Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
icosapent ethyl · 1 trial · 1 indication
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
| Arm | Type | Description |
|---|---|---|
| Omega-3 pentaenoic acid (MAT9001) | EXPERIMENTAL | 2g MAT9001 capsules twice daily with meals |
| Icosapent ethyl (Vascepa) | ACTIVE_COMPARATOR | 2g Vascepa capsules twice daily with meals |
| Name | Type | Description |
|---|---|---|
| Omega 3 pentaenoic acid | DRUG | Encapsulated omega-3 pentaenoic acid |
| icosapent ethyl | DRUG | Encapsulated omega-3 acid ethyl esters |
Inclusion Criteria: * Male or female, ≥18 y of age * Judged to be in generally good health * Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening * Body mass index of ≥20.0 kg/m2 * No clinically significant findings in a 12-lead ECG or physical examination * Willing and able to undergo t...
Icosapent ethyl is a small molecule being developed for the treatment of hypertriglyceridemia, a condition characterized by elevated levels of triglycerides in the blood. It is currently in Phase 2 clinical development for this metabolic indication.
Icosapent ethyl is being developed by Matinas Biopharma Holdings, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol MTNB. The company is conducting clinical trials to evaluate the drug's effects in patients with hypertriglyceridemia.
Icosapent ethyl is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities. Further clinical studies would be needed to support any potential approval.
Icosapent ethyl has been studied in one completed Phase 2 clinical trial, identified as NCT04177680. This trial, titled "Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia," enrolled 100 participants in the United States and used an active-controlled design.
Icosapent ethyl is a free-fatty acid formulation of omega-3 pentaenoic acid, as indicated by the title of its Phase 2 clinical trial. The trial evaluated the pharmacodynamic effects of this formulation in adults with hypertriglyceridemia.