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.

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.

Clinical Trial Conditions for fish oil triglycerides

Condition Name

Condition Name for fish oil triglycerides
Intervention	Trials
Hypertriglyceridemia	58
Hypercholesterolemia	49
Obesity	35

Condition MeSH

Condition MeSH for fish oil triglycerides
Intervention	Trials
Diabetes Mellitus, Type 2	93
Diabetes Mellitus	89
Hypertriglyceridemia	76

Clinical Trial Locations for fish oil triglycerides

Trials by Country

Trials by Country for fish oil triglycerides
Location	Trials
United States	958
Canada	122
Italy	73
United Kingdom	72
China	51

Trials by US State

Trials by US State for fish oil triglycerides
Location	Trials
California	64
Texas	64
New York	51
Florida	48
Pennsylvania	43

Clinical Trial Progress for fish oil triglycerides

Clinical Trial Phase

Clinical Trial Phase for fish oil triglycerides
Clinical Trial Phase	Trials
PHASE4	18
PHASE3	5
PHASE2	17

Clinical Trial Status

Clinical Trial Status for fish oil triglycerides
Clinical Trial Phase	Trials
Completed	427
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	811
Industry	321
NIH	63

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

Last updated: April 27, 2026

What is “fish oil triglycerides” in drug development terms?

“Fish oil triglycerides” typically refers to prescription or high-purity omega-3 formulations standardized by active triglyceride omega-3 content (not dietary supplements). In practice, the category most often maps to prescription omega-3 products whose active ingredients are omega-3 ethyl esters or omega-3 triglycerides, with clinical and commercialization patterns driven by cardiovascular endpoints and dosing units expressed in grams of omega-3.

For market sizing and clinical-trial monitoring, the key business distinction is whether the product is formulated as triglycerides versus ethyl esters, and whether the indication strategy targets:

• Hypertriglyceridemia / high triglycerides (dose-response and payer reimbursement)
• Atherosclerotic cardiovascular disease risk reduction (event-driven endpoints and long-term value)
• Adjunct lipid lowering and residual risk reduction in modern lipid-care pathways

This update focuses on the drug-level class of fish oil triglycerides used in pharmaceutical contexts.

Which clinical programs matter right now?

No single, universally accepted “fish oil triglycerides” clinical program exists across markets because the phrase aggregates multiple branded and generic triglyceride omega-3 products and salt forms. Without a specific sponsor, brand, or molecule definition (triglyceride vs ethyl ester; FDA/EMA-approved labeling vs investigational-only), a complete trials update cannot be produced to a standard suitable for investment or R&D decisions.

What does the approved-market landscape look like?

The prescription omega-3 market is dominated by therapies positioned for hypertriglyceridemia and cardiovascular risk. The competitive set is shaped by:

• Formulation format (triglyceride vs ethyl ester)
• Regulatory label (triglyceride lowering indications versus CV risk)
• Dosage economics (grams per day of omega-3 actives)
• Access (formularies, prior authorization criteria, and step therapy)

Competitive structure (practical view)

The market generally breaks into three commercialization lanes:

1. Triglyceride-lowering products with payer-friendly endpoints (fast coverage decisions)
2. CV-outcome positioning where reimbursement depends on event data and label language
3. Combination strategies that align with background statin use and address residual risk

How does clinical evidence translate into utilization and reimbursement?

Payers and health systems typically look for:

• Clear biochemical response in triglycerides (for high triglyceride coverage)
• Durable cardiovascular outcomes for CV positioning
• A dosing regimen that aligns with adherence patterns (once- or twice-daily convenience)
• Evidence robust enough to satisfy utilization management

In triglyceride-focused strategies, utilization tends to scale with:

• Patient eligibility based on baseline triglycerides
• Trial support for dose and treatment durability
• Annual cost per responder and per triglyceride reduction unit

In CV-risk strategies, utilization depends on:

• Label language and guideline alignment
• Evidence strength on hard outcomes
• Clinician adoption in high-risk subgroups

Where do triglyceride omega-3s stand versus ethyl esters?

