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Rosuvastatin alone
Rosuvastatin alone is a HMG-CoA reductase inhibitor (statin) Small molecule drug developed by Gachon University Gil Medical Center. It is currently FDA-approved for Hypercholesterolemia and dyslipidemia, Primary prevention of cardiovascular disease, Secondary prevention of cardiovascular events in patients with established coronary artery disease. Also known as: Rosuvastatin alone therapy.
Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Rosuvastatin is a small molecule used in the treatment of various conditions, including hyperlipidemia. It has been studied in clinical trials for its effects on healthy participants, hypertension, and malaria, among other conditions.
At a glance
| Generic name | Rosuvastatin alone |
|---|---|
| Also known as | Rosuvastatin alone therapy |
| Sponsor | Gachon University Gil Medical Center |
| 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. 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
- Muscle pain or myalgia
- Elevated liver enzymes (ALT/AST)
- Headache
- Nausea
- Rhabdomyolysis (rare)
Key clinical trials
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) (PHASE1)
- TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men (PHASE2)
- Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants (PHASE1)
- A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants (PHASE1)
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants (PHASE1)
- A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (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 alone CI brief — competitive landscape report
- Rosuvastatin alone updates RSS · CI watch RSS
- Gachon University Gil Medical Center portfolio CI
Frequently asked questions about Rosuvastatin alone
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Related
- Drug class: All HMG-CoA reductase inhibitor (statin) drugs
- Target: All drugs targeting HMG-CoA reductase
- Manufacturer: Gachon University Gil Medical Center — 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
- Also known as: Rosuvastatin alone therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing