Overview
Fenofibric acid is a lipid-lowering agent that is used in severe hypertriglyceridemia, primary hyperlipidemia, and mixed dyslipidemia. It works to decrease elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, apolipoprotein B, while increasing high-density lipoprotein cholesterol. Due to its high hydrophilicity and poor absorption profile, prodrug ,fenofibrate, and other conjugated compounds of fenofibric acid, such as choline fenofibrate, have been developed for improved solubility, gastrointestinal absorption, and bioavailability, and more convenient administration.
Indication
For use as an adjunctive therapy to diet to: (a) reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and (b) reduce elevated total cholesterol, low-density-lipoprotein (LDL-C), triglycerides, and apolipoprotein B, and to increase high-density-lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).
Associated Conditions
- Hypertriglyceridemias
- Mixed Dyslipidemias
- Primary Hypercholesterolemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/04/21 | Phase 1 | Completed | |||
2011/12/29 | Phase 1 | Completed | |||
2011/05/19 | Phase 2 | Recruiting | |||
2009/12/11 | Phase 3 | Withdrawn | |||
2009/12/03 | Phase 4 | Terminated | |||
2009/08/18 | Phase 1 | Completed | |||
2009/02/09 | Phase 1 | Completed | |||
2009/01/22 | Phase 1 | Completed | |||
2008/12/16 | Phase 1 | Completed | |||
2008/08/06 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Alembic Pharmaceuticals Limited | 46708-245 | ORAL | 135 mg in 1 1 | 1/30/2023 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1459 | ORAL | 45 mg in 1 1 | 11/10/2023 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1554 | ORAL | 45 mg in 1 1 | 11/10/2023 | |
| AR Scientific, Inc. | 13310-102 | ORAL | 105 mg in 1 1 | 10/31/2012 | |
| Graviti Pharmaceuticals Private Limited | 69844-022 | ORAL | 45 mg in 1 1 | 12/5/2022 | |
| Aurobindo Pharma Limited | 59651-217 | ORAL | 135 mg in 1 1 | 6/23/2021 | |
| Tribute Pharmaceuticals US, Inc. | 69916-035 | ORAL | 35 mg in 1 1 | 1/8/2016 | |
| Halton Laboratories | 69973-035 | ORAL | 35 mg in 1 1 | 1/5/2017 | |
| Laurus Labs Limited | 42385-944 | ORAL | 45 mg in 1 1 | 12/28/2022 | |
| AbbVie Inc. | 0074-3162 | ORAL | 135 mg in 1 1 | 11/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Trilipix Modified Release Capsules 45mg | SIN14375P | CAPSULE, DELAYED RELEASE PELLETS | 45mg | 7/3/2013 | |
| Trilipix Modified Release Capsules 135mg | SIN14376P | CAPSULE, DELAYED RELEASE PELLETS | 135mg | 7/3/2013 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.