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Fenofibric Acid

  • 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 Fenofibric Acid does in the body

Triglyceride (TG) levels

From the FDA-approved label: The active moiety of fenofibric acid delayed-release capsule is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate. The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα).

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 · BGF9MN2HU1 · read 2026-08-29

  • Its recorded molecular formula is C22H28ClNO5, weighing 421.91.

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-30

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 86 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

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.

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 29 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
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 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.
Which registered measures put each goal on this table
Cholesterol
triglycerides from baseline to final visit; calculated low density lipoprotein cholesterol; plasma triglycerides; high density lipoprotein cholesterol; total cholesterol; direct fasting plasma low density lipoprotein cholesterol; triglyceride change; changes serum triglyceride levels

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 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.

Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study

The study did not show it

Who was studied
NCT00300430
How many people
1911
Study design
Phase 3
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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Percent Change in Triglycerides From Baseline to Final Visit

The study did not show it

Who was studied
NCT00300482
How many people
1445
Study design
Phase 3
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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)

The study did not show it

Who was studied
NCT00463606
How many people
760
Study design
Phase 3
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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Primary Hierarchical Composite Endpoint

The study did not show it

Who was studied
NCT04517396
How many people
701
Study design
Phase 2
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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)

The study did not show it

Who was studied
NCT00616772
How many people
682
Study design
Phase 3
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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Percent Change in Triglycerides From Baseline to Final Visit

The study did not show it

Who was studied
NCT00300456
How many people
657
Study design
Phase 3
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
  • PubChem PUG-REST · 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 No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.15 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.1 registered measure inside human tissue.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  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.

No registered study measured anything of this kind.

Measured

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

  • triglycerides from baseline to final visit
  • calculated low density lipoprotein cholesterol
  • plasma triglycerides
  • high density lipoprotein cholesterol
  • total cholesterol
  • direct fasting plasma low density lipoprotein cholesterol
  • maximum plasma concentration of fenofibric acid
  • maximum plasma concentration
  • triglyceride change
  • pharmacokinetics maximum plasma concentration

and 6 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 (13)
  • pharmacokinetic parameters pharmacodynamic variables
  • vldl apoc iii transport rate
  • adverse event and safety laboratory assessments
  • pharmacokinetic parameters
  • pk interaction
  • area under the curve of fenofibric acid
  • efficacy
  • cmax
  • auctau
  • rate of response in receiving fenofibrate therapy
  • pruritus grading
  • carotid intima media thickness
  • tolerability of fenofibrate

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. 20 hours hours

    Read from the label, which states: “Elimination Fenofibric acid is eliminated with a half-life of approximately 20 hours, allowing once daily administration of fenofibric acid delayed-release capsules.”

  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.

  • Fenofibric acid delayed-release capsules indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.

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: “The safety and effectiveness of fenofibric acid delayed-release capsules have not been established in pediatric patients with severe hypertriglyceridemia or primary hyperlipidemia.”

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-30

  • On older people, the label states: “Assess renal function in geriatric patients and follow contraindications and dosing recommendations for patients with renal impairment [see Contraindications (4), Warnings and Precautions (5.3, 5.4), and Use in Specific Populations (8.6)] .”

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production.”

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-30

  • On people with reduced liver function, the label states: “The use of fenofibric acid delayed-release capsule has not been evaluated in patients with hepatic impairment.”

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Fenofibric acid delayed-release capsule is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73m 2 ), including those with end-stage renal disease (ESRD) and those receiving dialysis.”

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · 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 tablet, capsule, delayed release, 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.

Fenofibric Acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 686 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • blood creatinine increased — 115 reaction mentions
  • myalgia — 115 reaction mentions
  • blood triglycerides increased — 99 reaction mentions
  • rash — 91 reaction mentions
  • hepatic enzyme increased — 58 reaction mentions
  • high density lipoprotein decreased — 53 reaction mentions
  • blood creatine phosphokinase increased — 46 reaction mentions
  • rhabdomyolysis — 43 reaction mentions
  • pancreatitis — 34 reaction mentions
  • liver function test abnormal — 32 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

  • 16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.

    FDA National Drug Code directory · 42385-945 · read 2026-08-29

  • They are sold as capsule, delayed release and powder, taken oral.

    FDA National Drug Code directory · 42385-945 · read 2026-08-29

  • The regulator's established pharmacologic class for it is peroxisome proliferator receptor alpha agonist [epc].

