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Bempedoic 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 Bempedoic acid does in the body

High cholesterol and cardiovascular risk in people who cannot tolerate a statin

Bempedoic acid arrives inactive. An enzyme that exists in liver but not in muscle attaches a coenzyme A group to it, and only then can it block a step in cholesterol manufacture. So the drug switches itself on in the one tissue where it is meant to work and stays inert in the tissue where statin side effects are reported. The liver responds exactly as it does to a statin: more LDL receptors, more LDL cleared from the blood.

What happened in people

An LDL cholesterol reduction 29.2 mg/dL greater than placebo at 6 months from a mean baseline of 139.0 mg/dL

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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

The only lipid-lowering drug with a dedicated cardiovascular outcome trial conducted specifically in people who could not take statins

Where it acts
Hepatocyte cytoplasm (liver)
Kind of result
A number that stands in for health
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 · 1EJ6Z6Q368 · read 2026-08-29

  • Its recorded molecular formula is C19H36O5, weighing 344.5.

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · 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.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 116 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.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

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 21 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 moved10 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
calculated low density lipoprotein cholesterol; ldl cholesterol; low density lipoprotein cholesterol at week 12; low density lipoprotein cholesterol at week 6; low density lipoprotein cholesterol at month 2; low density lipoprotein cholesterol at day 56; direct low density lipsprotein cholesterol; ldl c level at week 12

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
10 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.

Composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or coronary revascularisation in statin-intolerant patients

The study showed what it set out to show

Who was studied
CLEAR Outcomes (NCT02993406)
How many people
13970
Study design
Randomised double-blind placebo-controlled trial, median 40.6 months
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
HR 0.87 (95% CI 0.79-0.96), P = 0.004; absolute difference 1.6 points
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No significant effect on fatal or non-fatal stroke, cardiovascular death or all-cause death. Gout 3.1% against 2.1% and cholelithiasis 2.2% against 1.2%. Enrolment rested on self-reported statin intolerance.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and a fixed combination with ezetimibe

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Safety, with percentage change in LDL cholesterol at week 12 as the principal efficacy endpoint

The study showed what it set out to show

Who was studied
CLEAR Harmony (NCT02666664)
How many people
2230
Study design
Randomised double-blind placebo-controlled safety trial, 52 weeks
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
LDL difference from placebo -18.1 percentage points (95% CI -20.0 to -16.1), P < 0.001
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Discontinuation for adverse events was 10.9% against 7.1% and gout 1.2% against 0.3%, despite no difference in overall or serious adverse events.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and a fixed combination with ezetimibe

Interval reported. 95% CI -20

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 2 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.12 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 No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  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 changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Bempedoic acid

    What a person takes: Oral tablet, and a fixed combination with ezetimibe.

    The measurement behind this step

    Once daily with or without food. Half-life around 21 hours. It inhibits OATP1B1 and OATP1B3, so it raises exposure to simvastatin and pravastatin, and the label limits the doses of those statins when used together — an interaction that matters precisely because the drug is intended for people who may still be taking a low statin dose.

  2. Getting in

    Swallowed inactive, and it stays inactive everywhere except the liver

    The tablet contains a molecule that does nothing on its own. It has to be chemically switched on, and the enzyme that does that is present in liver and essentially absent from muscle.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Bempedoic acid is absorbed and circulates as the free acid and its glucuronide, neither of which inhibits the target. Activation requires thioesterification to bempedoyl-CoA by very-long-chain acyl-CoA synthetase 1 (ACSVL1, SLC27A2), an enzyme expressed in liver and not meaningfully in skeletal muscle. Half-life is roughly 21 hours, supporting once-daily dosing.

  3. Reaching the cell

    It is carried into hepatocytes and converted there

    Liver cells take it up and attach a coenzyme A group, which is the switch. Muscle cells take it up too but cannot perform that step, so nothing happens there.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Hepatic uptake involves OATP1B1 and OATP1B3, and conversion to the active thioester occurs in the cytoplasm. The tissue restriction is at the activation step rather than at uptake, which is the design distinction from statins: statins reach muscle in active form and depend on transporter-driven hepatic concentration to spare it, while bempedoic acid reaches muscle in a form that cannot act.

