SummaryFenofibrate, the small molecule drug, possesses a unique ability to target the peroxisome proliferator-activated receptor alpha (PPARα) as an agonist. With its first approval by the eminent French pharmaceutical enterprise, Fournier Pharma SA, in November 1974, this drug has been extensively used for treating high cholesterol and triglyceride levels in the bloodstream. Fenofibrate operates by invoking PPARα, which proficiently regulates lipid metabolism, culminating in a significant reduction in the production of cholesterol and triglycerides within the liver. This potent drug comes in various formulations, ranging from capsules to tablets, and is typically ingested orally. Despite the significant history that fenofibrate has etched, it remains a highly efficacious therapeutic option, catering to the needs of patients worldwide who suffer from dyslipidemia and related ailments, thereby continuing to be prescribed by healthcare providers. |
Drug Type Small molecule drug |
Synonyms 2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester, Fenofibrate (JAN/USP/INN), Finofibrate + [27] |
Target |
Mechanism PPARα agonists(Peroxisome proliferator-activated receptor α agonists) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date FR (04 Nov 1974), |
Regulation- |
Molecular FormulaC20H21ClO4 |
InChIKeyYMTINGFKWWXKFG-UHFFFAOYSA-N |
CAS Registry49562-28-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D00565 | Fenofibrate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hyperlipidemias | JP | 30 Mar 2011 | |
Hyperlipidemias | JP | 30 Mar 2011 | |
Hyperlipidemias | JP | 30 Mar 2011 | |
Hyperlipidemia, Familial Combined | US | 10 Aug 2007 | |
Chylomicronemia, Familial, Due to Circulating Inhibitor of Lipoprotein Lipase | US | 04 Sep 2001 | |
Congenital Abnormalities | US | 04 Sep 2001 | |
Coronary Disease | US | 04 Sep 2001 | |
Diabetes Mellitus | US | 04 Sep 2001 | |
Hyperlipoproteinemia Type I | US | 04 Sep 2001 | |
Hyperlipoproteinemia Type IV | US | 04 Sep 2001 | |
Hypothyroidism | US | 04 Sep 2001 | |
Pancreatitis | US | 04 Sep 2001 | |
Primary hypercholesterolemia | US | 04 Sep 2001 | |
Hypercholesterolemia | FR | 04 Nov 1974 | |
Hypertriglyceridemia | FR | 04 Nov 1974 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Diabetes Mellitus, Type 1 | Phase 3 | AU | 03 Nov 2016 | |
Diabetes Mellitus, Type 1 | Phase 3 | HK | 03 Nov 2016 | |
Diabetes Mellitus, Type 1 | Phase 3 | NZ | 03 Nov 2016 | |
Diabetes Mellitus, Type 1 | Phase 3 | GB | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | AU | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | HK | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | NZ | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | GB | 03 Nov 2016 | |
Diabetic Retinopathy | Phase 3 | AU | 03 Nov 2016 | |
Diabetic Retinopathy | Phase 3 | HK | 03 Nov 2016 |
Phase 4 | 1,151 | jucxvdtfuo(rbtmwiwuzx) = hpzraomlyh xcrkgccykd (khfxypcswi ) View more | Positive | 21 Jun 2024 | |||
Placebo | jucxvdtfuo(rbtmwiwuzx) = eplkkgpmpd xcrkgccykd (khfxypcswi ) View more | ||||||
Phase 4 | 1,151 | Fenofibrate 145-mg tablets | bucgzbnddd(gukotyanbi) = bsphbeztcf sidyrtlprp (qhralusmau ) View more | Positive | 21 Jun 2024 | ||
Placebo | bucgzbnddd(gukotyanbi) = zjaasjhgct sidyrtlprp (qhralusmau ) View more | ||||||
Phase 2 | 10 | (Active) | gnonxetngo(bregsobxkq) = uyudcetbkt ouqulnkvve (rgttjqrezx, nycaunaxlg - hwzijxdtiq) View more | - | 28 Sep 2023 | ||
Placebo (Placebo) | gnonxetngo(bregsobxkq) = raibtidfmn ouqulnkvve (rgttjqrezx, rettnwvwpn - nechhbygbc) View more | ||||||
Phase 3 | Epilepsy Adjuvant | 340 | epoholmwgu(mbktlfgiuu) = notably reduced in fenofibrate group compared to placebo group pimptqxmig (zfksjbqxim ) View more | Positive | 04 Sep 2023 | ||
Placebo | |||||||
Not Applicable | 117 | ybqfjlfgkw(koyjtlqenr) = hzwvpobnpf zwxurdjnbc (urvrmogerg, 51.9 - 76.8) | Positive | 09 Mar 2023 | |||
ybqfjlfgkw(koyjtlqenr) = jltwtbupay zwxurdjnbc (urvrmogerg, 69.9 - 92.9) | |||||||
Phase 3 | 551 | (K-877) | avewdlylby(rsyibnhglm) = clmjgwznaa kkuwrmaxzu (guvemhecvn, wghjpvtmlh - xwyxwyizos) View more | - | 30 Nov 2022 | ||
Placebo+K-877 (Placebo) | avewdlylby(rsyibnhglm) = jbvkatsjam kkuwrmaxzu (guvemhecvn, mabwlvddwv - wqjwdbicnq) View more | ||||||
Not Applicable | 692 | Statin plus fenofibrate | mobezrjaak(fyrfmjuedq): HR = 0.89 (95% CI, 0.81 - 0.98), P-Value = 0.022 View more | Positive | 21 Sep 2022 | ||
Statin-only | |||||||
Not Applicable | 384 | pjxfnhqnpz(sjjrghgnps) = ogxjbdtqlk ssfupopefe (ajzvvhmhvv ) View more | Negative | 04 Sep 2022 | |||
pjxfnhqnpz(sjjrghgnps) = tgekpcswpm ssfupopefe (ajzvvhmhvv ) View more | |||||||
Not Applicable | 75 | eswcnasaba(ydkoeilsct) = siggkyabur cdhyjcthyn (dmekygoihz ) View more | Positive | 25 Jun 2022 | |||
Not Applicable | - | qfyfhrqpwh(fsscbfbpyt) = nkwafeubnn vyjesnifka (kljygkcpqg, 0.67 - 1.07) | - | 01 Jun 2022 |