CLINICAL TRIALS PROFILE FOR ICOSAPENT ETHYL

All Clinical Trials for ICOSAPENT ETHYL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

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

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Trials by Country for ICOSAPENT ETHYL
Location	Trials
United States	56
Canada	7
India	6
Australia	6
South Africa	4

Trials by US State

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−

Trials by US State for ICOSAPENT ETHYL
Location	Trials
Massachusetts	4
Louisiana	2
Kentucky	2
Indiana	2
Illinois	2

Clinical Trial Progress for ICOSAPENT ETHYL

Clinical Trial Phase

Clinical Trial Phase for ICOSAPENT ETHYL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	5
Phase 2/Phase 3	1

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
National Institutes of Health (NIH)	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for ICOSAPENT ETHYL
Sponsor	Trials
Other	25
Industry	10
NIH	4

Icosapent Ethyl: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction to Icosapent Ethyl

Icosapent ethyl, a highly purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA), has garnered significant attention in the medical and pharmaceutical industries. Derived from fish oil, this drug has shown promising results in reducing cardiovascular events and managing hypertriglyceridemia.

Clinical Trials: REDUCE-IT and Beyond

REDUCE-IT Trial Overview

The REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial) is a landmark clinical trial that has significantly impacted the understanding and treatment of cardiovascular diseases. Conducted by Deepak L. Bhatt, MD, MPH, and his team, the trial involved patients with high triglyceride levels, either with known cardiovascular disease or at high risk for developing it, and who were already on statin therapy with relatively well-controlled LDL levels[1][4].

Key Findings of the REDUCE-IT Trial

The trial demonstrated that participants who took icosapent ethyl experienced a 25% reduction in cardiovascular events and a 20% reduction in death due to cardiovascular causes compared to those receiving a placebo. These results were described as "remarkable" by Dr. Bhatt and set a new standard of care for these patients[1][4].

Additional Clinical Insights

The trial also showed that icosapent ethyl was superior to placebo in reducing triglycerides, cardiovascular events, and cardiovascular death among patients with high triglycerides. The benefits were consistent across various patient subgroups, including those with diabetes and prior myocardial infarction[4].

Cost-Effectiveness and Value Assessment

Economic Impact

The cost-effectiveness analysis of icosapent ethyl, based on the REDUCE-IT trial data, indicates that the drug is highly cost-effective. At a discounted price of approximately $125 per month, icosapent ethyl was found to offer better health outcomes at a lower overall cost. The analysis predicted that the use of icosapent ethyl would cost about $18,000 per quality-adjusted life year (QALY) gained, which is well below common U.S. willingness-to-pay thresholds[3].

Comparison with Other Treatments

When compared to PCSK9 inhibitors, another class of cardiovascular drugs, icosapent ethyl appears more favorable in terms of cost-effectiveness. While PCSK9 inhibitors can cost around $40,000 per QALY, icosapent ethyl offers significant health benefits at a substantially lower cost[3].

Market Analysis and Projections

Current Market Size and Growth

The global icosapent ethyl market was valued at USD 100 billion in 2023 and is projected to reach USD 147.74 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031. This growth is driven by an increasing need for effective treatments for cardiovascular diseases, improvements in healthcare infrastructure, and rising public awareness of preventive healthcare practices[2].

Market Segmentation

The market is segmented by type (capsules, tablets, softgels, liquid), application (cardiovascular disease risk reduction, hypertriglyceridemia management, anti-inflammatory, adjunct to statin therapy, clinical trials, research & development), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Key Drivers and Trends

The market expansion is fueled by several key factors:

• Increasing Prevalence of Cardiovascular Diseases: The aging population and rising frequency of cardiovascular illnesses worldwide have created a higher demand for effective treatment options like icosapent ethyl.
• Clinical Evidence: Positive results from clinical trials, such as the REDUCE-IT trial, have enhanced the drug's uptake among patients and healthcare professionals.
• Regulatory Approvals: Favorable regulatory approvals and guidelines have reinforced market penetration.
• Healthcare Spending and Awareness: Rising healthcare spending and increasing knowledge of the benefits of omega-3 fatty acids are also driving the market growth[2].

Key Players in the Icosapent Ethyl API Market

The main players in the icosapent ethyl API market include Chemport Inc, DSM Nutritional Products Ltd, Ak Biopharm Co Ltd, Huatai Pharma Inc, Bizen Chemical Co Ltd, Finorga Sas, and Sichuan Gowell Pharmaceutical Co Ltd. These companies are instrumental in the production and supply of icosapent ethyl, contributing to its global availability[5].

Applications and Formulations

Icosapent ethyl is available in various formulations, including capsules, tablets, softgels, and liquid forms. The drug is primarily used for cardiovascular disease risk reduction, hypertriglyceridemia management, and as an adjunct to statin therapy. Its anti-inflammatory properties and use in clinical trials and research & development are also significant applications[2].

Future Outlook

Given the robust clinical evidence and favorable market dynamics, the future outlook for icosapent ethyl is promising. As pharmaceutical companies continue to innovate and expand their product offerings, the global market for icosapent ethyl is expected to grow steadily.

"The REDUCE-IT trial sets a new standard of care for these patients," - Deepak L. Bhatt, MD, MPH[1].

Key Takeaways

• Clinical Efficacy: Icosapent ethyl has demonstrated a significant reduction in cardiovascular events and death in high-risk patients.
• Cost-Effectiveness: The drug is highly cost-effective, offering better health outcomes at a lower overall cost.
• Market Growth: The global market for icosapent ethyl is projected to grow significantly, driven by increasing demand and favorable market trends.
• Key Players: Several major pharmaceutical companies are involved in the production and supply of icosapent ethyl.
• Applications: The drug is used in various formulations for cardiovascular disease risk reduction, hypertriglyceridemia management, and other applications.

FAQs

What is the primary use of icosapent ethyl?

Icosapent ethyl is primarily used to reduce the risk of cardiovascular events and manage hypertriglyceridemia in patients with high triglyceride levels.

What were the key findings of the REDUCE-IT trial?

The REDUCE-IT trial showed that icosapent ethyl reduced cardiovascular events by 25% and cardiovascular death by 20% compared to a placebo.

How cost-effective is icosapent ethyl?

Icosapent ethyl is highly cost-effective, with a cost of approximately $18,000 per quality-adjusted life year (QALY) gained, which is well below common U.S. willingness-to-pay thresholds.

What is the projected market size for icosapent ethyl by 2031?

The global market for icosapent ethyl is expected to reach USD 147.74 billion by 2031, growing at a CAGR of 5% from 2024 to 2031.

Who are the main players in the icosapent ethyl API market?

The main players include Chemport Inc, DSM Nutritional Products Ltd, Ak Biopharm Co Ltd, Huatai Pharma Inc, Bizen Chemical Co Ltd, Finorga Sas, and Sichuan Gowell Pharmaceutical Co Ltd.

Sources

1. Brigham and Women's Hospital: REDUCE-IT Clinical Trial Results.
2. Market Research Intellect: Global Icosapent Ethyl Market Size and Projections.
3. The American Journal of Managed Care: Cost-Effectiveness Data and Pricing of Icosapent Ethyl.
4. American College of Cardiology: Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial - REDUCE-IT.
5. Valuates Reports: Icosapent Ethyl API - Market, Report Size, Worth, Revenue, Growth.