CLINICAL TRIALS PROFILE FOR EPANOVA

All Clinical Trials for Epanova

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00613197 ↗	EPANOVA in Crohn's Disease, Study 1	Completed	Tillotts Pharma AG	Phase 3	2003-01-01	The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics. Secondary objectives are to assess the: efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission safety and tolerability of Epanova ability of Epanova to maintain the quality of life of CD patients in remission
NCT01208961 ↗	Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation	Completed	Radiant Research	Phase 2	2010-09-01	The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.

Clinical Trial Conditions for Epanova

Condition Name

Condition Name for Epanova
Intervention	Trials
Hypertriglyceridemia	7
Severe Hypertriglyceridemia	3
Crohn's Disease	2

Condition MeSH

Condition MeSH for Epanova
Intervention	Trials
Hypertriglyceridemia	11
Cardiovascular Diseases	2
Crohn Disease	2

Clinical Trial Locations for Epanova

Trials by Country

Trials by Country for Epanova
Location	Trials
United States	112
Canada	14
India	7
Hungary	4
Denmark	4

Trials by US State

Trials by US State for Epanova
Location	Trials
Ohio	6
Illinois	6
Pennsylvania	5
Kentucky	5
Texas	4

Clinical Trial Progress for Epanova

Clinical Trial Phase

Clinical Trial Phase for Epanova
Clinical Trial Phase	Trials
Phase 3	6
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Epanova
Clinical Trial Phase	Trials
Completed	16

Clinical Trial Sponsors for Epanova

Sponsor Name

Sponsor Name for Epanova
Sponsor	Trials
AstraZeneca	14
Tillotts Pharma AG	2
Cleveland Clinic Coordinating Center for Clinical Research (C5R)	1

Sponsor Type

Sponsor Type for Epanova
Sponsor	Trials
Industry	19
Other	4

Clinical Trials and Market Analysis for Epanova

Introduction to Epanova

Epanova, developed by AstraZeneca, is a pharmaceutical formulation containing omega-3 carboxylic acids, specifically EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). It has been investigated for its efficacy in managing cardiovascular health, particularly in patients with mixed dyslipidaemia and hypertriglyceridemia.

Clinical Trials Update

STRENGTH Trial

The most significant clinical trial for Epanova was the Phase III STRENGTH trial. This large-scale, global cardiovascular outcomes trial aimed to evaluate the safety and efficacy of Epanova compared to a placebo, both in combination with standard-of-care statin medicines, in patients with mixed dyslipidaemia and at high risk for cardiovascular disease.

• Outcome: The trial was discontinued in January 2020 following a recommendation from the Independent Data Monitoring Committee, which concluded that Epanova was unlikely to demonstrate a benefit to patients[1].
• Patient Enrollment: The trial enrolled 13,086 patients at 675 sites in 22 countries[1].

EVOLVE II Trial

Another notable trial is the EVOLVE II study, a 12-week, randomized, double-blind, olive oil-controlled Phase 3 study. This trial assessed the efficacy and safety of Epanova as an adjunct therapy to diet for reducing very high triglycerides in patients with severe hypertriglyceridemia.

• Design: Patients were assigned to either Epanova 2g/day or an olive oil placebo. The study involved 379 participants and was conducted to evaluate the efficacy and safety of Epanova in this patient population[4].

Market Analysis

Cardiovascular Health Supplements Market

The market for cardiovascular health supplements, which includes omega-3 fatty acid products like Epanova, is growing significantly.

• Market Size: The cardiovascular health supplements market was valued at USD 10.35 billion in 2024 and is projected to reach USD 23.84 billion by 2034, with a CAGR of 8.7% from 2025 to 2034[2].
• Key Players: Companies such as NOW Foods, Nordic Naturals, Thorne, Inc., and Nestlé Health Science are prominent in this market[2].

EPA and DHA Market

The EPA and DHA market, which directly relates to the active ingredients in Epanova, is also experiencing substantial growth.

• Market Size: The EPA and DHA market is expected to reach USD 2.06 billion in 2025 and grow to USD 2.96 billion by 2030, with a CAGR of 7.51% during the forecast period[5].
• Regional Focus: The Asia-Pacific region is both the largest and the fastest-growing market for EPA and DHA products[5].

Market Projections

Impact of Clinical Trial Outcomes

The discontinuation of the STRENGTH trial due to the lack of efficacy has significant implications for Epanova's market prospects.

• Competitive Landscape: Epanova was expected to compete with other omega-3 fatty acid therapies like Vascepa (icosapent ethyl) from Amarin. However, with Epanova's trial results, Vascepa is likely to maintain its market dominance in the cardiovascular risk reduction segment[3].

Market Growth Despite Setbacks

Despite the setbacks from the STRENGTH trial, the overall market for cardiovascular health supplements and EPA/DHA products continues to grow.

• Consumer Demand: Increasing awareness of cardiovascular health and the benefits of omega-3 fatty acids drive consumer demand, supporting market growth[2][5].

Key Differentiators and Challenges

Efficacy and Safety

Epanova's potential advantage in better absorption and a once-daily dosing regimen may not be sufficient to overcome the lack of efficacy demonstrated in the STRENGTH trial. Side effects, such as gastrointestinal issues, also pose a challenge[3].

Marketing and Reimbursement

The success of cardiovascular health supplements often depends on marketing strategies and reimbursement policies. Epanova's failure in the STRENGTH trial may hinder its adoption and reimbursement by payers[3].

Expert Insights

"The academic leadership of the STRENGTH trial is obviously disappointed in this result, but we are very proud to have had the opportunity to answer this important scientific question. We are also grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry." - Steven E. Nissen MD, Study Chair for the STRENGTH trial[1].

Statistics and Trends

• Market Growth Rate: The cardiovascular health supplements market is expected to grow at a CAGR of 8.7% from 2025 to 2034[2].
• EPA and DHA Market Size: Expected to reach USD 2.06 billion in 2025 and USD 2.96 billion by 2030[5].

Key Takeaways

• Clinical Trials: The STRENGTH trial was discontinued due to Epanova's low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia.
• Market Analysis: The cardiovascular health supplements and EPA/DHA markets are growing, but Epanova's market prospects are diminished by the trial results.
• Competitive Landscape: Vascepa is likely to remain a dominant player in the cardiovascular risk reduction segment.
• Consumer Demand: Increasing awareness of cardiovascular health continues to drive the market for omega-3 fatty acid products.

FAQs

What was the outcome of the STRENGTH trial for Epanova?

The STRENGTH trial was discontinued due to Epanova's low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia and at high risk for cardiovascular disease[1].

How does Epanova compare to Vascepa in terms of efficacy and safety?

Epanova's efficacy was not demonstrated in the STRENGTH trial, whereas Vascepa showed positive results in the REDUCE-IT trial. Epanova may have more gastrointestinal side effects due to its free fatty acid content[3].

What is the projected market size for the EPA and DHA market by 2030?

The EPA and DHA market is expected to reach USD 2.96 billion by 2030, growing at a CAGR of 7.51% from 2025 to 2030[5].

Which region is the fastest-growing market for EPA and DHA products?

The Asia-Pacific region is the fastest-growing market for EPA and DHA products[5].

How does the discontinuation of the STRENGTH trial affect Epanova's market prospects?

The discontinuation significantly diminishes Epanova's market prospects, particularly in the cardiovascular risk reduction segment, where Vascepa is likely to remain dominant[3].

Sources

1. AstraZeneca Press Release: Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia.
2. NovaOneAdvisor Report: Cardiovascular Health Supplements Market Size 2024 To 2034.
3. Pharmaceutical Technology: Vascepa versus Epanova: future competition may arise.
4. AstraZeneca Clinical Trials: Epanova® for Lowering Very High Triglycerides II (EVOLVE II).
5. Mordor Intelligence: EPA and DHA Market - Outlook, Forecast, Companies & Size.