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Statin (simvastatin)
Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia, Primary prevention of cardiovascular disease in high-risk patients, Secondary prevention of cardiovascular events in patients with established coronary heart disease.
At a glance
| Generic name | Statin (simvastatin) |
|---|---|
| Sponsor | University of Aarhus |
| 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 binds to HMG-CoA reductase and blocks the conversion of HMG-CoA to mevalonate, a critical early step in the cholesterol biosynthetic pathway. This leads to decreased intracellular cholesterol production, upregulation of LDL receptors on hepatocytes, and increased clearance of LDL cholesterol from the bloodstream. The net result is a significant reduction in serum LDL cholesterol and triglycerides, with modest increases in HDL cholesterol.
Approved indications
- Hypercholesterolemia
- Primary prevention of cardiovascular disease in high-risk patients
- Secondary prevention of cardiovascular events in patients with established coronary heart disease
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
- Nausea
Key clinical trials
- Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis (PHASE2)
- Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer (PHASE1, PHASE2)
- Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis (PHASE4)
- T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer (PHASE2)
- [Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers] (PHASE1)
- Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer (EARLY_PHASE1)
- Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers (PHASE1)
- Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy (PHASE1, PHASE2)
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:
- Statin (simvastatin) CI brief — competitive landscape report
- Statin (simvastatin) updates RSS · CI watch RSS
- University of Aarhus portfolio CI