Drug intelligence / Profile preview

omega-3-acid ethyl esters (Sancilio & Co.)

Development stage
Discontinued
Lead developer
Sancilio & Co.
Modality
Small Molecules
Administration
Oral
01

Overview

SC401B is an oral pharmaceutical formulation of omega-3-acid ethyl esters, specifically a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), developed by Sancilio & Co. for the treatment of severe hypertriglyceridemia. The product utilizes the proprietary Advanced Lipid Technologies (ALT) platform, which is a self-emulsifying drug delivery system (SEDDS) incorporating specific surfactants to enhance the absorption and bioavailability of the fatty acids. This technology is designed to eliminate the "food effect" typically associated with omega-3 products like Lovaza, ensuring consistent bioavailability in both the fed and fasted states. SC401B has been evaluated in Phase 3 clinical trials for its efficacy in reducing triglyceride levels in patients with severe hypertriglyceridemia (triglycerides between 500 and 2,000 mg/dL).

Other names
EPA+DHAeicosapentaenoic acid and docosahexaenoic acid ethyl esters
02

Targets

LPL (Lipoprotein lipase)DGAT1 (Diacylglycerol O-acyltransferase 1)PPARA (Peroxisome proliferator-activated receptor alpha)SREBP-1 / SREBF1 (SREBP-1)

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