Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMR101 - /day · 2 trials · 1 indication
Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| AMR101 (ethyl icosapentate) - 2 g/day | EXPERIMENTAL | - |
| AMR101 (ethyl icosapentate) - 4 g/day | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMR101 (ethyl icosapentate) - 4 g/day | DRUG | AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks |
| AMR101 (ethyl icosapentate) - 2 g/day | DRUG | AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks |
| Placebo | DRUG | Placebo 4 capsules/day for 12 weeks |
Inclusion Criteria: * Men and women, ages \>18 * Fasting triglyceride ≥200 mg/dL and \<500 mg/dL * LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and \<100 mg/dL * High risk for coronary heart disease * On stable dose of statin (atorvastatin, rosuvastatin or simvastatin) * Provide written ...
AMR101 is used for hypertriglyceridemia, a condition of high triglyceride levels, and for cardiovascular diseases. It is being developed as a treatment to reduce cardiovascular events in high-risk patients with hypertriglyceridemia who are on statin therapy.
AMR101 is a small molecule that targets triglyceride levels in the blood. It is designed to lower elevated triglycerides, which are fats in the blood that can increase the risk of cardiovascular disease when levels are high.
AMR101 is being developed by Amarin Corporation plc, a biopharmaceutical company focused on cardiovascular health. The company's stock is traded under the ticker symbol AMRN.
AMR101 is in Phase 3 clinical development. It has completed three Phase 3 trials, including studies in patients with hypertriglyceridemia and a large cardiovascular outcomes trial. It is an investigational drug and is not yet approved.
AMR101 has completed three Phase 3 trials: NCT01047501 and NCT01047683 in hypertriglyceridemia, and NCT01492361 in cardiovascular diseases. These trials were placebo-controlled, double-blind, and randomized, with a total enrollment of 8,179 patients across multiple countries.
AMR101 is also known as ethyl icosapentate, a purified form of eicosapentaenoic acid. It is a small molecule developed to lower triglycerides and reduce cardiovascular risk in patients with elevated triglyceride levels.