{"success":true,"data":{"pressRelease":{"id":"159569","rtpr_id":"nBw2gHCtza-20261002","ticker":"PFE","exchange":"NYSE","all_tickers":["PFE"],"title":"Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation in Patients with Nonsegmental Vitiligo","author":"Business Wire","published_at":"2026-10-02T15:15:00.092Z","article_body":"Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation\nin Patients with Nonsegmental Vitiligo\n\nLITFULO significantly improved facial and total body repigmentation at Week 52\ncompared to placebo, with continuous improvement starting at Week 24,\nsupporting planned regulatory filings for a potential new oral systemic\ntherapy for adults with nonsegmental vitiligo\n\nPfizer Inc. (NYSE: PFE) today presented results from two Phase 3 trials\nevaluating the efficacy and safety of LITFULO(®) (ritlecitinib) as a\nonce-daily oral treatment across a wide range of disease extent.\n\nIn the two studies, TRANQUILLO 2 and TRANQUILLO, LITFULO 100 mg and 50 mg,\nrespectively, significantly improved facial and total body repigmentation\ncompared to placebo. These improvements were supported by patient-reported\noutcomes indicating reduced disease severity and meaningful change in facial\nand total body vitiligo, as well as greater disease stabilization compared to\nplacebo. These results from the largest Phase 3 program to date evaluating an\noral systemic therapy for nonsegmental vitiligo (NSV) were presented today in\na late-breaking oral presentation at the 35th European Academy of Dermatology\nand Venereology (EADV) Annual Congress in Vienna, Austria.\n\nPfizer intends to submit these data to regulatory authorities globally,\nincluding the U.S. Food and Drug Administration (FDA) and European Medicines\nAgency (EMA) for review.\n\n“LITFULO has dual selectivity for JAK3 and the TEC family kinases, signals\nthat immune cells use to attack pigment-producing cells in the skin, so it\naddresses a root cause of nonsegmental vitiligo rather than its visible\neffects alone. Across the largest Phase 3 program to date evaluating an oral\nsystemic therapy for nonsegmental vitiligo, both TRANQUILLO 2 and TRANQUILLO\ndemonstrated strong and increasing improvements in facial and total body\nrepigmentation over time and also improved patients’ own perception of\nfacial and overall disease severity. We look forward to discussing these\nresults with regulators to bring this potential option to patients as soon as\npossible.”\n\n- Michael Vincent, M.D., Ph.D., Chief Inflammation & Immunology Officer,\nPfizer\n\n“Nonsegmental vitiligo is a disease that can have a substantial burden on\npatients’ lives beyond the visible symptoms on their skin.( 1,2,3) It is a\nchronic autoimmune disease, yet patients often face stigma because it is\ntrivialized as a condition that affects only skin appearance.( 2) It can\nprogress unpredictably, often across highly visible areas, and for decades\npeople living with vitiligo have relied on limited available treatment\noptions.( 2,3) Research has shown that LITFULO (ritlecitinib) not only\nsignificantly improved facial and total body repigmentation, but also resulted\nin greater disease stabilization compared to the placebo. The results solidify\nthe potential of LITFULO to support a new treatment paradigm rooted in\nsystemic treatment that can address underlying disease drivers for people\nliving with nonsegmental vitiligo.”\n\n- Iltefat Hamzavi, M.D., Senior Staff Physician, Department of Dermatology,\nHenry Ford Health and Hamzavi Dermatology Specialists\n\nKey Results from TRANQUILLO Studies\n\n\n * Co-primary Endpoints – data presented from the TRANQUILLO 2 (100 mg LITFULO)\nand TRANQUILLO (50 mg LITFULO) studies, respectively:\n\n\n* 21.86% and 12.47% of patients taking LITFULO achieved F-VASI75 (≥75%\nimprovement in Facial Vitiligo Area Scoring Index) compared to 2.40% and 2.48%\non placebo, respectively.\n\n * 13.02% and 8.98% of patients taking LITFULO achieved T-VASI50 (≥50%\nimprovement in Total Vitiligo Area Scoring Index) compared to 2.40% and 1.98%\non placebo, respectively.\n\n\n\n\n * Key Secondary Endpoints: LITFULO achieved statistically significant and\nclinically meaningful improvements compared to placebo across multiple\nmeasures of facial and total body repigmentation. Across both trials,\nsignificant improvements from baseline in F-VASI and T-VASI were seen as early\nas Week 24 and increased through Week 36 and Week 52 compared to placebo.\nAdditionally, more patients on LITFULO achieved clinically meaningful\nimprovements at earlier timepoints, as measured by F-VASI75 and T-VASI50 at\nWeek 24 and Week 36 compared to placebo. LITFULO also significantly reduced\npatient-reported facial and overall disease severity compared to placebo at\nWeek 52.\n\n * Other Selected Endpoints (not type I error controlled): Patients on LITFULO\nalso reported benefit over placebo based on meaningful change in patient\nglobal impression of change in face (PGIC-F) and overall vitiligo (PGIC-V) vs\nplacebo. Noticeability (VNS) improved through Week 52 with more patients\nrating their vitiligo as “a lot less” or “no longer” noticeable\ncompared to placebo. Treatment with ritlecitinib, at both dose levels,\nresulted in greater disease stabilization compared with placebo from Week 24\nonward, with maintained stabilization through Week 52. In an assessment of 50\nmg LITFULO in TRANQUILLO 2, clinically meaningful improvement over placebo was\nobserved for both F-VASI75 and T-VASI50 at Week 52.\n\n * Safety: The safety profile of LITFULO in NSV was consistent with the\nestablished safety profile in alopecia areata. No new safety signals were\nobserved. Overall, the proportion of patients with treatment‑emergent\nadverse events (TEAEs) was similar across all treatment groups.\n\n\n* In TRANQUILLO 2, a TEAE was reported in 67.7% or 62.0% of patients treated\nwith LITFULO 100 mg or placebo, respectively. The most common TEAEs were upper\nrespiratory tract infection (8.9% vs. 3.4%), nasopharyngitis (7.9% vs. 7.3%),\nand headache (4.0% vs. 5.4%).\n\n * In TRANQUILLO, a TEAE was reported in 81.0% or 77.1% of patients treated with\nLITFULO 50 mg or placebo, respectively. The most common TEAEs were upper\nrespiratory tract infection (14.0% vs. 10.9%), increased blood creatine\nphosphokinase (11.0% vs. 8.0%), nasopharyngitis (10.5% vs. 9.5%), COVID-19\n(6.0% vs. 5.0%), decreased lymphocyte count (6.3% vs. 1.5%), and headache\n(5.5% vs. 5.0%).\n\n * Treatment-emergent serious AEs (TESAEs) were reported in a low number of\npatients across both studies: 3.4% or 3.4% in TRANQUILLO 2 for those on\nLITFULO 100 mg or placebo, respectively; 2.0% or 2.5% in TRANQUILLO for those\non LITFULO 50 mg or placebo, respectively.\n\n\n\n\nPhase 3 Clinical Trial Designs for TRANQUILLO 2 and TRANQUILLO\n\n\n * The Phase 3 TRANQUILLO clinical development program consists of two pivotal\ntrials — TRANQUILLO 2 and TRANQUILLO — and a long-term extension trial,\nTRANQUILLO LTE.\n\n * TRANQUILLO 2 and TRANQUILLO evaluated 2,174 patients in total with NSV across\n271 sites worldwide.