-VASI75 at Week 52, up from roughly 31% at Week 24. Long-term extension data showed continued improvement through Week 104, with 54.9% of initial non-responders eventually reaching F-VASI75 with continued treatment. Both oral JAK inhibitors will need to clear that bar to justify systemic use over a topical.

Vitiligo affects an estimated 1.5% of the global population, and until this week there were no approved systemic therapies anywhere in the world. argenx recently paid $2.2 billion to acquire Forte Biosciences and its Phase 1b anti-CD122 antibody FB102, partly on the strength of early vitiligo data, underscoring how hotly contested this market has become.

What to watch next: the specific F-VASI75 and T-VASI50 response rates when Pfizer presents full data at a medical meeting, and whether AbbVie’s Rinvoq gets a US PDUFA date. If Rinvoq wins FDA approval before LITFULO files, Pfizer arrives second to a market AbbVie just opened.

Pfizer press release | AbbVie EC approval | ClinicalTrials.gov TRANQUILLO