Vascepa

(Icosapent Ethyl)

Phase 3Small molecule

AAmarin Pharma Inc.

Vascepa is one of 168 small molecule programs targeting Metastasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

167

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MetastasisActive, not recruiting

PneumoniaActive, not recruiting

Colorectal CancerActive, not recruiting

COVID-19Active, not recruiting

HypertriglyceridemiaActive, not recruiting

MetastasisPhase 3

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Colorectal CancerPreclinical

Active, not recruiting

COVID-19Phase 2

Active, not recruiting

HypertriglyceridemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Vascepa

AAmarin Pharma Inc.

Phase 3

1 2

Spikevax

Moderna

Preclinical

21 3

Bnt162b2

BioNTech

Preclinical

29 4

Glucocorticoid

AbbVie

Preclinical

1 5

HB-Admscs

HHope Biosciences Research Foundation

Preclinical

4 6

Aprotinin

Bayer

Preclinical

1 7

DAS181

AAnsun Biopharma, Inc.

Preclinical

4 8

Exoflo

DDirect Biologics, LLC

Preclinical

3 9

Tpa

UUniversity of Florida

Preclinical

1 10

Sivelestat Sodium

TThe First Hospital of Jilin University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Aortic Valve Stenosis

NCT06466278

Q2 2027

Phase 3Not yet recruiting

Pneumonia

NCT06710080

Clinical

Trials by Indication[1]

Cardiovascular2 trials

A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

Terminated·KKaiser Permanente·Phase 4·NCT04505098·39,600 enrolled

The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk

Completed·CCanadian Medical and Surgical Knowledge Translation Research Group·Phase 4·NCT04562467·70 enrolled

Metastasis1 trial

EPA for Metastasis Trial 2

Active, not recruiting·MMark A Hull, PhD FRCP·Phase 3·NCT03428477·418 enrolled

Hypertriglyceridemia1 trial

Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia

Completed·MMatinas BioPharma Nanotechnologies, Inc.·Phase 2·NCT04177680·100 enrolled

Colorectal Cancer1 trial

Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases

Completed·UUniversity of Leeds··NCT04682665·81 enrolled

Prevention1 trial

PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial

Completed·EEstudios Clínicos Latino América·Phase 3·NCT04460651·4,093 enrolled

6 more indications

Amyloid1 trial

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

Completed·VVA Office of Research and Development·Phase 2/3·NCT02719327·131 enrolled

Pneumonia1 trial

Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia

Not yet recruiting·OOttawa Heart Institute Research Corporation·Phase 3·NCT06710080·168 enrolled

Lip1 trial

Vascepa to Accelerate Lipoprotein Uptake and Elimination

Completed·UUniversity of Pennsylvania·Phase 1·NCT03885661·20 enrolled

Endothelial Function1 trial

Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

Terminated·—·Phase 3·NCT02422446·2 enrolled

COVID-191 trial

An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19

Completed·CCanadian Medical and Surgical Knowledge Translation Research Group·Phase 2·NCT04412018·100 enrolled

Aortic Valve Stenosis1 trial

IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

Active, not recruiting·—·Phase 2·NCT06466278·110 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 26, 2012

VASCEPA

NDA NDA202057

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Icosapent Ethyl. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Icosapent Ethyl compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Icosapent Ethyl. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202057). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vascepa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Amarin Pharma Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAmarin Pharma Inc.

Patent Landscape[5]

Patent Cliff

May 31, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9700537May 31, 2027

9198892Sep 25, 2027

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Vascepa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Cardiovascular2 trials

Metastasis1 trial

Hypertriglyceridemia1 trial

Colorectal Cancer1 trial

Prevention1 trial

Amyloid1 trial

Pneumonia1 trial

Lip1 trial

Endothelial Function1 trial

COVID-191 trial

Aortic Valve Stenosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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