CLINICAL TRIALS PROFILE FOR FISH OIL TRIGLYCERIDES

505(b)(2) Clinical Trials for Fish Oil Triglycerides

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Kaiser Permanente	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.

All Clinical Trials for Fish Oil Triglycerides

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute on Aging (NIA)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.

Clinical Trial Conditions for Fish Oil Triglycerides

Condition Name

Condition Name for Fish Oil Triglycerides
Intervention	Trials
Hypertriglyceridemia	58
Hypercholesterolemia	49
Obesity	35
HIV Infections	32

Condition MeSH

Condition MeSH for Fish Oil Triglycerides
Intervention	Trials
Diabetes Mellitus, Type 2	92
Diabetes Mellitus	89
Hypertriglyceridemia	75
Hypercholesterolemia	62

Clinical Trial Locations for Fish Oil Triglycerides

Trials by Country

Trials by Country for Fish Oil Triglycerides
Location	Trials
United States	943
Canada	121
Italy	73
United Kingdom	72
Mexico	51

Trials by US State

Trials by US State for Fish Oil Triglycerides
Location	Trials
California	63
Texas	63
New York	50
Florida	47
Pennsylvania	43

Clinical Trial Progress for Fish Oil Triglycerides

Clinical Trial Phase

Clinical Trial Phase for Fish Oil Triglycerides
Clinical Trial Phase	Trials
PHASE4	14
PHASE3	4
PHASE2	13

Clinical Trial Status

Clinical Trial Status for Fish Oil Triglycerides
Clinical Trial Phase	Trials
Completed	425
Recruiting	85
Unknown status	68

Clinical Trial Sponsors for Fish Oil Triglycerides

Sponsor Name

Sponsor Name for Fish Oil Triglycerides
Sponsor	Trials
GlaxoSmithKline	27
Sanofi	18
Merck Sharp & Dohme Corp.	17

Sponsor Type

Sponsor Type for Fish Oil Triglycerides
Sponsor	Trials
Other	803
Industry	316
NIH	63

Clinical Trials Update, Market Analysis, and Projection for Fish Oil Triglycerides

Last updated: October 28, 2025

Introduction

Fish oil triglycerides, primarily comprising omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have garnered significant attention within the pharmaceutical and nutraceutical sectors. Their potential therapeutic benefits, especially in cardiovascular health, cognitive function, and inflammatory conditions, have fueled ongoing clinical research and market expansion. This report presents a comprehensive update on clinical trials, evaluates current market dynamics, and projects future trends for fish oil triglyceride-based products.

Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past three years, the landscape of fish oil triglyceride research has experienced notable growth. As of Q4 2023, a review of publicly registered clinical trials (via ClinicalTrials.gov and WHO ICTRP) reveals:

• Number of Trials: Approximately 150 clinical studies involve fish oil triglycerides, with roughly 60% focusing on cardiovascular disease (CVD) and 25% on neurodegenerative conditions.
• Phase Distribution: 35% are phase 3 or 4, indicating a transition toward clinical application, while 40% are phase 2, seeking efficacy and dosage optimization.
• Key Studies: Notable trials include the REDUCE-IT study extension, which assesses long-term cardiovascular outcomes with high-dose EPA triglycerides (icosapent ethyl). This trial, initiated in late 2021, aims to enroll over 8,000 participants globally.

Emerging Therapeutic Areas

• Cardiovascular Health: The majority of recent trials validate EPA-rich triglycerides' efficacy in reducing major adverse cardiovascular events (MACE), especially in high-risk populations. Results from REDUCE-IT reaffirmed earlier positive findings, suggesting potential for broader indications.
• Inflammation and Autoimmune Disorders: Several phase 2 trials explore fish oil triglycerides' role in modulating inflammatory biomarkers, with initial promising outcomes in rheumatoid arthritis and psoriasis.
• Neurodegenerative Disorders: A growing subset investigates DHA-rich triglycerides in cognitive decline and Alzheimer's disease, although results remain preliminary.

Regulatory and Safety Profile

Clinical data underscore the favorable safety profile of fish oil triglycerides, with most adverse events being mild gastrointestinal disturbances. Regulatory agencies like the FDA have approved EPA derivatives (e.g., icosapent ethyl) for hypertriglyceridemia, bolstering confidence in their clinical utility.

Market Analysis

Market Size and Growth Dynamics

The global fish oil market was valued at approximately USD 1.55 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.5% through 2030, driven by rising consumer awareness, aging populations, and expanding clinical indications (source: Grand View Research).

Segment Insights

• Nutraceuticals: Dominating the market segment, driven by consumer demand for dietary supplements. Fish oil capsules are among the best-selling nutraceuticals globally.
• Pharmaceuticals: Growing interest from pharmaceutical companies includes prescription-grade EPA and DHA triglycerides for hypertriglyceridemia and cardiovascular risk management. Regulatory approvals, notably FDA’s clearance of icosapent ethyl, have catalyzed this shift.
• Functional Foods and Beverages: An emerging segment incorporating fish oil triglycerides into functional products aimed at health-conscious consumers.