  4. What it acts on

    The activated form blocks a step above the statin target

    It shuts down the enzyme that supplies the raw material for cholesterol manufacture, two steps before the point where statins act in the same chain.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Bempedoyl-CoA inhibits ATP-citrate lyase, which converts cytosolic citrate and coenzyme A to acetyl-CoA and oxaloacetate. Acetyl-CoA is the substrate for acetoacetyl-CoA thiolase and then HMG-CoA synthase, whose product HMG-CoA is the substrate for the reductase that statins inhibit. Blocking the supply rather than the reductase produces the same downstream sterol depletion by a different route.

  5. The change it makes

    The sterol-starved liver builds more LDL receptors

    Short of cholesterol, the liver cell switches on the gene for the LDL catcher and puts more of them on its surface, pulling particles out of the blood.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Reduced hepatic cholesterol synthesis releases SREBP-2 through SCAP and the site-1 and site-2 proteases, raising LDLR transcription and surface receptor density, and clearance of circulating LDL increases. This is the identical downstream programme engaged by statins and by ezetimibe, which is why all three are additive with each other and why their effects on the blood number combine predictably.

  6. What that does for a person

    LDL falls about a fifth, and heart attacks fell by about a quarter relative

    Blood cholesterol drops by roughly a fifth. Over more than three years that produced fewer heart attacks and fewer stent procedures, and no measurable change in strokes or deaths.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    In CLEAR Outcomes, LDL fell 29.2 mg/dL more than placebo at 6 months from a mean baseline of 139.0 mg/dL. Fatal or non-fatal myocardial infarction was 3.7% against 4.8% (hazard ratio 0.77) and coronary revascularisation 6.2% against 7.6% (0.81). Stroke, cardiovascular death and all-cause death showed no significant effect.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

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.

  • calculated low density lipoprotein cholesterol
  • ldl cholesterol
  • low density lipoprotein cholesterol at week 12
  • low density lipoprotein cholesterol at week 6
  • low density lipoprotein cholesterol at month 2
  • low density lipoprotein cholesterol at day 56
  • direct low density lipsprotein cholesterol
  • ldl c level at week 12
  • pharmacokinetic parameter maximum observed concentration
  • maximum observed concentration

and 2 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 (9)
  • treatment emergent adverse events
  • major congenital malformations
  • fdg pet/ct endpoint
  • daily infant dose
  • relative infant dose
  • liver fat content
  • adverse events
  • pharmacokinetic parameter area under the curve
  • annualised change in percentage plaque burden

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. 21 ± 11 hours hours

    Read from the label, which states: “The mean ± SD half-life for bempedoic acid in humans was 21 ± 11 hours at steady-state.”

  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.

  • People with established cardiovascular disease or high risk who cannot tolerate a statin at the intensity needed, and people needing further LDL reduction on top of a statin. It has no generic anywhere.

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 NEXLETOL have not been established in pediatric patients.”

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · read 2026-08-30

  • On older people, the label states: “Of the 3,009 adult patients in the primary hypercholesterolemia trials of NEXLETOL, 1,753 (58%) were 65 years of age and older, while 478 (16%) were 75 years of age and older.”

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Discontinue NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.”

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Bempedoic acid was detected in breast milk of lactating women who received six consecutive daily doses of 180 mg bempedoic acid.”

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B) [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · read 2026-08-30

Where the result stopped carrying

  • Stroke, one of the four components of the primary composite, showed no significant effect
  • Neither cardiovascular death nor death from any cause was significantly reduced over 40.6 months
  • CLEAR Harmony found more discontinuations for adverse events on drug than on placebo despite identical overall adverse event rates
  • 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.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

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 (9)
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 tablet, and a fixed combination with ezetimibe

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

Once daily with or without food. Half-life around 21 hours.

