Clinical Trials

Numerous Phase II, Phase III, and Phase IV clinical trials evaluate bezafibrate for diverse metabolic, cardiovascular, and hepatobiliary disorders, including primary biliary cholangitis, primary sclerosing cholangitis, acute myocardial infarction, hypercholesterolemia, mitochondrial diseases, and X-linked adrenoleukodystrophy. Backed by institutional and industry sponsors such as Assistance Publique - Hôpitaux de Paris, Sanofi, and Intercept Pharmaceuticals, these protocols encompass completed, actively recruiting, and terminated studies. Notably, several completed trials assess therapeutic responses in cholestatic liver conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06443606 RECRUITING
BPC; Non Optimal Response to UDCA
Assistance Publique - Hôpitaux de Paris
 2025-03-27 PHASE3
NCT02481245 COMPLETED
Bipolar Disorder; Depressive Episode
Massachusetts General Hospital
 2018-01-11 PHASE2
NCT06488911 TERMINATED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2024-07-01 PHASE3
NCT04594694 TERMINATED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2019-10-02 PHASE2
NCT05239468 COMPLETED
Primary Biliary Cholangitis
Intercept Pharmaceuticals
 2022-03-21 PHASE2
NCT04997811 UNKNOWN
Myelodysplastic Syndromes (MDS)
Prof. Janet Dunn
 2021-12-21 PHASE2
NCT04309773 UNKNOWN
Primary Sclerosing Cholangitis; Cholestasis
Assistance Publique - Hôpitaux de Paris
 2021-04-06 PHASE3
NCT04751188 UNKNOWN
Primary Biliary Cirrhosis
Instituto Mexicano del Seguro Social
 2020-10-02 PHASE3
NCT02548832 COMPLETED
Mixed Dyslipidemia
University of Guadalajara
 2013-04 PHASE3
NCT02937012 UNKNOWN
Primary Biliary Cirrhosis
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-10 PHASE3
NCT02984982 COMPLETED
Hypercholesterolemia; Acute Coronary Syndrome
Sanofi
 2016-11-15 PHASE4
NCT02701166 UNKNOWN
Primary Biliary Cholangitis; Primary Sclerosing Cholangitis; Secondary Sclerosing Cholangitis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2016-02 PHASE3
NCT02398201 COMPLETED
Mitochondrial Diseases
Newcastle-upon-Tyne Hospitals NHS Trust
 2015-09 PHASE2
NCT01654731 COMPLETED
PBC
Assistance Publique - Hôpitaux de Paris
 2012-10-15 PHASE3
NCT03649269 COMPLETED
Hypertriglyceridemia
Ciprés Grupo Médico CGM SC
 2014-01-01
NCT02291796 COMPLETED
Acute Myocardial Infarction
Instituto Mexicano del Seguro Social
 2011-01 PHASE4
NCT00983788 COMPLETED
Carnitine Palmitoyltransferase II Deficiency; Very Long Chain Acyl Coa Dehydrogenase Deficiency
Rigshospitalet, Denmark
 2009-10 PHASE2
NCT01165060 COMPLETED
X-linked Adrenoleukodystrophy; Adrenomyeloneuropathy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2010-07
NCT02291796 Completed
Acute Myocardial Infarction
Instituto Mexicano del Seguro Social
 2011-01 Phase 4
NCT00506298 COMPLETED
Type 2 Diabetes
Zalicus
 2007-07 PHASE2
NCT00336167 UNKNOWN
Carnitine Palmitoyl Transferase 2 Deficiency
Assistance Publique - Hôpitaux de Paris
 2006-06 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-08-27)

Check the Bezafibrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bezafibrate functions as a pan-peroxisome proliferator-activated receptor (PPAR) agonist that binds and activates PPAR-alpha, PPAR-delta, and PPAR-gamma nuclear receptors, thereby stimulating downstream transcriptional programs governing fatty acid oxidation and lipid transport. This modulation enhances hepatic lipid clearance and dampens pro-inflammatory signaling pathways, providing clinical utility in ameliorating dyslipidemia and cholestatic liver damage in conditions like primary biliary cholangitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.