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Ezetimibe and Simvastatin
Ezetimibe and Simvastatin is a Combination lipid-lowering agent (ezetimibe + statin) Small molecule drug developed by University of Texas Southwestern Medical Center. It is currently FDA-approved for Hypercholesterolemia and mixed dyslipidemia, Cardiovascular disease risk reduction.
Ezetimibe and simvastatin work together to lower cholesterol by blocking intestinal cholesterol absorption and inhibiting hepatic cholesterol synthesis.
Ezetimibe and simvastatin work together to lower cholesterol by blocking intestinal cholesterol absorption and inhibiting hepatic cholesterol synthesis. Used for Hypercholesterolemia and mixed dyslipidemia, Cardiovascular disease risk reduction.
At a glance
| Generic name | Ezetimibe and Simvastatin |
|---|---|
| Sponsor | University of Texas Southwestern Medical Center |
| 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 is an HMG-CoA reductase inhibitor that blocks the rate-limiting enzyme in hepatic cholesterol synthesis. Together, they provide complementary mechanisms to reduce LDL cholesterol levels more effectively than either agent alone.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
- Cardiovascular disease risk reduction
Common side effects
- Myalgia
- Elevated liver transaminases
- Headache
- Abdominal pain
- Rhabdomyolysis
Key clinical trials
- Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (PHASE2)
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- LATAM LOWERS LDL-C (PHASE4)
- Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
- Anti-inflammatory Effects of Simvastatin (PHASE4)
- A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
- A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038) (PHASE3)
- Eze/Simva Switch Study in Diabetics (0653A-807) (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 and Simvastatin CI brief — competitive landscape report
- Ezetimibe and Simvastatin updates RSS · CI watch RSS
- University of Texas Southwestern Medical Center portfolio CI
Frequently asked questions about Ezetimibe and Simvastatin
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Related
- Drug class: All Combination lipid-lowering agent (ezetimibe + statin) drugs
- Target: All drugs targeting NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin)
- Manufacturer: University of Texas Southwestern Medical Center — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia and mixed dyslipidemia
- Indication: Drugs for Cardiovascular disease risk reduction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing