Overview
Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia. Fenofibrate was granted FDA approval on 31 December 1993.
Background
Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia. Fenofibrate was granted FDA approval on 31 December 1993.
Indication
Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia.
Associated Conditions
- Mixed Dyslipidemias
- Primary Hypercholesterolemia
- Severe Hypertriglyceridemia (sHTG)
- Severe Fredrickson Type IV Hypertriglyceridemia
- Severe Fredrickson Type V Hypertriglyceridemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/01 | Phase 2 | Recruiting | |||
2025/03/05 | N/A | Recruiting | |||
2025/01/01 | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | ||
2025/01/01 | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | ||
2024/10/02 | Phase 2 | Active, not recruiting | |||
2024/09/19 | Early Phase 1 | Active, not recruiting | Han Ying | ||
2024/06/11 | Phase 4 | Completed | |||
2024/04/15 | Phase 2 | Recruiting | Xijing Hospital of Digestive Diseases | ||
2024/04/04 | Phase 2 | Not yet recruiting | Muhammad Zark | ||
2024/01/05 | Phase 1 | Suspended | Lindsay Ferguson, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Shore Therapeutics, Inc | 52725-495 | ORAL | 120 mg in 1 1 | 11/15/2010 | |
| Amneal Pharmaceuticals NY LLC | 60219-5522 | ORAL | 160 mg in 1 1 | 1/5/2024 | |
| Major Pharmaceuticals | 0904-7480 | ORAL | 145 mg in 1 1 | 4/25/2025 | |
| Proficient Rx LP | 71205-949 | ORAL | 160 mg in 1 1 | 3/1/2022 | |
| Amneal Pharmaceuticals of New York LLC | 0115-0522 | ORAL | 134 mg in 1 1 | 9/7/2022 | |
| LUPIN LIMITED | 57297-361 | ORAL | 145 mg in 1 1 | 5/11/2016 | |
| NuCare Pharmaceuticals,Inc. | 68071-4289 | ORAL | 160 mg in 1 1 | 2/16/2021 | |
| NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8270 | ORAL | 160 mg in 1 1 | 3/8/2019 | |
| Aidarex Pharmaceuticals LLC | 33261-966 | ORAL | 54 mg in 1 1 | 1/1/2014 | |
| ANI Pharmaceuticals, Inc. | 62559-305 | ORAL | 50 mg in 1 1 | 9/23/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/26/2013 | ||
Authorised | 4/14/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AA-FENO MICRO CAPSULE 200 mg | SIN11666P | CAPSULE | 200 mg | 9/19/2001 | |
| TROLIP 300 CAPSULES 300 mg | SIN10668P | CAPSULE | 300 mg | 1/14/1999 | |
| Fenosup Lidose 160mg Capsule | SIN13351P | CAPSULE | 160mg | 9/4/2007 | |
| TROLATE CAPSULE 100mg | SIN16947P | CAPSULE | 100mg | 2/15/2024 | |
| TRICOR TABLET 160 MG | SIN17013P | TABLET, FILM COATED | 160 mg | 5/29/2024 | |
| FENOGAL Lidose 200 mg Capsule | SIN11831P | CAPSULE | 200 mg | 2/28/2002 | |
| TROLIP CAPSULES 100 mg | SIN10669P | CAPSULE | 100 mg | 1/14/1999 | |
| TROLATE CAPSULE 300mg | SIN16946P | CAPSULE | 300mg | 2/15/2024 | |
| LIPANTHYL SUPRA 160 TABLET 160 mg | SIN11612P | TABLET, FILM COATED | 160 mg | 8/7/2001 | |
| LIPANTHYL PENTA FILM COATED TABLET 145 mg | SIN13615P | TABLET, FILM COATED | 145mg | 3/18/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fenofibrate Soft Capsules | 国药准字H20080765 | 化学药品 | 胶囊剂 | 4/28/2023 | |
| Fenofibrate Sustained-release Tablets | 国药准字H20140140 | 化学药品 | 片剂 | 12/3/2019 | |
| Fenofibrate Dispersible Tablets | 国药准字H20168005 | 化学药品 | 片剂 | 7/10/2020 | |
| Fenofibrate Chewable Tablets | 国药准字H20153027 | 化学药品 | 片剂 | 1/15/2020 | |
| Fenofibrate Chewable Tablets | 国药准字H20030773 | 化学药品 | 片剂（咀嚼片） | 12/2/2019 | |
| FENOFIBRATE EXTENDED RELEASE CAPSULES | 国药准字H20094138 | 化学药品 | 胶囊剂 | 7/5/2024 | |
| FENOFIBRATE EXTENDED RELEASE CAPSULES | 国药准字H19990303 | 化学药品 | 胶囊剂（缓释） | 7/4/2024 | |
| Fenofibrate Tablets (III) | 国药准字H20253424 | 化学药品 | 片剂 | 2/20/2025 | |
| Fenofibrate Tablets (III) | 国药准字H20233780 | 化学药品 | 片剂 | 6/27/2023 | |
| Fenofibrate Tablets (III) | 国药准字HJ20171365 | 化学药品 | 片剂 | 12/1/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FECIBRAT TABLETS 145MG | N/A | N/A | N/A | 5/28/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ARX-FENOFIBRATE fenofibrate 145 mg film-coated tablet blister pack | 442671 | Medicine | A | 5/21/2024 | |
| FENOFIBRATE HT fenofibrate 145 mg film-coated tablet blister pack | 338710 | Medicine | A | 7/29/2020 | |
| FENOFIBRATE SUN fenofibrate 145mg film coated tablets blister pack | 233496 | Medicine | A | 2/29/2016 | |
| FENOFIBRATE LUPIN fenofibrate 145 mg film-coated tablet blister pack | 319522 | Medicine | A | 9/18/2023 | |
| BTC FENOFIBRATE fenofibrate 145 mg film-coated tablet blister pack | 406439 | Medicine | A | 7/20/2023 | |
| FENOFIB fenofibrate 145 mg tablet blister pack | 233988 | Medicine | A | 3/30/2016 | |
| FENOFIB fenofibrate 48 mg tablet blister pack | 233989 | Medicine | A | 3/30/2016 | |
| LENOFIL fenofibrate 145 mg film-coated tablets blister pack | 206723 | Medicine | A | 2/19/2014 | |
| FENOFIBRATE CIPLA fenofibrate 145 mg tablet blister pack | 288059 | Medicine | A | 4/30/2018 | |
| FENOFIBRATE GH fenofibrate 145 mg film-coated tablet blister pack | 319525 | Medicine | A | 9/18/2023 |