FENOFIBRIC ACID (choline fenofibrate) · MACLEODS PHARMS LTD
Fenofibric acid helps adults manage lipid levels when used alongside a healthy diet. It treats severe hypertriglyceridemia in patients with triglyceride levels of 500 mg/dL or higher. Additionally, it is used for patients with primary hyperlipidemia to lower elevated LDL cholesterol when standard recommended therapies are not an option.
How FENOFIBRIC ACID Works
This drug works by activating the PPAR alpha receptor, which triggers the breakdown and removal of triglyceride-rich particles from the plasma. This process occurs because the drug activates lipoprotein lipase and reduces the production of apoprotein C-III, a protein that usually inhibits lipid clearance.
Details
- Status
- Discontinued
- First Approved
- 2013-03-25
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
Companies
FENOFIBRIC ACID Approval History
What FENOFIBRIC ACID Treats
2 indicationsFENOFIBRIC ACID is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertriglyceridemia
- Hyperlipidemia
FENOFIBRIC ACID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05365425 | B-2111-720-003 | Ph 4 | recruiting | Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia |
| NCT01356290 MEMMAT | MUV-MEMMAT-01 | Ph 2 | recruiting | Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors |
| NCT01501435 | CJ_FEN_101 | Ph 1 | completed | To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra |
| NCT00960570 results posted | MPC-028-08-1018 R08-0056 | Ph 1 | completed | Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz |
| NCT00683176 | S348.2.001 2008-001064-37 | Ph 2 | completed | Effect of Choline Fenofibrate (SLV348) on Macular Edema |
| NCT00673881 results posted | ABT-335-001 | Ph 1, Ph 2 | completed | ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FENOFIBRIC ACID FDA Label Details
Indications & Usage
FDA Label (PDF)Fenofibric acid delayed-release capsules indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use • Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Pr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.