A Comprehensive Monograph on Fenofibric Acid (DB13873): Pharmacology, Clinical Efficacy, and Safety Profile

Executive Summary

Fenofibric acid (DrugBank ID: DB13873) is the pharmacologically active metabolite of the prodrug fenofibrate and a member of the fibric acid derivative (fibrate) class of antilipemic agents.[1] As a small molecule, it plays a critical role in the management of dyslipidemia, particularly conditions characterized by elevated triglycerides. The primary mechanism of action of fenofibric acid is its function as a potent agonist of the Peroxisome Proliferator-Activated Receptor alpha (PPARα).[1] Activation of this nuclear receptor modulates the transcription of a cascade of genes integral to lipid and lipoprotein metabolism. This results in a comprehensive improvement of the lipid profile, characterized by a substantial reduction in triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (Apo B), coupled with a clinically significant increase in high-density lipoprotein cholesterol (HDL-C).[1]

The principal therapeutic indications for fenofibric acid include severe hypertriglyceridemia (where it is used to reduce the risk of pancreatitis), primary hypercholesterolemia, and mixed dyslipidemia.[1] Its development was driven by the need to overcome the pharmacokinetic limitations of its parent compound, fenofibrate, such as poor bioavailability and a pronounced food effect. Formulations of fenofibric acid, such as choline fenofibrate (Trilipix) and fenofibric acid tablets (Fibricor), offer improved and more consistent absorption.[1] A landmark in its regulatory history is its approval by the U.S. Food and Drug Administration (FDA) for co-administration with HMG-CoA reductase inhibitors (statins), a distinction that sets it apart from other fibrates and positions it as a key agent for managing residual cardiovascular risk in patients with atherogenic dyslipidemia.[9]