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. The rest of the recorded wording: It inhibits OATP1B1 and OATP1B3, so it raises exposure to simvastatin and pravastatin, and the label limits the doses of those statins when used together — an interaction that matters precisely because the drug is intended for people who may still be taking a low statin dose.

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 takeRead from sources, not yet reviewed

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.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Hyperuricaemia and gout follow from inhibition of the renal urate transporter OAT2: gout occurred in 3.1% against 2.1% on placebo in CLEAR Outcomes. Cholelithiasis was 2.2% against 1.2%. Small increases in serum creatinine and hepatic enzymes are more frequent than on placebo. Tendon rupture is a labelled warning, with risk increased by age, renal impairment and prior fluoroquinolone use. The drug is not activated in skeletal muscle, which is the design rationale for its use in statin intolerance.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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.

Bempedoic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 198 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • myalgia — 47 reaction mentions
  • muscle spasms — 27 reaction mentions
  • pain in extremity — 27 reaction mentions
  • arthralgia — 25 reaction mentions
  • gout — 18 reaction mentions
  • blood creatine phosphokinase increased — 16 reaction mentions
  • blood triglycerides increased — 13 reaction mentions
  • muscular weakness — 9 reaction mentions
  • blood uric acid increased — 8 reaction mentions
  • hepatic enzyme increased — 8 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 tablet, and a fixed combination with ezetimibe

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

Half-life around 21 hours.

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 which forms are sold. The rest of the recorded wording: It inhibits OATP1B1 and OATP1B3, so it raises exposure to simvastatin and pravastatin, and the label limits the doses of those statins when used together — an interaction that matters precisely because the drug is intended for people who may still be taking a low statin dose.

No source is stored against this line.

What is recorded as being sold

  • 14 products list this as an active ingredient in the United States drug directory. 12 of them contain it and nothing else.

    FDA National Drug Code directory · 59651-880 · read 2026-08-29

  • They are sold as powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 59651-880 · read 2026-08-29

  • The regulator's established pharmacologic class for it is adenosine triphosphate-citrate lyase inhibitor [epc] and adenosine triphosphate-citrate lyase inhibitors [moa].

    FDA National Drug Code directory · 59651-880 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · 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

  • Nexletol is oral at 3 DOSAGE FORMS AND STRENGTHS NEXLETOL is available as: Tablets: 180 mg, white to off-white, oval shaped, debossed with "180" on one side and "ESP" on the other side., recorded as fda label in effect 2026-06-25 in the United States.

    US prescribing information · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · 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.

Names and forms linked to this record

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 Bempedoic 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

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That bempedoic acid reduces cardiovascular events generally — stroke, cardiovascular death and all-cause death all showed no significant effect

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That it causes fewer muscle symptoms than a statin — the argument rests on activation biochemistry and placebo-controlled tolerability, with no head-to-head randomised comparison

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That everyone in CLEAR Outcomes genuinely could not tolerate a statin — entry rested on self-report, and blinded n-of-1 trials find most such symptoms indistinguishable from placebo

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That a composite containing coronary revascularisation is measuring biology alone — revascularisation is a clinician decision as well as an event

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

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 Bempedoic 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.

Every line above can be traced to the study named beside it. Follow the link and read it.

CLEAR Outcomes: the composite fell, driven by infarction and revascularisation
In plain words
Nearly fourteen thousand people who could not take statins were randomised for over three years. The combined endpoint fell from 13.3% to 11.7%, and heart attacks from 4.8% to 3.7%.
What was measured
Four-component major adverse cardiovascular event composite and its components over a median 40.6 months
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CLEAR Outcomes randomised 13,970 statin-intolerant patients with or at high risk of cardiovascular disease: 6,992 to bempedoic acid and 6,978 to placebo, median follow-up 40.6 months. Mean baseline LDL was 139.0 mg/dL in both groups; at 6 months the reduction was 29.2 mg/dL greater on bempedoic acid, a 21.1 percentage-point difference in percent reduction. The primary composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or coronary revascularisation occurred in 819 (11.7%) against 927 (13.3%): hazard ratio 0.87 (95% CI 0.79 to 0.96), p=0.004. The three-component composite of cardiovascular death, non-fatal stroke or non-fatal infarction was 8.2% against 9.5% (0.85, 0.76 to 0.96, p=0.006). Fatal or non-fatal myocardial infarction was 3.7% against 4.8% (0.77, 0.66 to 0.91, p=0.002) and coronary revascularisation 6.2% against 7.6% (0.81, 0.72 to 0.92, p=0.001).
Source
Nissen SE et al., CLEAR Outcomes, N Engl J Med 2023;388:1353-1364 (NCT02993406)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Stroke and every measure of death showed no significant effect
In plain words
Inside the winning composite, two of the four components did not move. Neither did cardiovascular death or death from any cause.
What was measured
That bempedoic acid reduces cardiovascular events generally — stroke, cardiovascular death and all-cause death all showed no significant effect, and the composite was carried by infarction and revascularisation
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The published conclusion states plainly that bempedoic acid had no significant effects on fatal or non-fatal stroke, on death from cardiovascular causes, or on death from any cause. The composite was therefore carried by myocardial infarction (hazard ratio 0.77) and coronary revascularisation (0.81). Coronary revascularisation is a clinician-initiated procedure rather than a spontaneous event, so a composite in which it contributes substantially is partly measuring decisions as well as biology, particularly in an open lipid environment where the treating physician sees the LDL result. The absence of any mortality effect is expected for a lipid intervention of this size over this duration and is not a criticism of the trial. It is a limit on what the trial licenses being said, and it is why the approved indication names myocardial infarction and coronary revascularisation specifically rather than cardiovascular events in general.
Source
Nissen SE et al., CLEAR Outcomes, N Engl J Med 2023;388:1353-1364
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The tissue-selectivity design is real, and it is a prodrug argument rather than a trial result
In plain words
The drug is inert until an enzyme found in liver but not muscle switches it on. That is a genuine and deliberate design feature, and no trial has compared muscle symptoms head to head against a statin.
What was measured
Adverse event and discontinuation rates over 52 weeks against placebo, and percentage LDL reduction at week 12
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Bempedoic acid requires thioesterification to bempedoyl-CoA by very-long-chain acyl-CoA synthetase 1 (ACSVL1, gene SLC27A2) before it inhibits ATP-citrate lyase. That enzyme is expressed in liver and essentially absent from skeletal muscle, so the active species does not form in the tissue where statin-attributed symptoms are reported. In CLEAR Harmony, 2,230 patients on maximally tolerated statin therapy were randomised 2:1 to bempedoic acid or placebo for 52 weeks with safety as the primary endpoint: overall adverse events were 78.5% against 78.7% and serious adverse events 14.5% against 14.0%, though discontinuations for adverse events were higher on drug (10.9% against 7.1%) as was gout (1.2% against 0.3%). LDL fell 16.5% from baseline, a difference from placebo of -18.1 percentage points (p<0.001). What does not exist is a randomised head-to-head comparison of muscle symptoms between bempedoic acid and a statin, so the muscle claim rests on the activation biochemistry plus placebo-controlled tolerability, not on a comparison.
Source
