This page shows what was measured, who it was measured in, and what that does not settle.
What Omega-3-Acid Ethyl Esters does in the body
Triglyceride (TG) levels
From the FDA-approved label: The mechanism of action of omega-3-acid ethyl esters capsules are not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β -oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Omega-3-acid ethyl esters capsules may reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as mixture.
FDA substance registry · D87YGH4Z0Q · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 101 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Cholesterol
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved9 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Strength
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer1 registered performance measure of this kind.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Mood
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Cholesterol
non high density lipoprotein cholesterol; lipid profile; plasma triglycerides; fasting triglycerides; change in non hdl c from baseline to week 6; ldl c during each treatment; serum triglyceride level at study end; triglycerides from baseline to 16 weeks
Strength
quadriceps muscle strength
Mood
madrs
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
9 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Change in blood pressure
✗ The study did not show it
Who was studied
NCT01653678
How many people
25875
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Dry Eye Disease
✗ The study did not show it
Who was studied
NCT01880463
How many people
25875
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
upper respiratory infection
✗ The study did not show it
Who was studied
NCT01758081
How many people
25874
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Incident total, non-vertebral, and hip fractures
✗ The study did not show it
Who was studied
NCT01704859
How many people
25871
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
COPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years
✗ The study did not show it
Who was studied
NCT01728571
How many people
25871
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)
✗ The study did not show it
Who was studied
NCT01351805
How many people
25871
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.17 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
madrs
Measured
Things only a test, a scale or a device shows.
serum tg
heart rate variability indices at 2 months
non high density lipoprotein cholesterol
flow mediated dilation
blood pressure
heart rate
plasma triglycerides
fasting triglycerides
change in non hdl c from baseline to week 6
ldl c during each treatment
and 8 more.
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (21)
time to failure
first occurrence of any serious vascular event
first occurrence of any major bleed
carotid intimal media thickness at 12 months
lipid profile
microvolt t wave alternans status
recurrence of atrial fibrillation
platelet aggegation using a pap 8e
bleeding time
reduction of the ham d to less than 7 at week 8
baseline adipocyte size
adipocyte size after fish oil treatment
whole blood aggregometry in response to 4 agonists
efficacy parameters characterize the reduction in alt levels
liver fat
liver fibrosis
nafld fibrosis
normal sinus rhythm
creatine kinase activity measured in blood
interleukin 6 measured in blood
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-30
On older people, the label states: “A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters.”
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-30
On people who are pregnant, the label states: “Category C: There are no adequate and well-controlled studies in pregnant women.”
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-30
On people who are breastfeeding, the label states: “Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk.”
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as capsule, capsule, liquid filled, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
37 products list this as an active ingredient in the United States drug directory. 36 of them contain it and nothing else.
FDA National Drug Code directory · 72998-850 · read 2026-08-29
They are sold as capsule, capsule, liquid filled, liquid and oil, taken oral.
FDA National Drug Code directory · 72998-850 · read 2026-08-29
The regulator's established pharmacologic class for it is fatty acids, omega-3 fatty acid [epc] and omega-3 [cs].
FDA National Drug Code directory · 72998-850 · read 2026-08-29
26 published labels name it as an active ingredient. 25 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-29
1276 marketed supplement labels list this ingredient, classed as fat/fatty acid, non-nutrient/non-botanical and other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
OMEGA-3-ACID ETHYL ESTERS is oral at 3 DOSAGE FORMS AND STRENGTHS Omega-3-acid ethyl esters, USP are supplied as 1-gram oblong, transparent soft gelatin capsules filled with light yellowish oil printed with "O3" in white ink across one side., recorded as fda label in effect 2025-02-10 in the United States.
US prescribing information · 5cf3091e-4a88-4799-a88a-d53a5bc1de57 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Omega-3-Acid Ethyl Esters studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Omega-3-Acid Ethyl Esters are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
D87YGH4Z0Q
RxNorm concept
577208
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
16 approved applications cover products containing this substance. The earliest was NDA021654, approved 20041110 to WAYLIS THERAP.
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What is not here
6 questions this page could not answer
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Recorded evidence blocks (11)
Q1
What did Omega-3-Acid Ethyl Esters's largest trial (25875 people) and its longest (32 years) measure?
25875 people in Omega-3-Acid Ethyl Esters's largest registered study, 32 years in its longest registered window, measuring Evaluate the effect of omega-3 fatty acids on physical function. ClinicalTrials.gov · 2026-09-01
39 phase2, 29 na, 23 phase4, 20 phase3, 19 phase1, 4 early phase1, 4 na or unstated; NCT00135226; 2037-07-31. Last human test completed 2025, NCT03018041.
These counts include studies where Omega-3-Acid Ethyl Esters was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
39
na
29
phase4
23
phase3
20
phase1
19
early phase1
4
2 more recorded rows
na or unstated
4
Last recorded human testNCT03018041
2025-03-22
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Omega-3-Acid Ethyl Esters shown lifespan?
Could one person measure Omega-3-Acid Ethyl Esters's effect on time to failure?
Time to failure: measured in Omega-3-Acid Ethyl Esters's trials.
Interpretation time to failure is the recorded endpoint.
Show the evidence
biomarkers
time to failure; 2026-09-01
first occurrence of any serious vascular event; 2026-09-01
first occurrence of any major bleed; 2026-09-01
serum tg; 2026-09-01
heart rate variability indices at 2 months; 2026-09-01
carotid intimal media thickness at 12 months; 2026-09-01
14 more recorded rows
biomarkers
non high density lipoprotein cholesterol; 2026-09-01
biomarkers
lipid profile; 2026-09-01
biomarkers
flow mediated dilation; 2026-09-01
biomarkers
blood pressure; 2026-09-01
biomarkers
heart rate; 2026-09-01
biomarkers
microvolt t wave alternans status; 2026-09-01
biomarkers
recurrence of atrial fibrillation; 2026-09-01
biomarkers
platelet aggegation using a pap 8e; 2026-09-01
biomarkers
bleeding time; 2026-09-01
biomarkers
reduction of the ham d to less than 7 at week 8; 2026-09-01
biomarkers
plasma triglycerides; 2026-09-01
biomarkers
baseline adipocyte size; 2026-09-01
biomarkers
adipocyte size after fish oil treatment; 2026-09-01
biomarkers
fasting triglycerides; 2026-09-01
human trials at or under30
51
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT00507390; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of adipocyte size after fish oil treatment, adipose tissue inflammation and baseline adipocyte size did Omega-3-Acid Ethyl Esters's trials measure?
adipocyte size after fish oil treatment, adipose tissue inflammation and baseline adipocyte size lead 40 outcome terms across Omega-3-Acid Ethyl Esters's trials. ClinicalTrials.gov · 2026-09-01
serum tg, heart rate variability indices at 2 months, carotid intimal media thickness at 12 months, non high density lipoprotein cholesterol, lipid profile and flow mediated dilation follow.
Show the evidence
time to failure
1
first occurrence of any serious vascular event
1
first occurrence of any major bleed
1
serum tg
1
heart rate variability indices at 2 months
1
carotid intimal media thickness at 12 months
1
14 more recorded rows
non high density lipoprotein cholesterol
1
lipid profile
1
flow mediated dilation
1
blood pressure
1
heart rate
1
microvolt t wave alternans status
1
recurrence of atrial fibrillation
1
platelet aggegation using a pap 8e
1
bleeding time
1
reduction of the ham d to less than 7 at week 8
1
plasma triglycerides
1
baseline adipocyte size
1
adipocyte size after fish oil treatment
1
fasting triglycerides
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Omega-3-Acid Ethyl Esters's 3 ongoing trials reports first?
Number of Participants With First Occurrence of Any Serious Vascular Event (SVE); Mean Change in Bronchial Nodule Size; latest 2037-07-31
Show the evidence
Trial
NCT00135226
"ASCEND: A Study of Cardiovascular Events iN Diabetes"; n 15480; "Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)"; 2037-07-31
NCT03598309
"Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers"; n 19; "Mean Change in Bronchial Nodule Size"; 2026-05
NCT06195306
"Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction"; n 66; "Change in serum adiponectin"; 2028-01-01
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 26 trials of Omega-3-Acid Ethyl Esters posted no result?
Posted no result
26 of 26 completed trials
Registrations
NCT00004448, NCT00487591, NCT00688961, NCT00149409, NCT00328536 and NCT00454493, and 20 more
Completion dates
oldest 2007-08; newest 2022-08-03
Show the evidence
Trial
NCT00004448
2007-08
NCT00487591
2007-08
NCT00688961
2007-08
NCT00149409
2008-02
NCT00328536
2008-11
NCT00454493
2008-12
14 further recorded trials
NCT00794079
2010-12
NCT01092390
2011-05
NCT01431690
2011-10
NCT01277237
2012-08
NCT00549692
2012-09
NCT01594983
2013-07
NCT01725646
2013-08
NCT01367145
2014-03
NCT01308957
2014-12
NCT01712867
2014-12
NCT01624727
2015-01-15
NCT02865044
2015-04
NCT01744067
2015-12
NCT00760760
2016-03
Q9
At the median, Omega-3-Acid Ethyl Esters's trials enrolled 35 people — anything larger?
Median enrolment
35
Largest enrolment
25875
Registered trials counted
118
Q10
Was Omega-3-Acid Ethyl Esters studied with fasting and exercise?
fasting and exercise are named in Omega-3-Acid Ethyl Esters's label sentences: "We conducted a multicenter, randomized, placebo-controlled, double-blind, parallel-group study of twice-daily treatment with OMACOR (OM3EE), a prescription-only formulation of highly purified ethyl esters of omega-3 polyunsaturated fatty acids in Chinese adult patients (≥18 years) who had elevated…" openfda-label+europepmc · 2021-09-15
2 recorded statements; fasting, exercise
Show the evidence
fasting
We conducted a multicenter, randomized, placebo-controlled, double-blind, parallel-group study of twice-daily treatment with OMACOR (OM3EE), a prescription-only formulation of highly purified ethyl esters of omega-3 polyunsaturated fatty acids in Chinese adult patients (≥18 years) who had elevated baseline fasting serum triglycerides (TG).
exercise
Fourteen patients suffering from familial hypercholesterolemia (type IIa) participated in a double-blind, placebo-controlled trial that evaluated the effects of fish oil ethyl ester (K-85, 5.7 g/day) or a hydroxymethylglutaryl coenzyme A reductase inhibitor (lovastatin, 40 mg/day) alone or in combination on lipid metabolism and bleeding time at rest and after standardized exercise.
recorded 2021-09-15 · last checked 2026-09-04
Q11
What is recorded about Omega-3-Acid Ethyl Esters and IGF-1?
"Ral reduced serum IGF-1 in a dose-dependent manner (P<0.05) while Lovaza did not."
mTORPMID 21501117
"To answer this question, we evaluated the effect of 8 weeks of LCn-3PUFA supplementation (4 g of Lovaza®/day) in nine 25-45-year-old healthy subjects on the rate of muscle protein synthesis (by using stable isotope-labelled tracer techniques) and the activation (phosphorylation) of elements of the mTOR (mammalian target of rapamycin)/p70S6K (p70 S6 kinase) signalling pathway during basal…"
recorded 2012-06-06 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 7 source rows
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