Bezafibrate

Generic Name: Bezafibrate

Brand Names: Bezalip

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₀ClNO_₄

CAS Number: 41859-67-0

Unique Ingredient Identifier: Y9449Q51XH

Background: Antilipemic agent that lowers cholesterol and triglycerides. It decreases low density lipoproteins and increases high density lipoproteins.

Indication: For the treatment of primary hyperlipidaemia types IIa, IIb, III, IV and V (Fredrickson classification) corresponding to groups I, II and III of the European Atherosclerosis Society guidelines - when diet alone or improvements in lifestyle such as increased exercise or weight reduction do not lead to an adequate response. Also for the treatment of secondary hyperlipidaemias, e.g. severe hypertriglyceridemias, when sufficient improvement does not occur after correction of the underlying disorder (e.g. diabetes mellitus).

Associated Conditions: Fredrickson classification type IV Hyperlipidemia, Fredrickson classification type V Hyperlipidemia, Primary Hypercholesterolemia, Type IIb hyperlipoproteinaemia

Clinical Trials

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Not yet recruiting

Conditions: Atherosclerotic Cardiovascular Disease

Interventions: Drug: Atorvastatin
Drug: Simvastatin
Drug: Rozuvastatin
Drug: Ezetimibe
Drug: Niacin
Drug: Ciprofibrate
Drug: Fenofibrate
Drug: Bezafibrate
Drug: Evolocumab
Drug: Alirocumab
Drug: Inclisiran

First Posted Date: 2025-03-05

Last Posted Date: 2025-03-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 2382

Registration Number: NCT06858332

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

Phase 3

Not yet recruiting

Conditions: Non Optimal Response to UDCA
BPC

Interventions: Drug: Bezafibrate 200 mg in addition to UDCA therapy
Drug: Bezafibrate 400 mg in addition to UDCA therapy
Drug: Placebo in addition to UDCA therapy

First Posted Date: 2024-06-05

Last Posted Date: 2024-06-05

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 108

Registration Number: NCT06443606

Locations: 🇫🇷
Hepatology department - Hospital Saint Antoine, Paris, France

Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

Phase 2

Active, not recruiting

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Bezafibrate 200 mg
Drug: Bezafibrate 100 mg
Drug: Obeticholic Acid placebo
Drug: Obeticholic Acid 5 mg
Drug: Bezafibrate Placebo

First Posted Date: 2022-02-15

Last Posted Date: 2025-01-23

Lead Sponsor: Intercept Pharmaceuticals

Target Recruit Count: 60

Registration Number: NCT05239468

Locations: 🇺🇸
Methodist Clinical Research Institute (CRI), Dallas, Texas, United States
🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
🇺🇸
Beth Israel Deaconess Medical Center Harvard Liver Research Center, Boston, Massachusetts, United States

and more 14 locations

A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Bezafibrate 200 MG Oral Tablet
Drug: Placebo
Drug: Ursodeoxycholic Acid

First Posted Date: 2021-02-12

Last Posted Date: 2021-02-12

Lead Sponsor: Instituto Mexicano del Seguro Social

Target Recruit Count: 11

Registration Number: NCT04751188

Locations: 🇲🇽
Instituto Mexicano de Seguro Social, Puebla, Mexico

Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC

Phase 2

Active, not recruiting

Conditions: Primary Biliary Cholangitis

Interventions: Drug: Obeticholic acid
Drug: OCA
Drug: Bezafibrate 200 MG
Drug: OCA Placebo
Drug: Bezafibrate 200 mg Placebo
Drug: Bezafibrate
Drug: Bezafibrate 400 MG
Drug: Bezafibrate 400 mg Placebo

First Posted Date: 2020-10-20

Last Posted Date: 2024-11-04

Lead Sponsor: Intercept Pharmaceuticals

Target Recruit Count: 72

Registration Number: NCT04594694

Locations: 🇬🇷
Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa, Larissa, Greece
🇫🇷
Hôpital Henri Mondor, Créteil, France
🇩🇪
Medizinische Hochschule Hannover, Hannover, Germany

and more 30 locations

Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

Phase 3

Recruiting

Conditions: Cholestasis
Primary Sclerosing Cholangitis

Interventions: Drug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy
Drug: Placebo of Bezafibrate in addition to standard UDCA therapy

First Posted Date: 2020-03-16

Last Posted Date: 2022-05-10

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 104

Registration Number: NCT04309773

Locations: 🇫🇷
Hepatology department - Hopital Saint Antoine, Paris, France

PC-300 Tea Effect on Triglyceride Levels

Not Applicable

Completed

Conditions: Hypertriglyceridemia

Interventions: Dietary Supplement: PC-300 tea.
Drug: Bezafibrate

First Posted Date: 2018-08-28

Last Posted Date: 2018-08-28

Lead Sponsor: Ciprés Grupo Médico CGM SC

Target Recruit Count: 34

Registration Number: NCT03649269

Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Phase 4

Completed

Conditions: Hypercholesterolemia
Acute Coronary Syndrome

Interventions: Drug: Alirocumab SAR236553
Drug: Atorvastatin
Drug: Fenofibrate
Drug: Rosuvastatin
Drug: Bezafibrate
Drug: Ezetimibe
Drug: Antiplatelets
Drug: Anticoagulants

First Posted Date: 2016-12-07

Last Posted Date: 2019-09-09

Lead Sponsor: Sanofi

Target Recruit Count: 206

Registration Number: NCT02984982

Locations: 🇯🇵
Investigational Site Number 392008, Gifu-shi, Japan
🇯🇵
Investigational Site Number 392022, Chiyoda-ku, Japan
🇯🇵
Investigational Site Number 392039, Hiroshima-shi, Japan

and more 36 locations

Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Bezafibrate
Drug: Placebo (for Bezafibrate)
Drug: Ursodeoxycholic Acid

First Posted Date: 2016-10-18

Last Posted Date: 2018-04-23

Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Target Recruit Count: 34

Registration Number: NCT02937012

Locations: 🇲🇽
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico

The Effect of Bezafibrate on Cholestatic Itch

Phase 3

Conditions: Primary Sclerosing Cholangitis
Secondary Sclerosing Cholangitis
Primary Biliary Cholangitis

Interventions: Drug: Bezafibrate
Drug: Placebo

First Posted Date: 2016-03-08

Last Posted Date: 2016-03-08

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 84

Registration Number: NCT02701166

Locations: 🇳🇱
Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands
🇳🇱
Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
🇳🇱
Universitair Medisch Centrum Utrecht, Utrecht, Netherlands

and more 6 locations

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