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High-intensity statin
High-intensity statins inhibit HMG-CoA reductase to potently reduce LDL cholesterol synthesis in the liver.
High-intensity statins inhibit HMG-CoA reductase to potently reduce LDL cholesterol synthesis in the liver. Used for Primary prevention of cardiovascular disease in high-risk patients, Secondary prevention of cardiovascular events in patients with established coronary artery disease, Hypercholesterolemia.
At a glance
| Generic name | High-intensity statin |
|---|---|
| Sponsor | Jung-min Ahn |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Statins competitively inhibit 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme in cholesterol biosynthesis. This leads to decreased intracellular cholesterol levels, upregulation of LDL receptors on hepatocytes, and increased clearance of LDL cholesterol from the bloodstream. High-intensity statins (such as atorvastatin and rosuvastatin) achieve greater LDL reduction compared to moderate-intensity agents.
Approved indications
- Primary prevention of cardiovascular disease in high-risk patients
- Secondary prevention of cardiovascular events in patients with established coronary artery disease
- Hypercholesterolemia
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
Key clinical trials
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- Focusing on the Menopausal Transition to Improve Mid-Life Women's Health (PHASE2, PHASE3)
- Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial (PHASE2)
- triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PHASE3)
- Combined Effects of Statins and Exercise on Training Sensitive Health Markers (NA)
- Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial (NA)
- ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography (PHASE4)
- Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial (NA)
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-intensity statin CI brief — competitive landscape report
- High-intensity statin updates RSS · CI watch RSS
- Jung-min Ahn portfolio CI