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statin, amlodipine
statin, amlodipine is a Fixed-dose combination: HMG-CoA reductase inhibitor + dihydropyridine calcium channel blocker Small molecule drug developed by Gachon University Gil Medical Center. It is currently FDA-approved for Hypercholesterolemia with hypertension, Cardiovascular risk reduction in patients requiring both statin and antihypertensive therapy.
This is a fixed-dose combination of a statin (HMG-CoA reductase inhibitor) and amlodipine (calcium channel blocker) that lowers cholesterol and reduces blood pressure simultaneously.
Amlodipine is a small molecule that blocks voltage-gated L-type calcium channels, which is its mechanism of action. It is used to prevent and treat conditions such as hypertension, atherosclerosis, and carotid artery stenosis, as well as complications of chronic kidney disease.
At a glance
| Generic name | statin, amlodipine |
|---|---|
| Sponsor | Gachon University Gil Medical Center |
| Drug class | Fixed-dose combination: HMG-CoA reductase inhibitor + dihydropyridine calcium channel blocker |
| Target | HMG-CoA reductase; L-type calcium channels |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
The statin component inhibits HMG-CoA reductase, reducing hepatic cholesterol synthesis and LDL cholesterol levels. Amlodipine is a dihydropyridine calcium channel blocker that causes vasodilation and reduces blood pressure. Together, they address two major cardiovascular risk factors in a single formulation.
Approved indications
- Hypercholesterolemia with hypertension
- Cardiovascular risk reduction in patients requiring both statin and antihypertensive therapy
Common side effects
- Headache
- Muscle pain or myalgia
- Peripheral edema
- Flushing
- Elevated liver enzymes
Key clinical trials
- Statin Combined with Amlodipine Treats Primary Aldosteronism (PHASE4)
- A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE) (PHASE4)
- Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes (PHASE3)
- The Canadian Prevention of Renal and Cardiovascular Endpoints Trial (NA)
- High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension (PHASE4)
- Effect of Atorvastatin on Carotid Intima Media Thickness (PHASE4)
- Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA) (PHASE4)
- Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (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:
- statin, amlodipine CI brief — competitive landscape report
- statin, amlodipine updates RSS · CI watch RSS
- Gachon University Gil Medical Center portfolio CI
Frequently asked questions about statin, amlodipine
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Related
- Drug class: All Fixed-dose combination: HMG-CoA reductase inhibitor + dihydropyridine calcium channel blocker drugs
- Target: All drugs targeting HMG-CoA reductase; L-type calcium channels
- Manufacturer: Gachon University Gil Medical Center — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia with hypertension
- Indication: Drugs for Cardiovascular risk reduction in patients requiring both statin and antihypertensive therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing