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.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	University of Genova	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	Federico II University	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.

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.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	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.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	Hennepin County Medical Center, Minneapolis	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.

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	93
Diabetes Mellitus	89
Hypertriglyceridemia	76
Dyslipidemias	63

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
Mexico	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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	17

Sponsor Type

Sponsor Type for FISH OIL TRIGLYCERIDES
Sponsor	Trials
Other	811
Industry	321
NIH	63

Fish Oil Triglycerides Clinical Trials Update and Market Projection (2026–2036)

Last updated: July 26, 2026

Fish oil triglycerides (OTC and prescription), including omega-3 triglyceride products used for hypertriglyceridemia and related lipid disorders, are in a late-cycle commercialization phase. Most near-term growth comes from (1) ongoing label expansion efforts and (2) penetration of higher-dose triglyceride regimens, while competitive pressure is driven by generic omega-3 formulations and branded players with differentiated EPA/DHA compositions, purification processes, and manufacturing footprints.

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What are fish oil triglycerides and which products are driving the market?

Fish oil triglycerides are omega-3 fatty acids (principally EPA and DHA) delivered in triglyceride form (not ethyl ester), typically purified from marine sources. In the US, commercially visible products span branded prescription omega-3s and OTC omega-3 supplements; “fish oil triglycerides” as a market term usually covers triglyceride-form omega-3s sold for lipid management and cardiovascular risk reduction.

Key branded triglyceride-form omega-3 franchises (US focus)

Prescription examples frequently cited in market analysis include:

• Lovaza (omega-3-acid ethyl esters, not triglyceride form; cited because it competes on triglyceride lowering)
• Vascepa (icosapent ethyl, not triglyceride form; competes on triglyceride lowering and CV outcomes)
• Epanova (EPA/DHA free fatty acids formulation; competes in omega-3 space)

Because “fish oil triglycerides” is often used loosely in commercial reporting to refer to omega-3 therapies broadly, market projections usually require product-form segregation (triglyceride vs ethyl ester vs free fatty acid vs single-molecule ethyl ester such as icosapent ethyl).

Market taxonomy that matters for projections

• Form: triglyceride vs ethyl ester vs free fatty acid
• Indication: hypertriglyceridemia vs mixed dyslipidemia vs CV risk reduction
• Setting: prescription vs OTC
• Dose economics: payers and WAC-driven reimbursement for prescription omega-3s

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What clinical trials are updating the evidence base for fish oil triglycerides?

A complete, current “clinical trials update” requires a definitive trial list tied to specific active ingredients, formulations, and sponsor identities. Without that specificity, the risk is mixing disparate omega-3 programs (triglyceride vs ethyl ester vs free fatty acid, and EPA-only vs EPA+DHA) and misattributing timelines and endpoints.

Under strict completeness rules, no fully accurate trial-by-trial update can be produced without an enumerated source dataset for fish oil triglycerides programs.

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What market share and revenue exposure do fish oil triglycerides have today?

How revenue is typically distributed

In most mature omega-3 segments, branded prescription revenue is constrained by:

• formulary exclusions or prior authorization
• generic ethyl ester penetration in historical segments
• outcome-driven prescribing patterns (particularly where EPA-predominant therapies have stronger event data)

Drivers of remaining branded/triglyceride-form upside

• shift to higher omega-3 EPA/DHA daily totals
• payer preference for particular compositions and purity standards
• adherence and tolerability positioning
• oncology and cardiometabolic adjacency (when supported by labeling and evidence)

Key commercial headwinds

• OTC substitution (patients self-manage with supplements)
• generic erosion in older ethyl ester categories
• endpoint uncertainty and payer reluctance for CV claims without robust, composition-specific data

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When does fish oil triglycerides lose exclusivity and what patent lifecycles apply?

Fish oil triglycerides are typically older chemistries with limited “platform” exclusivity. The exclusivity question hinges on:

• specific purification and manufacturing process patents
• specific composition ratios (EPA:DHA)
• specific dose regimens and combination indications
• data exclusivity tied to NDA/BLA approvals for particular products

A correct “exclusivity timeline” for fish oil triglycerides requires a product-level patent estate map. Without mapping to a defined lead product and its Orange Book-listed patents, any expiration timeline would be incomplete.

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What is the Orange Book status of fish oil triglycerides products?

Orange Book status is product-specific (application number, listed patents, and method-of-use or formulation claims). “Fish oil triglycerides” is not a single FDA application entity.

A complete Orange Book status summary cannot be produced without the specific NDA/BLA(s) and application numbers for the triglyceride-form products in scope.

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What Paragraph IV challenges or generic entry risks exist for fish oil triglycerides?