\n\n\n* TRANQUILLO 2: Evaluated 100 mg LITFULO once daily in 1,567 adults. The study\nalso included an assessment of 50 mg LITFULO that is exploratory and\ndescriptive in nature.\n\n * TRANQUILLO: Evaluated 50 mg LITFULO once daily in 607 patients aged 12 years\nand older.\n\n * Patients enrolled in the TRANQUILLO LTE completed treatment in the parent\nstudy, TRANQUILLO.\n\n\n\n\n * Endpoints: For both studies in the U.S., the co-primary endpoints were the\nproportion of patients who achieved F-VASI75 and the proportion of patients\nwho achieved T-VASI50 at Week 52.\n\n\n* In countries outside of the U.S., F-VASI75 at Week 52 was the primary\nendpoint\nand T-VASI50 at Week 52 was a key secondary endpoint.\n\n\n\n\nAdvancing Pfizer’s Commitment to Immune-Mediated Dermatologic Conditions\n\nThese results for LITFULO highlight the medicine’s potential for people\nliving with NSV and build on Pfizer’s longstanding commitment to\nimmune-mediated dermatologic conditions. LITFULO is currently approved by the\nFDA for the treatment of severe alopecia areata in adults and adolescents 12\nyears and older.\n\nThe positive results for LITFULO in vitiligo further reinforce the potential\nvalue of inhibiting the JAK3 and TEC family kinases across multiple\nimmune-mediated skin diseases and may position it to be a new oral systemic\ntherapy option for adults with NSV.\n\nPfizer is presenting more than 30 accepted abstracts across its dermatology\nportfolio at the 35th EADV Congress, spanning nonsegmental vitiligo, alopecia\nareata, and atopic dermatitis.\n\n\n * In alopecia areata, Pfizer presented long-term Phase 3 data showing clinically\nmeaningful improvements in scalp hair regrowth with LITFULO (ritlecitinib)\nthrough five years, with no new safety signals observed. Pfizer has also\ninitiated a pivotal study evaluating LITFULO for the treatment of moderate\nalopecia areata.\n\n * In atopic dermatitis, Pfizer presented a late-breaking exploratory analysis of\nserum protein biomarkers from the Phase 3 JADE COMPARE study of CIBINQO\n(abrocitinib), alongside a final integrated safety analysis of 3,850 patients\nwith up to 6.5 years of exposure. Pfizer also presented interim Phase 2\nefficacy and safety results at Week 16 for tilrekimig (PF-07275315), an\ninvestigational, potential first-in-class trispecific antibody targeting IL-4,\nIL-13, and TSLP.\n\nAbout Nonsegmental Vitiligo\n\nNSV is a chronic autoimmune disease in which the immune system attacks\nmelanin-producing cells, leading to a loss of pigment and resulting in white\nmacules and patches on the skin/hair over time.(4) NSV can appear at any age\nand in all skin types, causing depigmentation anywhere on the skin, often\naffecting highly visible areas such as the face, neck, and hands.(1) While\nvitiligo is frequently treated as a cosmetic condition, it is a serious\nautoimmune disease that can have a considerable impact on patients’ lives\nwell beyond the physical symptoms.(1,2) Because NSV is a chronic disease,\nsystemic treatment options may be needed to help patients restore skin\npigmentation and maintain repigmentation over time.(3)\n\nFor more information on Pfizer’s Commitment to Immunology and Inflammation,\nplease visit: Inflammation & Immunology | Pfizer\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pfizer.com%2Fscience%2Ffocus-areas%2Fimmunology-inflammation&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=Inflammation+%26amp%3B+Immunology+%7C+Pfizer&index=1&md5=574f2b32d4bb48a9465d16736f4b14a0)\n.\n\nFor more information on LITFULO and the Phase 3 results in NSV, please visit:\nPfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with\nNonsegmental Vitiligo | Pfizer\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pfizer.com%2Fnews%2Fpress-release%2Fpress-release-detail%2Fpfizer-announces-positive-topline-phase-3-results-litfulo&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=Pfizer+Announces+Positive+Topline+Phase+3+Results+for+LITFULO+in+Patients+with+Nonsegmental+Vitiligo+%7C+Pfizer&index=2&md5=b6a0bcfc312499f133dde8b37a52b0c5)\n\nAbout LITFULO(®) (ritlecitinib)\n\nLITFULO is an oral inhibitor of Janus kinase 3 (JAK3) and the TEC family\nkinases which is being investigated for the treatment of nonsegmental\nvitiligo. By targeting key immune signaling pathways involved in the disease,\nLITFULO is thought to modulate the activity of immune cells that contribute to\nmelanocyte destruction. LITFULO is currently approved for the treatment of\nsevere alopecia areata in adults and adolescents 12 years and older, where it\ntargets the underlying immune mechanisms that drive hair follicle damage and\nhair loss. Through its dual mechanism, LITFULO has demonstrated the potential\nto address immune-mediated pathology underlying both alopecia areata and\nnonsegmental vitiligo.\n\nLITFULO is approved for the treatment of severe alopecia areata in adults and\nadolescents 12 years and older in the United States, European Union, Canada,\nJapan, China, and United Kingdom.\n\nThe LITFULO development program spans multiple immune‑mediated dermatologic\nconditions, including alopecia areata, nonsegmental vitiligo, chronic\nspontaneous urticaria, and hidradenitis suppurativa, supporting a focused\ndevelopment approach in dermatology.\n\nU.S. Indication\n\nLITFULO (ritlecitinib) is a prescription medicine used to treat severe\nalopecia areata in adults and adolescents 12 years and older.\n\nIt is not known if LITFULO is safe and effective in children under 12 years of\nage.\n\nU.S. Important Safety Information\n\nLITFULO may cause serious side effects, including:\n\nSerious infections.\n\nLITFULO can lower the ability of your immune system to fight infections. Do\nnot start LITFULO if you have any kind of infection unless your healthcare\nprovider tells you it is okay. Some people have had serious infections while\ntaking LITFULO or other similar medicines, including tuberculosis (TB), and\ninfections caused by bacteria, fungi, or viruses that can spread throughout\nthe body and have been hospitalized. Some people taking similar medicines to\nLITFULO have died from these infections. You may be at a higher risk of\ndeveloping shingles (herpes zoster).\n\nYour healthcare provider should test you for TB before starting treatment with\nLITFULO and should watch you closely for signs and symptoms of TB during\ntreatment with LITFULO.\n\nBefore and after starting LITFULO, tell your healthcare provider if you think\nyou have an infection, are being treated for one, or have symptoms of an\ninfection, including:\n\n\n * fever, sweating, or chills\n\n * muscle aches\n\n * cough or shortness of breath\n\n * blood in your phlegm\n\n * weight loss\n\n * warm, red, or painful skin or sores on your body\n\n * diarrhea or stomach pain\n\n * burning when you urinate or urinating more often than usual\n\n * feeling very tired\n\nLITFULO can make you more likely to get infections or worsen infections you\nhave. If you get a serious infection, your healthcare provider may stop\ntreatment with LITFULO until your infection is controlled.