NDAORALCAPSULE
Approved
Jul 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
VASCEPA (icosapent ethyl) by Inpharmus is low-density lipoprotein triglycerides (vldl-tg) synthesis and/or secretion and enhances tg clearance from circulating vldl particles. First approved in 2012.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VASCEPA (icosapent ethyl) is an oral prescription omega-3 fatty acid that reduces triglycerides by inhibiting VLDL-TG synthesis and enhancing triglyceride clearance from circulating particles. It is indicated for patients with elevated triglycerides despite statin therapy, targeting cardiovascular risk reduction in dyslipidemic populations.
$764MPart D
PeakStable
7.0 years to LOEPeak-cycle product with $764M in annual Part D spending demonstrates strong market penetration; teams are optimizing existing market share rather than driving growth.
Mechanism of Action
low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver;…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk
Started Sep 2020
70 enrolled
Cardiovascular DiseasesCardiovascular Risk FactorTriglycerides High+1 more
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Started Aug 2020
39,600 enrolled
Covid19AtherosclerosisCardiovascular Diseases+1 more
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19
Started Jun 2020
100 enrolled
COVID-19Inflammatory Response
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy
Started Mar 2017
80 enrolled
Hypertriglyceridemia
Vascepa to Accelerate Lipoprotein Uptake and Elimination
Started Jan 2016
20 enrolled
Lipid DisorderTriglycerides HighDyslipidemias
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.