Last reviewed · How we verify
Rosuvastatin and fenofibrate
This combination reduces cholesterol and triglycerides by inhibiting HMG-CoA reductase (rosuvastatin) and activating peroxisome proliferator-activated receptors (fenofibrate).
This combination reduces cholesterol and triglycerides by inhibiting HMG-CoA reductase (rosuvastatin) and activating peroxisome proliferator-activated receptors (fenofibrate). Used for Dyslipidemia with elevated cholesterol and triglycerides, Cardiovascular risk reduction in patients requiring dual lipid-lowering therapy.
At a glance
| Generic name | Rosuvastatin and fenofibrate |
|---|---|
| Also known as | Combination therapy with rosuvastatin and fenofibrate |
| Sponsor | Gachon University Gil Medical Center |
| Drug class | Statin and fibrate combination |
| Target | HMG-CoA reductase (rosuvastatin); PPAR-α (fenofibrate) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Rosuvastatin is a statin that blocks HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby lowering LDL cholesterol and triglycerides. Fenofibrate is a fibrate that activates PPAR-α, increasing lipolysis and reducing triglyceride-rich lipoprotein production while raising HDL cholesterol. Together, they provide complementary lipid-lowering effects targeting multiple pathways.
Approved indications
- Dyslipidemia with elevated cholesterol and triglycerides
- Cardiovascular risk reduction in patients requiring dual lipid-lowering therapy
Common side effects
- Myalgia or muscle pain
- Elevated liver enzymes
- Gastrointestinal disturbance
- 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)
- Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia (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:
- Rosuvastatin and fenofibrate CI brief — competitive landscape report
- Rosuvastatin and fenofibrate updates RSS · CI watch RSS
- Gachon University Gil Medical Center portfolio CI