{"id":"tofacitinib-5-mg","rwe":[{"pmid":"41358806","year":"2025","title":"Thromboembolic Risk in Ulcerative Colitis Patients on Advanced Therapy: A Real-World Data Analysis.","journal":"Inflammatory bowel diseases"},{"pmid":"40698211","year":"2025","title":"Efficacy and Safety of Tofacitinib in the Management of Ankylosing Spondylitis: A Comprehensive Systematic Review.","journal":"Cureus"},{"pmid":"40485866","year":"2025","title":"Clinical Assessment of Abrocitinib, Tofacitinib, and Cyclosporine in Adult Patients With Moderate to Severe Atopic Dermatitis: A Retrospective Analysis.","journal":"Cureus"},{"pmid":"40001326","year":"2025","title":"Efficacy and Safety of Tofacitinib in Lichen Planopilaris: A Retrospective Series of 74 Patients.","journal":"Archives of Iranian medicine"},{"pmid":"39695887","year":"2024","title":"Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis.","journal":"Advances in rheumatology (London, England)"}],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT00263328","NCT01276639","NCT04267380","NCT01815424","NCT04412252","NCT01786668","NCT01500551","NCT00976599","NCT02092467","NCT02996500","NCT00856544","NCT05195814","NCT02281552","NCT00413660","NCT04111614","NCT02147587","NCT01932372","NCT03159936","NCT05082428","NCT00483756","NCT05326464","NCT00814307","NCT01519089","NCT01736696","NCT03288324"],"aliases":[],"patents":[],"pricing":[],"allNames":"tofacitinib 5 mg","offLabel":[],"timeline":[{"date":"2004","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis) — Psoriasis"},{"date":"2008","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of R) — Arthritis, Rheumatoid"},{"date":"2010","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis) — Arthritis, Rheumatoid"},{"date":"2020","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid) — Arthritis, Rheumatoid"}],"aiSummary":"Tofacitinib 5 MG is a small molecule Janus Kinase (JAK) inhibitor used to treat conditions such as Psoriatic Arthritis and Psoriasis. It works by inhibiting the Janus Kinase (JAK) enzyme, which plays a role in the body's inflammatory response.","brandName":"Tofacitinib 5 MG","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Patients receive Tofacitinib and Naproxene","explanation":"Tofacitinib works by targeting and blocking proteins called JAK (Janus kinase) enzymes. These enzymes sit inside immune cells and act like molecular \"switches\" that turn on inflammatory signals. By blocking these switches, tofacitinib prevents immune cells from producing the chemical messengers that cause inflammation, pain, and joint damage.\n\nIn rheumatoid arthritis, the immune system mistakenly attacks joint tissue, causing swelling and destruction. Tofacitinib interrupts this process at a fundamental level by preventing the activation of T cells and B cells—the immune cells driving this attack. This dual action of blocking both cell activation and inflammatory messenger production makes it particularly effective at reducing symptoms and slowing disease progression.\n\nUnlike older biologic drugs that must be injected, tofacitinib is taken as an oral tablet, making it more convenient for patients. It typically works faster than traditional therapies, often providing symptom relief within weeks rather than months. However, because it broadly suppresses immune signaling, patients taking it need monitoring to ensure their immune system can still fight genuine infections.","oneSentence":"Patients receive Tofacitinib and Naproxene","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"tofacitinib-5-mg","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Axial Spondyloarthritis","phase":"preclinical","trialId":"","patients":null,"diseaseId":"musculoskeletal","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00263328","phase":"Phase 2","title":"Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidne","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":46,"indication":"Kidney Transplantation","completionDate":"2014-01","primaryEndpoint":"A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection."},{"nctId":"NCT01276639","phase":"Phase 3","title":"A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Sever","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":901,"indication":"Psoriasis","completionDate":"2013-04","primaryEndpoint":"The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis."},{"nctId":"NCT04267380","phase":"N/A","title":"A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":298,"indication":"Arthritis Rheumatoid","completionDate":"2019-08","primaryEndpoint":"It is hypothesized that patients prescribed tofacitinib 11 mg Modified Release (MR) formulation once daily (QD) will achieve similar benefit to those prescribed tofacitinib 5 mg twice a day (BID) dosa"},{"nctId":"NCT01815424","phase":"Phase 3","title":"A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe P","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":266,"indication":"Psoriasis","completionDate":"2015-07","primaryEndpoint":"The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of treatment in As"},{"nctId":"NCT04412252","phase":"Phase 2","title":"Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Rece","status":"Withdrawn","sponsor":"Pfizer","isPivotal":false,"enrollment":0,"indication":"COVID-19","completionDate":"2020-09","primaryEndpoint":"The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pn"},{"nctId":"NCT01786668","phase":"Phase 2","title":"Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":208,"indication":"Ankylosing Spondylitis","completionDate":"2015-03","primaryEndpoint":"This is the first study of oral tofacitinib in adults with active ankylosing spondylitis."