Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMR101 · 1 trial · 1 indication
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
| Arm | Type | Description |
|---|---|---|
| AMR101 | EXPERIMENTAL | AMR101 (icosapent ethyl) + statin therapy, daily |
| Placebo | PLACEBO_COMPARATOR | Placebo + statin therapy, daily |
| Name | Type | Description |
|---|---|---|
| AMR101 | DRUG | Parallel Assignment |
| Placebo | DRUG | Parallel Assignment |
| Statin therapy | DRUG | Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL) |
Inclusion Criteria: * Men and non-pregnant or sterile women ages 45 and older * Hypertriglyceridemia * On statin therapy for at least four weeks * Either having established cardiovascular disease or at high risk for cardiovascular disease Exclusion Criteria: * Severe heart failure * Any life-thre...
AMR101 is an investigational small molecule being developed for cardiovascular diseases and hypertriglyceridemia. It is studied in patients with high triglyceride levels, including those on statins with levels between 200 and 500 mg/dL, and those with fasting levels between 500 and 2000 mg/dL. It is also evaluated for reducing cardiovascular events in high-risk patients.
AMR101 is developed by Amarin Corporation plc, a biopharmaceutical company. The company's stock ticker is AMRN. Amarin is conducting clinical trials to evaluate the drug's efficacy and safety in treating hypertriglyceridemia and cardiovascular diseases.
AMR101 is in Phase 3 clinical development. All three trials listed are Phase 3 and have been completed. The drug is investigational and not yet approved, as it is still undergoing clinical evaluation for its intended indications.
AMR101 has completed three Phase 3 trials. NCT01047501 studied its effect on triglycerides in patients on statins with high levels. NCT01047683 evaluated efficacy and safety in patients with very high triglycerides. NCT01492361 assessed its ability to reduce cardiovascular events in high-risk patients with hypertriglyceridemia on statins.
AMR101 is a small molecule, but its specific molecular target is not disclosed. The drug is being studied for its effects on triglyceride levels and cardiovascular outcomes, but the exact mechanism of action has not been detailed in the available information.
AMR101 is also known as ethyl icosapentate, as indicated in the clinical trial titles. It is a purified form of eicosapentaenoic acid, an omega-3 fatty acid. The trials refer to it as AMR101 or ethyl icosapentate, confirming they are the same compound.