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high-dose rosuvastatin single administration
Rosuvastatin inhibits HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels.
Rosuvastatin inhibits HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Primary and secondary prevention of cardiovascular disease.
At a glance
| Generic name | high-dose rosuvastatin single administration |
|---|---|
| Sponsor | Korea University Anam Hospital |
| 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, the rate-limiting enzyme in cholesterol biosynthesis. This leads to decreased intracellular cholesterol production, upregulation of LDL receptors on hepatocytes, and enhanced clearance of LDL cholesterol from the bloodstream. High-dose single administration is used to rapidly achieve therapeutic cholesterol-lowering effects.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Primary and secondary prevention of cardiovascular disease
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Rhabdomyolysis (rare)
Key clinical trials
- A EUROpean Randomized Study on Blood-thinners and Cholesterol-lowering Treatments to Prevent Future Vascular Events in People With Covert Brain Infarcts (CBI) (PHASE3)
- Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (PHASE4)
- A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10510 in Healthy Subjects (PHASE1)
- A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin. (PHASE1)
- VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI) (PHASE1)
- A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects (PHASE1)
- Optimal Blood Pressure and Cholesterol Targets for Preventing Recurrent Stroke in Hypertensives (PHASE4)
- Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins (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 |
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