CLINICAL TRIALS PROFILE FOR ICOSAPENT ETHYL

All Clinical Trials for icosapent ethyl

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01492361 ↗	A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major	Completed	Amarin Pharma Inc.	Phase 3	2011-11-01	AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) being developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study is to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.
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.
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.
NCT02719327 ↗	Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid	Active, not recruiting	VA Office of Research and Development	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.
NCT02940223 ↗	Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer	Terminated	Bayer	Phase 2	2017-03-16	This randomized phase II trial studies how well ethyl icosapentate and physical activity work in treating fatigue in patients with cancer that has spread from where it started to other places in the body. Ethyl icosapentate and physical activity may provide more robust and clinically effective improvement of cancer related fatigue, which may facilitate patients continuing cancer therapy since it would be tolerated and effective in controlling disease.
NCT02940223 ↗	Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2017-03-16	This randomized phase II trial studies how well ethyl icosapentate and physical activity work in treating fatigue in patients with cancer that has spread from where it started to other places in the body. Ethyl icosapentate and physical activity may provide more robust and clinically effective improvement of cancer related fatigue, which may facilitate patients continuing cancer therapy since it would be tolerated and effective in controlling disease.
NCT02940223 ↗	Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer	Terminated	M.D. Anderson Cancer Center	Phase 2	2017-03-16	This randomized phase II trial studies how well ethyl icosapentate and physical activity work in treating fatigue in patients with cancer that has spread from where it started to other places in the body. Ethyl icosapentate and physical activity may provide more robust and clinically effective improvement of cancer related fatigue, which may facilitate patients continuing cancer therapy since it would be tolerated and effective in controlling disease.

Clinical Trial Conditions for icosapent ethyl

Condition Name

Condition Name for icosapent ethyl
Intervention	Trials
Hypertriglyceridemia	4
Cardiovascular Diseases	3
Eicosapentaenoic Acid	2
Endoscopic Surgery	2

Condition MeSH

Condition MeSH for icosapent ethyl
Intervention	Trials
Hypertriglyceridemia	6
Colorectal Neoplasms	4
Cardiovascular Diseases	3
Diabetes Mellitus, Type 2	2

Clinical Trial Locations for icosapent ethyl

Trials by Country

Trials by Country for icosapent ethyl
Location	Trials
United States	56
Canada	8
Australia	6
India	6
South Africa	4

Trials by US State

Trials by US State for icosapent ethyl
Location	Trials
Massachusetts	4
Kentucky	2
Indiana	2
Illinois	2
Virginia	2

Clinical Trial Progress for icosapent ethyl

Clinical Trial Phase

Clinical Trial Phase for icosapent ethyl
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for icosapent ethyl
Clinical Trial Phase	Trials
Recruiting	7
Completed	5
Active, not recruiting	2

Clinical Trial Sponsors for icosapent ethyl

Sponsor Name

Sponsor Name for icosapent ethyl
Sponsor	Trials
Amarin Pharma Inc.	4
Massachusetts General Hospital	2
Harvard School of Public Health	2

Sponsor Type

Sponsor Type for icosapent ethyl
Sponsor	Trials
Other	27
Industry	10
NIH	4

Icosapent Ethyl (Eicosapent Ethyl): Clinical Trials Update, Market Analysis, and 2026-2030 Projection

Last updated: April 29, 2026

What is the current clinical-trials footprint for icosapent ethyl?

Core approved indication set

• Atrial fibrillation (AF) / flutter risk reduction in high-risk patients after cardiovascular (CV) events is tied to the REDUCE-IT program outcomes.
• Hypertriglyceridemia (HTG) indication is tied to the use of icosapent ethyl in adults with elevated triglycerides on background statin therapy, consistent with REDUCE-IT.

Ongoing and recent trial directions that affect near-term market trajectory

• Trials in the class focus on:
  • Earlier disease stages (before established CV events)
  • Broader dyslipidemia phenotypes (including non-statin background)
  • Safety/real-world outcome durability, with specific attention to bleeding and AF signals that have regulatory and payer sensitivity.

Availability of new efficacy/safety readouts

• Publicly disclosed, registrable outcome drivers for market expansion are typically anchored to:
  • CV endpoint readouts (MACE reduction)
  • AF/bleeding event rate stability in broader populations
  • Subgroup consistency by baseline triglycerides, LDL-C, and diabetes status

Practical interpretation for a commercial pipeline review

• Without new registrable endpoint results, the commercial slope is dominated by:
  • Label-adjacent expansion uptake
  • Payer coverage evolution and guideline penetration
  • Competitive substitution from other triglyceride-lowering agents and omega-3 formulations

Key clinical evidence base (foundation for ongoing utilization)

• REDUCE-IT: Icosapent ethyl reduced CV events versus placebo in high-risk hypertriglyceridemia with statin background. (NEJM; trial results underpin current commercial positioning.) [1]
• STRENGTH: A “EPA/DHA” formulation did not replicate the REDUCE-IT efficacy signal, reinforcing that trial outcomes are molecule-specific and limiting cross-class substitution arguments. [2]

Sources used for clinical anchor evidence: [1], [2].

---

What is the market for icosapent ethyl today, and where does growth come from?

Market structure

• Product: Icosapent ethyl (EPA-only omega-3 ethyl ester)
• Customer: Retail and specialty pharmacy; payer-covered chronic preventive therapy with strong linkage to guideline-based statin add-on.
• Demand engine: High-risk patients with persistent hypertriglyceridemia despite statins.

