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EZE/simvastatin
EZE/simvastatin combines ezetimibe (which blocks cholesterol absorption in the intestine) with simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis) for dual lipid-lowering action.
EZE/simvastatin combines ezetimibe (which blocks cholesterol absorption in the intestine) with simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis) for dual lipid-lowering action. Used for Hypercholesterolemia and mixed dyslipidemia.
At a glance
| Generic name | EZE/simvastatin |
|---|---|
| Sponsor | Azienda Ospedaliero Universitaria di Sassari |
| Drug class | Combination lipid-lowering agent (ezetimibe + statin) |
| Target | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Ezetimibe selectively inhibits the Niemann-Pick C1-Like 1 (NPC1L1) transporter in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Together, these complementary mechanisms provide additive LDL-cholesterol reduction beyond either agent alone.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Abdominal pain
Key clinical trials
- Eze/Simva Switch Study in Diabetics (0653A-807) (PHASE3)
- A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121) (PHASE3)
- LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 (PHASE3)
- Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population (PHASE4)
- The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study (PHASE4)
- INdians Followed for INtensive Lipid Lowering Treatment and Its safetY (PHASE3)
- Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy (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:
- EZE/simvastatin CI brief — competitive landscape report
- EZE/simvastatin updates RSS · CI watch RSS
- Azienda Ospedaliero Universitaria di Sassari portfolio CI