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fenofibrate + rosuvastatin
Fenofibrate activates PPAR-alpha to reduce triglycerides and increase HDL, while rosuvastatin inhibits HMG-CoA reductase to lower LDL cholesterol.
Fenofibrate activates PPAR-alpha to reduce triglycerides and increase HDL, while rosuvastatin inhibits HMG-CoA reductase to lower LDL cholesterol. Used for Dyslipidemia with elevated triglycerides and LDL cholesterol, Cardiovascular risk reduction in patients with mixed dyslipidemia.
At a glance
| Generic name | fenofibrate + rosuvastatin |
|---|---|
| Sponsor | University of Campania Luigi Vanvitelli |
| Drug class | Fibrate + HMG-CoA reductase inhibitor (statin) |
| Target | PPAR-α; HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Fenofibrate is a fibrate that acts as a peroxisome proliferator-activated receptor alpha (PPAR-α) agonist, increasing lipolysis and reducing triglyceride-rich lipoprotein production while raising HDL cholesterol. Rosuvastatin is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Together, this combination addresses multiple lipid abnormalities in dyslipidemia.
Approved indications
- Dyslipidemia with elevated triglycerides and LDL cholesterol
- Cardiovascular risk reduction in patients with mixed dyslipidemia
Common side effects
- Myalgia or muscle pain
- Elevated liver enzymes
- Gastrointestinal disturbance
- Headache
- Rhabdomyolysis (rare)
Key clinical trials
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (PHASE3)
- 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)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia (PHASE3)
- Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia (PHASE4)
- Effects of Combined Therapy With Statin Plus Fenofibrate on Coronary Atherosclerotic Plaque Compared With Statin Alone (PHASE4)
- Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy (PHASE4)
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:
- fenofibrate + rosuvastatin CI brief — competitive landscape report
- fenofibrate + rosuvastatin updates RSS · CI watch RSS
- University of Campania Luigi Vanvitelli portfolio CI