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Ezetimibe 10/Simvastatin 20
This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin).
This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin). Used for Hypercholesterolemia and mixed dyslipidemia.
At a glance
| Generic name | Ezetimibe 10/Simvastatin 20 |
|---|---|
| Also known as | Inegy 10/20 |
| Sponsor | University Hospital Freiburg |
| Drug class | Combination lipid-lowering agent (ezetimibe/statin) |
| Target | NPC1L1 (ezetimibe); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Ezetimibe selectively inhibits Niemann-Pick C1-like 1 (NPC1L1) protein in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin is an HMG-CoA reductase inhibitor that decreases hepatic cholesterol synthesis. Together, they provide complementary mechanisms to lower LDL cholesterol and reduce cardiovascular risk.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Abdominal pain
- Rhabdomyolysis (rare)
Key clinical trials
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED) (PHASE3)
- Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377) (PHASE4)
- Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435) (PHASE4)
- A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED) (PHASE3)
- Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476) (PHASE4)
- Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED) (PHASE3)
- Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801) (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:
- Ezetimibe 10/Simvastatin 20 CI brief — competitive landscape report
- Ezetimibe 10/Simvastatin 20 updates RSS · CI watch RSS
- University Hospital Freiburg portfolio CI