High Quality EP Standard Pharmaceutical API White Powder Fenofibrate CAS 49562-28-9

Fenofibrate More Info

Fenofibrate is a lipid-modifying agent primarily used to treat hypercholesterolemia, mixed dyslipidemia, and severe hypertriglyceridemia by targeting lipid metabolism pathways.

Mechanism of Action

Fenofibrate is a prodrug that, after oral administration, is converted to its active metabolite fenofibric acid. It acts as a potent agonist of the nuclear receptor peroxisome proliferator-activated receptor alpha (PPARα). Activation of PPARα leads to:
Increased lipolysis through activation of lipoprotein lipase, enhancing the breakdown of triglyceride-rich lipoproteins.
Reduced production of apoprotein C-III, an inhibitor of lipoprotein lipase, further promoting triglyceride clearance.
Enhanced hepatic uptake of fatty acids and increased β-oxidation, reducing triglyceride synthesis.
Increased synthesis of apolipoproteins A-I and A-II, which raise high-density lipoprotein cholesterol (HDL-C) levels.
Alteration of low-density lipoprotein (LDL) particles from small, dense, atherogenic forms to larger, more easily cleared particles.
Reduction of serum uric acid levels by increasing its renal excretion.
These effects collectively lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides while increasing HDL cholesterol, improving lipid profiles and potentially reducing cardiovascular risk.

Applications

Treatment of primary hypercholesterolemia and mixed dyslipidemia.
Management of severe hypertriglyceridemia to reduce the risk of pancreatitis.
Adjunct to diet and lifestyle changes to improve lipid parameters.
Sometimes used to reduce serum uric acid in hyperuricemic patients.
Although fenofibrate improves lipid profiles, it has not been definitively shown to reduce the incidence of heart attacks or strokes.

Routes of Administration

Oral: Fenofibrate is administered orally in tablet or capsule form. Doses typically range from 50 mg to 150 mg once daily depending on the formulation and indication.
Bioavailability is enhanced when taken with food due to fenofibrate’s poor water solubility.

Pharmacokinetics

Absorption: Fenofibrate is well absorbed from the gastrointestinal tract after oral administration, with peak plasma levels of fenofibric acid (active metabolite) reached approximately 3 to 6 hours post-dose.
Distribution: Volume of distribution ranges from about 0.89 L/kg to as high as 60 L; fenofibrate is highly protein-bound (~99%), primarily to albumin.
Metabolism: Fenofibrate is rapidly hydrolyzed by liver carboxylesterase 1 to fenofibric acid, which undergoes glucuronidation (mainly via UGT1A9) and reduction pathways.
Elimination: Mainly excreted via urine (as fenofibric acid and metabolites) and feces.
Half-life: Approximately 19 to 27 hours, supporting once-daily dosing.

Safety and Side Effects

Common Side Effects: Elevated liver enzymes (AST, ALT), gastrointestinal symptoms, headache, rhinitis, muscle pain, and increased creatine phosphokinase (CPK).
Serious Side Effects:
Rhabdomyolysis (muscle breakdown), which can lead to renal failure.
Myopathy and muscle pain or weakness.
Cholelithiasis (gallstones).
Hepatitis and, rarely, severe liver injury including cirrhosis.
Allergic reactions ranging from mild rash to severe hypersensitivity.
Respiratory issues such as bronchitis and rare interstitial lung disease.
Warnings: Patients should be monitored for liver function tests and muscle symptoms, especially when used with statins or other drugs with myopathy risk.
Precautions: Use cautiously in patients with preexisting liver or kidney disease. Avoid in severe hepatic impairment.
Pregnancy and Lactation: Safety not well established; use only if clearly needed.

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FAQ

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Company Profile

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