    FDA National Drug Code directory · 42385-945 · read 2026-08-29

  • 8 published labels name it as an active ingredient. 8 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · read 2026-08-29

  • 22310 marketed supplement labels list this ingredient, classed as botanical with nutrients, non-nutrient/non-botanical and other combinations.

    NIH Dietary Supplement Label Database · 213895 · read 2026-08-29

  • 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.

    NIH Dietary Supplement Label Database · 213895 · read 2026-08-29

  • Fenofibric Acid is oral at 3 DOSAGE FORMS AND STRENGTHS • 45 mg capsules with a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to…, recorded as fda label in effect 2025-07-14 in the United States.

    US prescribing information · 8ffcb173-095a-4550-84f2-18959ad2aab8 · 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.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Fenofibric Acid 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 unclearRead from sources, not yet reviewed

What nobody knows yet

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

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 Fenofibric Acid 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.

How many documents were read

  • 8 documents were read for this substance.

    RNAWiki source record

  • 8 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 8 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 8 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
BGF9MN2HU1
CAS registry number
42017-89-0
PubChem compound
64929
ChEMBL
CHEMBL981
ChEBI
83469
RxNorm concept
24852
EMA substance identifier
100000128002
European Chemicals Agency number
255-626-9
DrugBank
DB13873

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  • Not passed

    Trial roles classified for highlighted evidence

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  • Passed

    Canonical metadata present

    slug and display name present

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

  • 1 approved application covers products containing this substance. The earliest was NDA022418, approved 20090814 to ROSEMONT.

    Drugs@FDA application register · NDA022418 · read 2026-08-29

  • Marketing status on the register: discontinued.

    Drugs@FDA application register · NDA022418 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20110101.

    FDA National Drug Code directory · 42385-945 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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What is not here

5 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

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The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (12)

What did Fenofibric Acid's largest trial (1911 people) and its longest (16 years) measure?


1911 people in Fenofibric Acid's largest registered study, 16 years in its longest registered window, measuring Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin. ClinicalTrials.gov · 2026-09-01

18 phase1, 10 phase3, 8 phase2, 8 phase4; NCT01356290; 2030-04; no ageing endpoint recorded. Last human test completed 2020, NCT03829514.

Interpretation These counts include studies where Fenofibric Acid 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
  • phase1
    18
  • phase3
    10
  • phase2
    8
  • phase4
    8
  • Last recorded human test NCT03829514
    2020-03-04

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

Fenofibric Acid was tested only in human — what did it show?


human: biomarker (43): the rungs where Fenofibric Acid has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT00585143
    biomarker; Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin; 43

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

6 of Fenofibric Acid's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (2), funding/business (2) and other (2): Fenofibric Acid's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Did not continue with development of DCCR in Very High Triglycerides"; 6 of 43 registered studies

Show the evidence

Trial

  • NCT00973271
    withdrawn; "Did not continue with development of DCCR in Very High Triglycerides"
  • NCT01025492
    terminated; "Collaborator/corporate sponsor withdrew funding and permission to continue."
  • NCT01030328
    withdrawn; "Lack of patient population"
  • NCT01574131
    terminated; "lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted"
  • NCT01965834
    terminated; "Lack of adequate accrual."
  • NCT05514119
    terminated; "Low Enrollment"

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

Human studies of Fenofibric Acid used warfarin plus ABT-335 plus rosuvastatin 5 mg — over how long?


Human studies of Fenofibric Acid used "warfarin plus ABT-335 plus rosuvastatin 5 mg". ClinicalTrials.gov · 2026-09-01

8 recorded entries; human; also "warfarin plus ABT-335 plus rosuvastatin 20 mg", "Fenofibric Acid (Fibricor™) 105 mg Tablet", "Fenofibric Acid 105 mg Tablet"

Show the evidence

human

  • NCT00487136
    warfarin plus ABT-335 plus rosuvastatin 5 mg
  • NCT00487136
    warfarin plus ABT-335 plus rosuvastatin 20 mg
  • NCT00960687
    Fenofibric Acid (Fibricor™) 105 mg Tablet
  • NCT00960856
    Fenofibric Acid 105 mg Tablet
  • NCT00973271
    135 mg fenofibric acid
  • NCT01964365
    Fenofibric acid 135mg
2 more recorded rows
  • human NCT01964365
    Cresto 20mg, Fenofibric acid 135mg
  • human NCT02422030
    Trilipix 135mg

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

Fenofibric Acid's half-life is 20 hours — which schedules were studied?


20 hours, the half-life Fenofibric Acid's label states. openfda-label · daa488be-f580-430c-a72c-80ac31bb3e40 · 2026-08-30

bioavailability 81% %.

Show the evidence
  • half life
    20 hours hours; Elimination Fenofibric acid is eliminated with a half-life of approximately 20 hours, allowing once daily administration of fenofibric acid delayed-release capsules.
  • bioavailability
    81% %; The absolute bioavailability of fenofibric acid is approximately 81%.

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

Could one person measure Fenofibric Acid's effect on triglycerides from baseline to final visit?


Triglycerides from baseline to final visit: measured in Fenofibric Acid's trials.

Interpretation triglycerides from baseline to final visit is the recorded endpoint.

Show the evidence

biomarkers

  • triglycerides from baseline to final visit; 2026-09-01
  • pharmacokinetic parameters pharmacodynamic variables; 2026-09-01
  • vldl apoc iii transport rate; 2026-09-01
  • calculated low density lipoprotein cholesterol; 2026-09-01
  • plasma triglycerides; 2026-09-01
  • high density lipoprotein cholesterol; 2026-09-01
14 more recorded rows
  • biomarkers
    total cholesterol; 2026-09-01
  • biomarkers
    adverse event and safety laboratory assessments; 2026-09-01
  • biomarkers
    pharmacokinetic parameters; 2026-09-01
  • biomarkers
    pk interaction; 2026-09-01
  • biomarkers
    direct fasting plasma low density lipoprotein cholesterol; 2026-09-01
  • biomarkers
    area under the curve of fenofibric acid; 2026-09-01
  • biomarkers
    maximum plasma concentration of fenofibric acid; 2026-09-01
  • biomarkers
    maximum plasma concentration; 2026-09-01
  • biomarkers
    efficacy; 2026-09-01
  • biomarkers
    triglyceride change; 2026-09-01
  • biomarkers
    pharmacokinetics maximum plasma concentration; 2026-09-01
  • biomarkers
    peak plasma concentration of fenofibric acid; 2026-09-01
  • biomarkers
    mitochondrial fatty acid oxygenation; 2026-09-01
  • biomarkers
    cmax; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 20 hours; 2026-08-30
  • human trials at or under30
    15
  • smallest human trial
    0; NCT00973271; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of adverse event and safety laboratory assessments, area under the curve of fenofibric acid and auctau did Fenofibric Acid's trials measure?


adverse event and safety laboratory assessments, area under the curve of fenofibric acid and auctau lead 29 outcome terms across Fenofibric Acid's trials. ClinicalTrials.gov · 2026-09-01

Interpretation calculated low density lipoprotein cholesterol, plasma triglycerides, high density lipoprotein cholesterol, total cholesterol, adverse event and safety laboratory assessments and pharmacokinetic parameters follow.

Show the evidence
  • triglycerides from baseline to final visit
    1
  • pharmacokinetic parameters pharmacodynamic variables
    1
  • vldl apoc iii transport rate
    1
  • calculated low density lipoprotein cholesterol
    1
  • plasma triglycerides
    1
  • high density lipoprotein cholesterol
    1
14 more recorded rows
  • total cholesterol
    1
  • adverse event and safety laboratory assessments
    1
  • pharmacokinetic parameters
    1
  • pk interaction
    1
  • direct fasting plasma low density lipoprotein cholesterol
    1
  • area under the curve of fenofibric acid
    1
  • maximum plasma concentration of fenofibric acid
    1
  • maximum plasma concentration
    1
  • efficacy
    1
  • triglyceride change
    1
  • pharmacokinetics maximum plasma concentration
    1
  • peak plasma concentration of fenofibric acid
    1
  • mitochondrial fatty acid oxygenation
    1
  • cmax
    1

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

Which of Fenofibric Acid's 2 ongoing trials reports first?


2 registered trials of Fenofibric Acid are open; earliest completion 2027-12-31. ClinicalTrials.gov · 2026-09-01

Efficacy; Carotid intima media thickness; latest 2030-04

Show the evidence

Trial

  • NCT01356290
    "Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors"; n 232; "Efficacy"; 2030-04
  • NCT05365425
    "Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia"; n 56; "Carotid intima media thickness"; 2027-12-31

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

Which 9 trials of Fenofibric Acid posted no result?


Posted no result
9 of 9 completed trials
Registrations
NCT00813527, NCT00487136, NCT00632840, NCT00585143, NCT00683176 and NCT01501435, and 3 more
Completion dates
oldest 2007-01; newest 2018-06-20
Show the evidence

Trial

  • NCT00813527
    2007-01
  • NCT00487136
    2007-07
  • NCT00632840
    2007-12
  • NCT00585143
    2008-10
  • NCT00683176
    2011-03
  • NCT01501435
    2012-06
3 further recorded trials
  • NCT01964365
    2013-12
  • NCT02422030
    2015-04-30
  • NCT03586674
    2018-06-20

At the median, Fenofibric Acid's trials enrolled 50 people — anything larger?


Median enrolment
50
Largest enrolment
1911
Registered trials counted
43

What do 686 spontaneous reports say about Fenofibric Acid — 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.

Fenofibric Acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 686 reaction mentions were counted: blood creatinine increased 115; myalgia 115; blood triglycerides increased 99; rash 91. open-targets-adr · CHEMBL1201745 · 2026-06-24

Show the evidence
  • blood creatinine increased
    115
  • myalgia
    115
  • blood triglycerides increased
    99
  • rash
    91
  • hepatic enzyme increased
    58
  • high density lipoprotein decreased
    53
4 more recorded rows
  • blood creatine phosphokinase increased
    46
  • rhabdomyolysis
    43
  • pancreatitis
    34
  • liver function test abnormal
    32

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

Fenofibric Acid and CYP1A2, CYP2A6 and CYP2C19: shared by which compounds?


CYP1A2, CYP2A6 and CYP2C19 appear in Fenofibric Acid's recorded interaction sentences, 8 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    Drug Interaction Studies In vitro studies using human liver microsomes indicate that fenofibric acid is not an inhibitor of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2.
  • CYP2A6 pharmacokinetics
    It is a weak inhibitor of CYP2C8, CYP2C19, and CYP2A6, and mild-to-moderate inhibitor of CYP2C9 at therapeutic concentrations.
  • CYP2C19 pharmacokinetics
    It is a weak inhibitor of CYP2C8, CYP2C19, and CYP2A6, and mild-to-moderate inhibitor of CYP2C9 at therapeutic concentrations.
  • CYP2C8 pharmacokinetics
    It is a weak inhibitor of CYP2C8, CYP2C19, and CYP2A6, and mild-to-moderate inhibitor of CYP2C9 at therapeutic concentrations.
  • CYP2C9 pharmacokinetics
    It is a weak inhibitor of CYP2C8, CYP2C19, and CYP2A6, and mild-to-moderate inhibitor of CYP2C9 at therapeutic concentrations.
  • CYP2D6 pharmacokinetics
    Drug Interaction Studies In vitro studies using human liver microsomes indicate that fenofibric acid is not an inhibitor of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2.
2 more recorded rows
  • CYP2E1 pharmacokinetics
    Drug Interaction Studies In vitro studies using human liver microsomes indicate that fenofibric acid is not an inhibitor of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2.
  • CYP3A4 pharmacokinetics
    Drug Interaction Studies In vitro studies using human liver microsomes indicate that fenofibric acid is not an inhibitor of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2.

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201745
PubChem CID
11350701
CAS number
856676-23-8
RxCUI
1433887
InChIKey
MQOBSOSZFYZQOK-UHFFFAOYSA-N
Also called
Choline fenofibrate
Development code
ABT-335, LF-153, NSC-281318
Also called
Fenofibrate de choline, Fenofibrato de colina, Fenofibric acid choline salt, Fenofibrate free acid, Fenofibrate related compound b, Procetofenic acid, fenofibrate, CHOLINE FENOFIBRATE [MART.], CHOLINE FENOFIBRATE [ORANGE BOOK], CHOLINE FENOFIBRATE [USAN], CHOLINE FENOFIBRATE [USP-RS], Choline fenofibrate [WHO-DD]
Trade name
Trilipix, Fenocor-67, Fibricor, Lipanthyl, Lofibra, Supralip, Fenofibric Acid / Trilipix, Fenofibric Acid Delayed-Release, Fibricor / Fenofibric Acid Delayed-Release
Component
Choline fenofibrate
Sources (9)

Sources

3 more sources
  • openfda-label daa488be-f580-430c-a72c-80ac31bb3e40 ·
  • openfda-label+europepmc K1:BGF9MN2HU1 ·
  • national registers US ·

ChEMBL ATC CC BY-SA · 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: 9 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.