{"id":"bezafibrate-drug","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Gastrointestinal disturbances"},{"rate":"5-10%","effect":"Musculoskeletal pain"},{"rate":"2-5%","effect":"Liver function abnormalities"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This activation results in increased breakdown of triglycerides in adipose tissue and decreased synthesis of triglycerides in the liver. Additionally, bezafibrate has been shown to have anti-inflammatory properties and improve endothelial function.","oneSentence":"Bezafibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPAR-alpha), leading to increased lipolysis and decreased lipogenesis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:13.075Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hyperlipidemia"},{"name":"Dyslipidemia"},{"name":"Atherosclerosis"}]},"trialDetails":[{"nctId":"NCT04594694","phase":"PHASE2","title":"Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2019-10-02","conditions":"Primary Biliary Cholangitis","enrollment":75},{"nctId":"NCT06488911","phase":"PHASE3","title":"To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate","status":"TERMINATED","sponsor":"Intercept Pharmaceuticals","startDate":"2024-07-01","conditions":"Primary Biliary Cholangitis","enrollment":63},{"nctId":"NCT02481245","phase":"PHASE2","title":"BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2018-01-11","conditions":"Bipolar Disorder, Depressive Episode","enrollment":30},{"nctId":"NCT05239468","phase":"PHASE2","title":"Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC","status":"COMPLETED","sponsor":"Intercept Pharmaceuticals","startDate":"2022-03-21","conditions":"Primary Biliary Cholangitis","enrollment":72},{"nctId":"NCT06443606","phase":"PHASE3","title":"Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2025-03-27","conditions":"BPC, Non Optimal Response to UDCA","enrollment":108},{"nctId":"NCT06858332","phase":"","title":"Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-04-15","conditions":"Atherosclerotic Cardiovascular Disease","enrollment":2382},{"nctId":"NCT04997811","phase":"PHASE2","title":"Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes","status":"UNKNOWN","sponsor":"Prof. Janet Dunn","startDate":"2021-12-21","conditions":"Myelodysplastic Syndromes (MDS)","enrollment":120},{"nctId":"NCT04561466","phase":"PHASE2, PHASE3","title":"Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy","status":"COMPLETED","sponsor":"Hôpital Necker-Enfants Malades","startDate":"2019-03-26","conditions":"Safety Issues, Efficacy, Self","enrollment":14},{"nctId":"NCT01654731","phase":"PHASE3","title":"Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2012-10-15","conditions":"PBC","enrollment":100},{"nctId":"NCT02548832","phase":"PHASE3","title":"Bezafibrate Plus Berberine in Mixed Dyslipidemia","status":"COMPLETED","sponsor":"University of Guadalajara","startDate":"2013-04","conditions":"Mixed Dyslipidemia","enrollment":36},{"nctId":"NCT04309773","phase":"PHASE3","title":"Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-04-06","conditions":"Primary Sclerosing Cholangitis, Cholestasis","enrollment":104},{"nctId":"NCT05213988","phase":"NA","title":"Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies","status":"UNKNOWN","sponsor":"Azienda Ospedaliero, Universitaria Pisana","startDate":"2018-07-30","conditions":"Glucose Metabolism Disorders","enrollment":50},{"nctId":"NCT04751188","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis","status":"UNKNOWN","sponsor":"Instituto Mexicano del Seguro Social","startDate":"2020-10-02","conditions":"Primary Biliary Cirrhosis","enrollment":11},{"nctId":"NCT02984982","phase":"PHASE4","title":"Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia","status":"COMPLETED","sponsor":"Sanofi","startDate":"2016-11-15","conditions":"Hypercholesterolemia, Acute Coronary Syndrome","enrollment":206},{"nctId":"NCT02584504","phase":"PHASE3","title":"Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin","status":"COMPLETED","sponsor":"Sanofi","startDate":"2015-11-30","conditions":"Hypercholesterolemia","enrollment":163},{"nctId":"NCT03649269","phase":"NA","title":"PC-300 Tea Effect on Triglyceride Levels","status":"COMPLETED","sponsor":"Ciprés Grupo Médico CGM SC","startDate":"2014-01-01","conditions":"Hypertriglyceridemia","enrollment":34},{"nctId":"NCT02937012","phase":"PHASE3","title":"Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders","status":"UNKNOWN","sponsor":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","startDate":"2016-10","conditions":"Primary Biliary Cirrhosis","enrollment":34},{"nctId":"NCT02398201","phase":"PHASE2","title":"A Study of Bezafibrate in Mitochondrial Myopathy","status":"COMPLETED","sponsor":"Newcastle-upon-Tyne Hospitals NHS Trust","startDate":"2015-09","conditions":"Mitochondrial Diseases","enrollment":6},{"nctId":"NCT02701166","phase":"PHASE3","title":"The Effect of Bezafibrate on Cholestatic Itch","status":"UNKNOWN","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2016-02","conditions":"Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis","enrollment":84},{"nctId":"NCT02291796","phase":"PHASE4","title":"Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Instituto Mexicano del Seguro Social","startDate":"2011-01","conditions":"Acute Myocardial Infarction","enrollment":100},{"nctId":"NCT01527318","phase":"PHASE4","title":"The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM)","status":"COMPLETED","sponsor":"Maastricht University Medical Center","startDate":"2011-08","conditions":"Neutral Lipid Storage Disease","enrollment":6},{"nctId":"NCT00983788","phase":"PHASE2","title":"Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2009-10","conditions":"Carnitine Palmitoyltransferase II Deficiency, Very Long Chain Acyl Coa Dehydrogenase Deficiency","enrollment":12},{"nctId":"NCT01165060","phase":"NA","title":"The Effect of Bezafibrate on the Level of Very Long Chain Fatty Acids (VLCFA) in X-linked Adrenoleukodystrophy (X-ALD)","status":"COMPLETED","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2010-07","conditions":"X-linked Adrenoleukodystrophy, Adrenomyeloneuropathy","enrollment":10},{"nctId":"NCT00506298","phase":"PHASE2","title":"Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes","status":"COMPLETED","sponsor":"Zalicus","startDate":"2007-07","conditions":"Type 2 Diabetes","enrollment":150},{"nctId":"NCT00336167","phase":"PHASE3","title":"Bezafibrate Trial in CPT2 Deficiency","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2006-06","conditions":"Carnitine Palmitoyl Transferase 2 Deficiency","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"bezafibrate (drug)","genericName":"bezafibrate (drug)","companyName":"Assistance Publique - Hôpitaux de Paris","companyId":"assistance-publique-h-pitaux-de-paris","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bezafibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPAR-alpha), leading to increased lipolysis and decreased lipogenesis. Used for Hyperlipidemia, Dyslipidemia, Atherosclerosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}