{"id":"filgotinib","rwe":[{"pmid":"41903081","year":"2026","title":"Efficacy/Effectiveness, Safety and Treatment Persistence of Filgotinib in Rheumatoid Arthritis: A Narrative Review of Clinical Trials and Real-World Evidence.","finding":"","journal":"Rheumatology and therapy","studyType":"Clinical Study"},{"pmid":"41901264","year":"2026","title":"Advanced Medical Therapies for Perianal Fistulizing Crohn's Disease: A Systematic Review of Clinical, Radiological, Surgical, and Composite Outcomes.","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41879068","year":"2026","title":"Filgotinib treatment modulates frequency and gene expression of circulating immune cell subsets in ulcerative colitis.","finding":"","journal":"Journal of Crohn's & colitis","studyType":"Clinical Study"},{"pmid":"41867665","year":"2026","title":"Successful and Risk-Minimizing Treatment of Ulcerative Colitis by Positive Switch from JAK Inhibitors to Ustekinumab.","finding":"","journal":"Biologics : targets & therapy","studyType":"Clinical Study"},{"pmid":"41848136","year":"2025","title":"Cardiovascular risk and JAK inhibitor for the treatment of spondyloarthritis: A systematic review.","finding":"","journal":"La Tunisie medicale","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Tyrosine-protein kinase JAK1","category":"target"},{"label":"JAK1","category":"gene"},{"label":"JAK2","category":"gene"},{"label":"TYK2","category":"gene"},{"label":"L04AA45","category":"atc"},{"label":"Active","category":"status"},{"label":"Rheumatoid arthritis","category":"indication"},{"label":"Ulcerative colitis","category":"indication"},{"label":"Gilead Sciences Ireland UC","category":"company"}],"phase":"marketed","safety":{"safetySignals":[{"llr":75.258,"date":"","count":9,"signal":"Rhesus antigen positive","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=75)"}],"commonSideEffects":[],"contraindications":["Active tuberculosis"]},"trials":[],"aliases":[],"company":"Gilead Sciences Ireland UC","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FILGOTINIB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:28:31.304681+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:28:38.891117+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:28:31.327932+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FILGOTINIB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:28:39.732811+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tyrosine-protein kinase JAK2 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:28:40.322272+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4298167/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:28:40.217720+00:00"}},"allNames":"jyseleca","offLabel":[],"synonyms":["filgotinib","filgotinib maleate","jyseleca","filgotinib hydrochloride","G-146034","G-146034-101","GLPG-0634"],"timeline":[{"date":"2020-09-24","type":"positive","source":"DrugCentral","milestone":"EMA approval (Gilead Sciences Ireland UC)"}],"aiSummary":"Jyseleca (Filgotinib) is a small molecule modality developed by Gilead Sciences Ireland UC, targeting the Tyrosine-protein kinase JAK1. It is used to treat Rheumatoid arthritis and Ulcerative colitis. The commercial status of Jyseleca is patented, with Gilead Sciences Ireland UC being the current owner. Key safety considerations include the potential for increased risk of infections and malignancies. Jyseleca works by inhibiting the JAK1 enzyme, which plays a crucial role in the signaling pathways of various immune cells.","approvals":[{"date":"2020-09-24","orphan":false,"company":"Gilead Sciences Ireland UC","regulator":"EMA"},{"date":"2020-09-25","orphan":false,"company":"Gilead Sciences","regulator":"PMDA"}],"brandName":"Jyseleca","ecosystem":[{"indication":"Rheumatoid arthritis","otherDrugs":[{"name":"abatacept","slug":"abatacept","company":"Bristol Myers Squibb"},{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"}],"globalPrevalence":18000000},{"indication":"Ulcerative