\n\nThere is an increased risk of death in people 50 years of age and older who\nhave at least one heart disease (cardiovascular) risk factor and are taking a\nJanus kinase (JAK) inhibitor. LITFULO is a kinase inhibitor medicine.\n\nCancer and immune system problems.\n\nLITFULO may increase your risk of certain cancers by changing the way your\nimmune system works. Lymphoma and other cancers, including skin cancers, can\nhappen. People taking JAK inhibitors have a higher risk of certain cancers\nincluding lymphoma and lung cancer, especially if you are a current or past\nsmoker. Follow your healthcare provider’s advice about having your skin\nchecked for skin cancer during treatment. Tell your healthcare provider if you\nhave ever had any type of cancer.\n\nThere is an increased risk of major cardiovascular events such as heart\nattack, stroke, or death in people 50 years of age and older who have at least\none heart disease (cardiovascular) risk factor and are taking a JAK inhibitor,\nespecially if you are a current or past smoker.\n\nGet emergency help right away if you have any symptoms of a heart attack or\nstroke while using LITFULO, including:\n\n\n * discomfort in the center of your chest that lasts for more than a few minutes,\nor that goes away and comes back\n\n * severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or\njaw\n\n * pain or discomfort in your arms, back, neck, jaw, or stomach\n\n * shortness of breath with or without chest discomfort\n\n * breaking out in a cold sweat\n\n * nausea or vomiting\n\n * feeling lightheaded\n\n * weakness in one part or on one side of your body\n\n * slurred speech\n\nBlood clots.\n\nBlood clots in the veins of your legs (deep vein thrombosis, DVT), lungs\n(pulmonary embolism, PE), or eyes can happen in some people taking LITFULO.\nThis may be life-threatening. Blood clots in the veins of the legs and lungs\nhave happened more often in people 50 years of age and older with at least one\nheart disease (cardiovascular) risk factor taking a JAK inhibitor. Tell your\nhealthcare provider if you have had blood clots in the past.\n\nStop taking LITFULO and get medical help right away if you have any signs and\nsymptoms of blood clots, including swelling, pain or tenderness in one or both\nlegs; sudden, unexplained chest or upper back pain; shortness of breath or\ndifficulty breathing; or changes in vision, especially in one eye only.\n\nAllergic reactions.\n\nSymptoms that may mean you are having an allergic reaction have been seen\nduring treatment with LITFULO. Some of these reactions were serious. Stop\ntaking LITFULO and get emergency medical help right away if you have symptoms\nof allergic reaction, including hives; rash; trouble breathing; feeling faint\nor dizzy; or swelling of your lips, tongue, or throat.\n\nLow blood sugar in people with diabetes.\n\nIf you have diabetes, your healthcare provider may instruct you to check your\nblood sugar levels more often during treatment with LITFULO. Call your\nhealthcare provider if you have any problems with low blood sugar\n(hypoglycemia).\n\nChanges in certain laboratory test results.\n\nYour healthcare provider should do blood tests before you start taking LITFULO\nand during treatment to check your lymphocyte and platelet counts and liver\nenzyme and creatine phosphokinase (CPK) levels. You should not take LITFULO if\nyour lymphocyte counts or platelet counts are too low or your liver tests are\ntoo high. Increased CPK levels in the blood are common with LITFULO and can\nalso be severe. Your healthcare provider may stop treatment for a period of\ntime if there are changes in these blood test results.\n\nDo not take LITFULO if you are allergic to ritlecitinib or any of the\ningredients in LITFULO. See the Medication Guide for a complete list of\ningredients.\n\nBefore taking LITFULO, tell your healthcare provider if you:\n\n\n * have an infection, are being treated for one, or have one that won’t go away\nor keeps returning\n\n * have diabetes\n\n * have chronic lung disease, HIV, or a weak immune system\n\n * have TB or have been in close contact with someone with TB\n\n * have had shingles (herpes zoster)\n\n * have had hepatitis B or hepatitis C\n\n * live, have lived, or traveled to certain parts of the country (such as the\nOhio & Mississippi River Valleys and the Southwest) where there is an\nincreased chance for getting certain kinds of fungal infections. These\ninfections may happen or worsen when taking LITFULO. Ask your healthcare\nprovider if you’re unsure if you have lived in an area where these\ninfections are common.\n\n * have had any type of cancer\n\n * have had blood clots\n\n * are a current or past smoker\n\n * have had a heart attack, other heart problems, or stroke\n\n * have liver problems\n\n * have low platelet counts or white blood cell counts\n\n * have recently received or are scheduled to receive any vaccinations. People\nwho take LITFULO should not receive live vaccines right before or during\ntreatment.\n\n * are pregnant or plan to become pregnant. It is not known if LITFULO will harm\nyour unborn baby. Tell your healthcare provider if you are pregnant or plan to\nbecome pregnant during treatment with LITFULO. There is a pregnancy registry\nfor people who take LITFULO during pregnancy. Report pregnancies to Pfizer\nInc. at 1-877-390-2940.\n\n * are breastfeeding or plan to breastfeed. It is not known if LITFULO passes\ninto your breast milk. Do not breastfeed during treatment with LITFULO and for\n14 hours after your last dose of LITFULO. Talk to your healthcare provider\nabout the best way to feed your baby during treatment with LITFULO.\n\nTell your healthcare provider about all the medicines you take, including\nprescription and over‑the‑counter medicines, vitamins, and herbal\nsupplements. LITFULO and other medicines may affect each other causing side\neffects.\n\nThe most common side effects of LITFULO include headache; diarrhea; acne;\nrash; hives; inflamed hair pores (folliculitis); fever; eczema; dizziness;\nshingles; decreased red blood cell counts; and mouth sores, redness and\nswelling of the lining of your mouth. These are not all of the possible side\neffects of LITFULO.\n\nYou are encouraged to report adverse events related to Pfizer products by\ncalling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S.\nFood and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.fda.gov%2FMedWatch&index=3&md5=d291e037eda69785c6efdc1572d986af)\nor call 1-800-FDA-1088.\n\nPlease see full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda_docs%2Flabel%2F2026%2F215830s001lbl.pdf&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=Prescribing+Information&index=4&md5=c0c7afee42e20b79d14db346dc79b059)\n, including BOXED WARNING, and Medication Guide.\n\nAbout Pfizer: Breakthroughs That Change Patients’ Lives\n\nAt Pfizer, we apply science and our global resources to bring therapies to\npeople that extend and significantly improve their lives. We strive to set the\nstandard for quality, safety and value in the discovery, development and\nmanufacture of health care products, including innovative medicines and\nvaccines. Every day, Pfizer colleagues work across developed and emerging\nmarkets to advance wellness, prevention, treatments and cures that challenge\nthe most feared diseases of our time. Consistent with our responsibility as\none of the world’s premier innovative biopharmaceutical companies, we\ncollaborate with health care providers, governments and local communities to\nsupport and expand access to reliable, affordable health care around the\nworld. For more than 175 years, we have worked to make a difference for all\nwho rely on us. We routinely post information that may be important to\ninvestors on our website at www.Pfizer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.Pfizer.com&index=5&md5=20cd634e14244bb7973a372c9494a854)\n. 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Pfizer\nassumes no obligation to update forward-looking statements contained in this\nrelease as the result of new information or future events or developments.\n\nThis release contains forward-looking information about LITFULO\n(ritlecitinib), including its potential benefits, the development program for\nLITFULO, results from two Phase 3 trials for LITFULO in patients with\nnonsegmental vitiligo, and plans to submit these data to regulatory\nauthorities globally, including the U.S. Food and Drug Administration and\nEuropean Medicines Agency, for review, that involves substantial risks and\nuncertainties that could cause actual results to differ materially from those\nexpressed or implied by such statements. Risks and uncertainties include,\namong other things, uncertainties regarding the commercial success of LITFULO;\nthe uncertainties inherent in research and development, including the ability\nto meet anticipated clinical endpoints, commencement and/or completion dates\nfor our clinical trials, regulatory submission dates, regulatory approval\ndates and/or launch dates, as well as the possibility of unfavorable new\nclinical data and further analyses of existing clinical data; the risks\nassociated with initial, preliminary or interim data; the risk that clinical\ntrial data are subject to differing interpretations and assessments by\nregulatory authorities; whether regulatory authorities will be satisfied with\nthe design of and results from our clinical studies; whether and when\napplications for LITFULO may be filed in particular jurisdictions for any\npotential indications; whether and when any such applications for LITFULO that\nmay be pending or filed may be approved by regulatory authorities, which will\ndepend on myriad factors, including making a determination as to whether the\nproduct’s benefits outweigh its known risks and determination of the\nproduct’s efficacy and, if approved, whether LITFULO will be commercially\nsuccessful; decisions by regulatory authorities impacting labeling,\nmanufacturing processes, safety and/or other matters that could affect the\navailability or commercial potential of LITFULO; risks and uncertainties\nrelated to issued or future executive orders or other new, or changes in, laws\nor regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s\nbusiness, operations and financial results; and competitive developments.\n\nA further description of risks and uncertainties can be found in Pfizer’s\nAnnual Report on Form 10-K for the fiscal year ended December 31, 2025, and in\nits subsequent reports on Form 10-Q, including in the sections thereof\ncaptioned “Risk Factors” and “Forward-Looking Information and Factors\nThat May Affect Future Results”, as well as in its subsequent reports on\nForm 8-K, all of which are filed with the U.S. Securities and Exchange\nCommission and available at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.sec.gov&index=12&md5=43c698713830c39994f7a616605a1738)\nand www.pfizer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.pfizer.com&index=13&md5=fb58f200b9929c574263574e5cd3646c)\n.\n\nReferences\n\n\n 1. Seneschal J, Bae JM, Ezzedine K, et al. Vitiligo. Nat Rev Dis Primers.\n2025;11(1):85. doi:10.1038/s41572-025-00670-x\n\n 2. Ma S, Zieneldien T, Tan IJ, Jafferany M. Cross-cultural beliefs and\nstigmatization in vitiligo: A systematic review. J Cosmet Dermatol.\n2026;25(4):e70725. doi:10.1111/jocd.70725\n\n 3. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet.\n2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7\n\n 4. Upadhya S, Andrade MJ, Shukla V, Rao R, Satyamoorthy K. Genetic and immune\ndysregulation in vitiligo: Insights into autoimmune mechanisms and disease\npathogenesis. Autoimmun Rev. 2025;24(8):103841.\ndoi:10.1016/j.autrev.2025.103841\n\nCategory: Prescription Medicines\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261002026421/en/\n(https://www.businesswire.com/news/home/20261002026421/en/)\n\nMedia Contact: \n\nPfizerMediaRelations@Pfizer.com (mailto:PfizerMediaRelations@Pfizer.com)\n\nInvestor Contact: \n\nIR@Pfizer.com (mailto:IR@Pfizer.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw2gHCtza-20261002","title":"Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation in Patients with Nonsegmental Vitiligo","author":"Business Wire","ticker":"PFE","created":"2026-10-02T15:15:00.092Z","tickers":["PFE"],"exchange":"NYSE","article_body":"Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation\nin Patients with Nonsegmental Vitiligo\n\nLITFULO significantly improved facial and total body repigmentation at Week 52\ncompared to placebo, with continuous improvement starting at Week 24,\nsupporting planned regulatory filings for a potential new oral systemic\ntherapy for adults with nonsegmental vitiligo\n\nPfizer Inc. (NYSE: PFE) today presented results from two Phase 3 trials\nevaluating the efficacy and safety of LITFULO(®) (ritlecitinib) as a\nonce-daily oral treatment across a wide range of disease extent.\n\nIn the two studies, TRANQUILLO 2 and TRANQUILLO, LITFULO 100 mg and 50 mg,\nrespectively, significantly improved facial and total body repigmentation\ncompared to placebo. These improvements were supported by patient-reported\noutcomes indicating reduced disease severity and meaningful change in facial\nand total body vitiligo, as well as greater disease stabilization compared to\nplacebo. These results from the largest Phase 3 program to date evaluating an\noral systemic therapy for nonsegmental vitiligo (NSV) were presented today in\na late-breaking oral presentation at the 35th European Academy of Dermatology\nand Venereology (EADV) Annual Congress in Vienna, Austria.\n\nPfizer intends to submit these data to regulatory authorities globally,\nincluding the U.S. Food and Drug Administration (FDA) and European Medicines\nAgency (EMA) for review.