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ezetimibe with simvastatin
ezetimibe with simvastatin is a Cholesterol absorption inhibitor and statin Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Hypercholesterolemia, Mixed dyslipidemia.
Ezetimibe inhibits the absorption of cholesterol in the small intestine, while simvastatin is a statin that inhibits HMG-CoA reductase, a key enzyme in cholesterol synthesis.
Ezetimibe inhibits the absorption of cholesterol in the small intestine, while simvastatin is a statin that inhibits HMG-CoA reductase, a key enzyme in cholesterol synthesis. Used for Hypercholesterolemia, Mixed dyslipidemia.
At a glance
| Generic name | ezetimibe with simvastatin |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Cholesterol absorption inhibitor and statin |
| Target | NPC1L1 and HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Ezetimibe works by binding to the Niemann-Pick C1-like 1 (NPC1L1) protein on the surface of intestinal cells, preventing the absorption of cholesterol from the diet. Simvastatin, on the other hand, inhibits HMG-CoA reductase, a key enzyme in the cholesterol synthesis pathway, which reduces the amount of cholesterol produced in the liver.
Approved indications
- Hypercholesterolemia
- Mixed dyslipidemia
Common side effects
- Muscle pain
- Liver enzyme elevations
- Diarrhea
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 with simvastatin CI brief — competitive landscape report
- ezetimibe with simvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about ezetimibe with simvastatin
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Related
- Drug class: All Cholesterol absorption inhibitor and statin drugs
- Target: All drugs targeting NPC1L1 and HMG-CoA reductase
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia
- Indication: Drugs for Mixed dyslipidemia
- Compare: ezetimibe with simvastatin vs similar drugs
- Pricing: ezetimibe with simvastatin cost, discount & access