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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR OMEGA-3-ACID ETHYL ESTERS TYPE A


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All Clinical Trials for Omega-3-acid Ethyl Esters Type A

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.
NCT00246701 ↗ Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects Completed GlaxoSmithKline Phase 3 2005-11-01 The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy. Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Omega-3-acid Ethyl Esters Type A

Condition Name

Condition Name for Omega-3-acid Ethyl Esters Type A
Intervention Trials
Hypertriglyceridemia 10
Hyperlipidemia 4
Breast Cancer 4
Cardiovascular Diseases 3
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Condition MeSH

Condition MeSH for Omega-3-acid Ethyl Esters Type A
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 Type A

Trials by Country

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

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

Clinical Trial Phase

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

Sponsor Name

Sponsor Name for Omega-3-acid Ethyl Esters Type A
Sponsor Trials
GlaxoSmithKline 11
Takeda 4
AstraZeneca 3
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Sponsor Type

Sponsor Type for Omega-3-acid Ethyl Esters Type A
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 medical research and the pharmaceutical industry due to their potential health benefits, particularly in cardiovascular health. This article will delve into the recent clinical trials, market analysis, and future projections for omega-3-acid ethyl esters.

Clinical Trials and Efficacy

Recent Studies on Omega-3-Acid Ethyl Esters

Recent clinical trials have provided valuable insights into the efficacy of omega-3-acid ethyl esters. The OMEGA-REMODEL trial, for instance, investigated the impact of omega-3-acid ethyl esters on adverse cardiac events in patients who had experienced acute myocardial infarction (AMI). The study involved 358 patients who were randomized to receive either omega-3-acid ethyl esters or a placebo for six months. While the overall results did not show a significant reduction in major adverse cardiovascular events (MACE) by intention-to-treat analysis, patients who achieved a ≥ 5% increase in the red blood cell omega-3 index (O3I) after treatment had significantly lower annualized MACE rates compared to those who did not[1].

Mechanism of Action and Therapeutic Effects

Omega-3-acid ethyl esters work by reducing triglyceride production, increasing fatty acid metabolism, inhibiting the release of fatty acids, and increasing triglyceride clearance. They also decrease the production of very low-density lipoprotein cholesterol (VLDL-C). These mechanisms are crucial in managing severe hypertriglyceridemia (HTG)[4].

Ongoing and Anticipated Trials

Several ongoing and anticipated trials are expected to further elucidate the benefits and potential expansions of omega-3-acid ethyl esters. For example, the REDUCE-IT and STRENGTH trials, though completed, have set the stage for future research. These trials evaluated the effects of omega-3-acid ethyl esters on cardiovascular events in patients with elevated triglyceride levels and other cardiovascular risk factors. Positive outcomes from such studies could significantly expand the market opportunity for omega-3-acid ethyl esters[3].

Market Analysis

Global Market Size and Growth

The global omega-3 fatty acids market is projected to experience substantial growth. From 2023 to 2031, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.1%, increasing from USD 2.21 billion in 2023 to USD 3.83 billion in 2031. This growth is driven by increasing demand for functional foods and supplements, infant formula, and the use of omega-3 fatty acids in pet food and animal feed[2].

North America Market

In North America, the omega-3 ingredients for pharmaceuticals market is also anticipated to grow significantly. The market is segmented by source (marine and plant), type (DHA, EPA, ALA), forms (liquid and dry), therapeutic areas, population type, and distribution channels. Key players in this market include Avestia Pharma, Novasep, AbbVie Inc., and others. The market is expected to see growth due to the increasing use of omega-3 ingredients in various therapeutic areas such as cardiovascular diseases, autoimmune diseases, and neurological disorders[5].

Market Drivers and Opportunities

Increasing Demand for Health Supplements

The rising demand for health supplements and functional foods is a significant driver for the omega-3 fatty acids market. Consumers are becoming more health-conscious, leading to an increased consumption of products that contain omega-3 fatty acids.

Expanding Therapeutic Areas

Research and development activities are expanding the potential therapeutic areas for omega-3-acid ethyl esters. For example, studies are being conducted to assess the effects of omega-3-acid ethyl esters on microbial and intestinal microbiota changes in patients at high risk of colorectal cancer. Such studies could establish new indications and boost market demand[2].

Growing Pet Food and Animal Feed Sector

The use of omega-3 fatty acids in pet food and animal feed is another growing segment. As pet owners become more aware of the health benefits of omega-3 fatty acids for their pets, this sector is expected to contribute significantly to the overall market growth.

Challenges and Limitations

Regulatory and Safety Concerns

While omega-3-acid ethyl esters have shown promising results, there are regulatory and safety concerns that need to be addressed. For instance, the mechanism of action of omega-3-acid ethyl esters in reducing triglyceride production is not fully understood, and there are contraindications and black box warnings associated with their use[4].

Competition and Market Saturation

The omega-3 fatty acids market is competitive, with several players offering similar products. Market saturation and competition could pose challenges for new entrants and existing players looking to expand their market share.

Key Takeaways

  • Clinical Efficacy: Omega-3-acid ethyl esters have shown mixed results in clinical trials, but patients with a positive response to treatment (increased O3I) have favorable outcomes.
  • Market Growth: The global omega-3 fatty acids market is projected to grow at a CAGR of 7.1% from 2023 to 2031.
  • Therapeutic Expansion: Research is expanding the potential therapeutic areas for omega-3-acid ethyl esters beyond cardiovascular health.
  • Market Drivers: Increasing demand for health supplements, expanding therapeutic areas, and growing use in pet food and animal feed are key drivers.
  • Challenges: Regulatory and safety concerns, as well as market competition, are significant challenges.

FAQs

Q: What are the primary indications for omega-3-acid ethyl esters?

A: Omega-3-acid ethyl esters are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (HTG)[4].

Q: What is the expected growth rate of the global omega-3 fatty acids market?

A: The global omega-3 fatty acids market is projected to grow at a CAGR of 7.1% from 2023 to 2031[2].

Q: What are the key therapeutic areas for omega-3-acid ethyl esters?

A: Besides cardiovascular diseases, omega-3-acid ethyl esters are being researched for their potential in autoimmune diseases, bone and joint disorders, neurological disorders, and other areas[5].

Q: What are the main drivers for the growth of the omega-3 fatty acids market?

A: The main drivers include increasing demand for health supplements and functional foods, expanding therapeutic areas, and growing use in pet food and animal feed[2].

Q: What are some of the challenges faced by the omega-3 fatty acids market?

A: Regulatory and safety concerns, as well as market competition and saturation, are significant challenges for the omega-3 fatty acids market[4].

Sources

  1. Effect of six month's treatment with omega-3 acid ethyl esters on ... - PubMed
  2. Omega-3 Fatty Acids Market Size, Share, Growth 2031 - MarketsandData
  3. NASDAQ & TSX-V: ACST Company Overview November/December ... - Gracell Biotechnologies
  4. Omega-3-acid ethyl esters: Uses, Interactions, Mechanism of Action - DrugBank
  5. North America Omega-3 Ingredients for Pharmaceuticals Market - Data Bridge Market Research

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