\n\n“LITFULO has dual selectivity for JAK3 and the TEC family kinases, signals\nthat immune cells use to attack pigment-producing cells in the skin, so it\naddresses a root cause of nonsegmental vitiligo rather than its visible\neffects alone. Across the largest Phase 3 program to date evaluating an oral\nsystemic therapy for nonsegmental vitiligo, both TRANQUILLO 2 and TRANQUILLO\ndemonstrated strong and increasing improvements in facial and total body\nrepigmentation over time and also improved patients’ own perception of\nfacial and overall disease severity. We look forward to discussing these\nresults with regulators to bring this potential option to patients as soon as\npossible.”\n\n- Michael Vincent, M.D., Ph.D., Chief Inflammation & Immunology Officer,\nPfizer\n\n“Nonsegmental vitiligo is a disease that can have a substantial burden on\npatients’ lives beyond the visible symptoms on their skin.( 1,2,3) It is a\nchronic autoimmune disease, yet patients often face stigma because it is\ntrivialized as a condition that affects only skin appearance.( 2) It can\nprogress unpredictably, often across highly visible areas, and for decades\npeople living with vitiligo have relied on limited available treatment\noptions.( 2,3) Research has shown that LITFULO (ritlecitinib) not only\nsignificantly improved facial and total body repigmentation, but also resulted\nin greater disease stabilization compared to the placebo. The results solidify\nthe potential of LITFULO to support a new treatment paradigm rooted in\nsystemic treatment that can address underlying disease drivers for people\nliving with nonsegmental vitiligo.”\n\n- Iltefat Hamzavi, M.D., Senior Staff Physician, Department of Dermatology,\nHenry Ford Health and Hamzavi Dermatology Specialists\n\nKey Results from TRANQUILLO Studies\n\n\n * Co-primary Endpoints – data presented from the TRANQUILLO 2 (100 mg LITFULO)\nand TRANQUILLO (50 mg LITFULO) studies, respectively:\n\n\n* 21.86% and 12.47% of patients taking LITFULO achieved F-VASI75 (≥75%\nimprovement in Facial Vitiligo Area Scoring Index) compared to 2.40% and 2.48%\non placebo, respectively.\n\n * 13.02% and 8.98% of patients taking LITFULO achieved T-VASI50 (≥50%\nimprovement in Total Vitiligo Area Scoring Index) compared to 2.40% and 1.98%\non placebo, respectively.\n\n\n\n\n * Key Secondary Endpoints: LITFULO achieved statistically significant and\nclinically meaningful improvements compared to placebo across multiple\nmeasures of facial and total body repigmentation. Across both trials,\nsignificant improvements from baseline in F-VASI and T-VASI were seen as early\nas Week 24 and increased through Week 36 and Week 52 compared to placebo.\nAdditionally, more patients on LITFULO achieved clinically meaningful\nimprovements at earlier timepoints, as measured by F-VASI75 and T-VASI50 at\nWeek 24 and Week 36 compared to placebo. LITFULO also significantly reduced\npatient-reported facial and overall disease severity compared to placebo at\nWeek 52.\n\n * Other Selected Endpoints (not type I error controlled): Patients on LITFULO\nalso reported benefit over placebo based on meaningful change in patient\nglobal impression of change in face (PGIC-F) and overall vitiligo (PGIC-V) vs\nplacebo. Noticeability (VNS) improved through Week 52 with more patients\nrating their vitiligo as “a lot less” or “no longer” noticeable\ncompared to placebo. Treatment with ritlecitinib, at both dose levels,\nresulted in greater disease stabilization compared with placebo from Week 24\nonward, with maintained stabilization through Week 52. In an assessment of 50\nmg LITFULO in TRANQUILLO 2, clinically meaningful improvement over placebo was\nobserved for both F-VASI75 and T-VASI50 at Week 52.\n\n * Safety: The safety profile of LITFULO in NSV was consistent with the\nestablished safety profile in alopecia areata. No new safety signals were\nobserved. Overall, the proportion of patients with treatment‑emergent\nadverse events (TEAEs) was similar across all treatment groups.\n\n\n* In TRANQUILLO 2, a TEAE was reported in 67.7% or 62.0% of patients treated\nwith LITFULO 100 mg or placebo, respectively. The most common TEAEs were upper\nrespiratory tract infection (8.9% vs. 3.4%), nasopharyngitis (7.9% vs. 7.3%),\nand headache (4.0% vs. 5.4%).\n\n * In TRANQUILLO, a TEAE was reported in 81.0% or 77.1% of patients treated with\nLITFULO 50 mg or placebo, respectively. The most common TEAEs were upper\nrespiratory tract infection (14.0% vs. 10.9%), increased blood creatine\nphosphokinase (11.0% vs. 8.0%), nasopharyngitis (10.5% vs. 9.5%), COVID-19\n(6.0% vs. 5.0%), decreased lymphocyte count (6.3% vs. 1.5%), and headache\n(5.5% vs. 5.0%).\n\n * Treatment-emergent serious AEs (TESAEs) were reported in a low number of\npatients across both studies: 3.4% or 3.4% in TRANQUILLO 2 for those on\nLITFULO 100 mg or placebo, respectively; 2.0% or 2.5% in TRANQUILLO for those\non LITFULO 50 mg or placebo, respectively.\n\n\n\n\nPhase 3 Clinical Trial Designs for TRANQUILLO 2 and TRANQUILLO\n\n\n * The Phase 3 TRANQUILLO clinical development program consists of two pivotal\ntrials — TRANQUILLO 2 and TRANQUILLO — and a long-term extension trial,\nTRANQUILLO LTE.\n\n * TRANQUILLO 2 and TRANQUILLO evaluated 2,174 patients in total with NSV across\n271 sites worldwide.\n\n\n* TRANQUILLO 2: Evaluated 100 mg LITFULO once daily in 1,567 adults. The study\nalso included an assessment of 50 mg LITFULO that is exploratory and\ndescriptive in nature.\n\n * TRANQUILLO: Evaluated 50 mg LITFULO once daily in 607 patients aged 12 years\nand older.\n\n * Patients enrolled in the TRANQUILLO LTE completed treatment in the parent\nstudy, TRANQUILLO.\n\n\n\n\n * Endpoints: For both studies in the U.S., the co-primary endpoints were the\nproportion of patients who achieved F-VASI75 and the proportion of patients\nwho achieved T-VASI50 at Week 52.\n\n\n* In countries outside of the U.S., F-VASI75 at Week 52 was the primary\nendpoint\nand T-VASI50 at Week 52 was a key secondary endpoint.\n\n\n\n\nAdvancing Pfizer’s Commitment to Immune-Mediated Dermatologic Conditions\n\nThese results for LITFULO highlight the medicine’s potential for people\nliving with NSV and build on Pfizer’s longstanding commitment to\nimmune-mediated dermatologic conditions. LITFULO is currently approved by the\nFDA for the treatment of severe alopecia areata in adults and adolescents 12\nyears and older.\n\nThe positive results for LITFULO in vitiligo further reinforce the potential\nvalue of inhibiting the JAK3 and TEC family kinases across multiple\nimmune-mediated skin diseases and may position it to be a new oral systemic\ntherapy option for adults with NSV.\n\nPfizer is presenting more than 30 accepted abstracts across its dermatology\nportfolio at the 35th EADV Congress, spanning nonsegmental vitiligo, alopecia\nareata, and atopic dermatitis.\n\n\n * In alopecia areata, Pfizer presented long-term Phase 3 data showing clinically\nmeaningful improvements in scalp hair regrowth with LITFULO (ritlecitinib)\nthrough five years, with no new safety signals observed. Pfizer has also\ninitiated a pivotal study evaluating LITFULO for the treatment of moderate\nalopecia areata.