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Rosuvastatin Calcium 20 MG, QD
Rosuvastatin Calcium 20 MG, QD is a HMG-CoA reductase inhibitor (statin) Small molecule drug developed by Kuhnil Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Hypercholesterolemia and dyslipidemia, Primary prevention of cardiovascular disease, Secondary prevention of cardiovascular events in patients with established coronary artery disease.
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 prevention of cardiovascular disease, Secondary prevention of cardiovascular events in patients with established coronary artery disease.
At a glance
| Generic name | Rosuvastatin Calcium 20 MG, QD |
|---|---|
| Sponsor | Kuhnil Pharmaceutical Co., Ltd. |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
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. This inhibition decreases hepatic cholesterol production, leading to 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 and dyslipidemia
- Primary prevention of cardiovascular disease
- Secondary prevention of cardiovascular events in patients with established coronary artery disease
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
- Nausea
Key clinical trials
- Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial (NA)
- Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM) (PHASE4)
- A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C. (PHASE1)
- Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque (PHASE4)
- A Study to Investigate The Effect of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects (PHASE1)
- Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects (PHASE1)
- Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors (PHASE1)
- A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants (PHASE1)
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:
- Rosuvastatin Calcium 20 MG, QD CI brief — competitive landscape report
- Rosuvastatin Calcium 20 MG, QD updates RSS · CI watch RSS
- Kuhnil Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Rosuvastatin Calcium 20 MG, QD
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Related
- Drug class: All HMG-CoA reductase inhibitor (statin) drugs
- Target: All drugs targeting HMG-CoA reductase
- Manufacturer: Kuhnil Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia and dyslipidemia
- Indication: Drugs for Primary prevention of cardiovascular disease
- Indication: Drugs for Secondary prevention of cardiovascular events in patients with established coronary artery disease
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