Ray KK et al., CLEAR Harmony, N Engl J Med 2019;380:1022-1032 (NCT02666664)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Gout, gallstones and biochemical changes are the price, and they are quantified
In plain words
Gout occurred in about one in thirty-two patients against one in forty-eight on placebo, and gallstones in about one in forty-five against one in eighty-three. Uric acid, creatinine and liver enzymes all rose slightly.
What was measured
Randomised incidence of gout, cholelithiasis and biochemical abnormalities against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In CLEAR Outcomes, gout occurred in 3.1% on bempedoic acid against 2.1% on placebo and cholelithiasis in 2.2% against 1.2%, alongside more frequent small increases in serum creatinine, uric acid and hepatic enzyme levels. In CLEAR Harmony the gout rates were 1.2% against 0.3% over 52 weeks and discontinuation for adverse events was 10.9% against 7.1%. The uric acid effect has a specific mechanism: bempedoic acid and its glucuronide inhibit the renal urate transporter OAT2, reducing urate excretion, which is a predictable pharmacological consequence rather than an idiosyncratic reaction. Tendon rupture is a separate labelled warning. Set against a 1.6 percentage-point absolute reduction in the primary composite over 40.6 months, these are the numbers a reader needs on the same page.
Source
Nissen SE et al., N Engl J Med 2023;388:1353-1364; Ray KK et al., N Engl J Med 2019;380:1022-1032
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The trial population was defined by self-reported statin intolerance
In plain words
Everyone in the outcome trial was there because they said they could not take statins. Two independent n-of-1 programmes suggest most such symptoms are not caused by the drug.
What was measured
That everyone enrolled in CLEAR Outcomes genuinely could not tolerate a statin — the entry criterion was self-reported, and blinded n-of-1 trials find most such symptoms indistinguishable from placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CLEAR Outcomes enrolled patients "unable or unwilling to take statins", a definition that rests on the participant's and clinician's account rather than on a blinded rechallenge. The two randomised n-of-1 programmes on the atorvastatin page bear directly on that: SAMSON found symptom scores of 16.3 in statin months against 15.4 in placebo months in 60 people who had abandoned statins (p=0.388, nocebo ratio 0.90), and StatinWISE found a mean difference of -0.11 points across 151 people with previously severe statin-attributed muscle symptoms. Half the SAMSON participants restarted a statin within six months of seeing their own data. This does not diminish the CLEAR Outcomes result, which is a genuine randomised comparison against placebo in the population as recruited. It does mean that a substantial fraction of that population would, on the n-of-1 evidence, have tolerated a statin — and a statin costs about 2.3 cents a tablet against US$13.81 for this one.
Source
Nissen SE et al., N Engl J Med 2023;388:1353-1364; Howard JP et al., J Am Coll Cardiol 2021;78:1210-1222; Herrett E et al., BMJ 2021;372:n135
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The LDL reduction is about half a statin's and the mechanism is two enzymes upstream
In plain words
It lowers LDL by roughly a fifth, where a moderate statin dose lowers it by a third to a half. The blocked step sits above the one statins block, in the same pathway.
What was measured
Absolute and percentage LDL cholesterol reduction against placebo, with and without background statin therapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ATP-citrate lyase converts cytosolic citrate to acetyl-CoA and oxaloacetate, supplying the acetyl-CoA that feeds HMG-CoA synthase and then HMG-CoA reductase — the statin target — so bempedoic acid acts two enzymatic steps upstream in the same pathway. In CLEAR Outcomes the LDL difference at 6 months was 29.2 mg/dL, a 21.1 percentage-point difference in percent reduction from a mean baseline of 139.0 mg/dL. In CLEAR Harmony, added to maximally tolerated statin therapy, the reduction was 16.5% from baseline with a placebo-adjusted difference of -18.1 percentage points. Because the pathway is shared, the effect is partly attenuated on top of a statin and fully expressed when a statin is absent, which is consistent with the larger reduction seen in the statin-intolerant population.
Source
Nissen SE et al., N Engl J Med 2023;388:1353-1364; Ray KK et al., N Engl J Med 2019;380:1022-1032
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