\n\n * In atopic dermatitis, Pfizer presented a late-breaking exploratory analysis of\nserum protein biomarkers from the Phase 3 JADE COMPARE study of CIBINQO\n(abrocitinib), alongside a final integrated safety analysis of 3,850 patients\nwith up to 6.5 years of exposure. Pfizer also presented interim Phase 2\nefficacy and safety results at Week 16 for tilrekimig (PF-07275315), an\ninvestigational, potential first-in-class trispecific antibody targeting IL-4,\nIL-13, and TSLP.\n\nAbout Nonsegmental Vitiligo\n\nNSV is a chronic autoimmune disease in which the immune system attacks\nmelanin-producing cells, leading to a loss of pigment and resulting in white\nmacules and patches on the skin/hair over time.(4) NSV can appear at any age\nand in all skin types, causing depigmentation anywhere on the skin, often\naffecting highly visible areas such as the face, neck, and hands.(1) While\nvitiligo is frequently treated as a cosmetic condition, it is a serious\nautoimmune disease that can have a considerable impact on patients’ lives\nwell beyond the physical symptoms.(1,2) Because NSV is a chronic disease,\nsystemic treatment options may be needed to help patients restore skin\npigmentation and maintain repigmentation over time.(3)\n\nFor more information on Pfizer’s Commitment to Immunology and Inflammation,\nplease visit: Inflammation & Immunology | Pfizer\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pfizer.com%2Fscience%2Ffocus-areas%2Fimmunology-inflammation&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=Inflammation+%26amp%3B+Immunology+%7C+Pfizer&index=1&md5=574f2b32d4bb48a9465d16736f4b14a0)\n.\n\nFor more information on LITFULO and the Phase 3 results in NSV, please visit:\nPfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with\nNonsegmental Vitiligo | Pfizer\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.pfizer.com%2Fnews%2Fpress-release%2Fpress-release-detail%2Fpfizer-announces-positive-topline-phase-3-results-litfulo&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=Pfizer+Announces+Positive+Topline+Phase+3+Results+for+LITFULO+in+Patients+with+Nonsegmental+Vitiligo+%7C+Pfizer&index=2&md5=b6a0bcfc312499f133dde8b37a52b0c5)\n\nAbout LITFULO(®) (ritlecitinib)\n\nLITFULO is an oral inhibitor of Janus kinase 3 (JAK3) and the TEC family\nkinases which is being investigated for the treatment of nonsegmental\nvitiligo. By targeting key immune signaling pathways involved in the disease,\nLITFULO is thought to modulate the activity of immune cells that contribute to\nmelanocyte destruction. LITFULO is currently approved for the treatment of\nsevere alopecia areata in adults and adolescents 12 years and older, where it\ntargets the underlying immune mechanisms that drive hair follicle damage and\nhair loss. Through its dual mechanism, LITFULO has demonstrated the potential\nto address immune-mediated pathology underlying both alopecia areata and\nnonsegmental vitiligo.\n\nLITFULO is approved for the treatment of severe alopecia areata in adults and\nadolescents 12 years and older in the United States, European Union, Canada,\nJapan, China, and United Kingdom.\n\nThe LITFULO development program spans multiple immune‑mediated dermatologic\nconditions, including alopecia areata, nonsegmental vitiligo, chronic\nspontaneous urticaria, and hidradenitis suppurativa, supporting a focused\ndevelopment approach in dermatology.\n\nU.S. Indication\n\nLITFULO (ritlecitinib) is a prescription medicine used to treat severe\nalopecia areata in adults and adolescents 12 years and older.\n\nIt is not known if LITFULO is safe and effective in children under 12 years of\nage.\n\nU.S. Important Safety Information\n\nLITFULO may cause serious side effects, including:\n\nSerious infections.\n\nLITFULO can lower the ability of your immune system to fight infections. Do\nnot start LITFULO if you have any kind of infection unless your healthcare\nprovider tells you it is okay. Some people have had serious infections while\ntaking LITFULO or other similar medicines, including tuberculosis (TB), and\ninfections caused by bacteria, fungi, or viruses that can spread throughout\nthe body and have been hospitalized. Some people taking similar medicines to\nLITFULO have died from these infections. You may be at a higher risk of\ndeveloping shingles (herpes zoster).\n\nYour healthcare provider should test you for TB before starting treatment with\nLITFULO and should watch you closely for signs and symptoms of TB during\ntreatment with LITFULO.\n\nBefore and after starting LITFULO, tell your healthcare provider if you think\nyou have an infection, are being treated for one, or have symptoms of an\ninfection, including:\n\n\n * fever, sweating, or chills\n\n * muscle aches\n\n * cough or shortness of breath\n\n * blood in your phlegm\n\n * weight loss\n\n * warm, red, or painful skin or sores on your body\n\n * diarrhea or stomach pain\n\n * burning when you urinate or urinating more often than usual\n\n * feeling very tired\n\nLITFULO can make you more likely to get infections or worsen infections you\nhave. If you get a serious infection, your healthcare provider may stop\ntreatment with LITFULO until your infection is controlled.\n\nThere is an increased risk of death in people 50 years of age and older who\nhave at least one heart disease (cardiovascular) risk factor and are taking a\nJanus kinase (JAK) inhibitor. LITFULO is a kinase inhibitor medicine.\n\nCancer and immune system problems.\n\nLITFULO may increase your risk of certain cancers by changing the way your\nimmune system works. Lymphoma and other cancers, including skin cancers, can\nhappen. People taking JAK inhibitors have a higher risk of certain cancers\nincluding lymphoma and lung cancer, especially if you are a current or past\nsmoker. Follow your healthcare provider’s advice about having your skin\nchecked for skin cancer during treatment. Tell your healthcare provider if you\nhave ever had any type of cancer.\n\nThere is an increased risk of major cardiovascular events such as heart\nattack, stroke, or death in people 50 years of age and older who have at least\none heart disease (cardiovascular) risk factor and are taking a JAK inhibitor,\nespecially if you are a current or past smoker.\n\nGet emergency help right away if you have any symptoms of a heart attack or\nstroke while using LITFULO, including:\n\n\n * discomfort in the center of your chest that lasts for more than a few minutes,\nor that goes away and comes back\n\n * severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or\njaw\n\n * pain or discomfort in your arms, back, neck, jaw, or stomach\n\n * shortness of breath with or without chest discomfort\n\n * breaking out in a cold sweat\n\n * nausea or vomiting\n\n * feeling lightheaded\n\n * weakness in one part or on one side of your body\n\n * slurred speech\n\nBlood clots.\n\nBlood clots in the veins of your legs (deep vein thrombosis, DVT), lungs\n(pulmonary embolism, PE), or eyes can happen in some people taking LITFULO.