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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR OMEGA-3-ACID ETHYL ESTERS


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All Clinical Trials for Omega-3-acid Ethyl Esters

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000473 ↗ Do Fish Oils Prevent Restenosis Post-Coronary Angioplasty? Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1989-07-01 To determine whether a dietary supplement of n-3 polyunsaturated fatty acids (PUFAs) derived from fish oil would decrease the restenosis rate in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).
NCT00001146 ↗ Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial Completed National Institute of Mental Health (NIMH) Phase 2 1999-10-01 This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants and fish, in treating bipolar disorder. Some studies have indicated that omega-3 fatty acids may be effective in treating mood disorders. For example, one investigator has shown a correlation between the prevalence of major depression and the amount of fish consumed per capita worldwide. Others have found decreased amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells of patients with major depression. And a recent small study of patients with bipolar illness indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients. Patients with bipolar disorder who are not benefiting satisfactorily on their current medications are eligible to participate in this study. Candidates will be screened with a psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor medications. Participants will be randomly assigned to one of two groups: one group will receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a placebo (inactive capsule). In addition, patients in both groups will continue to take their previous medications. Every 2 weeks, all patients will have their vital signs checked and be evaluated for side effects and mood changes. At the end of the 16-week study period, all patients will be given the opportunity to continue in the study for another 8 months and receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a month and will have blood drawn on the last visit for routine tests.
NCT00074542 ↗ An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease Completed Tillotts Pharma AG Phase 3 2002-09-01 The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy. Patient safety and quality of life will also be monitored throughout the study.
NCT00246636 ↗ Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension Completed GlaxoSmithKline Phase 4 2005-10-01 The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides. The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Omega-3-acid Ethyl Esters

Condition Name

Condition Name for Omega-3-acid Ethyl Esters
Intervention Trials
Hypertriglyceridemia 10
Hyperlipidemia 4
Breast Cancer 4
Psoriasis 3
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Condition MeSH

Condition MeSH for Omega-3-acid Ethyl Esters
Intervention Trials
Hypertriglyceridemia 14
Psoriasis 6
Diabetes Mellitus 5
Breast Neoplasms 4
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Clinical Trial Locations for Omega-3-acid Ethyl Esters

Trials by Country

Trials by Country for Omega-3-acid Ethyl Esters
Location Trials
United States 119
Japan 11
Germany 8
Canada 8
Egypt 6
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Trials by US State

Trials by US State for Omega-3-acid Ethyl Esters
Location Trials
California 8
Texas 7
Kansas 6
Ohio 6
Pennsylvania 6
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Clinical Trial Progress for Omega-3-acid Ethyl Esters

Clinical Trial Phase

Clinical Trial Phase for Omega-3-acid Ethyl Esters
Clinical Trial Phase Trials
Phase 4 18
Phase 3 17
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Omega-3-acid Ethyl Esters
Clinical Trial Phase Trials
Completed 51
Unknown status 5
Recruiting 5
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Clinical Trial Sponsors for Omega-3-acid Ethyl Esters

Sponsor Name

Sponsor Name for Omega-3-acid Ethyl Esters
Sponsor Trials
GlaxoSmithKline 11
Takeda 4
Alexion Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Omega-3-acid Ethyl Esters
Sponsor Trials
Other 64
Industry 38
NIH 7
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Omega-3-Acid Ethyl Esters: Clinical Trials, Market Analysis, and Projections

Introduction

Omega-3-acid ethyl esters, commonly known as omega-3 fatty acids, have been a focal point in both clinical and market realms due to their potential health benefits, particularly in cardiovascular health. This article delves into the recent clinical trials, market analysis, and future projections for these compounds.

Clinical Trials Update

Cardiovascular Event Lowering

Clinical trials have shown mixed results regarding the efficacy of omega-3 fatty acids in lowering cardiovascular events. However, certain formulations have demonstrated significant benefits. For instance, icosapent ethyl, a highly purified form of eicosapentaenoic acid (EPA), has been shown to reduce triglyceride (TG) levels and residual cardiovascular risk in patients with hypertriglyceridemia and those treated with statins.

  • The MARINE trial demonstrated a 33.1% reduction in TG levels with 4 g/day of icosapent ethyl without increasing low-density lipoprotein cholesterol (LDL-C) levels[1].
  • The ANCHOR trial also confirmed the safety and efficacy of icosapent ethyl in reducing TG levels in high-risk statin-treated patients, with a median placebo-adjusted change in TG levels of 21.5%[1].

Anti-Inflammatory and Antithrombotic Effects

Beyond triglyceride lowering, omega-3 fatty acids have been shown to have pleiotropic effects, including anti-inflammatory and antithrombotic actions. These effects are mediated by EPA and include the reduction of markers of inflammation, such as oxidized LDL and lipoprotein-associated phospholipase A2[1].

Long-Term Outcomes Post-Myocardial Infarction

The OMEGA-REMODEL trial investigated the impact of omega-3 fatty acids on long-term clinical outcomes post-acute myocardial infarction (AMI). While the trial did not show a reduction in major adverse cardiovascular events (MACE) by intention-to-treat analysis, patients who achieved a significant increase in the red blood cell omega-3 index (O3I) had lower annualized MACE rates[4].

Mechanism of Action

Pharmacodynamics

Omega-3-acid ethyl esters work by reducing triglyceride production in the liver, increasing fatty acid metabolism, inhibiting the release of fatty acids, and enhancing triglyceride clearance. They also decrease the production of very low-density lipoprotein cholesterol (VLDL-C) by inhibiting acyl-CoA:1,2-diacylglycerol acyltransferase and increasing paroxysmal beta-oxidation[3].

Market Analysis

Market Size and Growth

The global omega-3 fatty acids market is projected to grow significantly, with a compound annual growth rate (CAGR) of 7.1% from 2024 to 2031, increasing from USD 2.21 billion in 2023 to USD 3.83 billion by 2031[2].

Market Drivers

  • Increasing Health Awareness: Growing awareness about the health benefits of omega-3 fatty acids, such as their role in managing autoimmune diseases and supporting heart health, is driving market growth[2].
  • Rising Consumption of Dietary Supplements: The increased consumption of dietary supplements, including omega-3 fish oil supplements, is a major trend supporting market growth[2].
  • Expanding Product Formulations: Improvements in product formulations, such as the development of more appealing omega-3 soft capsules, are making these products more attractive to consumers[5].

Market Opportunities

  • Growing Health Consciousness: Increasing health consciousness among consumers is driving the demand for omega-3 supplements[5].
  • Rising Prevalence of Lifestyle-Related Diseases: The growing prevalence of lifestyle-related diseases is boosting the consumption of omega-3 supplements[5].
  • Expanding Geriatric Population: The increasing geriatric population creates significant market potential for omega-3 products due to their benefits in managing age-related health issues[5].

Market Challenges

  • Logistical and Distribution Challenges: Streamlining logistics and distribution channels to ensure global product availability is a significant challenge[5].
  • Rising Raw Material Costs: Handling the rising costs of raw materials and their implications on product pricing is another challenge[5].
  • Regulatory Landscape: Understanding and navigating the complex regulatory landscape affecting product approvals is crucial for market growth[5].

Market Segmentation

Product Type

The market is segmented into various product types, including liquid formulations and soft gel capsules. Soft gel capsules, particularly the omega-3-acid ethyl ester 90 soft capsules, are gaining traction due to their concentrated form and ease of consumption[5].

Source Type

Omega-3 fatty acids can be derived from various sources, including fish oil, krill oil, and algae oil. Fish oil remains a primary source due to its high concentration of EPA and DHA[5].

Future Projections

Research and Development

Ongoing research and development activities are expected to further establish the safety and efficacy of omega-3 fatty acids in preventing various diseases. For example, a study by the University of Kansas Medical Center is investigating the effects of omega-3-acid ethyl esters on microbial and intestinal microbiota changes in patients at high risk of colorectal cancer[2].

Expanding Applications

The use of omega-3 fatty acids is expanding beyond human health to include pet food and animal feed, further boosting market demand[2].

Key Takeaways

  • Clinical Efficacy: Omega-3-acid ethyl esters have shown significant benefits in reducing triglyceride levels and residual cardiovascular risk, particularly with formulations like icosapent ethyl.
  • Market Growth: The global omega-3 fatty acids market is projected to grow at a CAGR of 7.1% from 2024 to 2031.
  • Health Awareness: Growing health awareness and the increasing consumption of dietary supplements are key drivers of market growth.
  • Challenges: Logistical, cost-related, and regulatory challenges need to be addressed to ensure sustained market growth.

FAQs

Q: What are the primary health benefits of omega-3-acid ethyl esters?

A: The primary health benefits include reducing triglyceride levels, lowering residual cardiovascular risk, and providing anti-inflammatory and antithrombotic effects.

Q: Which clinical trials have shown significant benefits of omega-3 fatty acids?

A: The MARINE and ANCHOR trials have demonstrated significant reductions in triglyceride levels with icosapent ethyl, while the OMEGA-REMODEL trial highlighted benefits in patients with increased red blood cell omega-3 index.

Q: What is the projected market size of the omega-3 fatty acids market by 2031?

A: The market is projected to reach USD 3.83 billion by 2031, growing at a CAGR of 7.1% from 2024 to 2031[2].

Q: What are the main challenges facing the omega-3 fatty acids market?

A: The main challenges include logistical and distribution issues, rising raw material costs, and navigating the complex regulatory landscape.

Q: What are the expanding applications of omega-3 fatty acids beyond human health?

A: The use of omega-3 fatty acids is expanding to include pet food and animal feed, further boosting market demand[2].

Sources

  1. Omega-3 fatty acids for cardiovascular event lowering - European Journal of Preventive Cardiology[1]
  2. Omega-3 Fatty Acids Market Size, Share, Growth 2031 - MarketsandData[2]
  3. Omega-3-Acid Ethyl Esters: Uses, Interactions, Mechanism of Action - DrugBank[3]
  4. Effect of six month's treatment with omega-3 acid ethyl esters on ... - PubMed[4]
  5. Omega-3-acid Ethyl Ester 90 Soft Capsules Market 2025-2030 - 360 Research Reports[5]

More… ↓

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