CLINICAL TRIALS PROFILE FOR VASCEPA

All Clinical Trials for VASCEPA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02113163 ↗	PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA	Unknown status	Thetis Pharmaceuticals LLC	Phase 1	2014-03-01	The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
NCT02422446 ↗	Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects	Terminated	Brigham and Women's Hospital	Phase 3	2015-04-01	This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.
NCT02719327 ↗	Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid	Active, not recruiting	University of Wisconsin, Madison	Phase 2/Phase 3	2017-06-08	The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.

Clinical Trial Conditions for VASCEPA

Condition Name

Condition Name for VASCEPA
Intervention	Trials
Hypertriglyceridemia	4
Gastrointestinal Microbiome	2
Colorectal Cancer	2

Condition MeSH

Condition MeSH for VASCEPA
Intervention	Trials
Hypertriglyceridemia	5
Colorectal Neoplasms	3
Atherosclerosis	3

Clinical Trial Locations for VASCEPA

Trials by Country

Trials by Country for VASCEPA
Location	Trials
United States	23
Canada	3
United Kingdom	2
New Zealand	1

Trials by US State

Trials by US State for VASCEPA
Location	Trials
Massachusetts	4
California	3
Kentucky	2
Florida	2
Louisiana	2

Clinical Trial Progress for VASCEPA

Clinical Trial Phase

Clinical Trial Phase for VASCEPA
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for VASCEPA
Clinical Trial Phase	Trials
Recruiting	7
Completed	4
Active, not recruiting	2

Clinical Trial Sponsors for VASCEPA

Sponsor Name

Sponsor Name for VASCEPA
Sponsor	Trials
National Institutes of Health (NIH)	2
Massachusetts General Hospital	2
Amarin Pharma Inc.	2

Sponsor Type

Sponsor Type for VASCEPA
Sponsor	Trials
Other	29
Industry	7
NIH	3

VASCEPA Market Analysis and Financial Projection

Last updated: April 30, 2026

Vascepa (icosapent ethyl): clinical-trial update, market analysis, and 2026-2030 projection

What is Vascepa and how is it positioned?

Vascepa (icosapent ethyl) is an oral, prescription omega-3 fatty acid ethyl ester indicated to reduce cardiovascular (CV) risk in high-risk patient populations. The product is marketed by Amarin and is anchored by REDUCE-IT, a landmark outcomes trial in patients with elevated triglycerides on statin therapy, which established CV risk reduction versus placebo plus mineral oil. (U.S. prescribing information; [1])

Core label anchor (US):

• Indicated to reduce the risk of CV events in statin-treated adults with elevated triglycerides and established cardiovascular disease (CVD) or diabetes plus additional risk factors. (U.S. prescribing information; [1])

What is the current clinical-trials landscape for Vascepa?

A complete, line-by-line inventory of all ongoing and planned Vascepa studies is not provided in the available sources in this thread. The highest-confidence “update” therefore focuses on trial results and label-relevant evidence already published in the public record, with the REDUCE-IT outcomes evidence as the defining clinical milestone. (U.S. prescribing information; [1])

Key outcomes evidence defining market expectations

• REDUCE-IT: demonstrated a statistically significant reduction in CV events with icosapent ethyl vs placebo (mineral oil). This trial is the basis for the principal CV risk-reduction positioning used commercially. (U.S. prescribing information; [1])

What market data and commercial drivers matter most?

1) Category structure and demand drivers

Vascepa competes in the “TG and residual CV risk” segment within lipid management and cardiometabolic care. Demand is driven by:

• Patient selection consistent with label criteria (high-risk CVD or diabetes plus additional risk factors; elevated triglycerides; background statin therapy). (U.S. prescribing information; [1])
• Secondary uptake from cardiology and endocrinology practices seeking CV risk reduction beyond LDL lowering in patients with persistent hypertriglyceridemia. (U.S. prescribing information; [1])

2) Evidence-based differentiation

The market differentiator is not triglyceride lowering alone; it is CV outcomes benefit documented in REDUCE-IT and incorporated into prescribing guidance. (U.S. prescribing information; [1])

3) Payor and formulary dynamics

No explicit formulary or rebate terms are supplied in the available sources here, so a data-backed payor projection cannot be stated without introducing uncited assumptions.

How should investors and planners project Vascepa revenue through 2030?

A precise revenue forecast requires baseline sales, segment mix, and explicit historical trend data. No Vascepa sales time series is included in the provided source material in this thread. Under the operating constraints, a complete and accurate numeric projection cannot be produced.

Key Takeaways

• Vascepa’s market position is anchored by REDUCE-IT outcomes and encoded in US prescribing guidance for reducing CV risk in statin-treated adults with elevated triglycerides and high baseline risk profiles. (U.S. prescribing information; [1])
• A verified “clinical trials update” in this response is limited to the publicly available, label-defining outcomes evidence present in the available sources: REDUCE-IT. (U.S. prescribing information; [1])
• A 2026-2030 numeric revenue projection cannot be produced from the available source material in this thread without risking incorrect figures.

FAQs

1. What is Vascepa’s principal clinical evidence?
   REDUCE-IT outcomes evidence versus placebo (mineral oil), used to support CV risk reduction positioning. (U.S. prescribing information; [1])

2. Who is Vascepa indicated for in the US?
   Statin-treated adults with elevated triglycerides who have established CVD or diabetes plus additional risk factors. (U.S. prescribing information; [1])

3. Does Vascepa’s market case rest on triglyceride lowering or cardiovascular outcomes?
   The market case is built on cardiovascular risk reduction supported by REDUCE-IT and reflected in prescribing guidance. (U.S. prescribing information; [1])

4. Can this update list all ongoing clinical trials for Vascepa?
   Not from the available source set in this thread; this response limits to label-defining public evidence. (U.S. prescribing information; [1])

5. Can a revenue forecast through 2030 be quantified here?
   Not with complete accuracy from the available source material in this thread, since no historical sales baseline is provided.

---

References

[1] Amarin Pharma, Inc. Vascepa (icosapent ethyl) U.S. Prescribing Information. (Source accessed via the labeling record).