Competitive landscape and how it influences pricing power

Direct substitutes

• Other omega-3 products (including EPA/DHA mixes) compete for triglyceride management, but clinical differentiation is constrained by differing trial outcomes (REDUCE-IT vs STRENGTH). [1], [2]

Non-omega-3 triglyceride lowering

• Fibrates, niacin (where used), emerging triglyceride-lowering mechanisms compete on cost-effectiveness and endpoints, but payer coverage is usually tightened after head-to-head outcome evidence is assessed.

Adoption constraints that directly affect uptake (commercial bottlenecks)

• Guideline interpretation of “who qualifies” (baseline triglycerides, statin status, CV risk definition).
• Safety monitoring practicality:
  • AF and bleeding event awareness can influence payer prior authorization language and prescriber caution.
• Real-world prescribing patterns:
  • Uptake tends to track cardiology and endocrinology intensity and formulary design rather than broad lipid-panel treatment alone.

Payer and procurement effects (how coverage changes future revenue)

• Coverage expansion typically correlates with:
  • New guideline endorsements
  • Reduction in prior authorization friction
  • Price concessions or rebate structures after competitive formulary pressure

(Commercial sizing is not fully enumerated below because publicly citable, label-specific global and US revenue series with 2024-2025 granularity are not provided in the supplied evidence set for this response. This prevents producing a complete and accurate numerical market forecast.)

---

What is the 2026-2030 revenue and utilization projection for icosapent ethyl?

Projection framework (what moves the curve)

• Base case drivers

  • Continued penetration in guideline-eligible populations with persistent triglycerides
  • Persistence (low discontinuation) because the therapy is chronic prevention-based
  • Uptake in secondary prevention patients after CV events

• Downside drivers

  • Payer tightening triggered by bleeding/AF utilization concerns
  • Competitive formulary exclusions if comparable outcome data emerge from rival agents
  • Generic or direct competitive pricing pressure if market conditions change

• Upside drivers

  • Broader label/indication adjacency if additional endpoint support is accepted
  • Earlier-line prescribing if outcomes translate to wider risk strata
  • Increased cardiometabolic integration in primary care risk management

Projected commercialization outcome (directional)

• Market growth is expected to be modest-to-steady unless a new, definitive endpoint readout expands label boundaries or payer coverage substantially.
• The REDUCE-IT-specific efficacy signal keeps icosapent ethyl positioned as the “trial-proven EPA-only” option rather than one part of a generic omega-3 basket. [1]

What can be projected accurately from cited evidence in this response

• This response can support only mechanism-and-evidence-driven directionality based on the clinical evidence set anchored by REDUCE-IT and STRENGTH, and on the known payer sensitivities embedded in the current use case. [1], [2]
• A precise 2026-2030 numeric forecast is not produced here because the response does not include a complete, cited set of revenue baselines, unit volumes, formulary penetration, or trial enrollment and readout timing required for an accurate quantitative projection.

---

What clinical endpoints matter most for commercial and regulatory momentum?

Efficacy endpoints that drive adoption

• MACE reduction (composite CV endpoint and its components) aligned with REDUCE-IT design and results. [1]
• Subgroup durability
  • Diabetic vs non-diabetic
  • Baseline triglyceride strata
  • Secondary prevention vs high-risk primary prevention

Safety endpoints that drive payer and prescribing behavior

• Atrial fibrillation/flutter events monitoring
• Bleeding events awareness, especially in patients on antithrombotic regimens

These safety endpoints are commercially material because they affect formulary acceptance criteria and risk management workflows.

---

How does REDUCE-IT differentiation affect market share dynamics?

• The REDUCE-IT outcome was positive for an EPA-only regimen, while STRENGTH was negative for an EPA/DHA formulation. That asymmetry reduces the ability of mixed omega-3 products to claim similar outcome benefits, shaping prescriber and payer preference toward icosapent ethyl. [1], [2]

---

Key Takeaways

• Icosapent ethyl’s clinical adoption is anchored to REDUCE-IT, which shows CV event reduction in high-risk hypertriglyceridemia on statin background. [1]
• Competitive omega-3 substitution is constrained because STRENGTH did not replicate efficacy for EPA/DHA, reinforcing molecule-specific outcome claims. [2]
• Near-term market growth depends more on payer coverage and guideline-driven penetration than on class-level omega-3 substitution arguments.
• A fully numeric 2026-2030 revenue forecast is not provided here because the response lacks a complete cited baseline dataset for revenue/unit volumes and future trial timing required for an accuracy-grade projection.

---

FAQs

1) What clinical trial most directly supports today’s icosapent ethyl use for CV risk reduction?
REDUCE-IT. [1]

2) Why do EPA/DHA omega-3 products face weaker market substitution?
STRENGTH did not show the same CV outcome benefit signal as REDUCE-IT for EPA-only icosapent ethyl. [2]

3) Which safety signals most affect payer coverage and prescribing workflow?
Atrial fibrillation/flutter and bleeding event monitoring. (These are central to how the therapy is managed in practice and payer criteria aligned with REDUCE-IT safety discussions.) [1]

4) What is the most likely bottleneck to faster uptake?
Payer and guideline-defined eligibility for persistent hypertriglyceridemia on statins, plus risk-management burden around AF/bleeding. [1]

5) What would change the 2026-2030 growth outlook materially?
New registrable endpoint evidence that expands label-adjacent populations or reduces safety/payer friction while maintaining CV efficacy. [1]

---

References (APA)

[1] Bhatt, D. L., Steg, P. G., Miller, M., et al. (2019). Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. New England Journal of Medicine, 380(1), 11-22.
[2] Nicholls, S. J., Lincoff, A. M., Barter, P. J., et al. (2020). Effect of high-dose omega-3 fatty acids vs placebo on major adverse cardiovascular events in patients at high cardiovascular risk: The STRENGTH randomized clinical trial. JAMA, 324(22), 2268-2280.