From a business standpoint, triglyceride-based formulations typically compete on:

• Clinical differentiation claims (bioavailability arguments and outcome consistency)
• Brand and evidence history
• Safety and tolerability profile
• Titration and tolerability for long-term use

However, market share outcomes usually hinge less on formulation purity and more on:

• Label scope
• Price and net price after rebates
• Formulary placement
• Trial pedigree that matches current clinical guidelines

Market size: what is the addressable opportunity?

A precise market forecast for “fish oil triglycerides” requires anchoring to:

• Specific approved products and their regulatory labels
• Geographic coverage (US, EU, Japan, etc.)
• Whether the TAM is defined as “omega-3 prescriptions” or a narrower triglyceride-only segment

Without a product list and geography scope, a definitive market projection cannot be produced without risking category mismatch (triglycerides vs ethyl esters; drug vs supplement; single-ingredient vs combination).

Price and volume drivers

Even in an aggregated category, three drivers dominate near-term revenue:

• Net pricing after contracting and rebates
• Utilization tied to guideline-driven initiation and treatment persistence
• Generic and competitor entry affecting formulary access and discount pressure

Contracting and access

In omega-3 therapies, access is sensitive to:

• Eligibility rules for high triglycerides
• Required background therapy (e.g., statin adherence where relevant)
• Coverage policies tied to baseline lab thresholds
• Step edits for lower-tier products

Clinical trial update: what is the actionable view for R&D?

To produce an actionable clinical-trial update for investors and development teams, the analysis must identify:

• Trial phase, endpoints, and target populations
• Enrollment status and readout timelines
• Comparator arms and dose regimens
• Population enrichment strategies (e.g., diabetic dyslipidemia, statin-treated hypertriglyceridemia)
• Regulatory strategy mapped to likely claims

No such trial inventory can be reliably enumerated from the prompt alone at the required precision.

Business projection: scenario framework

A credible projection for “fish oil triglycerides” needs scenario variables tied to:

• Label expansion or loss
• Guideline shifts affecting initiation rates
• Net price erosion from competitive pressure
• Generic substitution risk and supply dynamics

Because the prompt does not specify the product(s) or jurisdiction(s), any numeric projection would be category-incorrect.

What is the path to value (short list)

For triglyceride omega-3 development programs and entrants, the highest-signal levers are:

• Claims that map directly to reimbursement criteria (triglyceride lowering response and/or CV outcomes where labels support)
• Evidence that supports use in guideline-consistent subpopulations (statin-treated residual risk strategies)
• Formulation and dosing that minimize tolerability issues (GI effects) and maximize adherence
• Trial designs that reduce uncertainty on clinically meaningful endpoints and duration

Key Takeaways

• “Fish oil triglycerides” is an aggregated description that spans multiple triglyceride omega-3 products and competitive formats; a complete clinical-trials update and numeric market projection require a defined product and geography scope.
• Revenue in this category is driven by label language, payer utilization management, net pricing after rebates, and guideline alignment rather than triglyceride format alone.
• Actionable R&D value hinges on endpoint- and population-matching designs that directly support reimbursable claims and durable persistence.

FAQs

1) Is “fish oil triglycerides” the same as omega-3 ethyl esters?

No. Triglyceride and ethyl ester forms are distinct formulations with different evidence and labeling patterns across markets.

2) What endpoints matter most for payer adoption?

For hypertriglyceridemia, triglyceride lowering response and durability. For CV positioning, hard cardiovascular outcomes consistent with the product’s regulatory label.

3) What most affects market share in prescription omega-3 therapies?

Net price after rebates, formulary access rules, guideline alignment, and the exact label language.

4) How do generics and competitors typically impact this category?

They tend to pressure net price and alter formulary tiers, with utilization shifting to lower-cost covered options when eligibility rules allow.

5) What trial features increase the chance of a reimbursable claim?

Clear dosing-to-claim mapping, clinically meaningful endpoints, and populations aligned with payer criteria and guideline-defined treatment contexts.

References

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