{"id":"isis-fxirx-dose-2","_chembl":{"chemblId":"CHEMBL499450","moleculeType":"Small molecule","molecularWeight":"7343.20"},"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"Factor XI (FXI)","explanation":"ISIS-FXIRx uses antisense technology to bind to FXI messenger RNA, reducing the synthesis of factor XI protein in the liver. By lowering FXI levels, the drug inhibits the intrinsic coagulation pathway, providing anticoagulation with potentially lower bleeding risk than traditional anticoagulants that target other clotting factors.","oneSentence":"Antisense oligonucleotide that reduces production of factor XI, a clotting protein, to prevent thrombosis while minimizing bleeding risk."},"_scrapedAt":"2026-03-28T01:56:40.659Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123945,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"apixaban","brand":"Eliquis","company":"Bristol Myers Squibb/Pfizer","rationale":"Oral factor Xa inhibitor for thrombosis prevention"},{"name":"rivaroxaban","brand":"Xarelto","company":"Bayer/Janssen","rationale":"Oral factor Xa inhibitor anticoagulant"},{"name":"enoxaparin","brand":"Lovenox","company":"Sanofi","rationale":"Injectable low molecular weight heparin anticoagulant"}],"description":"ISIS-FXIRx Dose #2 is an investigational antisense oligonucleotide developed by Ionis Pharmaceuticals targeting factor XI (FXI) for anticoagulation. It is being evaluated in Phase 2 clinical trials as a potential treatment for thrombosis prevention with reduced bleeding risk compared to traditional anticoagulants.","indications":{"approved":[{"status":"investigational","condition":"Thrombosis prevention","patientPopulation":"Adult patients requiring anticoagulation"},{"status":"investigational","condition":"Prevention of venous thromboembolism","patientPopulation":"Adult surgical patients"}]},"trialDetails":[{"nctId":"NCT03358030","phase":"PHASE2","title":"A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis","status":"COMPLETED","sponsor":"Ionis Pharmaceuticals, Inc.","startDate":"2017-12-26","conditions":"End-stage Renal Disease (ESRD)","enrollment":213},{"nctId":"NCT01713361","phase":"PHASE2","title":"Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Ionis Pharmaceuticals, Inc.","startDate":"2012-10","conditions":"Venous Thromboembolism","enrollment":315}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ISIS-FXIRx"],"phase":"phase_2","status":"active","brandName":"ISIS-FXIRx Dose #2","genericName":"ISIS-FXIRx Dose #2","companyName":"Ionis Pharmaceuticals, Inc.","companyId":"ionis-pharmaceuticals-inc","firstApprovalDate":"","aiSummary":"ISIS-FXIRx Dose #2 is being studied in a clinical trial for its potential to treat End-stage Renal Disease (ESRD) and Venous Thromboembolism. The trial, NCT03358030, is evaluating the efficacy of ISIS 416858, a treatment that includes ISIS-FXIRx Dose #2, compared to a placebo.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}