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Icosapent

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Icosapent does in the body

The nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers

Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.

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 chemical.

    FDA substance registry · AAN7QOV9EA · read 2026-08-29

  • The supplement label database classes it as fatty acid, under the name EPA (Eicosapentaenoic Acid).

    NIH Dietary Supplement Label Database · 1011 · read 2026-08-29

Where each sentence above came from

No plain explanation of what this changes is stored. 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 79 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 peopleRead 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
MoodNothing 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 reviewer4 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.
CholesterolNothing 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 moved6 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.
FocusNothing 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.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.
Blood sugarNothing 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 moved1 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.
Body weightNothing 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 moved2 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.
MuscleNothing 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 moved1 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.
Which registered measures put each goal on this table
Mood
on a depression severity rating scale over eight weeks; hamilton rating scale for depression; montgomery asberg depression scale; edinburgh postnatal depression scale; beck depression scale; depression severity; depressive symptoms
Cholesterol
triglycerides; total cholesterol; high density cholesterol; low density cholesterol; very low density cholesterol; low density lipoprotein cholesterol
Focus
attention; working memory; sustained attention; divided attention
Blood sugar
incident type 2 diabetes; hba1c
Body weight
body weight; body mass index
Muscle
skeletal muscle mass

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.
Waiting for a reviewer
4 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
6 registered test measure.

What happened in peopleRead 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.

Rate of confirmed viral URIs

The study did not show it

Who was studied
NCT04505098
How many people
39600
Study design
Phase 4
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 NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

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 NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · 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 NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · 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 NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · 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 NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · 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 NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · 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 peopleRead 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.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.4 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.11 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No 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 takeRead 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.

  • hamilton rating scale for depression
  • montgomery asberg depression scale
  • edinburgh postnatal depression scale
  • beck depression scale

Measured

Things only a test, a scale or a device shows.

  • serum albumin
  • triglycerides
  • total cholesterol
  • high density cholesterol
  • low density cholesterol
  • very low density cholesterol
  • body weight
  • body mass index
  • low density lipoprotein cholesterol
  • skeletal muscle mass

and 1 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 (25)
  • on a depression severity rating scale over eight weeks
  • hscrp levels after 8 weeks of treatment pufa
  • n 6 hufa in total hufa
  • incident autoimmune diseases
  • omega 3 index
  • incident type 2 diabetes
  • dropout rate
  • tg 4
  • tc 4
  • hd c 4
  • interleukin 6
  • tumor necrosis factor alpha
  • attention
  • working memory
  • sustained attention
  • stimulus reaction incompatibility
  • go/ no go
  • divided attention
  • alertness
  • phase i recommended phase ii dose of epa

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 89 hours hours

    Read from the label, which states: “The plasma elimination half-life (t1/2) of EPA is approximately 89 hours.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead 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.

  • TriStart DHA™ is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA™ can also be beneficial in improving the nutritional status of women prior to conception.

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 · 1aca884c-c464-900d-ac06-33aee7118df8 · read 2026-08-30

  • On older people, the label states: “Of the total number of patients in well-controlled clinical studies of icosapent ethyl, 45% were 65 years of age and over.”

    US prescribing information · 1aca884c-c464-900d-ac06-33aee7118df8 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary The available data from published case reports and the pharmacovigilance database on the use of icosapent ethyl in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.”

    US prescribing information · 1aca884c-c464-900d-ac06-33aee7118df8 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk.”

    US prescribing information · 1aca884c-c464-900d-ac06-33aee7118df8 · read 2026-08-30

  • On people with reduced liver function, the label states: “In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with icosapent ethyl.”

    US prescribing information · 1aca884c-c464-900d-ac06-33aee7118df8 · 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 takeRead 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 takeRead 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, gelatin coated, capsule, coated, 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 takeNothing 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.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Icosapent appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 607 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • blood triglycerides increased — 137 reaction mentions
  • product odour abnormal — 75 reaction mentions
  • gastrooesophageal reflux disease — 67 reaction mentions
  • somnolence — 64 reaction mentions
  • coma — 62 reaction mentions
  • pneumonia aspiration — 62 reaction mentions
  • myalgia — 47 reaction mentions
  • abdominal discomfort — 34 reaction mentions
  • eructation — 33 reaction mentions
  • atrial fibrillation — 26 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

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 unclearRead 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

  • 8 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.

    FDA National Drug Code directory · 15370-250 · read 2026-08-29

  • They are sold as capsule, capsule, coated, capsule, gelatin coated and capsule, liquid filled, taken oral.

    FDA National Drug Code directory · 15370-250 · read 2026-08-29

  • 4 published labels name it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.

    US prescribing information · e5acfb2a-0959-4542-9b4c-790be194d581 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · e5acfb2a-0959-4542-9b4c-790be194d581 · read 2026-08-29

  • 4222 marketed supplement labels list this ingredient, classed as fat/fatty acid and other combinations.

    NIH Dietary Supplement Label Database · 179990 · read 2026-08-29

  • Those labels carry all other, nutrient and qualified health 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.

    NIH Dietary Supplement Label Database · 179990 · read 2026-08-29

  • Icosapent is oral at 3 DOSAGE FORMS AND STRENGTHS Icosapent ethyl capsules are supplied as: 1 gram transparent natural colored oblong shaped soft gelatin capsules imprinted with “RDY 267” in white ink on one side., recorded as fda label in effect 2026-07-22 in the United States.

    US prescribing information · 1aca884c-c464-900d-ac06-33aee7118df8 · 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 takeRead 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.

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Questions worth asking

  • Which of the trials of Icosapent 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?

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What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

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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 Icosapent 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 peopleRead 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)
AAN7QOV9EA
CAS registry number
10417-94-4
PubChem compound
446284
ChEMBL
CHEMBL460026
ChEBI
28364
WHO international nonproprietary name list entry
6328
RxNorm concept
90
EMA substance identifier
100000079270
DrugBank
DB00159

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    Trial roles classified for highlighted evidence

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What is missing or unclearRead 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

  • The earliest marketing start date recorded for a listed product is 20090417.

    FDA National Drug Code directory · 15370-250 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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Recorded evidence blocks (14)

What did Icosapent's largest trial (25871 people) and its longest (15 years) measure?


25871 people in Icosapent's largest registered study, 15 years in its longest registered window, measuring Plasma Levels of Triglycerides and Lipoprotein Cholesterol. ClinicalTrials.gov · 2026-09-01

14 na, 10 phase3, 5 phase2, 5 phase4, 3 early phase1, 2 phase1, 1 na or unstated; NCT01351805; 2025-02; no ageing endpoint recorded. Last human test completed 2026, NCT07711444.

Interpretation These counts include studies where Icosapent 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
  • na
    14
  • phase3
    10
  • phase2
    5
  • phase4
    5
  • early phase1
    3
  • phase1
    2
2 more recorded rows
  • na or unstated
    1
  • Last recorded human test NCT07711444
    2026-06-01

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Icosapent shown lifespan?


mouse: lifespan, rat: mechanism-only and human: biomarker (37): the rungs where Icosapent has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Plasma Levels of Triglycerides and Lipoprotein Cholesterol — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat mechanism-onlyDog Non-human primate Human biomarker
Show the evidence
  • mouse
    lifespan
  • rat
    mechanism-only
  • human NCT00167310
    biomarker; Plasma Levels of Triglycerides and Lipoprotein Cholesterol; 37

recorded 2026-09-01 · last checked 2026-09-04

6 of Icosapent's trials stopped: accrual/recruitment, other?


accrual/recruitment (5) and other (1): Icosapent's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"CRP is no longer SOC - enrollment halted and will analyze available data."; 6 of 37 registered studies

Show the evidence

Trial

  • NCT00578578
    terminated; "CRP is no longer SOC - enrollment halted and will analyze available data."
  • NCT02422446
    terminated; "Difficulty enrolling patients with elevated triglycerides under statin treatment"
  • NCT03101527
    terminated; "Insufficient recruitment"
  • NCT03101540
    terminated; "Insufficient recruitment"
  • NCT03915535
    terminated; "Several impacts of COVID-19 on recruitment and organization"
  • NCT04006847
    terminated; "Product complaint"

recorded 2026-09-01 · last checked 2026-09-04

Did Icosapent move PhenoAge, and by how much?


PhenoAge: "In multivariate linear regression models, eight of the twelve individual serum PUFAs showed a significantly negative association with PhenoAge acceleration, Specifically, per-unit increases in linoleic acid (LA), gamma-linolenic acid (GLA), arachidonic acid (AA), alpha-linolenic acid (ALA), stearidonic acid (SDA),…" Europe PMC · epigenetic clock search · 2025-03-08

1 recorded sentence; 2025; biomarker

Show the evidence
  • PhenoAge PMID 40057623
    2025; "In multivariate linear regression models, eight of the twelve individual serum PUFAs showed a significantly negative association with PhenoAge acceleration, Specifically, per-unit increases in linoleic acid (LA), gamma-linolenic acid (GLA), arachidonic acid (AA), alpha-linolenic acid (ALA), stearidonic acid (SDA), eicosapentaenoic acid (EPA), docosapentaenoic acid (n-3 DPA), and docosahexaenoic…"

recorded 2025-03-08 · last checked 2026-09-04

More Icosapent was worse in human: at what point?


Hormetic in human: "For egg quality, HT reduced yolk TBARS linearly after 30 days at 22 ± 4°C (P < 0.001), while Haugh units showed a quadratic, hormetic response with best preservation at 10-20 mg/kg (P < 0.001) and lower efficacy at 50 mg/kg. Docosahexaenoic acid (DHA) content in yolk was highest at 20 mg/kg (P = 0.032), with a…" Europe PMC · dose-response search · 2026-04-20

2 recorded sentences naming Icosapent; hormetic, dose-response

Show the evidence
  • hormetic PMID 42102754
    "For egg quality, HT reduced yolk TBARS linearly after 30 days at 22 ± 4°C (P < 0.001), while Haugh units showed a quadratic, hormetic response with best preservation at 10-20 mg/kg (P < 0.001) and lower efficacy at 50 mg/kg. Docosahexaenoic acid (DHA) content in yolk was highest at 20 mg/kg (P = 0.032), with a quadratic response for eicosapentaenoic acid (EPA) concentration (Quadratic effect: P =…"
  • dose-response PMID 35647665
    "Background Current evidence might support the use of omega-3 fatty acids (preferably docosahexaenoic acid and eicosapentaenoic acid) for lowering blood pressure (BP), but the strength and shape of the dose-response relationship remains unclear."

recorded 2026-04-20 · last checked 2026-09-04

Icosapent's half-life is 89 hours — which schedules were studied?


89 hours, the half-life Icosapent's label states. openfda-label · 2026-08-30

Show the evidence
  • half life
    89 hours hours; The plasma elimination half-life (t1/2) of EPA is approximately 89 hours.

recorded 2026-08-30 · last checked 2026-09-04

Could one person measure Icosapent's effect on on a depression severity rating scale over eight weeks?


On a depression severity rating scale over eight weeks: measured in Icosapent's trials.

Interpretation on a depression severity rating scale over eight weeks is the recorded endpoint.

Show the evidence

biomarkers

  • on a depression severity rating scale over eight weeks; 2026-09-01
  • hscrp levels after 8 weeks of treatment pufa; 2026-09-01
  • serum albumin; 2026-09-01
  • n 6 hufa in total hufa; 2026-09-01
  • incident autoimmune diseases; 2026-09-01
  • omega 3 index; 2026-09-01
14 more recorded rows
  • biomarkers
    incident type 2 diabetes; 2026-09-01
  • biomarkers
    dropout rate; 2026-09-01
  • biomarkers
    triglycerides; 2026-09-01
  • biomarkers
    total cholesterol; 2026-09-01
  • biomarkers
    high density cholesterol; 2026-09-01
  • biomarkers
    low density cholesterol; 2026-09-01
  • biomarkers
    very low density cholesterol; 2026-09-01
  • biomarkers
    body weight; 2026-09-01
  • biomarkers
    body mass index; 2026-09-01
  • biomarkers
    tg 4; 2026-09-01
  • biomarkers
    tc 4; 2026-09-01
  • biomarkers
    hd c 4; 2026-09-01
  • biomarkers
    interleukin 6; 2026-09-01
  • biomarkers
    tumor necrosis factor alpha; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 89 hours; 2026-08-30
  • human trials at or under30
    8
  • smallest human trial
    0; NCT00585390; PHASE2/PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED

Which of adverse events, alertness and attention did Icosapent's trials measure?


adverse events, alertness and attention lead 40 outcome terms across Icosapent's trials. ClinicalTrials.gov · 2026-09-01

n 6 hufa in total hufa, incident autoimmune diseases, omega 3 index, incident type 2 diabetes, dropout rate and triglycerides follow.

Show the evidence
  • on a depression severity rating scale over eight weeks
    1
  • hscrp levels after 8 weeks of treatment pufa
    1
  • serum albumin
    1
  • n 6 hufa in total hufa
    1
  • incident autoimmune diseases
    1
  • omega 3 index
    1
14 more recorded rows
  • incident type 2 diabetes
    1
  • dropout rate
    1
  • triglycerides
    1
  • total cholesterol
    1
  • high density cholesterol
    1
  • low density cholesterol
    1
  • very low density cholesterol
    1
  • body weight
    1
  • body mass index
    1
  • tg 4
    1
  • tc 4
    1
  • hd c 4
    1
  • interleukin 6
    1
  • tumor necrosis factor alpha
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Icosapent's 4 ongoing trials reports first?


4 registered trials of Icosapent are open; earliest completion 2027-02-05. ClinicalTrials.gov · 2026-09-01

Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue; Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time; latest 2028-09

Show the evidence

Trial

  • NCT02295059
    "Omega 3 Fatty Acids and ERPR(-)HER2(+/-) Breast Cancer Prevention"; n 80; "Changes in eicosanoids/metabolites including PGE2, PGE3 in breast adipose tissue"; 2027-02-05
  • NCT06494488
    "Differential Thrombogenesis by EPA and DHA Mediated by HDL"; n 80; "Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time"; 2028-03-31
  • NCT07439744
    "NUTRIMOOD-Inflammation and Depressive Comorbidity in Obesity: Modulation by Omega-3 Polyunsaturated Fatty Acids Status"; n 50; "Depression Diagnosis"; 2027-12
  • NCT07462013
    "Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice"; n 120; "Depressive Symptoms"; 2028-09

recorded 2026-09-01 · last checked 2026-09-04

Which 13 trials of Icosapent posted no result?


Posted no result
13 of 13 completed trials
Registrations
NCT00031707, NCT00114595, NCT00014027, NCT00432913, NCT00585390 and NCT02537236, and 7 more
Completion dates
oldest 2004-01; newest 2021-07-14
Show the evidence

Trial

  • NCT00031707
    2004-01
  • NCT00114595
    2005-03
  • NCT00014027
    2008-04-11
  • NCT00432913
    2008-06
  • NCT00585390
    2009-11
  • NCT02537236
    2009-12
7 further recorded trials
  • NCT01369550
    2011-01
  • NCT03258840
    2014-08
  • NCT02179372
    2016-11
  • NCT03192579
    2017-06-02
  • NCT02101970
    2018-08-27
  • NCT03693131
    2019-06-29
  • NCT04221217
    2021-07-14

At the median, Icosapent's trials enrolled 60 people — anything larger?


Median enrolment
60
Largest enrolment
25871
Registered trials counted
37

What do 607 spontaneous reports say about Icosapent — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Icosapent appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 607 reaction mentions were counted: blood triglycerides increased 137; product odour abnormal 75; gastrooesophageal reflux disease 67; somnolence 64. open-targets-adr · CHEMBL460026 · 2026-06-24

Show the evidence
  • blood triglycerides increased
    137
  • product odour abnormal
    75
  • gastrooesophageal reflux disease
    67
  • somnolence
    64
  • coma
    62
  • pneumonia aspiration
    62
4 more recorded rows
  • myalgia
    47
  • abdominal discomfort
    34
  • eructation
    33
  • atrial fibrillation
    26

recorded 2026-06-24 · last checked 2026-09-04

Was Icosapent studied with fasting and exercise?


fasting and exercise are named in Icosapent's label sentences: "Randomization to treatment with 2 g twice daily of icosapent ethyl or matching placebo was performed among 8179 participants receiving statin therapy with established cardiovascular disease or age ≥50 years with diabetes and ≥1 additional risk factor, fasting triglyceride 1.69-5.63 mmol/L, and…" openfda-label+europepmc · 2026-04-01

2 recorded statements; fasting, exercise

Show the evidence
  • fasting
    Randomization to treatment with 2 g twice daily of icosapent ethyl or matching placebo was performed among 8179 participants receiving statin therapy with established cardiovascular disease or age ≥50 years with diabetes and ≥1 additional risk factor, fasting triglyceride 1.69-5.63 mmol/L, and low-density lipoprotein cholesterol 1.06-2.59 mmol/L. Total hospitalizations were analyzed with a…
  • exercise
    In this work, a meta-analysis was conducted that adhered to the PRISMA 2020 criteria, incorporating evidence from 41 randomized controlled trials on eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation, all of which had been conducted as evidence between 2011 and 2025 and evaluated the effects of EPA and DHA supplementation on the primary markers of the impact of exercise on…

recorded 2026-04-01 · last checked 2026-09-04

What is recorded about Icosapent and autophagy?


"Therapeutically, interventions such as the SGLT2 inhibitor empagliflozin and eicosapentaenoic acid restore lysosomal function and autophagic activity." — where Icosapent and autophagy appear together. Europe PMC · pathway abstract search · 2025-07-21

autophagy, sirtuin; PMID 40131605, 36574744, 40761352, 31408587

Show the evidence
  • autophagy PMID 40131605
    "Therapeutically, interventions such as the SGLT2 inhibitor empagliflozin and eicosapentaenoic acid restore lysosomal function and autophagic activity."
  • sirtuin PMID 36574744
    "Icosapent alleviated acetic acid-induced colitis via its anti-inflammatory, antioxidant, and anti-apoptotic effects mediated in part by SIRT1 pathway activation."
  • autophagy PMID 40761352
    "Omega-3 PUFAs [including eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA)] may mitigate prostate cancer risk through various molecular mechanisms, such as inhibiting pro-inflammatory eicosanoid production via COX-2 pathway, regulating apoptosis and autophagy, and potentially influencing other signaling pathways like NF-κB."
  • sirtuin PMID 31408587
    "The present study aims to determine whether supplementation of the maternal diet with eicosapentaenoic acid (EPA) can decrease placental lipid deposition and improve antioxidant ability, in a SIRT1-dependent manner."
  • autophagy PMID 37450014
    "Eicosapentaenoic acid ethyl ester (EPA-E) is an antihyperlipidemic derivative of omega-3 fatty acids that exhibited affinity to peroxisome proliferator-activated receptor-γ (PPAR-γ) that possesses both antioxidant and autophagy modulating properties."

recorded 2025-07-21 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL460026
PubChem CID
446284
CAS number
10417-94-4
RxCUI
90
InChIKey
JAZBEHYOTPTENJ-JLNKQSITSA-N
Also called
All-cis-fatty acid 20:5 omega-3, C20:5 (n-3), Eicosapentaenoate, Eicosapentaenoic acid, Icosapento, Incromega e 7010sr, Ropufa 70, Timnodonic acid, dha, docosahexaenoic acid, epa, epa-ffa
Development code
EPA 45G
Trade name
Pnv-Omega, Bp Vit 3, Tristart DHA, Prenate Essential, Pnv-Omega / Bp Vit 3 / Tristart DHA / Prenate Essential
Sources (11)

Sources

  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC epigenetic clock search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · 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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.