The goal of this clinical trial is to learn if icosapent ethyl (Vascepa) works to lessen the amount of inflammation in adults diagnosed with Community-Acquired Pneumonia (CAP). The main question it aims to answer is:
What is the effect of taking Vascepa on inflammation in the arteries in patients with CAP? Researchers will compare the drug Vascepa to a placebo (a look-alike submstance that contains no drug) to see if Vascepa works to reduce inflammation in patients with CAP.
Participants wil:
* take Vacscepa or a placebo twice a day for 6 months
* Visit the clinic 3 times (baseline, 30 days, and 6 months) for checkups and tests

Start Date15 Dec 2024

Sponsor / Collaborator

Ottawa Heart Institute Research Corp.

ISRCTN15140257

/ RecruitingNot ApplicableIIT

Effect of icosapent ethyl on coronary Fat Attenuation Index score in high-risk, statin treated patients with established cardiovascular disease and elevated plasma triglycerides

Start Date31 Aug 2024

Sponsor / Collaborator

Imperial College London

NCT06280976

/ WithdrawnPhase 4IIT

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.

Start Date01 Mar 2024

Sponsor / Collaborator

University of Louisville

100 Clinical Results associated with Icosapent Ethyl

100 Translational Medicine associated with Icosapent Ethyl

100 Patents (Medical) associated with Icosapent Ethyl

1,080

Literatures (Medical) associated with Icosapent Ethyl

01 Sep 2025·Comparative Biochemistry and Physiology D-Genomics & Proteomics

α-Ketoglutarate modulates the mechanisms of toxicity in crucian carp kidneys chronically exposed to NaHCO3: Metabolomics insights

Article

Author: Han, Lin ; Yuan, Fangying ; Liu, Wenzhi ; Liu, Qianwen ; Cheng, Hongyu ; Jin, Xiaofeng ; Sun, Yanchun

Due to the unique physicochemical properties of saline-alkaline water, aquatic organisms find it challenging to survive under such conditions. This study established a freshwater control group (C), a 20 mmol/L NaHCO₃ exposure group (T), a 40 mmol/L NaHCO₃ exposure group (F), a 20 mmol/L NaHCO₃ exposure with α-ketoglutarate (AKG)-supplemented feed group (TA), and a 40 mmol/L NaHCO₃ exposure with AKG-supplemented feed group (FA). Histopathological analysis, biochemical assays, and UPLC-QTOF/MS metabolomics were employed to explore the potential mechanisms by which AKG alleviates oxidative damage in freshwater teleosts induced by saline-alkaline stress. Histopathological results showed that as the concentration of carbonate alkali exposure increased, the severity of kidney lesions in crucian carp (Carassius auratus) worsened. However, in the TA and FA groups, the damage showed varying degrees of repair, with the kidney tissue morphology in the TA group almost restored to the state of the C group. Under carbonate alkali exposure, compared to the C group, the activity of antioxidant enzymes Catalase and Superoxide dismutase in crucian carp kidneys decreased in a dose-dependent manner, but increased upon AKG supplementation. Conversely, the levels of Malondialdehyde, blood ammonia, Urea nitrogen, and Uric acid showed the opposite trend. Metabolomics analysis revealed that carbonate-alkali stress caused a series of metabolic disruptions in fish, including amino acid metabolism, lipid metabolism, and energy metabolism. AKG positively regulated metabolic pathways such as the pentose phosphate pathway, arachidonic acid metabolism, and amino acid metabolism, thereby enhancing the antioxidant, anti-inflammatory, and immune capabilities of fish under saline-alkaline stress, alleviating oxidative damage induced by the stress. Overall, our research indicates that saline-alkaline stress significantly alters kidney function and metabolic characteristics, disrupts the antioxidant system and energy homeostasis, inhibits protein catabolism, and induces kidney damage in crucian carp. Exogenous AKG supplementation effectively mitigates oxidative damage and metabolic disorders in crucian carp kidneys under carbonate-alkaline stress. This study elucidates the physiological mechanisms by which AKG alleviates kidney tissue damage under saline-alkaline stress at the metabolic level, providing scientific evidence for the development of aquaculture in saline-alkaline water.

13 Mar 2025·European Heart Journal-Cardiovascular Pharmacotherapy

Management of dyslipidaemia in patients with comorbidities—facing the challenge

Review

Author: Huber, Kurt ; Agewall, Stefan ; Frühwald, Lisa ; Fasching, Peter ; Kaski, Juan Carlos ; Borghi, Claudio ; Dobrev, Dobromir ; Drexel, Heinz ; Semb, Anne Grete ; Wassmann, Sven

Abstract:

This review aims to examine the evidence on the benefits and risks of lipid-lowering drugs in patients with liver disease. Elevated liver enzyme levels often lead to cautious discontinuation of these drugs, potentially withholding from patients their benefit in reducing cardiovascular disease morbidity and mortality. Using a literature search of PubMed, we examine the efficacy and safety profiles of various lipid-lowering agents, including statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, fibrates, and icosapent ethyl, focusing particularly on their potential side effects related to liver health. A major challenge in the assessment of drug-induced hepatotoxicity is the fact that it relies heavily on case reports rather than real-world evidence. There is currently a lack of robust evidence on lipid-lowering therapy in people with pre-existing liver disease. Nevertheless, we have attempted to summarize the available data for all the drugs mentioned in order to provide guidance for the treatment of patients with liver dysfunction. This review highlights the need for further research to optimize treatment strategies for patients with coexisting liver and cardiovascular disease.

04 Mar 2025·Journal of the American Heart Association

Cardiovascular Outcomes With Icosapent Ethyl by Baseline Low‐Density Lipoprotein Cholesterol: A Secondary Analysis of the REDUCE‐IT Randomized Trial

Article

Author: Szarek, Michael ; Tardif, Jean‐Claude ; Martens, Fabrice M. A. C. ; Ketchum, Steven B. ; Brinton, Eliot A. ; Aggarwal, Rahul ; Mason, R. Preston ; Steg, Ph. Gabriel ; Dunbar, Richard L. ; Miller, Michael ; Bhatt, Deepak L. ; Ballantyne, Christie M.

Background:

The efficacy of icosapent ethyl among patients with very well‐controlled baseline low‐density lipoprotein cholesterol (LDL‐C) is unknown.

Methods:

In this post hoc analysis of the REDUCE‐IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial) randomized clinical trial, statin‐treated patients with high cardiovascular risk, elevated triglycerides (135–499 mg/dL), and baseline LDL‐C of 41 to 100 mg/dL were included. Patients were randomized to icosapent ethyl (2 g twice daily) or placebo and then post hoc stratified by baseline LDL‐C (<55 mg/dL versus ≥55 mg/dL). The primary composite end point included cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina.

Results:

Among 8175 patients with baseline LDL‐C data, 7117 (87.1%) had LDL‐C ≥55 mg/dL and 1058 (12.9%) had LDL‐C <55 mg/dL. In patients with LDL‐C <55 mg/dL, the rate of the primary composite end point was lower in the icosapent ethyl group (16.2% versus 22.8%) than in the placebo group (hazard ratio [HR], 0.66 [95% CI, 0.50–0.87]; absolute risk reduction, 6.6%; P =0.003). Among patients with LDL‐C ≥55 mg/dL, a primary composite end point event occurred in a lower proportion of patients in the icosapent ethyl group (17.4% versus 21.9%) than in the placebo group (HR, 0.76 [95% CI, 0.69–0.85]; absolute risk reduction, 4.5%; P <0.0001). No significant interaction was observed between baseline LDL‐C and treatment group ( P for interaction=0.40). Findings were consistent among secondary cardiovascular end points and in sensitivity analyses.

Conclusions:

Among statin‐treated patients with elevated triglycerides and high cardiovascular risk, icosapent ethyl reduced the rate of cardiovascular end points irrespective of baseline LDL‐C, including among eligible patients with optimal LDL‐C control.

Registration:

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

138

News (Medical) associated with Icosapent Ethyl

31 Mar 2025

·www.globenewswire.com

Amarin Highlights Recent Data Presented at ACC.25 Evaluating Mechanistic Effects of Eicosapentaenoic Acid (EPA) in Lp(a)-Enriched Plasma and in Combination with GLP-1 Agonist

– Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of Action and Utility as A Complementary Therapy for Residual Risk Reduction in Combination with Statins in Important Patient Sub-Categories –DUBLIN and BRIDGEWATER, N.J., March 31, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted key data presentations at ACC.25 showcasing the mechanistic activity of eicosapentaenoic acid (EPA) on lipoprotein(a) [Lp(a)]-enriched plasma and the effects of a glucagon-like peptide-1 (GLP-1) receptor agonist in combination with EPA on the expression of proteins in endothelial cells. “The data presented at ACC.25 continue to underscore the therapeutic value of icosapent ethyl (IPE) and EPA in potentially addressing known pathways of cardiovascular (CV) risk beyond LDL lowering for patients,” said R. Preston Mason, Ph.D., Brigham and Women’s Hospital. “While emerging therapeutic approaches are being explored to address residual CV risk, especially in patients with additional risk factors like obesity and elevated glucose levels, cardiovascular disease remains the world's leading cause of death and we cannot afford to wait. High-risk patients must be treated now, using proven therapies that have consistently demonstrated their ability to reduce CV risk—on top of the standard of care, including statins. We already have effective treatments available, and it is imperative that we utilize them to reduce patients’ CV risk and save lives today. These learnings further advance understanding of how EPA and VASCEPA/VAZKEPA may be working to reduce CV events in at-risk patients.” The key findings are outlined below: More Rapid Oxidation of Lipoprotein(a) [Lp(a)]-enriched Plasma Compared to Small Dense- and Triglyceride-rich Lipoproteins is Limited by Eicosapentaenoic Acid (EPA) In this analysis, researchers analyzed rates of oxidation for Lp(a)-enriched plasma to other atherogenic particles, including enriched small dense LDL (sdLDL), LDL, or triglyceride (TG)-rich lipoproteins (VLDL) with and without the introduction of EPA at a pharmacologic concentration. An elevated Lp(a) level is known to increase CV risk. New data from this analysis show that EPA dose-dependently inhibited oxidation in all lipoproteins tested, especially Lp(a) enriched human plasma. This is an important finding as the potent inhibition of Lp(a) oxidation by EPA may contribute to the benefit observed in REDUCE-IT, including in those subjects with elevated Lp(a) levels as recently reported in this publication. Addition of Eicosapentaenoic Acid (EPA) to a GLP-1 Agonist Enhanced Expression of Detoxification Proteins in Endothelial Cells During Inflammation In Vitro In this mechanistic analysis, researchers evaluated the separate versus combined effects of EPA and GLP-1 receptor agonist liraglutide on expression of proteins in endothelial cells. We know there is clear evidence backing the benefits of EPA in reducing cardiovascular events in at-risk patients. However, with emerging therapeutic approaches to address residual cardiovascular risk there is added value in exploring the combination of proven therapies, in this case EPA and GLP-1 receptor agonist, with complementary or additive protective mechanisms that may potentially play a role in further reducing cardiovascular risk on top of the statin therapy. The combination of EPA and GLP-1 receptor agonist favorably modulated the expression of proteins associated with detoxifying reactive oxygen species under disease-like conditions. Recent Data Published in JAHA: REDUCE-IT Analysis Shows Clear VASCEPA/ VAZKEPA Outcomes Benefit in Patients with Well-Controlled LDL-C A recent post hoc analysis of REDUCE-IT was published in the Journal of the American Heart Association this past month evaluating the impact of icosapent ethyl on top of statin therapy in reducing cardiovascular events in at-risk patients with various baseline LDL-C levels, including those with well-controlled LDL-C (<55 mg/dL). These findings showed cardiovascular risk reduction benefit consistent with the primary endpoint of the REDUCE-IT trial, which further reinforces the story around VASCEPA/VAZKEPA being a “complementary” therapy to current LDL-C lowering therapies. Additionally, these data point out that even when a patient has a very low LDL-C level (<55 mg/dL and down to 40 mg/dL), patients were still at risk and saw benefit from taking VAZKEPA, highlighting the need to go beyond LDL-C lowering for greater cardiovascular risk reduction. About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.   About REDUCE-IT® REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.1 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.3  About Cardiovascular Risk Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.4 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.5 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,7,8 About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy and Denmark. United States Indications and Limitation of Use VASCEPA is indicated:   As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and   established cardiovascular disease or   diabetes mellitus and two or more additional risk factors for cardiovascular disease.   As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.   Important Safety Information   VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.   VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.   It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.   VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.   Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).   Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).   Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.   Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.   FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe   For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here. Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2024. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact InformationInvestor & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.com Investor.relations@amarincorp.com 1 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.2 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.3 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.4 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.7 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.8 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563

Drug ApprovalAHAClinical ResultClinical Study

28 Mar 2025

·www.fiercepharma.com

Ionis, Arrowhead, Amarin sponsor new triglyceride group to educate physicians

The National Triglyceride Alliance plans to work with the American Society for Preventive Cardiology and other organizations with shared objectives to “provide evidence-based education, expert-driven resources and clinical guidance to healthcare providers.” Ionis Pharmaceuticals and Arrowhead Pharmaceuticals have found a common cause amid their emerging rivalry. While preparing to go head to head in a rare disease market, the companies have signed up to be the top two sponsors of the newly launched National Triglyceride Alliance (NTA). The biotechs are both targeting conditions characterized by elevated triglyceride levels in the blood. Ionis won FDA approval for its antisense oligonucleotide Tryngolza late last year, and the FDA is reviewing Arrowhead’s application for approval of RNAi therapy plozasiran in the same indication. Both companies are also working to bring their molecules to market in another indication in which elevated triglycerides drive disease.While Ionis and Arrowhead are in direct competition, that rivalry gives the companies shared interest. Enter the NTA. The working group will “offer educational programs, clinical resources and ongoing initiatives aimed at improving understanding and treatment strategies for high triglycerides,” according to Friday’s launch announcement.Ionis is a founding sponsor of the NTA, Arrowhead is a national sponsor and Amarin, which sells Vascepa for use in certain adults with elevated triglycerides, has come on board as a local sponsor. The NTA lists the founder, national and local sponsorship levels at $250,000, $50,000 and $15,000, respectively. The NTA plans to work with the American Society for Preventive Cardiology and other organizations with shared objectives to “provide evidence-based education, expert-driven resources and clinical guidance to healthcare providers.” Through such initiatives, the NTA is aiming to give healthcare professionals the education and tools to effectively manage patients with high triglyceride levels. Ionis and Arrowhead are also working independently to lay the foundations for sales growth. With FDA approval in the bag, Ionis recently kicked off Tryngolza campaigns aimed at patients and healthcare professionals. Arrowhead, meanwhile, is yet to win approval but began priming the market last year with “We’ll Get There Soon,” a push to spread the word about the importance of treating patients with triglycerides above 500 mg/dL.

Drug Approval

20 Mar 2025

·www.fiercepharma.com

Investor group calls for strategy shift as Amarin shares continue to flounder post-Sarissa Capital takeover

Another stakeholder is gearing up for a public face-off with struggling Amarin. Activist investor Sarissa Capital won control over Amarin’s board two years ago on a fierce campaign of stirring up value for shareholders. But after another year of lackluster sales and declining share prices, another activist investor group could be looking to spark some changes at the company.Bradley Radoff and managing director of JEC Capital Partners Michael Torok have collectively obtained 15 million shares of Amarin stock, or around a 3.6% stake in the company. The duo penned a letter to Amarin’s Sarissa-controlled board as a “concerned shareholder group,” calling for an immediate strategic review and a public response. The complaint comes after Sarissa successfully won shareholders’ support to replace seven of Amarin’s board members with its own appointments back in February 2023, bringing an end to a months-long heated back-and-forth. Shortly after winning dominance over the company, the newly-created Sarissa board pledged that it had “begun the hard work of creating value for shareholders.” But two years later, Radoff and Torok argue that that promise had not been delivered on.At the time of the Sarissa takeover, the company’s share price was trading at $2.03. Now, shares are hovering at $0.43, representing a freefall of nearly 80%, the investors pointed out.The shareholder group also highlighted a share buyback plan of up to $50 million that the company announced last year. However, with no mention of the previous plan, Amarin instead went for a ratio change of its American Depositary Shares, or a 1-for-20 reverse split, to maintain its Nasdaq listing.Despite the reasoning, the move “does not inspire confidence, as reverse splits typically have a negative effect on a stock’s future price,” Radoff and Torok noted.The investors urged the company’s board to “immediately announce and run” a strategic review process and emphasized that it should respond publicly, given “the commitments you and Sarissa have made to shareholders.”Sarissa took a stake in Amarin years ago to try and revive the company after a loss of patent protection for its sole product, fish-oil-derived heart pill Vascepa, sent sales plummeting. The activist investor took issue with Vascepa’s slow European launch and “spending mismanagement,” while Amarin at the time argued that despite its issues, Sarissa is “not the answer.” Despite Amarin’s efforts, Sarissa ultimately won control of the company and quickly initiated a restructuring that chopped off about one-third of the company through 120 layoffs. The company is now on its third CEO in just two years after Karim Mikhail left his post following the Sarissa takeover and his replacement Patrick Holt stepped down in June. Amarin’s total net revenue in 2024 added up to $204 million in a 28% decline from the prior year’s $285 million haul. But the company believes that its current cash, investments and other assets are “adequate to support continuing operations for the foreseeable future,” it said in an earnings release. For now, the drugmaker is still looking at opportunities to get Vascepa “into the hands of as many at-risk patients as possible.”Radoff and Torok have stirred the pot at other drugmakers before. In 2023, the investors alleged that they were offered a bribe to support a planned merger at Sesen Bio. More recently, they’ve urged for change at Atea Pharmaceuticals in a similar “concerned shareholders” letter.

Executive ChangeAcquisitionIPO

100 Deals associated with Icosapent Ethyl

External Link

KEGG	Wiki	ATC	Drug Bank
D01892	Icosapent Ethyl	C10AX	DB08887

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cardiovascular Diseases	United States	Amarin Pharmaceuticals Ireland Ltd.	13 Dec 2019
Hypertriglyceridemia	United States	Amarin Pharmaceuticals Ireland Ltd.	26 Jul 2012
Arteriosclerosis Obliterans	Japan	Mochida Pharmaceutical Co., Ltd.	15 Oct 1998
Hyperlipidemias	Japan	Mochida Pharmaceutical Co., Ltd.	05 Oct 1994

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 3	United Kingdom	Amarin Pharma, Inc.	02 May 2018
Liver metastases	Phase 3	United Kingdom	Amarin Pharma, Inc.	02 May 2018
Hodgkin's Lymphoma	Phase 3	United States	Amarin Neuroscience Ltd.	01 Sep 2005
Hodgkin's Lymphoma	Phase 3	Canada	Amarin Neuroscience Ltd.	01 Sep 2005
Huntington Disease	Phase 3	United States	Amarin Neuroscience Ltd.	01 Sep 2005
Huntington Disease	Phase 3	Canada	Amarin Neuroscience Ltd.	01 Sep 2005
Nonalcoholic Steatohepatitis	Phase 2	United States	Mochida Pharmaceutical Co., Ltd.	01 Jun 2010
Nonalcoholic Steatohepatitis	Phase 2	Puerto Rico	Mochida Pharmaceutical Co., Ltd.	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01492361 (REDUCE-IT, Pubmed \| J Am Heart Assoc) Manual	Phase 3	Cardiovascular Diseases LDL-C	8,175	Icosapent Ethyl 2g twice dailyIcosapent Ethyl 2g twice daily (LDL‐C <55 mg/dL)	hvrzwkiirf(dgrinetbcq) = rfbrqkqqkl kfkalsdypk (tmmjnujuqu )	Positive	19 Feb 2025
				Placebo (LDL‐C <55 mg/dL)	hvrzwkiirf(dgrinetbcq) = tqksyiltbu kfkalsdypk (tmmjnujuqu )
NCT05198843 (CTgov)	Phase 1/2	Metastatic breast cancer \| Metastatic Triple-Negative Breast Carcinoma	1	Dasatinib+EPA	qhpzjzexmt(dvyjprjtjv) = ggvifczexe zurwuijntm (zzwcsfoogv, yogsogxklb - jtmuwjrxrd) View more	-	04 Sep 2024
ESC2024	Not Applicable	-	-	Icosapent ethyl	pkqlwfgtoa(btxsvlezjo) = zefxclwpej hbjbmlddxe (leudydgjrr )	-	30 Aug 2024
				Placebo	pkqlwfgtoa(btxsvlezjo) = cykizhnelz hbjbmlddxe (leudydgjrr )
NCT01492361 (REDUCE-IT, GlobeNewswire) Manual	Phase 3	Cardiovascular Diseases	-	Icosapent Ethyl (IPE) (Lp(a) ≥50 mg/dL)	vxkyhqakpw(prlaveivsv) = snxhdfmcvi xrhszofuyt (nebaygucyw ) View more	Positive	06 Apr 2024
				Icosapent Ethyl (IPE) (Lp(a) <50 mg/dL)	vxkyhqakpw(prlaveivsv) = uxouswmxhs xrhszofuyt (nebaygucyw ) View more
NCT01492361 (REDUCE-IT USA, Pubmed)	Phase 3	-	3,146	Icosapent Ethyl	towxhlrdhr(uefwpsjykz) = nrrryfzzcy egtbygvvvm (bormzimdpi ) View more	-	02 Jan 2024
NCT01492361 (REDUCE-IT, GlobeNewswire) Manual	Phase 3	Cardiovascular Diseases \| Metabolic Syndrome	2,866	VASCEPA	qunphxqqvc(knmkyuflhh): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9 View more	Positive	12 Nov 2023
				placebo
NCT01492361 (REDUCE-IT, Pubmed)	Phase 3	Metabolic Syndrome	8,179	Icosapent ethyl 4 g/day	jdbydokjwf(dyebjpvank) = xczwbynaxn vpbgnvurky (jakzcctmlq )	Positive	03 Nov 2023
NCT01492361 (REDUCE-IT, ESC2023)	Phase 3	-	-	Icosapent ethyl	ouogqbfbxc(aoluzxhgrf) = umojgmjpmu epyhxbljvp (vlgfyrqcsd, 1.8 - 8.7)	-	27 Aug 2023
				Placebo	ouogqbfbxc(aoluzxhgrf) = dkzgwqghvj epyhxbljvp (vlgfyrqcsd, 1.9 - 9.4)
NCT01492361 (REDUCE-IT, Pubmed)	Phase 3	Atrial Fibrillation	8,179	Icosapent Ethyl	htllfeubyy(luuztryumk) = lobhzcuwhv dcbkccyyld (qgntavrqbl )	-	21 Feb 2023
				Placebo	htllfeubyy(luuztryumk) = llouwrugbc dcbkccyyld (qgntavrqbl )
NCT01492361 (REDUCE-IT, Pubmed \| J Am Coll Cardiol)	Phase 3	Hypertriglyceridemia \| Cardiovascular Diseases	8,179	Icosapent ethyl	xpihfrcugc(omecvvvrhe) = there was a slight increase in atrial fibrillation bqwmbjzhff (tfgwgjiizi ) View more	Positive	03 May 2022
				Placebo

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