Epanova

Hypertriglyceridemia

Treatment

2 FDA approvals

16 Active Studies for Epanova

What is Epanova

Omega-3-carboxylic acids

The Generic name of this drug

Treatment Summary

Omega-3 carboxylic acid (OM3-CA) is a new formulation of omega-3 fatty acids that has a higher rate of absorption than other omega-3 products. OM3-CA is made up of two main types of fatty acids – eicosapentaenoic acid (55%) and docosahexaenoic acid (20%) – as well as trace amounts of other components like alpha-tocopherol and glycerol. OM3-CA was developed by AstraZeneca Pharmaceuticals and approved by the FDA in 2014.

Epanova

is the brand name

Epanova Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Epanova

Omega-3-carboxylic acids

2015

1

Approved as Treatment by the FDA

Omega-3-carboxylic acids, otherwise known as Epanova, is approved by the FDA for 2 uses such as Hypertriglyceridemias and Hypertriglyceridemia .

Hypertriglyceridemias

Hypertriglyceridemia

Effectiveness

How Epanova Affects Patients

OM3-CA is highly effective in lowering triglyceride levels. After just two weeks of treatment, triglyceride levels can be reduced by up to 21%. With the highest dose of 4g, this reduction can even reach 25%.

How Epanova works in the body

OM3-CA is composed of eicosapentaenoic acid and docosahexaenoic acid, which are not good sources for the enzymes that create triglycerides. This prevents triglycerides from being made in the liver. OM3-CA also helps get rid of triglycerides in the bloodstream by blocking an enzyme called acyl-CoA:1,2-diacylglycerol acyltransferase, increasing fat burning, and increasing a lipase enzyme that helps break down fats.

When to interrupt dosage

The amount of Epanova is contingent upon the determined condition. The dosage fluctuates as per the delivery technique featured in the table beneath.

Condition

Dosage

Administration

Hypertriglyceridemia

1000.0 mg,

, Capsule, gelatin coated - Oral, Capsule, gelatin coated, Oral

Warnings

There are 20 known major drug interactions with Epanova.

Common Epanova Drug Interactions

Drug Name

Risk Level

Description

(R)-warfarin

Minor

The therapeutic efficacy of (R)-warfarin can be increased when used in combination with Omega-3-carboxylic acids.

(S)-Warfarin

Minor

The therapeutic efficacy of (S)-Warfarin can be increased when used in combination with Omega-3-carboxylic acids.

4-hydroxycoumarin

Minor

The therapeutic efficacy of 4-hydroxycoumarin can be increased when used in combination with Omega-3-carboxylic acids.

Abciximab

Minor

The therapeutic efficacy of Abciximab can be increased when used in combination with Omega-3-carboxylic acids.

Acenocoumarol

Minor

The therapeutic efficacy of Acenocoumarol can be increased when used in combination with Omega-3-carboxylic acids.

Epanova Toxicity & Overdose Risk

Tests on OM3-CA have found that it does not cause cancer in males, but has increased instances of benign ovarian tumors. It is also not mutagenic or clastogenic, and does not appear to affect fertility.

Epanova Novel Uses: Which Conditions Have a Clinical Trial Featuring Epanova?

Currently, there are zero active studies examining the potential of Epanova to ameliorate Hypertriglyceridemias.

Condition

Clinical Trials

Trial Phases

Hypertriglyceridemia

16 Actively Recruiting

Phase 2, Phase 3, Phase 1, Early Phase 1

Patient Q&A Section about epanova

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Epanova used for?

"EPANOVA is a prescription medication that is used in conjunction with a low-fat and low-cholesterol diet to lower very high triglyceride (fat) levels in adults. The medication is not known to change the risk of inflammation of the pancreas (pancreatitis)."

Answered by AI

Is Epanova available?

"The Epanova drug has been discontinued and is no longer available in the United States. However, there may be generic equivalents of the drug available if they have been approved by the FDA."

Answered by AI

Why was Epanova discontinued?

"As per the recommendation from an independent Data Monitoring Committee, AstraZeneca has decided to close the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids). The reason for this is that it is very unlikely that the patients with mixed dyslipidaemia (MDL) would benefit from this, and they are already at an increased risk of cardiovascular disease."

Answered by AI

How much DHA is in Epanova?

"EPA and DHA make up about 48% of the total fatty acids).

The main difference between Lovaza and Omtryg is that Lovaza contains omega-3-acid ethyl esters (EPA and DHA) while Omtryg only contains DHA. Epanova is a mixture of polyunsaturated free fatty acids, which contain EPA and DHA."

Answered by AI

Clinical Trials for Epanova

Image of Clinical Research Site 4 in Santa Clarita, United States.

Plozasiran for Hypertriglyceridemia

18+
All Sexes
Santa Clarita, CA

This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.

Phase 3
Recruiting

Clinical Research Site 4 (+11 Sites)

Arrowhead Pharmaceuticals

Have you considered Epanova clinical trials?

We made a collection of clinical trials featuring Epanova, we think they might fit your search criteria.
Go to Trials
Image of University of Michigan in Ann Arbor, United States.

Mibavademab for Fat Loss Syndrome

Any Age
All Sexes
Ann Arbor, MI

This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months. The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin. The study is looking at several other research questions, including: * What side effects may happen from taking mibavademab * How much mibavademab is in the blood at different times * Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)

Phase 3
Waitlist Available

University of Michigan (+1 Sites)

Clinical Trial Management

Regeneron Pharmaceuticals

Have you considered Epanova clinical trials?

We made a collection of clinical trials featuring Epanova, we think they might fit your search criteria.
Go to Trials
Image of Jubilee Clinical Research, Inc. in Las Vegas, United States.

MN-001 for Non-alcoholic Fatty Liver Disease

21 - 75
All Sexes
Las Vegas, NV

The design of the Phase 2 clinical trial includes the following elements: * Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S. * Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks. * The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FibroScan® is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response. * Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).

Phase 2
Waitlist Available

Jubilee Clinical Research, Inc. (+1 Sites)

Kazuko Matsuda, MD PhD MPH

MediciNova

Have you considered Epanova clinical trials?

We made a collection of clinical trials featuring Epanova, we think they might fit your search criteria.
Go to Trials