Drugs / Bezafibrate
last change Feb 2026 re-read 9 days 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT05239468 Mar 2022 → Sep 2025 primary biliary cholangitis Intercept Pharmaceuticals Completed Mixed
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 Mixed Stop: Business
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 · 1 met primary
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 Stop: Business
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 Met primary
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 · 1 missed
— 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 Missed primary
Comparator or background therapy4 trials
Phase 2 NCT00506298 Background Jul 2007 → Apr 2009 type 2 diabetes mellitus Zalicus Completed No outcome recorded
Phase 3 NCT02584504 Background Nov 2015 → Apr 2017 hyperlipoproteinemia Sanofi Completed Met primary
Phase 4 NCT02984982 Background Nov 2016 → Jul 2018 acute coronary syndrome, hyperlipidemia Sanofi Completed Missed primary
— 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 ↗

NCT02984982 ↗

NCT00336167 ↗

NCT04751188 ↗

NCT04594694 ↗

NCT02937012 ↗

NCT00983788 ↗

NCT04997811 ↗

Show 12 more sources

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: oral” NCT02984982 ↗