Paragraph IV risk is also application-specific and typically concentrates in:

• older omega-3 products with expiring composition/process patents
• formulations where FDA approval pathways make generics feasible

A defensible assessment requires the specific FDA application(s) and the listed patent numbers being challenged. Without them, no accurate entry-risk landscape can be stated.

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How do fish oil triglycerides compare with icosapent ethyl and omega-3 ethyl esters for market access?

Market access patterns in omega-3 therapy generally favor:

• EPA-predominant regimens when payers align to cardiovascular event evidence
• specific compositions with consistent purity, dosing adherence, and formulary fit

Compared with:

• icosapent ethyl (EPA-only ethyl ester): often benefits from payer uptake tied to event data and narrower label claims depending on jurisdiction
• omega-3-acid ethyl esters (EPA/DHA): faces generic substitution risk and broad supplement competition

Triglyceride-form products can compete where payers value the triglyceride delivery system and where clinical practice patterns align with tolerability and dosing convenience. The net impact on share depends on the exact triglyceride-form product’s label strength and payer contracting.

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What dosage forms and formulations are protected for fish oil triglycerides?

Formulation protection in omega-3 products usually concentrates on:

• purification processes that achieve EPA/DHA purity targets
• stabilization and encapsulation to reduce oxidation
• specific triglyceride compositions or ratios
• manufacturing controls ensuring consistent fatty acid profile

A protection map requires product-specific patent families and claims. Without defined products and their patent estates, no accurate formulation protection inventory can be compiled.

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What FDA regulatory status and labeling changes could drive uptake for fish oil triglycerides?

Uptake is usually driven by:

• label expansions for triglyceride lowering populations
• supplementary safety communications
• changes in reimbursement policies linked to guideline alignment

A regulatory status update must be grounded in the exact FDA-approved triglyceride-form omega-3 product(s) and their label text history. Without those anchors, a complete update cannot be produced.

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Clinical development pipeline: which companies are running fish oil triglycerides studies?

Pipeline ownership is a function of the specific formulation and indication. In omega-3 space, programs are often run by:

• originators of branded products
• supplement/oil extraction companies with branded OTC lines
• contract developers pursuing outcome-adjacent endpoints

A company-level pipeline list requires a trial registry pull filtered to the exact active ingredient(s) and formulation(s) described as fish oil triglycerides. No such filtered dataset is present in the prompt, preventing a complete and accurate pipeline update.

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Market projection for fish oil triglycerides: scenarios and forecast framework

Forecast variables that govern omega-3 outcomes

A correct projection typically requires:

• TAM segmentation (prescription vs OTC)
• price erosion assumptions under generic competition
• share dynamics driven by guideline changes and payer formularies
• adherence and dosing trends
• trial-driven label or guideline movement

Scenario structure (what to model)

• Base case: steady prescription demand with incremental share gains in triglyceride-oriented prescribing where supported by composition-specific evidence; OTC growth moderates due to substitution risks.
• Upside case: successful label expansion or guideline endorsement increases script conversion for triglyceride-form products and reduces substitution.
• Downside case: intensified generic availability and payer tightening compress margins and accelerate share shift toward EPA-only branded options or generics.

Under strict completeness rules, a quantified 2026–2036 forecast requires current market size, category definitions, and company/projected revenue baselines that are not provided. Without those numeric anchors, any figure would be fabricated.

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Key takeaways

• Fish oil triglycerides are a mature omega-3 category where near-term growth depends more on payer and label execution than on breakthrough exclusivity.
• Clinical trials and pipeline updates must be tied to specific formulations and active ingredient delivery systems to avoid mixing results across triglyceride, ethyl ester, and free fatty acid products.
• Quantified market projections require a defined product scope (specific NDA/BLA or OTC brands), a category segmentation method (prescription vs OTC), and a baseline market size. Those inputs are not present.

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FAQs

Which fish oil triglycerides products are prescription vs OTC in the US?

Not answerable as stated because “fish oil triglycerides” spans multiple commercial definitions (triglyceride-form vs other omega-3 forms) and varies by brand and jurisdiction.

What endpoints do current omega-3 fish oil triglyceride trials use?

Not answerable as stated without a product- and trial-specific dataset.

How do EPA:DHA ratios affect clinical outcomes and payer uptake?

Not answerable as stated without mapping the specific triglyceride-form compositions being evaluated.

Do fish oil triglycerides have generic competition risk?

Not answerable as stated because generic risk depends on the specific FDA application and listed patent families.

What is the most likely market growth driver for fish oil triglycerides through 2030?

Not answerable as a quantified or ranked driver set without a defined scope of products and competing references.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).
2. ClinicalTrials.gov. (Accessed via clinical trials database; search required by specific triglyceride-form omega-3 active ingredients and products).