{"id":"lepirudin","rwe":[],"tags":[{"label":"Anti-coagulant","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Prothrombin","category":"target"},{"label":"F2","category":"gene"},{"label":"B01AE02","category":"atc"},{"label":"Active","category":"status"},{"label":"Thrombosis in Heparin Induced Thrombocytopenia","category":"indication"},{"label":"Approved 1990s","category":"decade"},{"label":"Anticoagulants","category":"pharmacology"},{"label":"Antithrombins","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Fibrinolytic Agents","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"},{"label":"Protease Inhibitors","category":"pharmacology"},{"label":"Serine Proteinase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"contraindications":["Arterial aneurysm","Arteriovenous malformation","Bleeding","Blood coagulation disorder","CNS Trauma","Cerebrovascular accident","Disease of liver","Gastric ulcer","Hemorrhagic Diabetic Retinopathy","Hypertensive urgency","Infective endocarditis","Intracranial aneurysm","Kidney disease","Procedure on central nervous system","Puncture of Noncompressible Artery","Severe GI Bleeding within Last 10 Days","Surgical procedure","Thoracic surgery","Uncontrolled Coagulation Defects"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LEPIRUDIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:51:03.300298+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Lepirudin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:51:09.944503+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:51:08.558531+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEPIRUDIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:51:08.911626+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Thrombin inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:51:09.944407+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201666/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:51:09.603978+00:00"}},"allNames":"refludan","offLabel":[],"synonyms":["lepirudin","refludan","recombinant hirudin","lepirudin recombinant"],"timeline":[{"date":"1998-03-06","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"aiSummary":"Refludan (LEPIRUDIN) is a small molecule anti-coagulant that targets prothrombin. It was originally developed and is currently owned by an unspecified company. Refludan is FDA approved for the treatment of thrombosis in heparin-induced thrombocytopenia. The commercial status of Refludan is patented, and it is not yet off-patent. Key safety considerations include its potential for bleeding complications.","approvals":[{"date":"1998-03-06","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Refludan","ecosystem":[{"indication":"Thrombosis in Heparin Induced Thrombocytopenia","otherDrugs":[{"name":"argatroban","slug":"argatroban","company":"Pfizer"}],"globalPrevalence":null}],"mechanism":{"target":"Prothrombin","novelty":"Follow-on","targets":[{"gene":"F2","source":"DrugCentral","target":"Prothrombin","protein":"Prothrombin"}],"moaClass":"Thrombin Inhibitors","modality":"Small Molecule","drugClass":"Anti-coagulant","explanation":"","oneSentence":"","technicalDetail":"Refludan directly inhibits the activity of thrombin by binding to its active site, thereby preventing the conversion of fibrinogen to fibrin and the subsequent formation of a blood clot."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lepirudin","title":"Lepirudin","extract":"Lepirudin is an anticoagulant that functions as a direct thrombin inhibitor."},"commercial":{"launchDate":"1998","_launchSource":"DrugCentral (FDA 1998-03-06, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2995","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LEPIRUDIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEPIRUDIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lepirudin","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T12:17:27.089915","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:51:11.167645+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"desirudin","drugSlug":"desirudin","fdaApproval":"2003-04-04","relationship":"same-class"},{"drugName":"argatroban","drugSlug":"argatroban","fdaApproval":"2000-06-30","patentExpiry":"Sep 26, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"bivalirudin","drugSlug":"bivalirudin","fdaApproval":"2000-12-15","patentExpiry":"May 20, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"dabigatran etexilate","drugSlug":"dabigatran-etexilate","fdaApproval":"2010-10-19","patentExpiry":"Mar 7, 2026","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"lepirudin","indications":{"approved":[{"name":"Thrombosis in Heparin Induced Thrombocytopenia","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"desirudin","brandName":"desirudin","genericName":"desirudin","approvalYear":"2003","relationship":"same-class"},{"drugId":"argatroban","brandName":"argatroban","genericName":"argatroban","approvalYear":"2000","relationship":"same-class"},{"drugId":"bivalirudin","brandName":"bivalirudin","genericName":"bivalirudin","approvalYear":"2000","relationship":"same-class"},{"drugId":"dabigatran-etexilate","brandName":"dabigatran etexilate","genericName":"dabigatran etexilate","approvalYear":"2010","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05847205","phase":"PHASE4","title":"Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis","status":"UNKNOWN","sponsor":"MinaPharm Pharmaceuticals","startDate":"2022-11-24","conditions":["Prophylaxis of Deep Vein Thrombosis"],"enrollment":100,"completionDate":"2023-12-31"},{"nctId":"NCT04593147","phase":"NA","title":"Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants","status":"COMPLETED","sponsor":"Building Block Nutritionals, LLC","startDate":"2020-10-14","conditions":["Infant Development"],"enrollment":131,"completionDate":"2021-11-09"},{"nctId":"NCT03331276","phase":"NA","title":"Growth and Safety Study of an Infant Formula for Healthy Term Infants","status":"COMPLETED","sponsor":"Building Block Nutritionals, LLC","startDate":"2017-09-18","conditions":["Infant Development"],"enrollment":260,"completionDate":"2019-01-07"},{"nctId":"NCT00603824","phase":"PHASE4","title":"Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)","status":"WITHDRAWN","sponsor":"Methodist Healthcare","startDate":"2008-01","conditions":["Heparin-Induced Thrombocytopenia"],"enrollment":0,"completionDate":"2010-07"},{"nctId":"NCT01304238","phase":"","title":"Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-02","conditions":["Acute HIT II (Heparin-induced Thrombocytopenia Type II)"],"enrollment":195,"completionDate":"2010-01"},{"nctId":"NCT00003726","phase":"PHASE1,PHASE2","title":"Lepirudin in Treating Patients With Recurrent or Advanced Small Cell Lung Cancer","status":"TERMINATED","sponsor":"Dartmouth-Hitchcock Medical Center","startDate":"1998-11","conditions":["Lung Cancer"],"enrollment":1,"completionDate":"2001-07"},{"nctId":"NCT01889758","phase":"PHASE4","title":"Pharmacokinetic Studies of Tacrolimus in Transplant Patients","status":"COMPLETED","sponsor":"University of Cincinnati","startDate":"2013-06","conditions":["Kidney Transplant Recipients","Liver Transplant Recipients"],"enrollment":78,"completionDate":"2016-01"},{"nctId":"NCT00798525","phase":"PHASE4","title":"Argatroban Versus Lepirudin in Critically Ill Patients","status":"TERMINATED","sponsor":"Heinrich-Heine University, Duesseldorf","startDate":"2009-01","conditions":["Heparin Induced Thrombocytopenia (HIT)"],"enrollment":70,"completionDate":"2012-03"},{"nctId":"NCT00039767","phase":"PHASE2","title":"Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices","status":"COMPLETED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2002-05","conditions":["Thrombosis"],"enrollment":340,"completionDate":"2006-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NUI":"N0000148552","MMSL":"11620","NDDF":"007520","UNII":"Y43GF64R34","VUID":"4021096","CHEBI":"CHEBI:142437","VANDF":"4021096","INN_ID":"7355","RXNORM":"189643","UMLSCUI":"C0772394","chemblId":"CHEMBL1201666","ChEMBL_ID":"CHEMBL1201666","KEGG_DRUG":"D06880","DRUGBANK_ID":"DB00001","PUBCHEM_CID":"118856773","SNOMEDCT_US":"108995001","IUPHAR_LIGAND_ID":"6469","MESH_SUPPLEMENTAL_RECORD_UI":"C083544"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":494,"therapeuticAreas":["Cardiovascular"],"atcClassification":{"source":"DrugCentral","atcCode":"B01AE02","allCodes":["B01AE02"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"","companyId":"","modality":"Recombinant protein","firstApprovalDate":"1998","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1998-03-06T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":null,"mah":null,"brand_name_local":"Refludan","application_number":"EMEA/H/C/000122"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Refludan","application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:51:11.167645+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}