Drug intelligence / Profile preview

Epanova

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

Overview

Epanova (omega-3 carboxylic acids) is a prescription-strength mixture of polyunsaturated free fatty acids derived from fish oil, primarily composed of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Developed by AstraZeneca following its acquisition of Omthera Pharmaceuticals, it was the first FDA-approved omega-3 in free fatty acid form, a formulation designed to improve bioavailability by allowing absorption without the requirement of hydrolysis by pancreatic lipase. It was indicated as an adjunct to diet for reducing triglyceride levels in adults with severe hypertriglyceridemia (triglycerides ≥500 mg/dL). The drug's mechanism involves reducing hepatic triglyceride synthesis by inhibiting enzymes such as acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT) and increasing mitochondrial and peroxisomal β-oxidation of fatty acids. Although approved in 2014, AstraZeneca discontinued the product from the market after the Phase 3 STRENGTH trial, which investigated its impact on major adverse cardiovascular events in patients with high cardiovascular risk, was terminated for futility in early 2020.

Brand names
Epanova
Other names
omega-3 carboxylic acidsomega3 carboxylic acidsomega 3 carboxylic acidsomega-3 free fatty acidsomega3 free fatty acidsomega 3 free fatty acidsEPA/DHA free fatty acids
02

Targets

DGAT2 (Hepatic diacylglycerol acyltransferase 2)LPL (Lipoprotein lipase)

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