{"id":"benepali","rwe":[],"tags":[],"trials":[],"_chembl":null,"aliases":["Etanercept"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"_scrapedAt":"2026-03-27T23:30:52.656Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Etanercept","title":"Etanercept","extract":"Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF is the \"master regulator\" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF."},"references":[],"biosimilars":[],"competitors":[],"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04610476","phase":"PHASE3","title":"Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis","status":"UNKNOWN","sponsor":"University of Erlangen-Nürnberg Medical School","startDate":"2020-10-19","conditions":"Psoriatic Arthritis, Withdrawal, Reduction","enrollment":270},{"nctId":"NCT03100734","phase":"","title":"Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel","status":"COMPLETED","sponsor":"Biogen","startDate":"2017-06-01","conditions":"Rheumatoid Arthritis, Axial Spondyloarthritis","enrollment":585},{"nctId":"NCT03016260","phase":"","title":"RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis","status":"TERMINATED","sponsor":"TcLand Expression S.A.","startDate":"2016-12","conditions":"RheumatoId Arthritis","enrollment":250},{"nctId":"NCT03813771","phase":"PHASE4","title":"Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification","status":"UNKNOWN","sponsor":"University of Leeds","startDate":"2019-03","conditions":"Rheumatoid Arthritis","enrollment":106},{"nctId":"NCT03327454","phase":"","title":"Benepali® PEN Patient Satisfaction Survey","status":"COMPLETED","sponsor":"Biogen","startDate":"2017-08-10","conditions":"Rheumatoid Arthritis, Spondyloarthropathies","enrollment":500}],"_emaApprovals":[],"_faersSignals":[{"count":159,"reaction":"DRUG INEFFECTIVE"},{"count":145,"reaction":"RHEUMATOID ARTHRITIS"},{"count":80,"reaction":"PRODUCT SUBSTITUTION ISSUE"},{"count":76,"reaction":"PRODUCT USE IN UNAPPROVED INDICATION"},{"count":72,"reaction":"IMMUNOSUPPRESSION"},{"count":69,"reaction":"LOWER RESPIRATORY TRACT INFECTION"},{"count":69,"reaction":"MALAISE"},{"count":69,"reaction":"PRODUCT USE ISSUE"},{"count":68,"reaction":"PAIN"},{"count":66,"reaction":"FATIGUE"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":37,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Benepali","genericName":"Benepali","companyName":"University of Leeds","companyId":"university-of-leeds","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":2,"withResults":0},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}