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ANTARA® (fenofibrate)
Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol.
Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPARα) to reduce triglycerides and increase HDL cholesterol. Used for Hypertriglyceridemia, Mixed dyslipidemia, Primary hypercholesterolemia.
At a glance
| Generic name | ANTARA® (fenofibrate) |
|---|---|
| Sponsor | Ranbaxy Laboratories Limited |
| Drug class | Fibrate (PPARα agonist) |
| Target | PPARα (Peroxisome proliferator-activated receptor alpha) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Fenofibrate is a fibric acid derivative that acts as a PPARα agonist, enhancing the transcription of genes involved in lipid metabolism. This leads to increased lipolysis and elimination of triglyceride-rich particles from the bloodstream, while simultaneously raising HDL cholesterol levels. It is primarily used to treat dyslipidemia, particularly hypertriglyceridemia and mixed lipid disorders.
Approved indications
- Hypertriglyceridemia
- Mixed dyslipidemia
- Primary hypercholesterolemia
Common side effects
- Elevated liver enzymes (ALT/AST)
- Myalgia
- Abdominal pain
- Headache
- Rash
Key clinical trials
- Fenofibrate Role in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone (VRd) Protocol in the Treatment of Patients With Multiple Myeloma (MM) (PHASE4)
- Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females (PHASE4)
- Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (PHASE3)
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (PHASE3)
- Fenofibrate for Patients With COVID-19 Requiring Hospitalization (PHASE3)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
- Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) (PHASE2)
- Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ANTARA® (fenofibrate) CI brief — competitive landscape report
- ANTARA® (fenofibrate) updates RSS · CI watch RSS
- Ranbaxy Laboratories Limited portfolio CI