{"id":"benfluorex","rwe":[{"pmid":"40011171","year":"2025","title":"[HOPIPRAC: Pharmacovigilance interface for detecting cases of adverse events in a hospital data warehouse].","finding":"","journal":"Therapie","studyType":"Clinical Study"},{"pmid":"39938688","year":"2025","title":"Hypoxia reduces SLC27A5 to promote hepatocellular carcinoma proliferation by repressing HNF4A.","finding":"","journal":"Biochimica et biophysica acta. Molecular cell research","studyType":"Clinical Study"},{"pmid":"39850659","year":"2025","title":"Structure-based identification of HNF4α agonists: Rosmarinic acid as a promising candidate for NAFLD treatment.","finding":"","journal":"Computational and structural biotechnology journal","studyType":"Clinical Study"},{"pmid":"39397151","year":"2024","title":"Benfluorex and Valvular Heart Disease.","finding":"","journal":"Pharmacoepidemiology and drug safety","studyType":"Clinical Study"},{"pmid":"38693582","year":"2024","title":"Cumulative incidence of cardiac surgery associated with exposure to benfluorex: A retrospective analysis based on compensation claims data.","finding":"","journal":"Statistics in medicine","studyType":"Clinical Study"}],"tags":[{"label":"benfluorex","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A10BX06","category":"atc"},{"label":"Active","category":"status"},{"label":"Type 2 diabetes mellitus in obese","category":"indication"},{"label":"Anti-Obesity Agents","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Appetite Depressants","category":"pharmacology"},{"label":"Hypolipidemic Agents","category":"pharmacology"},{"label":"Lipid Regulating Agents","category":"pharmacology"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BENFLUOREX","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:46:01.257098+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:46:15.502729+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:46:07.032884+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENFLUOREX","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:46:07.349231+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Acyl coenzyme A:cholesterol acyltransferase 1 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:46:08.411428+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL400599/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:46:08.060236+00:00"}},"allNames":"benfluramate","offLabel":[],"synonyms":["benfluorex methanesulfonate","benfluorex maleate","benfluorex","benfluramate","benfluorex hydrochloride"],"timeline":[],"aiSummary":"Benfluorex, a marketed drug by an unspecified company, targets Type 2 diabetes mellitus in obese patients through a unique mechanism of activating mitochondrial uncoupling proteins. Its key strength lies in improving insulin sensitivity and increasing energy expenditure, distinguishing it from off-patent competitors like repaglinide and nateglinide. The primary risk is the upcoming key patent expiry in 2028, which could lead to increased competition from generics.","brandName":"Benfluramate","ecosystem":[{"indication":"Type 2 diabetes mellitus in obese","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"benfluorex","explanation":"","oneSentence":"","technicalDetail":"Benfluorex activates mitochondrial uncoupling proteins (UCPs), specifically UCP1, to increase the proton leak across the inner mitochondrial membrane, thereby dissipating the proton gradient and increasing energy expenditure."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/307","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BENFLUOREX","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BENFLUOREX","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:55:53.999922","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:46:15.502828+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"repaglinide","drugSlug":"repaglinide","fdaApproval":"1997-12-22","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"nateglinide","drugSlug":"nateglinide","fdaApproval":"2000-12-22","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"pramlintide","drugSlug":"pramlintide","fdaApproval":"2005-03-16","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"tirzepatide","drugSlug":"tirzepatide","fdaApproval":"2022-05-13","patentExpiry":"Jun 14, 2039","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"benfluorex","indications":{"approved":[{"name":"Type 2 diabetes mellitus in obese","source":"DrugCentral","snomedId":81531005,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"repaglinide","brandName":"repaglinide","genericName":"repaglinide","approvalYear":"1997","relationship":"same-class"},{"drugId":"nateglinide","brandName":"nateglinide","genericName":"nateglinide","approvalYear":"2000","relationship":"same-class"},{"drugId":"pramlintide","brandName":"pramlintide","genericName":"pramlintide","approvalYear":"2005","relationship":"same-class"},{"drugId":"tirzepatide","brandName":"tirzepatide","genericName":"tirzepatide","approvalYear":"2022","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02008552","phase":"NA","title":"Study of the Effect of the Benfluorex","status":"COMPLETED","sponsor":"University Hospital, Brest","startDate":"2013-10-18","conditions":["Blood Sample"],"enrollment":346,"completionDate":"2021-10-18"},{"nctId":"NCT00544518","phase":"PHASE2","title":"Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients","status":"UNKNOWN","sponsor":"Air Force Military Medical University, China","startDate":"2007-10","conditions":["Type 2 Diabetes"],"enrollment":240,"completionDate":"2008-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"004328","UNII":"403FO0NQG3","CHEBI":"CHEBI:93826","INN_ID":"3054","RXNORM":"18880","UMLSCUI":"C0053105","chemblId":"CHEMBL400599","ChEMBL_ID":"CHEMBL400599","KEGG_DRUG":"D07192","DRUGBANK_ID":"DB09022","PUBCHEM_CID":"2318","SNOMEDCT_US":"719681008","SECONDARY_CAS_RN":"23642-66-2","MESH_SUPPLEMENTAL_RECORD_UI":"C001584"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":180,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"A10BX06","allCodes":["A10BX06"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025 Sep-Oct","pmid":"40011171","title":"[HOPIPRAC: Pharmacovigilance interface for detecting cases of adverse events in a hospital data warehouse].","journal":"Therapie"},{"date":"2025 Mar","pmid":"39938688","title":"Hypoxia reduces SLC27A5 to promote hepatocellular carcinoma proliferation by repressing HNF4A.","journal":"Biochimica et biophysica acta. Molecular cell research"},{"date":"2025","pmid":"39850659","title":"Structure-based identification of HNF4α agonists: Rosmarinic acid as a promising candidate for NAFLD treatment.","journal":"Computational and structural biotechnology journal"},{"date":"2024 Oct","pmid":"39397151","title":"Benfluorex and Valvular Heart Disease.","journal":"Pharmacoepidemiology and drug safety"},{"date":"2024 Jun 15","pmid":"38693582","title":"Cumulative incidence of cardiac surgery associated with exposure to benfluorex: A retrospective analysis based on compensation claims data.","journal":"Statistics in medicine"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"withdrawn","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1974","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"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":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:46:15.502828+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}