colitis","otherDrugs":[{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"},{"name":"azathioprine","slug":"azathioprine","company":"Prometheus Labs"},{"name":"balsalazide","slug":"balsalazide","company":"Salix Pharms"},{"name":"choriogonadotropin alfa","slug":"choriogonadotropin-alfa","company":"Emd Serono"}],"globalPrevalence":5000000}],"mechanism":{"target":"Tyrosine-protein kinase JAK1","targets":[{"gene":"JAK1","source":"DrugCentral","target":"Tyrosine-protein kinase JAK1","protein":"Tyrosine-protein kinase JAK1"},{"gene":"JAK2","source":"DrugCentral","target":"Tyrosine-protein kinase JAK2","protein":"Tyrosine-protein kinase JAK2"},{"gene":"TYK2","source":"DrugCentral","target":"Non-receptor tyrosine-protein kinase TYK2","protein":"Non-receptor tyrosine-protein kinase TYK2"},{"gene":"FLT4","source":"DrugCentral","target":"Vascular endothelial growth factor receptor 3","protein":"Vascular endothelial growth factor receptor 3"},{"gene":"FLT3","source":"DrugCentral","target":"Receptor-type tyrosine-protein kinase FLT3","protein":"Receptor-type tyrosine-protein kinase FLT3"},{"gene":"CSF1R","source":"DrugCentral","target":"Macrophage colony-stimulating factor 1 receptor","protein":"Macrophage colony-stimulating factor 1 receptor"},{"gene":"JAK3","source":"DrugCentral","target":"Tyrosine-protein kinase JAK3","protein":"Tyrosine-protein kinase JAK3"},{"gene":"STK10","source":"DrugCentral","target":"Serine/threonine-protein kinase 10","protein":"Serine/threonine-protein kinase 10"},{"gene":"ADCK1","source":"DrugCentral","target":"Uncharacterized aarF domain-containing protein kinase 1","protein":"Uncharacterized aarF domain-containing protein kinase 1"},{"gene":"MAPK10","source":"DrugCentral","target":"Mitogen-activated protein kinase 10","protein":"Mitogen-activated protein kinase 10"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Filgotinib selectively inhibits the JAK1 enzyme, which is a key component of the JAK/STAT signaling pathway. This pathway is involved in the regulation of immune cell function and cytokine production, making JAK1 a critical target for the treatment of inflammatory diseases such as Rheumatoid arthritis and Ulcerative colitis."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5419","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FILGOTINIB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FILGOTINIB","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T11:27:58.354819","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:28:42.092805+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"muromonab-CD3","drugSlug":"muromonab-cd3","fdaApproval":"1992-09-14","relationship":"same-class"},{"drugName":"mycophenolic acid","drugSlug":"mycophenolic-acid","fdaApproval":"2004-02-27","relationship":"same-class"},{"drugName":"sirolimus","drugSlug":"sirolimus","fdaApproval":"1999-09-15","patentExpiry":"Oct 28, 2040","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"leflunomide","drugSlug":"leflunomide","fdaApproval":"1998-09-10","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"alefacept","drugSlug":"alefacept","fdaApproval":"2003-01-30","relationship":"same-class"},{"drugName":"everolimus","drugSlug":"everolimus","fdaApproval":"2009-03-30","patentExpiry":"May 1, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"efalizumab","drugSlug":"efalizumab","fdaApproval":"2003-10-27","relationship":"same-class"},{"drugName":"natalizumab","drugSlug":"natalizumab","fdaApproval":"2004-11-23","relationship":"same-class"},{"drugName":"abatacept","drugSlug":"abatacept","fdaApproval":"2005-12-23","relationship":"same-class"},{"drugName":"eculizumab","drugSlug":"eculizumab","fdaApproval":"2007-03-16","relationship":"same-class"},{"drugName":"belimumab","drugSlug":"belimumab","fdaApproval":"2011-03-09","relationship":"same-class"},{"drugName":"fingolimod","drugSlug":"fingolimod","fdaApproval":"2010-09-21","patentExpiry":"Sep 30, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"belatacept","drugSlug":"belatacept","fdaApproval":"2011-06-15","relationship":"same-class"},{"drugName":"tofacitinib","drugSlug":"tofacitinib","fdaApproval":"2012-11-06","patentExpiry":"Sep 14, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"teriflunomide","drugSlug":"teriflunomide","fdaApproval":"2012-09-12","patentExpiry":"Sep 14, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"apremilast","drugSlug":"apremilast","fdaApproval":"2014-03-21","patentExpiry":"Nov 29, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"vedolizumab","drugSlug":"vedolizumab","fdaApproval":"2014-05-20","relationship":"same-class"},{"drugName":"alemtuzumab","drugSlug":"alemtuzumab","fdaApproval":"2001-05-07","relationship":"same-class"},{"drugName":"ocrelizumab","drugSlug":"ocrelizumab","fdaApproval":"2017-03-28","relationship":"same-class"},{"drugName":"baricitinib","drugSlug":"baricitinib","fdaApproval":"2018-05-31","patentExpiry":"Nov 30, 2032","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"filgotinib","indications":{"approved":[{"name":"Rheumatoid arthritis","source":"DrugCentral","snomedId":69896004,"regulator":"FDA","usPrevalence":1500000,"globalPrevalence":18000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Rheumatology, 2023"},{"name":"Ulcerative colitis","source":"DrugCentral","snomedId":64766004,"regulator":"FDA","usPrevalence":900000,"globalPrevalence":5000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Gastroenterology, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"muromonab-cd3","brandName":"muromonab-CD3","genericName":"muromonab-CD3","approvalYear":"1992","relationship":"same-class"},{"drugId":"mycophenolic-acid","brandName":"mycophenolic acid","genericName":"mycophenolic acid","approvalYear":"2004","relationship":"same-class"},{"drugId":"sirolimus","brandName":"sirolimus","genericName":"sirolimus","approvalYear":"1999","relationship":"same-class"},{"drugId":"leflunomide","brandName":"leflunomide","genericName":"leflunomide","approvalYear":"1998","relationship":"same-class"},{"drugId":"alefacept","brandName":"alefacept","genericName":"alefacept","approvalYear":"2003","relationship":"same-class"},{"drugId":"everolimus","brandName":"everolimus","genericName":"everolimus","approvalYear":"2009","relationship":"same-class"},{"drugId":"efalizumab","brandName":"efalizumab","genericName":"efalizumab","approvalYear":"2003","relationship":"same-class"},{"drugId":"natalizumab","brandName":"natalizumab","genericName":"natalizumab","approvalYear":"2004","relationship":"same-class"},{"drugId":"abatacept","brandName":"abatacept","genericName":"abatacept","approvalYear":"2005","relationship":"same-class"},{"drugId":"eculizumab","brandName":"eculizumab","genericName":"eculizumab","approvalYear":"2007","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07177209","phase":"","title":"Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population","status":"NOT_YET_RECRUITING","sponsor":"Pfizer","startDate":"2026-02-27","conditions":["Ulcerative Colitis"],"enrollment":4000,"completionDate":"2026-05-31"},{"nctId":"NCT06865417","phase":"PHASE3","title":"A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis","status":"RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2025-09-29","conditions":["Ulcerative Colitis"],"enrollment":80,"completionDate":"2028-06"},{"nctId":"NCT06964113","phase":"PHASE4","title":"A Study of Filgotinib 200 mg in Korean Participants With Moderately to Severely Active Ulcerative Colitis Under Routine Clinical Practice","status":"RECRUITING","sponsor":"Eisai Korea Inc.","startDate":"2025-06-11","conditions":["Ulcerative Colitis"],"enrollment":94,"completionDate":"2027-11-30"},{"nctId":"NCT05817942","phase":"","title":"Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2023-06-12","conditions":["Ulcerative Colitis"],"enrollment":509,"completionDate":"2027-12"},{"nctId":"NCT05323591","phase":"","title":"Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2022-05-03","conditions":["Rheumatoid