},{"nctId":"NCT01500551","phase":"Phase 2/3","title":"Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":302,"indication":"Juvenile Idiopathic Arthritis","completionDate":"2025-02","primaryEndpoint":"Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies."},{"nctId":"NCT00976599","phase":"Phase 2","title":"A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":29,"indication":"Rheumatoid Arthritis","completionDate":"2011-07","primaryEndpoint":"To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis."},{"nctId":"NCT02092467","phase":"Phase 4","title":"Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":4372,"indication":"Arthritis, Rheumatoid","completionDate":"2020-07","primaryEndpoint":"This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancer"},{"nctId":"NCT02996500","phase":"Phase 2","title":"Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Respons","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":269,"indication":"Rheumatoid Arthritis","completionDate":"2018-08","primaryEndpoint":"This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at Week 12 in subjects with"},{"nctId":"NCT00856544","phase":"Phase 3","title":"A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Pat","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":795,"indication":"Arthritis, Rheumatoid","completionDate":"2011-01","primaryEndpoint":"This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheum"},{"nctId":"NCT05195814","phase":"N/A","title":"A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":141,"indication":"Psoriatic Arthritis","completionDate":"2023-10","primaryEndpoint":"The purpose of this study is to learn about the safety and effects of the study medicine for the potential treatment of Psoriatic Arthritis (PsA)."},{"nctId":"NCT02281552","phase":"Phase 3","title":"A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofa","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":209,"indication":"Rheumatoid Arthritis","completionDate":"2017-03","primaryEndpoint":"This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrex"},{"nctId":"NCT00413660","phase":"Phase 2","title":"Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of R","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":509,"indication":"Arthritis, Rheumatoid","completionDate":"2008-08","primaryEndpoint":"The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid "},{"nctId":"NCT04111614","phase":"Phase 1","title":"A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":12,"indication":"Healthy","completionDate":"2019-12","primaryEndpoint":"This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet i"},{"nctId":"NCT02147587","phase":"Phase 2","title":"A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":112,"indication":"Rheumatoid Arthritis","completionDate":"2015-06","primaryEndpoint":"This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tof"},{"nctId":"NCT01932372","phase":"N/A","title":"Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":9968,"indication":"Rheumatoid Arthritis","completionDate":"2021-08","primaryEndpoint":"The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice."},{"nctId":"NCT03159936","phase":"Phase EARLY1","title":"Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythem","status":"Terminated","sponsor":"Tufts Medical Center","isPivotal":false,"enrollment":5,"indication":"Discoid Lupus Erythematosus","completionDate":"2020-05","primaryEndpoint":"Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE."},{"nctId":"NCT05082428","phase":"N/A","title":"This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatmen","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":252,"indication":"Ulcerative Colitis","completionDate":"2022-11","primaryEndpoint":"The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib."},{"nctId":"NCT00483756","phase":"Phase 2","title":"Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":338,"indication":"Kidney Transplantation","completionDate":"2010-02","primaryEndpoint":"A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection."},{"nctId":"NCT05326464","phase":"Phase 3","title":"Tofacitinib in Recurrent GBM Patients","status":"Active Not Recruiting","sponsor":"University of Texas Southwestern Medical Center","isPivotal":false,"enrollment":17,"indication":"Glioblastoma","completionDate":"2025-06","primaryEndpoint":"The purpose of this study is to examine the effects of Tofacitinib in patients with recurrent Glioblastoma."},{"nctId":"NCT00814307","phase":"Phase 3","title":"A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":611,"indication":"Arthritis, Rheumatoid","completionDate":"2010-06","primaryEndpoint":"This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Ar"},{"nctId":"NCT01519089","phase":"Phase 3","title":"A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With M","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":95,"indication":"Psoriasis","completionDate":"2014-01","primaryEndpoint":"The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis."},{"nctId":"NCT01736696","phase":"Phase 1","title":"Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":59,"indication":"Psoriasis","completionDate":"2004-04","primaryEndpoint":"This study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics."},{"nctId":"NCT03288324","phase":"Phase 1/2","title":"Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus","status":"Completed","sponsor":"Children's Hospital Medical Center, Cincinnati","isPivotal":false,"enrollment":13,"indication":"Cutaneous Lupus","completionDate":"2022-11","primaryEndpoint":"This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA adminis"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":6,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}