Drug intelligence / Profile preview

omega-3-carboxylic acids + statin

Development stage
Discontinued
Lead developer
AstraZeneca
Modality
Small Molecules
Administration
Oral
01

Overview

Omega-3-carboxylic acids (marketed as Epanova) is a prescription-grade mixture of free fatty acids, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), derived from fish oil. Unlike ethyl ester formulations, the carboxylic acid form is absorbed directly in the small intestine without requiring hydrolysis by pancreatic lipase, which may enhance bioavailability, particularly in the absence of a high-fat meal. This agent was developed for the treatment of severe hypertriglyceridemia and was extensively studied in combination with statins (HMG-CoA reductase inhibitors) to reduce residual cardiovascular risk. The landmark STRENGTH trial investigated the addition of Epanova to standard-of-care statin therapy in patients with mixed dyslipidemia and high cardiovascular risk; however, the trial was terminated in 2020 due to a lack of clinical benefit compared to the corn oil placebo. Consequently, AstraZeneca discontinued the development of the combination and withdrew Epanova from the market.

Other names
Epanova + statinomega-3 free fatty acids + statinomega-3-carboxylic acids and HMG-CoA reductase inhibitorsomega3-carboxylic acids and HMG-CoA reductase inhibitorsomega 3-carboxylic acids and HMG-CoA reductase inhibitors
02

Targets

PPARA (Peroxisome proliferator-activated receptor alpha)HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase)

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