Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eicosapentaenoic acid-ethyl · 2 trials · 1 indication
The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
| Arm | Type | Description |
|---|---|---|
| TAK-085 2 g | EXPERIMENTAL | TAK-085 2 g, orally, once daily for up to 12 weeks. |
| TAK-085 4 g | EXPERIMENTAL | TAK-085 2 g, orally, twice daily for up to 12 weeks. |
| EPA-E 1.8 g | EXPERIMENTAL | Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Omega-3-acid ethyl esters 90 (TAK-085) | DRUG | Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters. |
| Eicosapentaenoic acid-ethyl (EPA-E) | DRUG | EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks. |
| Eicosapentaenoic acid-ethyl (EPA) | DRUG | EPA-E capsules |
Inclusion Criteria: 1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one. 2. Participants with differences between 2 values of f...
Eicosapentaenoic acid-ethyl is an investigational 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 3 clinical development and has not been approved by regulatory authorities.
Eicosapentaenoic acid-ethyl is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The drug is currently in Phase 3 clinical trials for hypertriglyceridemia.
Eicosapentaenoic acid-ethyl is in Phase 3 clinical development for hypertriglyceridemia. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials have been completed.
Eicosapentaenoic acid-ethyl has completed two Phase 3 trials: NCT01350973, a study of its efficacy in participants with hypertriglyceridemia, and NCT01350999, a long-term efficacy and safety study. Both trials were randomized, double-blind, and active-controlled, with a combined enrollment of 1,114 participants.
Yes, Eicosapentaenoic acid-ethyl is also known as TAK-085. The clinical trials NCT01350973 and NCT01350999 refer to the drug as TAK-085 in their titles, confirming that both names refer to the same investigational treatment for hypertriglyceridemia.