Arthritis"],"enrollment":155,"completionDate":"2026-07"},{"nctId":"NCT06222034","phase":"PHASE1","title":"Study to Measure Filgotinib in the Blood of Children and Teenagers With Arthritis Taking Filgotinib (SCALESIA)","status":"RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2024-05-13","conditions":["Juvenile Idiopathic Arthritis"],"enrollment":10,"completionDate":"2026-08"},{"nctId":"NCT05785611","phase":"PHASE3","title":"A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2023-04-05","conditions":["Axial Spondyloarthritis"],"enrollment":495,"completionDate":"2028-12"},{"nctId":"NCT06625242","phase":"PHASE4","title":"A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eisai Korea Inc.","startDate":"2024-10-22","conditions":["Rheumatoid Arthritis"],"enrollment":118,"completionDate":"2026-03-19"},{"nctId":"NCT04871919","phase":"","title":"Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2021-05-11","conditions":["Rheumatoid Arthritis"],"enrollment":1304,"completionDate":"2028-06"},{"nctId":"NCT04985435","phase":"PHASE4","title":"Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)","status":"RECRUITING","sponsor":"R.Bos","startDate":"2021-05-12","conditions":["Rheumatoid Arthritis"],"enrollment":100,"completionDate":"2025-09-30"},{"nctId":"NCT03025308","phase":"PHASE3","title":"Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Alfasigma S.p.A.","startDate":"2017-02-28","conditions":["Rheumatoid Arthritis"],"enrollment":2731,"completionDate":"2025-05-16"},{"nctId":"NCT06246123","phase":"","title":"A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants","status":"RECRUITING","sponsor":"Eisai Korea Inc.","startDate":"2024-02-27","conditions":["Arthritis, Rheumatoid","Colitis, Ulcerative"],"enrollment":2040,"completionDate":"2027-07-30"},{"nctId":"NCT06089590","phase":"","title":"Ibd CAncer and seRious Infections in France (I-CARE 2)","status":"RECRUITING","sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","startDate":"2024-01-25","conditions":["IBD","Ulcerative Colitis","Crohn Disease"],"enrollment":6000,"completionDate":"2031-03-01"},{"nctId":"NCT02714634","phase":"PHASE4","title":"Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide","status":"RECRUITING","sponsor":"University Hospital, Strasbourg, France","startDate":"2016-03-30","conditions":["Rheumatoid Arthritis","Insufficient Response to Methotrexate or Leflunomide"],"enrollment":286,"completionDate":"2029-03"},{"nctId":"NCT02914535","phase":"PHASE3","title":"Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alfasigma S.p.A.","startDate":"2017-02-23","conditions":["Ulcerative Colitis"],"enrollment":1173,"completionDate":"2026-09"},{"nctId":"NCT06687551","phase":"PHASE4","title":"JAK Inhibitor Dose TAPering Strategy Study","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Toulouse","startDate":"2025-01-01","conditions":["Rhumatoid Arthisis"],"enrollment":308,"completionDate":"2029-04-01"},{"nctId":"NCT03201445","phase":"PHASE2","title":"Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease","status":"TERMINATED","sponsor":"Galapagos NV","startDate":"2017-07-11","conditions":["Inflammatory Bowel Disease"],"enrollment":139,"completionDate":"2023-10-24"},{"nctId":"NCT05479058","phase":"PHASE3","title":"A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission","status":"TERMINATED","sponsor":"Galapagos NV","startDate":"2022-07-26","conditions":["Ulcerative Colitis"],"enrollment":22,"completionDate":"2023-10-09"},{"nctId":"NCT06604273","phase":"PHASE2,PHASE3","title":"Unravelling Intestinal Fibrosis in Ulcerative Colitis","status":"RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2024-04-03","conditions":["Ulcerative Colitis (UC)","Inflammatory Bowel Disease (IBD)","Fibroblast Activation Protein