Pfizer LITFULO vitiligo data moved into the spotlight on October 2, 2026, when Pfizer Inc. (NYSE: PFE) presented results from two Phase 3 trials of LITFULO (ritlecitinib) in nonsegmental vitiligo (NSV). The medicine is a once-daily oral treatment. The trials, TRANQUILLO 2 and TRANQUILLO, tested 100 mg and 50 mg doses, respectively, across a wide range of disease extent. According to Pfizer, both doses significantly improved facial and total body repigmentation compared with placebo.
The results were delivered in a late-breaking oral presentation at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria. Pfizer describes the TRANQUILLO program as the “largest Phase 3 program to date” for an oral systemic therapy in NSV. Patient-reported outcomes pointed in the same direction. They indicated reduced disease severity, meaningful change in facial and total body vitiligo, and greater disease stabilization than placebo.
Pfizer intends to submit the data to regulators globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company says the findings support planned filings for a potential new oral systemic option for adults with NSV. The key context is that the Pfizer LITFULO vitiligo results are company-reported trial data, and LITFULO is not yet approved for vitiligo.
Pfizer LITFULO Vitiligo Trial Design: TRANQUILLO 2 and TRANQUILLO Enrolled 2,174 Patients
The Pfizer LITFULO vitiligo development effort, known as the TRANQUILLO program, comprises two pivotal trials plus a long-term extension study named TRANQUILLO LTE. Together, the two pivotal studies evaluated 2,174 patients with NSV across 271 sites worldwide.
TRANQUILLO 2 enrolled 1,567 adults who received LITFULO 100 mg once daily. That study also included an exploratory and descriptive assessment of the 50 mg dose. TRANQUILLO evaluated 50 mg once daily in 607 patients aged 12 years and older. The extension study enrolled patients who had completed treatment in the parent TRANQUILLO trial.
Endpoints differ by region. For the U.S., the co-primary endpoints were the proportion of patients reaching F-VASI75 and T-VASI50 at Week 52. Outside the U.S., F-VASI75 at Week 52 was the primary endpoint, and T-VASI50 at Week 52 was a key secondary endpoint. F-VASI75 means at least 75% improvement in the Facial Vitiligo Area Scoring Index. T-VASI50 means at least 50% improvement in the Total Vitiligo Area Scoring Index.
TRANQUILLO Phase 3 Trial Design
| Parameter | TRANQUILLO 2 | TRANQUILLO |
|---|---|---|
| Drug | LITFULO (ritlecitinib) | LITFULO (ritlecitinib) |
| Dose | 100 mg once daily (50 mg exploratory, descriptive) | 50 mg once daily |
| Patients | 1,567 adults | 607 patients aged 12 years and older |
| Combined enrollment | 2,174 patients with NSV across 271 sites | 2,174 patients with NSV across 271 sites |
| U.S. co-primary endpoints | F-VASI75 and T-VASI50 at Week 52 | F-VASI75 and T-VASI50 at Week 52 |
| Ex-U.S. primary endpoint | F-VASI75 at Week 52 (T-VASI50 key secondary) | F-VASI75 at Week 52 (T-VASI50 key secondary) |
| Long-term extension | Not applicable | TRANQUILLO LTE |
| ClinicalTrials.gov identifiers | Not disclosed | Not disclosed |
Pfizer LITFULO Vitiligo Efficacy: F-VASI75 and T-VASI50 Results Versus Placebo
In the Pfizer LITFULO vitiligo co-primary facial analysis, 21.86% of TRANQUILLO 2 patients on LITFULO 100 mg achieved F-VASI75, versus 2.40% on placebo. In TRANQUILLO, 12.47% of patients on 50 mg reached F-VASI75, versus 2.48% on placebo. These figures come from the co-primary endpoint data Pfizer presented for the two studies.
On the total body measure, 13.02% of patients in TRANQUILLO 2 achieved T-VASI50 on LITFULO versus 2.40% on placebo. In TRANQUILLO, the figures were 8.98% versus 1.98%. Michael Vincent, M.D., Ph.D., Pfizer’s Chief Inflammation & Immunology Officer, said both trials showed strong and increasing repigmentation improvements over time and better patient-perceived disease severity.
