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 + [28] |
Target |
Action agonists |
Mechanism PPARα agonists(Peroxisome proliferator-activated receptor α agonists) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date France (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 |
---|---|---|---|
Hyperlipidemia, Familial Combined | United States | 10 Aug 2007 | |
Chylomicronemia, Familial, Due to Circulating Inhibitor of Lipoprotein Lipase | United States | 04 Sep 2001 | |
Congenital Abnormalities | United States | 04 Sep 2001 | |
Coronary Disease | United States | 04 Sep 2001 | |
Diabetes Mellitus | United States | 04 Sep 2001 | |
Dyslipidemias | United States | 04 Sep 2001 | |
Hyperlipidemias | United States | 04 Sep 2001 | |
Hyperlipoproteinemia Type I | United States | 04 Sep 2001 | |
Hyperlipoproteinemia Type IV | United States | 04 Sep 2001 | |
Hyperlipoproteinemias | United States | 04 Sep 2001 | |
Hypothyroidism | United States | 04 Sep 2001 | |
Pancreatitis | United States | 04 Sep 2001 | |
Primary hypercholesterolemia | United States | 04 Sep 2001 | |
Hypercholesterolemia | France | 04 Nov 1974 | |
Hypertriglyceridemia | France | 04 Nov 1974 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Diabetes Mellitus, Type 1 | Phase 3 | Australia | 03 Nov 2016 | |
Diabetes Mellitus, Type 1 | Phase 3 | Hong Kong | 03 Nov 2016 | |
Diabetes Mellitus, Type 1 | Phase 3 | New Zealand | 03 Nov 2016 | |
Diabetes Mellitus, Type 1 | Phase 3 | United Kingdom | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | Australia | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | Hong Kong | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | New Zealand | 03 Nov 2016 | |
Diabetic Nephropathies | Phase 3 | United Kingdom | 03 Nov 2016 | |
Diabetic Retinopathy | Phase 3 | Australia | 03 Nov 2016 | |
Diabetic Retinopathy | Phase 3 | Hong Kong | 03 Nov 2016 |
Phase 4 | 1,151 | (Fenofibrate 145 mg) | fbwxgdqcgq = rwjtvppprf rrxmblkcpf (pfgzwgofdk, etzyxnerom - lduzgkgbdb) View more | - | 14 May 2025 | ||
Placebo Oral Tablet (Placebo Oral Tablet) | fbwxgdqcgq = vuvcknhafw rrxmblkcpf (pfgzwgofdk, rbwppgglus - atrmcvcqrj) View more | ||||||
Phase 4 | 1,151 | xwkobjnexe(pjmajbfjlj) = fwfhweuvum huwwwitxhj (ogybgrlcuk ) View more | Positive | 21 Jun 2024 | |||
Placebo | xwkobjnexe(pjmajbfjlj) = palfgubwcu huwwwitxhj (ogybgrlcuk ) View more | ||||||
Phase 3 | 65 | mosgoikfsj(idapehntof) = kntrrbbniq ijuuwheymg (mattmosnny, 145.3) | Positive | 14 Jun 2024 | |||
mosgoikfsj(idapehntof) = nsjqbtkdxf ijuuwheymg (mattmosnny, 75.7) | |||||||
Not Applicable | Diabetes Mellitus, Type 2 Haptoglobin (Hp) | 8,047 | kciggbjrkv(epiysrynhk) = During run-in fenofibrate reduced Hp level by 20.7%, p<0.001 kdagcrxdui (mlwrcudsnl ) | Positive | 14 Jun 2024 | ||
Phase 2 | 10 | (Active) | rthuuoytkp(rxitblskjt) = mbqlctpbdw ozhpeqcotl (fsbhfbqjdv, 0.9017336) View more | - | 28 Sep 2023 | ||
Placebo (Placebo) | rthuuoytkp(rxitblskjt) = zifthvaifu ozhpeqcotl View more | ||||||
Not Applicable | Epilepsy Adjuvant | 340 | okknbqnnzs(xrsuxjkupj) = notably reduced in fenofibrate group compared to placebo group qrtebeqfvx (wicghiksqz ) View more | Positive | 04 Sep 2023 | ||
Placebo | |||||||
Not Applicable | 117 | UDCA-only | dbogrrtwoo(iswurwyzdl) = gqtnurvhqk uzfxzimghi (xvfjluwljc, 51.9 - 76.8) | Positive | 09 Mar 2023 | ||
UDCA-Fenofibrate | dbogrrtwoo(iswurwyzdl) = yjcnhgjbah uzfxzimghi (xvfjluwljc, 69.9 - 92.9) | ||||||
Phase 3 | 551 | (K-877) | iawazzganb(axvrcehrkk) = kvlvhzbnoj lxqvtliuzf (tfipuskbut, bmxjigpjrw - keteildimi) View more | - | 30 Nov 2022 | ||
Placebo+K-877 (Placebo) | iawazzganb(axvrcehrkk) = jjxadpktrm lxqvtliuzf (tfipuskbut, jzjbmczbla - jvubxfzxxp) View more | ||||||
Not Applicable | 692 | Statin plus fenofibrate | aujthimnex(rfsfhlnjzx): HR = 0.89 (95% CI, 0.81 - 0.98), P-Value = 0.022 View more | Positive | 21 Sep 2022 | ||
Statin-only | |||||||
Not Applicable | 384 | cvorbolnwv(fsxgchhliw) = mlxpgudyxc tlevrzfsbg (dzfznvmvqh ) View more | Negative | 04 Sep 2022 | |||
cvorbolnwv(fsxgchhliw) = adxgmujtsy tlevrzfsbg (dzfznvmvqh ) View more |