Inhibitor"],"enrollment":10,"completionDate":"2026-04-03"},{"nctId":"NCT06527534","phase":"PHASE4","title":"Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)","status":"RECRUITING","sponsor":"Universita di Verona","startDate":"2024-07-15","conditions":["Rheumatoid Arthritis"],"enrollment":30,"completionDate":"2025-09-15"},{"nctId":"NCT02914600","phase":"PHASE3","title":"Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease","status":"TERMINATED","sponsor":"Galapagos NV","startDate":"2017-03-17","conditions":["Crohn's Disease"],"enrollment":1188,"completionDate":"2023-08-01"},{"nctId":"NCT06285539","phase":"PHASE2","title":"Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases","status":"RECRUITING","sponsor":"UMC Utrecht","startDate":"2024-03-12","conditions":["Behcet's Disease","Idiopathic Inflammatory Myopathies","IgG4-related Disease"],"enrollment":60,"completionDate":"2026-12"},{"nctId":"NCT02065700","phase":"PHASE2","title":"Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2014-02-25","conditions":["Rheumatoid Arthritis"],"enrollment":739,"completionDate":"2023-01-19"},{"nctId":"NCT03926195","phase":"PHASE2","title":"Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2019-05-28","conditions":["Rheumatoid Arthritis","Psoriatic Arthritis","Ankylosing Spondylitis","Non-Radiographical Axial Spondyloarthritis"],"enrollment":109,"completionDate":"2023-05-10"},{"nctId":"NCT02914561","phase":"PHASE3","title":"Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2016-10-31","conditions":["Crohn's Disease"],"enrollment":1372,"completionDate":"2022-11-11"},{"nctId":"NCT06043739","phase":"PHASE1","title":"Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2023-09-22","conditions":["Bioavailability"],"enrollment":12,"completionDate":"2023-11-12"},{"nctId":"NCT05653791","phase":"","title":"Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis","status":"UNKNOWN","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2022-10-01","conditions":["Ulcerative Colitis"],"enrollment":20,"completionDate":"2024-10-01"},{"nctId":"NCT05502731","phase":"PHASE4","title":"Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid Arthritis","status":"UNKNOWN","sponsor":"Leiden University Medical Center","startDate":"2022-10","conditions":["Rheumatoid Arthritis"],"enrollment":40,"completionDate":"2025-10"},{"nctId":"NCT04608344","phase":"PHASE1","title":"Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2020-11-04","conditions":["Rheumatoid Arthritis"],"enrollment":27,"completionDate":"2021-01-13"},{"nctId":"NCT04115748","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2019-12-03","conditions":["Psoriatic Arthritis"],"enrollment":67,"completionDate":"2021-05-11"},{"nctId":"NCT03320876","phase":"PHASE2","title":"An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.","status":"TERMINATED","sponsor":"Galapagos NV","startDate":"2017-07-26","conditions":["Psoriatic Arthritis"],"enrollment":122,"completionDate":"2021-06-30"},{"nctId":"NCT03077412","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-04-06","conditions":["Fistulizing Crohn's Disease"],"enrollment":57,"completionDate":"2021-02-17"},{"nctId":"NCT04115839","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2019-11-13","conditions":["Psoriatic Arthritis"],"enrollment":106,"completionDate":"2021-03-18"},{"nctId":"NCT03207815","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2017-07-26","conditions":["Noninfectious Uveitis"],"enrollment":74,"completionDate":"2021-04-22"},{"nctId":"NCT05119452","phase":"NA","title":"Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis","status":"UNKNOWN","sponsor":"Medical University of Vienna","startDate":"2022-03","conditions":["Rheumatoid Arthritis"],"enrollment":85,"completionDate":"2024-09"},{"nctId":"NCT05090410","phase":"PHASE3","title":"Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate","status":"UNKNOWN","sponsor":"Atsushi Kawakami","startDate":"2021-03-03","conditions":["Rheumatoid Arthritis","JAK Inhibitor","IL-6 Inhibitor","Musculoskeletal