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.
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 |
|---|---|---|---|---|---|
2025/08/05 | Not Applicable | Recruiting | Xijing Hospital of Digestive Diseases | ||
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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PMS-FENOFIBRATE SUPRA | 02251736 | Tablet - Oral | 160 MG | N/A | |
| FENOMAX | 02250004 | Capsule - Oral | 160 MG | 11/14/2006 | |
| LIPIDIL EZ | BGP Pharma ULC | 02269074 | Tablet - Oral | 48 MG | 7/26/2005 |
| LIPIDIL CAP 100MG | laboratoires fournier s.a.s. | 00885827 | Capsule - Oral | 100 MG / CAP | 12/31/1990 |
| PRO-FENO-SUPER - 160 | PRO DOC LIMITEE | 02310236 | Tablet - Oral | 160 MG | 7/10/2008 |
| Q-FENOFIBRATE MICRO | qd pharmaceuticals ulc | 02371405 | Capsule - Oral | 200 MG | 5/29/2012 |
| AA-FENO-MICRO | aa pharma inc | 02243180 | Capsule - Oral | 67 MG | 2/21/2001 |
| AA-FENO-MICRO | aa pharma inc | 02239864 | Capsule - Oral | 200 MG | 3/29/1999 |
| DOM-FENOFIBRATE MICRO | dominion pharmacal | 02240337 | Capsule - Oral | 200 MG | 12/16/1999 |
| PMS-FENOFIBRATE MICRO | 02231780 | Capsule - Oral | 200 MG | 4/19/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FENOFIBRATO TEVA 160 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 72706 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| FENOFIBRATO PENSA PHARMA 145 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 86797 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| Cholib 145 mg/40 mg comprimidos recubiertos con pelicula | 113866004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| PRAVAFENIX 40 MG/160 MG CAPSULAS DURAS | Laboratoires S.M.B. S.A. | 11679004IP | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| PRAVAFENIX 40 MG/160 MG CAPSULAS DURAS | Laboratoires S.M.B. S.A. | 11679004IP2 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| FENOFIBRATO PENSA 160 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 72535 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| Cholib 145 mg/20 mg comprimidos recubiertos con pelicula | 113866002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| FENOFIBRATO PENSA 200 mg CAPSULAS DURAS EFG | Towa Pharmaceutical S.A. | 69368 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| FENOFIBRATO SUN 200 mg CAPSULAS DURAS EFG | 69369 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| FENOFIBRATO TEVA 200 mg CAPSULAS DURAS EFG | Teva Pharma S.L.U. | 72705 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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