\nThis may be life-threatening. Blood clots in the veins of the legs and lungs\nhave happened more often in people 50 years of age and older with at least one\nheart disease (cardiovascular) risk factor taking a JAK inhibitor. Tell your\nhealthcare provider if you have had blood clots in the past.\n\nStop taking LITFULO and get medical help right away if you have any signs and\nsymptoms of blood clots, including swelling, pain or tenderness in one or both\nlegs; sudden, unexplained chest or upper back pain; shortness of breath or\ndifficulty breathing; or changes in vision, especially in one eye only.\n\nAllergic reactions.\n\nSymptoms that may mean you are having an allergic reaction have been seen\nduring treatment with LITFULO. Some of these reactions were serious. Stop\ntaking LITFULO and get emergency medical help right away if you have symptoms\nof allergic reaction, including hives; rash; trouble breathing; feeling faint\nor dizzy; or swelling of your lips, tongue, or throat.\n\nLow blood sugar in people with diabetes.\n\nIf you have diabetes, your healthcare provider may instruct you to check your\nblood sugar levels more often during treatment with LITFULO. Call your\nhealthcare provider if you have any problems with low blood sugar\n(hypoglycemia).\n\nChanges in certain laboratory test results.\n\nYour healthcare provider should do blood tests before you start taking LITFULO\nand during treatment to check your lymphocyte and platelet counts and liver\nenzyme and creatine phosphokinase (CPK) levels. You should not take LITFULO if\nyour lymphocyte counts or platelet counts are too low or your liver tests are\ntoo high. Increased CPK levels in the blood are common with LITFULO and can\nalso be severe. Your healthcare provider may stop treatment for a period of\ntime if there are changes in these blood test results.\n\nDo not take LITFULO if you are allergic to ritlecitinib or any of the\ningredients in LITFULO. See the Medication Guide for a complete list of\ningredients.\n\nBefore taking LITFULO, tell your healthcare provider if you:\n\n\n * have an infection, are being treated for one, or have one that won’t go away\nor keeps returning\n\n * have diabetes\n\n * have chronic lung disease, HIV, or a weak immune system\n\n * have TB or have been in close contact with someone with TB\n\n * have had shingles (herpes zoster)\n\n * have had hepatitis B or hepatitis C\n\n * live, have lived, or traveled to certain parts of the country (such as the\nOhio & Mississippi River Valleys and the Southwest) where there is an\nincreased chance for getting certain kinds of fungal infections. These\ninfections may happen or worsen when taking LITFULO. Ask your healthcare\nprovider if you’re unsure if you have lived in an area where these\ninfections are common.\n\n * have had any type of cancer\n\n * have had blood clots\n\n * are a current or past smoker\n\n * have had a heart attack, other heart problems, or stroke\n\n * have liver problems\n\n * have low platelet counts or white blood cell counts\n\n * have recently received or are scheduled to receive any vaccinations. People\nwho take LITFULO should not receive live vaccines right before or during\ntreatment.\n\n * are pregnant or plan to become pregnant. It is not known if LITFULO will harm\nyour unborn baby. Tell your healthcare provider if you are pregnant or plan to\nbecome pregnant during treatment with LITFULO. There is a pregnancy registry\nfor people who take LITFULO during pregnancy. Report pregnancies to Pfizer\nInc. at 1-877-390-2940.\n\n * are breastfeeding or plan to breastfeed. It is not known if LITFULO passes\ninto your breast milk. Do not breastfeed during treatment with LITFULO and for\n14 hours after your last dose of LITFULO. Talk to your healthcare provider\nabout the best way to feed your baby during treatment with LITFULO.\n\nTell your healthcare provider about all the medicines you take, including\nprescription and over‑the‑counter medicines, vitamins, and herbal\nsupplements. LITFULO and other medicines may affect each other causing side\neffects.\n\nThe most common side effects of LITFULO include headache; diarrhea; acne;\nrash; hives; inflamed hair pores (folliculitis); fever; eczema; dizziness;\nshingles; decreased red blood cell counts; and mouth sores, redness and\nswelling of the lining of your mouth. These are not all of the possible side\neffects of LITFULO.\n\nYou are encouraged to report adverse events related to Pfizer products by\ncalling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S.\nFood and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.fda.gov%2Fsafety%2Fmedwatch-fda-safety-information-and-adverse-event-reporting-program&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.fda.gov%2FMedWatch&index=3&md5=d291e037eda69785c6efdc1572d986af)\nor call 1-800-FDA-1088.\n\nPlease see full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda_docs%2Flabel%2F2026%2F215830s001lbl.pdf&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=Prescribing+Information&index=4&md5=c0c7afee42e20b79d14db346dc79b059)\n, including BOXED WARNING, and Medication Guide.\n\nAbout Pfizer: Breakthroughs That Change Patients’ Lives\n\nAt Pfizer, we apply science and our global resources to bring therapies to\npeople that extend and significantly improve their lives. We strive to set the\nstandard for quality, safety and value in the discovery, development and\nmanufacture of health care products, including innovative medicines and\nvaccines. Every day, Pfizer colleagues work across developed and emerging\nmarkets to advance wellness, prevention, treatments and cures that challenge\nthe most feared diseases of our time. Consistent with our responsibility as\none of the world’s premier innovative biopharmaceutical companies, we\ncollaborate with health care providers, governments and local communities to\nsupport and expand access to reliable, affordable health care around the\nworld. For more than 175 years, we have worked to make a difference for all\nwho rely on us. We routinely post information that may be important to\ninvestors on our website at www.Pfizer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.Pfizer.com&index=5&md5=20cd634e14244bb7973a372c9494a854)\n. In addition, to learn more, please visit us on www.Pfizer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.Pfizer.com&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.Pfizer.com&index=6&md5=6801219d3624b1380a4861ff0c855ac8)\nand follow us on X at @Pfizer\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fpfizer&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=%40Pfizer&index=7&md5=99a6eb8c7dfab021986d815b9f449472)\nand @Pfizer_News\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fpfizer_news&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=%40Pfizer_News&index=8&md5=eb8e93828c1bb0fa0092befa9f6b84fb)\n, LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fpfizer%2F&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=LinkedIn&index=9&md5=9626c17b234658a62ac43786b3147f20)\n, YouTube\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.youtube.com%2Fpfizer&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=YouTube&index=10&md5=8e2b9e8ba9d6dad13aa7a9e06dbdd16b)\nand like us on Facebook at www.facebook.com/Pfizer/\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2FPfizer%2F&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.facebook.com%2FPfizer%2F&index=11&md5=fd660c450c339a3b9cf67a0cb5d9fec3)\n.