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High dose Rosuvastatin
Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Primary and secondary prevention of cardiovascular disease, Reduction of LDL cholesterol in patients at high cardiovascular risk.
At a glance
| Generic name | High dose Rosuvastatin |
|---|---|
| Also known as | Rosuvastatin Calcium, Crestor |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Rosuvastatin is a statin that competitively inhibits HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. By reducing hepatic cholesterol production, the drug increases LDL receptor expression on hepatocytes, enhancing clearance of LDL cholesterol from the bloodstream. High-dose rosuvastatin provides more potent LDL-lowering effects compared to standard doses, reducing cardiovascular risk in patients with hypercholesterolemia and established cardiovascular disease.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Primary and secondary prevention of cardiovascular disease
- Reduction of LDL cholesterol in patients at high cardiovascular risk
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
- Nausea
Key clinical trials
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men (PHASE2)
- Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (PHASE4)
- Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome (NA)
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) (PHASE3)
- A EUROpean Randomized Study on Blood-thinners and Cholesterol-lowering Treatments to Prevent Future Vascular Events in People With Covert Brain Infarcts (CBI) (PHASE3)
- Comparative Study of Rosuvastatin/Ezetimib 20/10 mg and Atovastatin/Ezetimib 40/10 mg (TOLERANT Trial) (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:
- High dose Rosuvastatin CI brief — competitive landscape report
- High dose Rosuvastatin updates RSS · CI watch RSS
- Nanjing First Hospital, Nanjing Medical University portfolio CI