Drugs / Bezafibrate
last change Feb 2026 re-read 2 minutes ago

Bezafibrate

Small molecule

Developed for
primary biliary cholangitis · primary sclerosing cholangitis · acute myocardial infarction · adrenomyeloneuropathy · bipolar depression · carnitine palmitoyl transferase II deficiency, myopathic form · carnitine palmitoyltransferase II deficiency · cholestasis
+8 more · glucose metabolism disease · hyperlipidemia, combined, 2 · mitochondrial disease · myelodysplastic syndrome · neutral lipid storage disease · secondary sclerosing cholangitis · very long chain acyl-CoA dehydrogenase deficiency · hypertriglyceridemia
Investigated by
Assistance Publique - Hôpitaux de Paris · Intercept Pharmaceuticals · Academic Medical Center - University of Amsterdam · Maastricht University Medical Center · Mexican Social Security Institute · Association Française contre les Myopathies (AFM), Paris
+28 more · Azienda Ospedaliero, Universitaria Pisana · Blood Cancer UK · Brain & Behavior Research Foundation · Dudley Group NHS Foundation Trust · Erasmus Medical Center · French National Institute of Health and Medical Research · Friedrich-Alexander-Universität Erlangen-Nürnberg · Groupe Hospitalier Pitie-Salpetriere · Istituto Clinico Humanitas · J Willard and Alice S. Marriott Foundation · King's College Hospital NHS Trust · Leiden University Medical Center · Ludwig-Maximilians - University of Munich · Massachusetts General Hospital · National Institute of Medical Sciences and Nutrition Salvador Zubiran · Newcastle University · Newcastle-upon-Tyne Hospitals NHS Trust · Prof. Janet Dunn · Radboud University Medical Center · Rigshospitalet, Denmark · The Stop ALD Foundation · UMC Utrecht · University Hospital Brussels · University Medical Center Groningen · University of Barcelona · University of Birmingham · University of Guadalajara · University of Manchester

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT05239468 Mar 2022 → Sep 2025 primary biliary cholangitis Intercept Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04997811 Dec 2021 → Jan 2025 myelodysplastic syndrome Prof. Janet Dunn Unknown No outcome recorded
Phase 2 NCT04594694 Oct 2019 → Oct 2025 primary biliary cholangitis Intercept Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT02481245 Jan 2018 → Feb 2026 overdue bipolar depression Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT02398201 Sep 2015 → Jan 2017 mitochondrial disease Newcastle-upon-Tyne Hospitals NHS Trust Completed No outcome recorded
Phase 2 NCT00983788 Oct 2009 → Sep 2011 carnitine palmitoyltransferase II deficiency, very long chain acyl-CoA dehydrogenase deficiency Rigshospitalet, Denmark Completed No outcome recorded
Phase 39 trials
Phase 3 NCT06443606 Mar 2025 → Dec 2027 expected Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT06488911 Jul 2024 → Oct 2025 primary biliary cholangitis Intercept Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT04309773 Apr 2021 → Mar 2023 cholestasis, primary sclerosing cholangitis Assistance Publique - Hôpitaux de Paris Unknown No outcome recorded
Phase 3 NCT04751188 Oct 2020 → Jun 2021 primary biliary cholangitis Mexican Social Security Institute Unknown No outcome recorded
Phase 3 NCT02937012 Oct 2016 → Apr 2019 primary biliary cholangitis National Institute of Medical Sciences and Nutrition Salvador Zubiran Unknown No outcome recorded
Phase 3 NCT02701166 Feb 2016 → Feb 2018 primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis Academic Medical Center - University of Amsterdam Unknown No outcome recorded
Phase 3 NCT02548832 Apr 2013 → Apr 2020 hyperlipidemia, combined, 2 University of Guadalajara Completed No outcome recorded
Phase 3 NCT01654731 Oct 2012 → Dec 2016 primary biliary cholangitis Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 3 NCT00336167 Jun 2006 → Jul 2007 carnitine palmitoyl transferase II deficiency, myopathic form Assistance Publique - Hôpitaux de Paris Unknown No outcome recorded
Phase 42 trials
Phase 4 NCT01527318 Aug 2011 → Dec 2012 neutral lipid storage disease Maastricht University Medical Center Completed No outcome recorded
Phase 4 NCT02291796 Jan 2011 → Dec 2013 acute myocardial infarction Mexican Social Security Institute Completed No outcome recorded
Phase not applicable2 trials
NCT05213988 Jul 2018 → Jan 2025 glucose metabolism disease Azienda Ospedaliero, Universitaria Pisana Unknown No outcome recorded
NCT01165060 Jul 2010 → Aug 2011 adrenomyeloneuropathy Academic Medical Center - University of Amsterdam Completed No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT00506298 Background Jul 2007 → Apr 2009 type 2 diabetes mellitus Zalicus Completed No outcome recorded
Phase 31 trial
Phase 3 NCT02584504 Background Nov 2015 → Apr 2017 hyperlipoproteinemia Sanofi Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02984982 Background Nov 2016 → Jul 2018 acute coronary syndrome, hyperlipidemia Sanofi Completed No outcome recorded
Phase not applicable1 trial
NCT03649269 Comparator Jan → Nov 2014 hypertriglyceridemia Ciprés Grupo Médico CGM SC Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

FieldValueCited text
Known as Bezafibrate “An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects...” NCT06488911
22

“Patients will receive a dosage of 400mg Bezafibrate every day during 28 weeks” NCT01527318

“Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.” NCT02584504

Bezafibrate 400 mg/day” NCT05213988

NCT02937012

NCT03649269

NCT02291796

NCT01654731

NCT04997811

NCT04751188

NCT04309773

NCT02984982

NCT02701166

NCT00506298

NCT02481245

NCT04594694

NCT00336167

NCT06443606

NCT05239468

NCT00983788

NCT02398201

NCT02548832

NCT01165060

Known as Bezafibrato ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as Bezagen xl ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as Bezalip ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as Bezalip-mono ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as Bezatol sr ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as BM 15.075 ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as BZF “An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects...” NCT06488911
2

“investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF)” NCT04594694

“Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR” NCT05239468

Known as Fibrazate xl ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as Liparol xl ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as NSC-758174 ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Known as Zimbacol xl ChEMBL registry synonym — accepted as the source's own label CHEMBL264374
Action Activate “We recently shown that bezafibrate, a PPAR alpha agonist, was able to restore close to the normal the apparent CPT2 activity and the LCFAO in both fibroblasts and cultured...” NCT00336167
Modality Small molecule “the hypolipidemic drug bezafibrate” NCT00983788
Route Oral “Route of administration: oralNCT02984982