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Label indication VASCEPA ® (icosapent ethyl) 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 2 or more additional risk factors for cardiovascular disease. FDA label
Also known as Icosapent ethyl (IPE), Vascepa
Icosapent Ethyl · 4 trials · 8 indications
PFS is defined as the time from randomisation to death (from any cause), first documented evidence of disease progression, new recurrence or clinical deterioration unequivocally due to disease progression
SARS-CoV-2 positive subjects are defined as subjects with positive tests for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies after developing COVID-19 disease at any stage within the follow-up period (including those subjects with or without symptomatic COVID-19 evaluated before the final visit) or those individuals who test positive for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies at the final visit (day 60).
The production rate of very low-density lipoprotein apolipoprotein B100 as determined by stable-isotope lipid kinetics techniques based on a primed constant infusion of deuterated leucine.
| Arm | Type | Description |
|---|---|---|
| Icosapent Ethyl (EPA-EE) | EXPERIMENTAL | Soft gelatin capsules containing 1g pure EPA-EE equivalent to 914mg EPA-FFA. Administered as 4g per day to be taken as 2 capsules in the morning and 2 capsules in the evening. |
| Placebo | PLACEBO_COMPARATOR | Soft gelatin capsules containing light mineral oil. 4 capsules to be taken per day (2 in the morning and 2 in the evening). |
| Active treatment | ACTIVE_COMPARATOR | Participants in this arm will receive study medication icosapent ethyl (IPE) with a specific dose scheme. |
| Usual Care | NO_INTERVENTION | Participants in this arm will continue with usual care |
| Icosapent Ethyl | EXPERIMENTAL | Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) |
| Name | Type | Description |
|---|---|---|
| Icosapent Ethyl | DRUG | Composition: soft amber to light yellow, oblong gelatin capsules. One capsule contains 1g pure EPA-EE Dose: 4 capsules per day |
| Placebo | OTHER | Composition: soft, amber to light yellow, oblong gelatin capsules containing light mineral oil: Dose: 4 capsules per day |
| Icosapent ethyl (IPE) | DRUG | Participants in this arm will receive study medication IPE with the following dosage schedule: 8 g of IPE (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of IPE (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm) |
| Icosapent Ethyl 1000 MG [Vascepa] | DRUG | Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate. |
Inclusion Criteria: * Aged ≥ 18 years * Able to provide written informed consent * Histological diagnosis of colorectal cancer with evidence of liver metastases * Planned liver resection surgery for colorectal cancer liver metastases with curative intent, including repeat 're-do' colorectal cancer ...
Icosapent ethyl is a small molecule drug developed by Amarin Corporation plc (ticker AMRN). It has been studied across several indications, including COVID-19, lipid disorders, and liver metastasis. It is also known by the brand name Vascepa and is referred to as icosapent ethyl (IPE).
Icosapent ethyl has been investigated for COVID-19, lipid disorders, and liver metastasis. Clinical trials have studied it in patients with COVID-19, individuals with high triglycerides and dyslipidemias, and patients with liver metastasis from colon cancer. It is not approved for these indications and remains investigational in these settings.
Icosapent ethyl is developed by Amarin Corporation plc, which trades under the ticker AMRN. The company is responsible for the clinical development of the drug across its studied indications.
Icosapent ethyl is in Phase 2 development according to the overall development stage. Individual trials have been conducted across Phase 1, Phase 2, and Phase 3. It is an investigational drug and has not been approved for the indications studied in these trials.
Icosapent ethyl has been studied in several clinical trials, including NCT04460651 (PREPARE-IT), a Phase 3 trial in COVID-19 with 4,093 participants; NCT04412018, a Phase 2 trial in COVID-19 and inflammatory response; NCT03885661, a Phase 1 trial in lipid disorders; and NCT03428477 (EPA for Metastasis Trial 2), a Phase 3 trial in liver metastasis and colon cancer.
Yes, icosapent ethyl is also known by the brand name Vascepa. It is also referred to as icosapent ethyl (IPE) and icosapent ethyl 1000 MG [Vascepa]. These names refer to the same active ingredient developed by Amarin Corporation plc.