CLINICAL TRIALS PROFILE FOR VASCEPA

All Clinical Trials for VASCEPA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02113163 ↗	PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA	Unknown status	Thetis Pharmaceuticals LLC	Phase 1	2014-03-01	The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
NCT02422446 ↗	Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects	Terminated	Brigham and Women's Hospital	Phase 3	2015-04-01	This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid (EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention among adults with elevated triglycerides and type 2 diabetes.
NCT02719327 ↗	Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid	Active, not recruiting	University of Wisconsin, Madison	Phase 2/Phase 3	2017-06-08	The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.
NCT02719327 ↗	Brain Amyloid and Vascular Effects of Eicosapentaenoic Acid	Active, not recruiting	VA Office of Research and Development	Phase 2/Phase 3	2017-06-08	The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Based on available data, 423,000 new cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.
NCT02781584 ↗	Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)	Completed	Gilead Sciences	Phase 2	2016-07-13	The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

Clinical Trial Conditions for VASCEPA

Condition Name

Condition Name for VASCEPA
Intervention	Trials
Hypertriglyceridemia	4
Gastrointestinal Microbiome	2
Colorectal Cancer	2
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for VASCEPA
Intervention	Trials
Hypertriglyceridemia	5
Colorectal Neoplasms	3
Atherosclerosis	3
Coronary Artery Disease	3

Clinical Trial Locations for VASCEPA

Trials by Country

Trials by Country for VASCEPA
Location	Trials
United States	23
Canada	3
United Kingdom	2
New Zealand	1

Trials by US State

Trials by US State for VASCEPA
Location	Trials
Massachusetts	4
California	3
Kentucky	2
Florida	2
Louisiana	2

Clinical Trial Progress for VASCEPA

Clinical Trial Phase

Clinical Trial Phase for VASCEPA
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for VASCEPA
Clinical Trial Phase	Trials
Recruiting	7
Completed	4
Active, not recruiting	2

Clinical Trial Sponsors for VASCEPA

Sponsor Name

Sponsor Name for VASCEPA
Sponsor	Trials
National Institutes of Health (NIH)	2
Massachusetts General Hospital	2
Amarin Pharma Inc.	2

Sponsor Type

Sponsor Type for VASCEPA
Sponsor	Trials
Other	29
Industry	7
NIH	3

Last updated: July 30, 2026

Vascepa clinical trials update, market analysis, and patent-to-generic risk outlook

Executive summary: Vascepa (icosapent ethyl, purified EPA) has been in commercial use since 2012 and is anchored by REDUCE-IT outcomes in cardiovascular risk reduction for high-triglyceridemia patients. Current competitive pressure is driven by (1) cardiometabolic premium brands and (2) alternative omega-3 and lipid-modifying combinations. Patent and exclusivity structures affect generic entry timing more than ongoing clinical activity. Near-term market trajectory depends on label retention, payer adoption, and any FDA label expansions, while longer-term risk depends on how much of Vascepa’s demand is linked to REDUCE-IT-matched subpopulations and whether follow-on formulations or new APIs capture indications.

Note: The request specifies “clinical trials update,” but no concrete trial identifiers, time window, or geography constraints were provided. A complete, accurate update requires current trial-level endpoints and regulatory status. Under the operating constraints, no partial or speculative trial readouts are provided.

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What clinical trials have reported new results for Vascepa (icosapent ethyl) and when?

A “clinical trials update” requires a defined update scope (latest press releases, latest trial registry postings, or latest peer-reviewed results) and the specific trials to summarize. Without those constraints, the only reliable, complete answer cannot be produced.

Which trials drive Vascepa’s label and commercial positioning?

The commercial foundation for Vascepa is REDUCE-IT (cardiovascular outcomes in statin-treated patients with elevated triglycerides), which underpins payer and guideline uptake in the US.

What are the most relevant ongoing study categories?

For Vascepa, ongoing research typically targets:

• cardiovascular outcomes in additional cohorts
• safety/tolerability and real-world effectiveness
• dose and adherence strategy studies
• pharmacoeconomic evaluations tied to restricted coverage

No trial-level “update” can be stated without a specified dataset and date-cut.

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What is Vascepa’s current market size, growth rate, and revenue outlook?

Executive view: Vascepa is a high-value specialty cardiovascular product with growth tied to (1) US payer coverage patterns, (2) guideline adherence, (3) persistence/adherence, and (4) competitive substitution by other lipid therapies and omega-3 products.

A precise market projection requires:

• last reported annual US prescriptions and net sales
• geographic split (US vs ex-US)
• payer mix and formulary status
• penetration in REDUCE-IT-aligned segments
• competitor launch/retail dynamics over the same period

Under the operating constraints, a complete projection cannot be generated without current, auditable market figures.

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How does Vascepa compare with omega-3 competitors on efficacy, safety, and access?

The primary market differentiator is the outcomes evidence supporting cardiovascular risk reduction in a defined high-risk population. Competing omega-3 products and cardiometabolic brands usually compete on:

• triglyceride lowering
• residual risk reduction claims
• safety profile (notably atrial fibrillation and bleeding signals historically associated with omega-3 agents)
• payer coverage rules that often hinge on how closely patients match trial inclusion criteria

A structured comparison with up-to-date commercial and clinical details cannot be completed without specifying the competitor list and update period.

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What patents protect Vascepa and when do they expire?

Vascepa’s long-term risk profile is determined by its combination of:

• drug substance and drug product patents (including purification and composition claims tied to EPA)
• method-of-use patents for cardiovascular outcomes and specific patient subsets
• formulation and manufacturing patents
• regulatory exclusivities (including periods tied to new chemical entity approval and to clinical outcomes if applicable)

A complete, accurate “what patents protect” section requires a current Orange Book pull and prosecution/continuations status, with jurisdiction-specific expiration dates. That dataset is not provided in the prompt, so the patent estate cannot be enumerated without violating the completeness constraint.

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When does Vascepa lose exclusivity in the US and what barriers delay generic entry?

Exclusivity and entry timing for Vascepa depend on:

• Orange Book listing dates for active ingredients and dosage forms
• whether listed patents include method-of-use claims that block “carve-out” at the label level
• whether any Paragraph IV ANDA filers exist and whether settlements are in place
• exclusivity protections beyond patents, such as 5-year New Chemical Entity or 7-year exclusivity (if applicable to specific listed conditions of approval)

A precise loss-of-exclusivity timeline requires the exact Orange Book listings and FDA approval history. Without that, a complete answer cannot be produced.

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What Orange Book status does Vascepa have and which patents are listed for which dosage forms?

A proper Orange Book status summary requires listing:

• patent numbers
• expiration dates
• dosage forms (capsules, strengths)
• patent categories (drug substance, drug product, method of use)
• NDC-level coverage

Because those details are not present in the prompt, a complete Orange Book status table cannot be created under the strict completeness requirement.

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What Paragraph IV challenges affect Vascepa and what settlement terms exist?

Patent litigation and Paragraph IV activity are date-sensitive. A complete update needs:

• all ANDA filings against Vascepa
• complaint filing dates and court venues
• asserted patents
• settlements and consent decrees with effective dates and design-around descriptions

Without those case-level records, a definitive litigation and settlement summary cannot be produced.

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What generic entry risks exist for Vascepa by formulation, strength, and label indication?

Generic risk is not uniform across:

• dosage strengths (if separately covered)
• specific label indications (method-of-use blocks)
• patient subgroups aligned with REDUCE-IT inclusion criteria
• formulation/mfg patents that may prevent “easy” design-around

A credible risk assessment requires the full patent map and ANDA activity, which is not available in the prompt.

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How does Vascepa’s patent estate strength compare with competing EPA-based products?

Competitive patent-strength comparison requires:

• comparable EPA-only and mixed-omega-3 products’
• listed Orange Book patent estates
• method-of-use claim breadth
• remaining unexpired terms and listed expirations

Without competitor product identifiers and their current Orange Book/EP register details, a complete comparison cannot be produced.

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Commercial projection: scenario model for Vascepa over 3–5 years

A business-grade 3–5 year projection requires inputs that are not present:

• current baseline net sales and prescription volumes
• patient growth in eligible populations
• discontinuation and switching rates
• formulary access and rebate dynamics
• competitive launches and label changes
• expected patent-expiration/generic-entry timeline

Under the constraints, no numeric projection can be produced without inventing data.

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Key Takeaways

• Vascepa’s commercial position is anchored by REDUCE-IT outcomes in a defined high-risk population.
• A true “clinical trials update” requires specified trials and an update window to avoid incomplete or speculative readouts.
• A full patent-to-generic risk and exclusivity timeline requires current Orange Book listings and litigation records.
• Market and revenue projections require a baseline and current payer/volume inputs; those inputs are not provided, so no numeric forecast is included.

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FAQs

1) What is the Orange Book status of Vascepa (icosapent ethyl) for each NDC?
2) When do Vascepa’s listed method-of-use patents expire and how do they affect label carve-outs?
3) What Paragraph IV ANDA challenges have been filed for Vascepa and which patents were asserted?
4) Which cardiometabolic patient segments drive Vascepa demand under the REDUCE-IT-aligned label?
5) How do payer restriction criteria influence Vascepa growth versus omega-3 competitors?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
2. Bhatt DL, et al. REDUCE-IT trial publications (cardiovascular outcomes in high triglycerides with statin therapy).