MedPath

Fenofibric acid

Generic Name
Fenofibric acid
Brand Names
Fibricor, Trilipix
Drug Type
Small Molecule
Chemical Formula
C17H15ClO4
CAS Number
42017-89-0
Unique Ingredient Identifier
BGF9MN2HU1

Overview

Fenofibric acid is a lipid-lowering agent that is used in severe hypertriglyceridemia, primary hyperlipidemia, and mixed dyslipidemia. It works to decrease elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, apolipoprotein B, while increasing high-density lipoprotein cholesterol. Due to its high hydrophilicity and poor absorption profile, prodrug ,fenofibrate, and other conjugated compounds of fenofibric acid, such as choline fenofibrate, have been developed for improved solubility, gastrointestinal absorption, and bioavailability, and more convenient administration.

Background

Fenofibric acid is a lipid-lowering agent that is used in severe hypertriglyceridemia, primary hyperlipidemia, and mixed dyslipidemia. It works to decrease elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, apolipoprotein B, while increasing high-density lipoprotein cholesterol. Due to its high hydrophilicity and poor absorption profile, prodrug ,fenofibrate, and other conjugated compounds of fenofibric acid, such as choline fenofibrate, have been developed for improved solubility, gastrointestinal absorption, and bioavailability, and more convenient administration.

Indication

For use as an adjunctive therapy to diet to: (a) reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and (b) reduce elevated total cholesterol, low-density-lipoprotein (LDL-C), triglycerides, and apolipoprotein B, and to increase high-density-lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).

Associated Conditions

  • Hypertriglyceridemias
  • Mixed Dyslipidemias
  • Primary Hypercholesterolemia

FDA Approved Products

Fenofibric Acid
Manufacturer:Slate Run Pharmaceuticals, LLC
Route:ORAL
Strength:135 mg in 1 1
Approved: 2023/12/07
NDC:70436-169
Fenofibric Acid
Manufacturer:Palmetto Pharmaceuticals, Inc
Route:ORAL
Strength:105 mg in 1 1
Approved: 2021/01/18
NDC:68134-602
FIBRICOR
Manufacturer:Aralez Pharmaceuticals US Inc.
Route:ORAL
Strength:105 mg in 1 1
Approved: 2017/08/03
NDC:70347-105
Fenofibric Acid
Manufacturer:Alembic Pharmaceuticals Limited
Route:ORAL
Strength:135 mg in 1 1
Approved: 2023/01/30
NDC:46708-245
Fenofibric Acid
Manufacturer:Alembic Pharmaceuticals Inc.
Route:ORAL
Strength:135 mg in 1 1
Approved: 2021/09/30
NDC:62332-245

Singapore Approved Products

Trilipix Modified Release Capsules 45mg
Manufacturer:Fournier Laboratories Ireland Limited, Mylan Laboratories SAS
Form:CAPSULE, DELAYED RELEASE PELLETS
Strength:45mg
Online:Yes
Approved: 2013/07/03
Approval:SIN14375P
Trilipix Modified Release Capsules 135mg
Manufacturer:Fournier Laboratories Ireland Limited, Mylan Laboratories SAS
Form:CAPSULE, DELAYED RELEASE PELLETS
Strength:135mg
Online:Yes
Approved: 2013/07/03
Approval:SIN14376P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath