Last reviewed · How we verify
Zocor (simvastatin)
At a glance
| Generic name | simvastatin |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | HMG-CoA Reductase Inhibitor [EPC] |
| Target | Nuclear receptor subfamily 1 group I member 3, Nuclear receptor subfamily 4 group A member 2, 3-hydroxy-3-methylglutaryl-coenzyme A reductase |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Approved indications
- Arteriosclerotic vascular disease
- Cerebrovascular accident
- Familial hypercholesterolemia - heterozygous
- Familial hypercholesterolemia - homozygous
- Familial type 3 hyperlipoproteinemia
- Hypercholesterolemia
- Hypertriglyceridemia
- Hypoalphalipoproteinemia
- Mixed hyperlipidemia
- Myocardial Infarction Prevention
- Prevention of Transient Ischemic Attacks
- Slow Progression of Coronary Artery Disease
Common side effects
- Upper respiratory infection
- Headache
- Abdominal pain
- Constipation
- Nausea
Serious adverse events
- Myopathy (80 mg daily)
- Rhabdomyolysis (80 mg daily)
- Persistent liver enzyme elevation (>3xULN)
- Myopathy (40 mg daily)
- Myopathy (20 mg daily)
- Myopathy/Rhabdomyolysis (40 mg daily)
Key clinical trials
- NCT00546559 (N/A)
- Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins (EARLY/Phase 1)
- Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy (NA)
- A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia (Phase 3)
- A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-Drug Pharmacokinetic Interaction Between DBPR108 at Steady-state and Metformin Hydrochloride/Glibenclamide/Valsartan (Phase 1)
- A Phase 1, Randomized, Open-label, Cross-over Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Simvastatin in Healthy Adult Subjects (Phase 1)
- A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients (Phase 3)
- A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia (Phase 1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9597289 | 2030-02-23 | Formulation |
| 10300041 | 2027-04-26 | Formulation |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zocor CI brief — competitive landscape report
- Zocor updates RSS · CI watch RSS
- Merck & Co. portfolio CI