Key secondary endpoints also favored LITFULO. Across both trials, the Pfizer LITFULO vitiligo data showed significant improvements from baseline in F-VASI and T-VASI as early as Week 24, increasing through Week 36 and Week 52. More patients on LITFULO also reached F-VASI75 and T-VASI50 at Weeks 24 and 36, and patient-reported facial and overall disease severity fell significantly at Week 52. Selected other endpoints were not type I error controlled. They included patient global impression of change and vitiligo noticeability, and disease stabilization was greater than placebo from Week 24 through Week 52. In TRANQUILLO 2, the exploratory 50 mg assessment also showed clinically meaningful improvement over placebo on both F-VASI75 and T-VASI50 at Week 52.
Co-Primary Endpoint Results at Week 52
| Endpoint | Study (LITFULO dose) | LITFULO | Placebo |
|---|---|---|---|
| F-VASI75 (≥75% improvement, face) | TRANQUILLO 2 (100 mg) | 21.86% | 2.40% |
| F-VASI75 (≥75% improvement, face) | TRANQUILLO (50 mg) | 12.47% | 2.48% |
| T-VASI50 (≥50% improvement, total body) | TRANQUILLO 2 (100 mg) | 13.02% | 2.40% |
| T-VASI50 (≥50% improvement, total body) | TRANQUILLO (50 mg) | 8.98% | 1.98% |
| Earliest significant F-VASI and T-VASI improvement | Both trials | Week 24 | Not applicable |
| Disease stabilization vs placebo | Both doses | From Week 24, maintained through Week 52 | Not applicable |
Pfizer LITFULO Vitiligo Safety Profile: No New Signals Versus Alopecia Areata Experience
The safety profile of LITFULO in NSV was consistent with its established profile in alopecia areata, and Pfizer reported no new safety signals. In the Pfizer LITFULO vitiligo trials, the proportion of patients with treatment-emergent adverse events (TEAEs) was similar across all treatment groups.
In TRANQUILLO 2, a TEAE was reported in 67.7% of patients on LITFULO 100 mg and 62.0% on placebo. The most common TEAEs were upper respiratory tract infection (8.9% vs. 3.4%), nasopharyngitis (7.9% vs. 7.3%), and headache (4.0% vs. 5.4%).
In TRANQUILLO, a TEAE was reported in 81.0% of patients on LITFULO 50 mg and 77.1% on placebo. Common events included upper respiratory tract infection (14.0% vs. 10.9%), increased blood creatine phosphokinase (11.0% vs. 8.0%), nasopharyngitis (10.5% vs. 9.5%), COVID-19 (6.0% vs. 5.0%), decreased lymphocyte count (6.3% vs. 1.5%), and headache (5.5% vs. 5.0%). Treatment-emergent serious adverse events were low in both studies: 3.4% on LITFULO versus 3.4% on placebo in TRANQUILLO 2, and 2.0% versus 2.5% in TRANQUILLO.
The U.S. prescribing information for LITFULO carries a boxed warning. Pfizer’s safety summary covers serious infections including tuberculosis, increased risk of death and major cardiovascular events in people aged 50 and older with a cardiovascular risk factor who take a JAK inhibitor, cancers, and blood clots. It also lists allergic reactions, low blood sugar in people with diabetes, and laboratory changes. Clinicians should review the full Prescribing Information, and patients can report adverse events through FDA MedWatch. The current U.S. indication is severe alopecia areata in adults and adolescents 12 years and older. This safety information is relevant to every Pfizer LITFULO vitiligo discussion because vitiligo is an investigational use.
Treatment-Emergent Adverse Events (TEAEs)
| Adverse Event | TRANQUILLO 2: LITFULO 100 mg | TRANQUILLO 2: Placebo | TRANQUILLO: LITFULO 50 mg | TRANQUILLO: Placebo |
|---|---|---|---|---|
| Any TEAE | 67.7% | 62.0% | 81.0% | 77.1% |
| Upper respiratory tract infection | 8.9% | 3.4% | 14.0% | 10.9% |
| Nasopharyngitis | 7.9% | 7.3% | 10.5% | 9.5% |
| Headache | 4.0% | 5.4% | 5.5% | 5.0% |
| Increased blood creatine phosphokinase | Not disclosed | Not disclosed | 11.0% | 8.0% |
| COVID-19 | Not disclosed | Not disclosed | 6.0% | 5.0% |
| Decreased lymphocyte count | Not disclosed | Not disclosed | 6.3% | 1.5% |
| Treatment-emergent serious AEs | 3.4% | 3.4% | 2.0% | 2.5% |