\n\nDisclosure Notice\n\nThe information contained in this release is as of October 2, 2026. Pfizer\nassumes no obligation to update forward-looking statements contained in this\nrelease as the result of new information or future events or developments.\n\nThis release contains forward-looking information about LITFULO\n(ritlecitinib), including its potential benefits, the development program for\nLITFULO, results from two Phase 3 trials for LITFULO in patients with\nnonsegmental vitiligo, and plans to submit these data to regulatory\nauthorities globally, including the U.S. Food and Drug Administration and\nEuropean Medicines Agency, for review, that involves substantial risks and\nuncertainties that could cause actual results to differ materially from those\nexpressed or implied by such statements. Risks and uncertainties include,\namong other things, uncertainties regarding the commercial success of LITFULO;\nthe uncertainties inherent in research and development, including the ability\nto meet anticipated clinical endpoints, commencement and/or completion dates\nfor our clinical trials, regulatory submission dates, regulatory approval\ndates and/or launch dates, as well as the possibility of unfavorable new\nclinical data and further analyses of existing clinical data; the risks\nassociated with initial, preliminary or interim data; the risk that clinical\ntrial data are subject to differing interpretations and assessments by\nregulatory authorities; whether regulatory authorities will be satisfied with\nthe design of and results from our clinical studies; whether and when\napplications for LITFULO may be filed in particular jurisdictions for any\npotential indications; whether and when any such applications for LITFULO that\nmay be pending or filed may be approved by regulatory authorities, which will\ndepend on myriad factors, including making a determination as to whether the\nproduct’s benefits outweigh its known risks and determination of the\nproduct’s efficacy and, if approved, whether LITFULO will be commercially\nsuccessful; decisions by regulatory authorities impacting labeling,\nmanufacturing processes, safety and/or other matters that could affect the\navailability or commercial potential of LITFULO; risks and uncertainties\nrelated to issued or future executive orders or other new, or changes in, laws\nor regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s\nbusiness, operations and financial results; and competitive developments.\n\nA further description of risks and uncertainties can be found in Pfizer’s\nAnnual Report on Form 10-K for the fiscal year ended December 31, 2025, and in\nits subsequent reports on Form 10-Q, including in the sections thereof\ncaptioned “Risk Factors” and “Forward-Looking Information and Factors\nThat May Affect Future Results”, as well as in its subsequent reports on\nForm 8-K, all of which are filed with the U.S. Securities and Exchange\nCommission and available at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.sec.gov&index=12&md5=43c698713830c39994f7a616605a1738)\nand www.pfizer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=54613803&newsitemid=20261002026421&lan=en-US&anchor=www.pfizer.com&index=13&md5=fb58f200b9929c574263574e5cd3646c)\n.\n\nReferences\n\n\n 1. Seneschal J, Bae JM, Ezzedine K, et al. Vitiligo. Nat Rev Dis Primers.\n2025;11(1):85. doi:10.1038/s41572-025-00670-x\n\n 2. Ma S, Zieneldien T, Tan IJ, Jafferany M. Cross-cultural beliefs and\nstigmatization in vitiligo: A systematic review. J Cosmet Dermatol.\n2026;25(4):e70725. doi:10.1111/jocd.70725\n\n 3. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet.\n2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7\n\n 4. Upadhya S, Andrade MJ, Shukla V, Rao R, Satyamoorthy K. Genetic and immune\ndysregulation in vitiligo: Insights into autoimmune mechanisms and disease\npathogenesis. Autoimmun Rev. 2025;24(8):103841.\ndoi:10.1016/j.autrev.2025.103841\n\nCategory: Prescription Medicines\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261002026421/en/\n(https://www.businesswire.com/news/home/20261002026421/en/)\n\nMedia Contact: \n\nPfizerMediaRelations@Pfizer.com (mailto:PfizerMediaRelations@Pfizer.com)\n\nInvestor Contact: \n\nIR@Pfizer.com (mailto:IR@Pfizer.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-02T15:15:00.146115003Z","server_sent_at_ms":1790954100146},"received_at":"2026-10-02T15:15:00.303Z","source_url":"https://www.businesswire.com/news/home/20261002026421/en/"},"analysis":{"id":"148169","press_release_id":"159569","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Pfizer presented Phase 3 TRANQUILLO results showing LITFULO significantly improved facial and total body repigmentation in nonsegmental vitiligo at Week 52 versus placebo, with both co-primary endpoints met.\n\nF-VASI75 was achieved by 21.86% (100 mg) and 12.47% (50 mg) of patients versus roughly 2.4% on placebo, and the safety profile was consistent with the drug's established alopecia areata label with no new safety signals.\n\nPfizer plans to submit the data to the FDA and EMA, positioning LITFULO as a potential first oral systemic therapy for NSV and expanding the drug's lifecycle beyond alopecia areata.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Label-expansion catalyst: positive Phase 3 vitiligo data set up regulatory filings for LITFULO, a new oral systemic option in an underserved autoimmune skin disease."},"keyFigures":{"drugName":"LITFULO (ritlecitinib)","phaseOfTrial":"Phase 3","customDimensions":{"sites":271,"fvasi75_50mg":"12.47%","tvasi50_50mg":"8.98%","endpoint_week":52,"fvasi75_100mg":"21.86%","tvasi50_100mg":"13.02%","patients_enrolled":2174,"fvasi75_placebo_study1":"2.48%","fvasi75_placebo_study2":"2.40%"}},"quotedText":"both TRANQUILLO 2 and TRANQUILLO demonstrated strong and increasing improvements in facial and total body repigmentation over time and also improved patients' own perception of facial and overall disease severity","namedEntities":{"people":[{"name":"Michael Vincent, M.D., Ph.D.","role":"Chief Inflammation & Immunology Officer, Pfizer"},{"name":"Iltefat Hamzavi, M.D.","role":"Senior Staff Physician, Henry Ford Health"}],"products":["LITFULO (ritlecitinib)","CIBINQO (abrocitinib)","tilrekimig (PF-07275315)"],"companies":[{"name":"Pfizer Inc.","ticker":"PFE","relationship":"filer"},{"name":"Henry Ford Health","relationship":"investigator affiliation"},{"name":"European Academy of Dermatology and Venereology","relationship":"conference"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive Phase 3 TRANQUILLO data for LITFULO in nonsegmental vitiligo, both co-primary endpoints met, supporting planned global regulatory filings. 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