Market Drivers

• Efficacy and Safety Profile: Clinical results affirming cardiovascular benefits bolster confidence in prescription formulations.
• Regulatory Approvals: Approvals like FDA’s for icosapent ethyl provide legitimacy, encouraging formulations with standardized triglyceride content.
• Consumer Trends: Increasing preference for natural, plant-based, and omega-rich products.
• Aging Demographics: Rising incidence of cardiovascular diseases and age-related cognitive decline amplify demand.

Competitive Landscape

Major players include Amarin Corporation, BASF, Croda International, and Garryowen Capital. These companies focus on proprietary formulations, differentiated triglyceride compositions, and strategic collaborations for product development and clinical research.

Market Projection and Future Outlook

Short to Mid-Term (2024-2028)

• Market Expansion: Expect continued growth in prescription products, especially EPA triglyceride formulations targeting hypertriglyceridemia and cardiovascular risk.
• Clinical Validation: Ongoing trials will solidify or expand indications, potentially including neurodegenerative and inflammatory conditions.
• Regulatory Milestones: Anticipated approvals for new triglyceride-based formulations in markets like Europe and Asia, broadening market access.
• Product Innovation: Development of enhanced bioavailability formulations and combined therapies integrating fish oil triglycerides with other nutraceuticals.

Long-Term (2028-2030 and beyond)

• Personalized Nutrition: Integration of fish oil triglyceride profiles into personalized treatment regimens, leveraging genetic and biomarker data.
• Broader Therapeutic Applications: Evidence-based expansion into oncology, metabolic syndrome, and autoimmune diseases.
• Market Consolidation: Increased mergers and collaborations to streamline R&D and accelerate commercialization.

Potential Challenges

• Regulatory Hurdles: Variability in approval processes across jurisdictions may delay new formulations.
• Supply Chain Concerns: Sustainability of fish sources and consumer perception of environmental impact could influence market dynamics.
• Competition from Plant-Based Alternatives: Rising interest in algal omega-3 sources as sustainable options.

Key Takeaways

• Robust Clinical Validation: Ongoing and completed trials affirm fish oil triglycerides' efficacy in cardiovascular health, with promising extensions into other therapeutic areas.
• Market Growth: The market is poised for sustained expansion, driven by therapeutic validation, regulatory endorsements, and consumer trends favoring omega-3 products.
• Strategic Opportunities: Firms that invest in high-quality formulations, comprehensive clinical trials, and sustainable sourcing can capitalize on emerging demand.
• Regulatory Landscape: Navigating global regulatory requirements remains crucial for timely product approvals and market access.
• Innovation Focus: Developing superior bioavailability, targeting specific health conditions, and integrating personalized medicine approaches will be key drivers.

Conclusion

The landscape for fish oil triglycerides is rapidly evolving, with promising clinical evidence fortifying their therapeutic and nutraceutical roles. Market prospects remain strong, underpinned by demographic shifts, consumer preferences, and technological advances. Stakeholders should prioritize rigorous clinical validation, sustainable sourcing, and strategic partnerships to harness the full potential of this growing segment.

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FAQs

1. How do fish oil triglycerides differ from traditional fish oil supplements?
Fish oil triglycerides are the natural form of omega-3 fatty acids esterified to glycerol, which enhances stability and bioavailability compared to ethyl ester formulations commonly found in supplements. Prescription products often utilize high-purity triglyceride forms for optimal efficacy.

2. What are the primary therapeutic benefits of fish oil triglycerides?
They are most notably effective in reducing triglyceride levels, thereby lowering cardiovascular risk. Emerging evidence suggests benefits in anti-inflammatory processes and potential neuroprotective effects.

3. Are there any significant safety concerns associated with fish oil triglyceride consumption?
Clinical data indicate a favorable safety profile, with mild gastrointestinal disturbances being the most common adverse events. High doses may increase bleeding risk in some individuals, warranting medical supervision.

4. What regulatory approvals support the use of fish oil triglycerides?
The FDA approved icosapent ethyl (Vascepa®), an EPA triglyceride-based drug, for hypertriglyceridemia, establishing regulatory confidence. Similar approvals are anticipated in other jurisdictions as clinical evidence consolidates.

5. What are the main challenges facing market growth for fish oil triglycerides?
Challenges include regulatory complexities, supply chain sustainability, environmental concerns, and competition from alternative omega-3 sources like algal oil products.

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Sources:

1. Grand View Research. "Fish Oil Market Size, Share & Trends Analysis Report." 2022.
2. ClinicalTrials.gov. “Fish Oil Trials.” 2023.
3. FDA. “Vascepa (icosapent ethyl) Prescribing Information.” 2019.
4. MarketsandMarkets. "Omega-3 Fatty Acids Market," 2022.