Ultrasound","Biomarker"],"enrollment":400,"completionDate":"2023-12-31"},{"nctId":"NCT03046056","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-04-11","conditions":["Small Bowel Crohn's Disease"],"enrollment":78,"completionDate":"2020-07-20"},{"nctId":"NCT02889796","phase":"PHASE3","title":"Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-08-30","conditions":["Rheumatoid Arthritis"],"enrollment":1759,"completionDate":"2019-06-20"},{"nctId":"NCT02886728","phase":"PHASE3","title":"Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-08-08","conditions":["Rheumatoid Arthritis"],"enrollment":1252,"completionDate":"2019-05-08"},{"nctId":"NCT02873936","phase":"PHASE3","title":"Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-07-27","conditions":["Rheumatoid Arthritis"],"enrollment":449,"completionDate":"2018-06-26"},{"nctId":"NCT02914522","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-11-14","conditions":["Ulcerative Colitis"],"enrollment":1351,"completionDate":"2020-03-31"},{"nctId":"NCT03417778","phase":"PHASE1","title":"Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2018-04-03","conditions":["Rheumatoid Arthritis"],"enrollment":20,"completionDate":"2018-08-09"},{"nctId":"NCT04483687","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy","status":"WITHDRAWN","sponsor":"Gilead Sciences","startDate":"2020-12","conditions":["Ankylosing Spondylitis"],"enrollment":0,"completionDate":"2024-09"},{"nctId":"NCT04483700","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy","status":"WITHDRAWN","sponsor":"Gilead Sciences","startDate":"2020-12","conditions":["Ankylosing Spondylitis"],"enrollment":0,"completionDate":"2024-06"},{"nctId":"NCT01894516","phase":"PHASE2","title":"Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2013-10-08","conditions":["Rheumatoid Arthritis"],"enrollment":287,"completionDate":"2015-05-29"},{"nctId":"NCT01888874","phase":"PHASE2","title":"Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2013-07-17","conditions":["Rheumatoid Arthritis"],"enrollment":599,"completionDate":"2015-05-14"},{"nctId":"NCT03100942","phase":"PHASE2","title":"Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-05-01","conditions":["Sjogren's Syndrome"],"enrollment":152,"completionDate":"2019-10-02"},{"nctId":"NCT03134222","phase":"PHASE2","title":"Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-05-24","conditions":["Cutaneous Lupus Erythematosus"],"enrollment":47,"completionDate":"2019-12-18"},{"nctId":"NCT03285711","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-10-06","conditions":["Lupus Membranous Nephropathy"],"enrollment":9,"completionDate":"2020-02-03"},{"nctId":"NCT02885181","phase":"PHASE2","title":"Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-09-21","conditions":["Rheumatoid Arthritis"],"enrollment":83,"completionDate":"2017-09-20"},{"nctId":"NCT03117270","phase":"PHASE2","title":"A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2017-03-07","conditions":["Ankylosing Spondylitis"],"enrollment":116,"completionDate":"2018-07-02"},{"nctId":"NCT03101670","phase":"PHASE2","title":"A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2017-03-09","conditions":["Psoriatic Arthritis"],"enrollment":131,"completionDate":"2018-03-12"},{"nctId":"NCT02048618","phase":"PHASE2","title":"Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2014-02","conditions":["Crohn's Disease"],"enrollment":175,"completionDate":"2016-02"},{"nctId":"NCT02162355","phase":"PHASE1","title":"Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2014-06","conditions":["Healthy"],"enrollment":36,"completionDate":"2014-09"},{"nctId":"NCT02084199","phase":"PHASE1","title":"Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2014-03","conditions":["Renal Impairment"],"enrollment":24,"completionDate":"2014-07"},{"nctId":"NCT01915667","phase":"PHASE1","title":"Oral Bioavailability of Two Solid Formulations of