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Simvast CR
Simvastatin is an HMG-CoA reductase inhibitor that lowers cholesterol by blocking the enzyme responsible for cholesterol synthesis in the liver.
Simvastatin is an HMG-CoA reductase inhibitor that lowers cholesterol by blocking the enzyme responsible for cholesterol synthesis in the liver. Used for Hypercholesterolemia and dyslipidemia, Primary and secondary prevention of cardiovascular disease.
At a glance
| Generic name | Simvast CR |
|---|---|
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Simvastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in the mevalonate pathway of cholesterol biosynthesis. This reduces hepatic cholesterol production, leading to upregulation of LDL receptors on liver cells and increased clearance of LDL cholesterol from the bloodstream. The CR (controlled-release) formulation provides sustained drug delivery to optimize cholesterol-lowering efficacy.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Primary and secondary prevention of cardiovascular disease
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
- Gastrointestinal upset
Key clinical trials
- Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia (PHASE3)
- Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia (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:
- Simvast CR CI brief — competitive landscape report
- Simvast CR updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI