Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as omega-3-acid ethyl esters 90 (TAK-085)
omega-3-acid ethyl esters 90 · 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...
Omega-3-acid ethyl esters 90 (TAK-085) is being developed for the treatment of hypertriglyceridemia, a metabolic condition marked by elevated triglyceride levels in the blood. It is a small molecule therapeutic studied in adults aged 20 years and older with this condition.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of omega-3-acid ethyl esters 90 (TAK-085). The company has sponsored Phase 3 clinical development of the asset in hypertriglyceridemia.
Omega-3-acid ethyl esters 90 (TAK-085) is in Phase 3 clinical development for hypertriglyceridemia. Both of its Phase 3 trials have been completed, and no trials are currently active. It remains an investigational therapy rather than an approved product.
Two completed Phase 3 trials have studied omega-3-acid ethyl esters 90 (TAK-085) in hypertriglyceridemia: NCT01350999, a long-term efficacy and safety study that enrolled 503 participants, and NCT01350973, an efficacy study that enrolled 611 participants. Together they enrolled 1,114 participants.
Both Phase 3 trials of omega-3-acid ethyl esters 90 (TAK-085) were randomized, double-blind, and actively controlled studies in participants with hypertriglyceridemia. NCT01350999 enrolled 503 participants and NCT01350973 enrolled 611, with enrollment open to all sexes starting at age 20.
Yes, omega-3-acid ethyl esters 90 is also known as TAK-085. TAK-085 is the development code used by Takeda Pharmaceutical Company Limited for this small molecule in its hypertriglyceridemia program, so the two names refer to the same investigational asset.