GLPG0634","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2013-07","conditions":["Healthy"],"enrollment":12,"completionDate":"2013-09"},{"nctId":"NCT01668641","phase":"PHASE2","title":"Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2012-05","conditions":["Rheumatoid Arthritis"],"enrollment":91,"completionDate":"2012-10"},{"nctId":"NCT01798979","phase":"PHASE1","title":"A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2013-02","conditions":["Healthy"],"enrollment":20,"completionDate":"2013-04"},{"nctId":"NCT01820806","phase":"PHASE1","title":"Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2013-03","conditions":["Healthy"],"enrollment":6,"completionDate":"2013-04"},{"nctId":"NCT01665924","phase":"PHASE1","title":"Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2012-07","conditions":["Healthy"],"enrollment":36,"completionDate":"2012-10"},{"nctId":"NCT01384422","phase":"PHASE2","title":"Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2011-06","conditions":["Rheumatoid Arthritis"],"enrollment":36,"completionDate":"2011-11"},{"nctId":"NCT01419990","phase":"PHASE1","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2011-08","conditions":["Healthy"],"enrollment":16,"completionDate":"2011-10"},{"nctId":"NCT01179581","phase":"PHASE1","title":"First-in-Human Single Ascending and Multiple Dose of GLPG0634","status":"COMPLETED","sponsor":"Galapagos NV","startDate":"2010-08","conditions":["Healthy"],"enrollment":48,"completionDate":"2011-03"}],"_emaApprovals":[{"date":"2020-09-24","status":"Authorised","company":"Gilead Sciences Ireland UC"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"018759","UNII":"3XVL385Q0M","INN_ID":"9720","UMLSCUI":"C4310256","chemblId":"CHEMBL4298167","ChEMBL_ID":"CHEMBL3301607","KEGG_DRUG":"D11106","DRUGBANK_ID":"DB14845","PDB_CHEM_ID":" 2HB","PUBCHEM_CID":"49831257","IUPHAR_LIGAND_ID":"7913","SECONDARY_CAS_RN":"1802998-75-9","MESH_SUPPLEMENTAL_RECORD_UI":"C584571"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Gilead Sciences Ireland UC","relationship":"Original Developer"},{"period":"2020","companyName":"Gilead Sciences","relationship":"PMDA Licensee"}],"publicationCount":503,"therapeuticAreas":["Immunology"],"_revenueScrapedAt":"2026-03-31 10:40:42.473302+00","atcClassification":{"source":"DrugCentral","atcCode":"L04AA45","allCodes":["L04AA45"]},"biosimilarFilings":[],"originalDeveloper":"Gilead Sciences Ireland UC","recentPublications":[{"date":"2026 Mar 28","pmid":"41903081","title":"Efficacy/Effectiveness, Safety and Treatment Persistence of Filgotinib in Rheumatoid Arthritis: A Narrative Review of Clinical Trials and Real-World Evidence.","journal":"Rheumatology and therapy"},{"date":"2026 Mar 4","pmid":"41901264","title":"Advanced Medical Therapies for Perianal Fistulizing Crohn's Disease: A Systematic Review of Clinical, Radiological, Surgical, and Composite Outcomes.","journal":"Pharmaceuticals (Basel, Switzerland)"},{"date":"2026 Mar 10","pmid":"41879068","title":"Filgotinib treatment modulates frequency and gene expression of circulating immune cell subsets in ulcerative colitis.","journal":"Journal of Crohn's & colitis"},{"date":"2026","pmid":"41867665","title":"Successful and Risk-Minimizing Treatment of Ulcerative Colitis by Positive Switch from JAK Inhibitors to Ustekinumab.","journal":"Biologics : targets & therapy"},{"date":"2025 Sep 9","pmid":"41848136","title":"Cardiovascular risk and JAK inhibitor for the treatment of spondyloarthritis: A systematic review.","journal":"La Tunisie medicale"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Gilead Sciences Ireland UC","companyId":"gilead-sciences","modality":"Small molecule","firstApprovalDate":"2020","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"2020-09-25T00:00:00.000Z","mah":"Gilead Sciences","brand_name_local":null,"application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":2,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:28:42.092805+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}