Vascepa

(Icosapent Ethyl)

ApprovedSmall molecule

AAmarin Pharma Inc.

Vascepa is one of 184 small molecule programs targeting Colorectal Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

183

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Colorectal CancerActive, not recruiting

Coronary Artery DiseaseNot yet recruiting

Aortic Valve StenosisActive, not recruiting

MetastasisActive, not recruiting

PneumoniaNot yet recruiting

Colorectal CancerPreclinical

Active, not recruiting

Coronary Artery DiseaseApproved

Not yet recruiting

Aortic Valve StenosisPhase 2

Active, not recruiting

MetastasisPhase 3

Active, not recruiting

PneumoniaPhase 3

Not yet recruiting

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

25 2

Opdivo

Bristol-Myers Squibb

Phase 3

24 3

Wellcovorin

GGlaxo Dba Glaxosmithkline

Phase 3

37 4

Vascepa

AAmarin Pharma Inc.

Approved

1 5

Tecentriq

Roche

Phase 3

6 6

Decadron

AAspen Global Incorporated

Phase 3

7 7

Trifluridine/tipiracil

AbbVie

Phase 3

3 8

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Phase 3

4 9

BL-M07D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

1 10

Biological Check-up

UUniversity Hospital, Bordeaux

Phase 3

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

Q4 2029

ApprovedNot yet recruiting

Coronary Artery Disease

NCT07762755

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

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

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

Aortic Valve Stenosis1 trial

IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

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

Endothelial Function1 trial

Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects

Terminated·—·Phase 3·NCT02422446·2 enrolled

7 more indications

Colorectal Cancer1 trial

Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases

Completed·UUniversity of Leeds··NCT04682665·81 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

Amyloid1 trial

Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid

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

Metastasis1 trial

EPA for Metastasis Trial 2

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

Coronary Artery Disease1 trial

A Randomized Controlled Trial Evaluating the Effect of Icosapent Ethyl on High-Risk Coronary Plaques Using 18F-Sodium Fluoride PET/CT

Not yet recruiting·CChina National Center for Cardiovascular Diseases·Approved·NCT07762755·100 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 26, 2012

VASCEPA

NDA NDA202057

Sources

References

[1]
ClinicalTrials.gov — 13 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: Approved[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

Q4 2029

Trials by Indication[1]

Cardiovascular2 trials

COVID-191 trial

Hypertriglyceridemia1 trial

Aortic Valve Stenosis1 trial

Endothelial Function1 trial

Colorectal Cancer1 trial

Pneumonia1 trial

Lip1 trial

Amyloid1 trial

Prevention1 trial

Metastasis1 trial

Coronary Artery Disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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