{"id":"tofacitinib-xr","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"","Geriatric use":"","Paediatric use":"","Renal impairment":"","Hepatic impairment":""},"seriousAdverseEvents":[]},"status":"active","trials":["NCT05104723","NCT04876781","NCT05048238","NCT03964649","NCT03002649"],"_pubmed":{"count":5,"papers":[{"date":"2022 Sep","pmid":"36001100","title":"Characteristics of adverse event reporting of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to the US Food and Drug Administration.","authors":"Qian J","journal":"Journal of managed care & specialty pharmacy"},{"date":"2022 Aug","pmid":"35560874","title":"Bridging Efficacy of Tofacitinib Immediate-Release to Extended-Release Formulations for Treatment of Ulcerative Colitis: Application of a Model-Informed Drug Development Approach.","authors":"Mukherjee A","journal":"Clinical pharmacology in drug development"},{"date":"2018 Apr","pmid":"29196988","title":"Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors.","authors":"Verden A","journal":"Drug safety"},{"date":"2017 Jun","pmid":"27859030","title":"Model-Informed Development and Registration of a Once-Daily Regimen of Extended-Release Tofacitinib.","authors":"Lamba M","journal":"Clinical pharmacology and therapeutics"},{"date":"2016 Nov","pmid":"26970526","title":"Extended-Release Once-Daily Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared With Immediate-Release Tofacitinib and Impact of Food.","authors":"Lamba M","journal":"Journal of clinical pharmacology"}]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=tofacitinib-xr","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-22T02:02:50.440060+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-21T02:01:40.340275+00:00"}},"allNames":"tofacitinib xr","offLabel":[],"timeline":[{"date":"2012-05-30","type":"positive","milestone":"FDA approval for rheumatoid arthritis","regulator":"FDA","description":"Tofacitinib received FDA approval for the treatment of moderate to severe rheumatoid arthritis."},{"date":"2017-03-22","type":"positive","milestone":"EMA marketing authorization for rheumatoid arthritis","regulator":"EMA","description":"Tofacitinib received EMA marketing authorization for the treatment of moderate to severe rheumatoid arthritis."},{"date":"2018-05-01","type":"positive","milestone":"FDA approval for ulcerative colitis","regulator":"FDA","description":"Tofacitinib received FDA approval for the treatment of moderately to severely active ulcerative colitis."},{"date":"2019-06-03","type":"positive","milestone":"EMA marketing authorization for ulcerative colitis","regulator":"EMA","description":"Tofacitinib received EMA marketing authorization for the treatment of moderately to severely active ulcerative colitis."},{"date":"2020-01-01","type":"neutral","milestone":"Phase 1 trial completion for cutaneous lupus","regulator":"none","description":"Completed Phase 1 trial evaluating tofacitinib in the prevention of photosensitivity in lupus."},{"date":"2020-01-01","type":"neutral","milestone":"Phase 1 trial completion for dermatomyositis","regulator":"none","description":"Completed Phase 1 trial studying tofacitinib in refractory dermatomyositis."}],"aiSummary":"Tofacitinib XR is a small molecule used to treat various inflammatory conditions, including Chronic Granulomatous Disease, Inflammatory Gastrointestinal Disease, Inflammatory Skin Disease, Inflammatory Lung Disease, and Cutaneous Lupus. 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The extended-release formulation provides sustained plasma levels, allowing for once-daily dosing."},"_companyIR":{"irUrl":"https://pfizerinc.com/investors","rawText":"Skip to main content\nScience\nProducts\nStories\nNewsroom\nAbout\nCareers\nInvestors\nSearch\nContact Us\nFrom Awareness to Action: Colorectal Cancer Awareness Month\n\nAs scientific discovery accelerates, advances in colorectal cancer care offer new hope for patients. 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