FDA substance identifier (UNII)
1EJ6Z6Q368
RxNorm concept
2282408

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  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

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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

  • 2 approved applications cover products containing this substance. The earliest was NDA211616, approved 20200221 to ESPERION THERAPS INC.

    Drugs@FDA application register · NDA211616 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA211616 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20191213.

    FDA National Drug Code directory · 59651-880 · 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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What is not here

3 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.

  • What it may clash with — found nothing in the sources checked.
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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.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

The first lipid-lowering drug designed around avoiding muscle, tested in 13,970 statin-intolerant patients over a median 40.6 months: the primary composite fell from 13.3% to 11.7% and myocardial infarction from 4.8% to 3.7%, while stroke, cardiovascular death and death from any cause showed no significant effect and gout and gallstones both roughly doubled in absolute terms.

Recorded evidence blocks (13)

What did Bempedoic acid's largest trial (13970 people) and its longest (11 years) measure?


13970 people in Bempedoic acid's largest registered study, 11 years in its longest registered window, measuring Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites. ClinicalTrials.gov · 2026-09-01

13 phase2, 12 phase3, 6 phase1, 4 na or unstated, 3 phase4, 1 na; NCT05103254; 2032-05; no ageing endpoint recorded. Last human test completed 2026, NCT07268625.

Interpretation These counts include studies where Bempedoic 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
  • phase2
    13
  • phase3
    12
  • phase1
    6
  • na or unstated
    4
  • phase4
    3
  • na
    1
1 more recorded row
  • Last recorded human test NCT07268625
    2026-02-24

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

Bempedoic acid was tested only in human — what did it show?


human: biomarker (39): the rungs where Bempedoic acid has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT01779453
    biomarker; Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites; 39

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

Human studies of Bempedoic acid used Bempedoic acid 180 mg tablet — over how long?


Human studies of Bempedoic acid used "Bempedoic acid 180 mg tablet". ClinicalTrials.gov · 2026-09-01

6 recorded entries; human; tablet; also "Bempedoic acid 180mg", "bempedoic acid 180mg", "Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab"

Show the evidence

human

  • NCT02993406
    tablet; Bempedoic acid 180 mg tablet
  • NCT03051100
    Bempedoic acid 180mg
  • NCT03193047
    bempedoic acid 180mg
  • NCT05546398
    Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab
  • NCT06021951
    Bempedoic Acid 180 MG Oral Tablet
  • NCT06021951
    Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet

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

Bempedoic acid's half-life is 21 ± 11 hours — which schedules were studied?


21 ± 11 hours, the half-life Bempedoic acid's label states. openfda-label · 88d06d89-a3da-40b4-b273-8f4f7d56c4c9 · 2026-08-30

Show the evidence
  • half life
    21 ± 11 hours hours; The mean ± SD half-life for bempedoic acid in humans was 21 ± 11 hours at steady-state.
  • tmax
    Absorption Pharmacokinetic data indicate that bempedoic acid is absorbed with a median time to maximum concentration of 3.5 hours when administered as NEXLETOL 180 mg tablets.
  • bioavailability
    Effect of Food Concomitant food administration had no effect on the oral bioavailability of bempedoic acid.
  • metabolism
    Metabolism The primary route of elimination for bempedoic acid is through metabolism of the acyl glucuronide.

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

Could one person measure Bempedoic acid's effect on calculated low density lipoprotein cholesterol?


Calculated low density lipoprotein cholesterol: measured in Bempedoic acid's trials.

Interpretation calculated low density lipoprotein cholesterol is the recorded endpoint.

Show the evidence

biomarkers

  • calculated low density lipoprotein cholesterol; 2026-09-01
  • ldl cholesterol; 2026-09-01
  • treatment emergent adverse events; 2026-09-01
  • low density lipoprotein cholesterol at week 12; 2026-09-01
  • low density lipoprotein cholesterol at week 6; 2026-09-01
  • low density lipoprotein cholesterol at month 2; 2026-09-01
14 more recorded rows
  • biomarkers
    major congenital malformations; 2026-09-01
  • biomarkers
    fdg pet/ct endpoint; 2026-09-01
  • biomarkers
    daily infant dose; 2026-09-01
  • biomarkers
    relative infant dose; 2026-09-01
  • biomarkers
    liver fat content; 2026-09-01
  • biomarkers
    low density lipoprotein cholesterol at day 56; 2026-09-01
  • biomarkers
    direct low density lipsprotein cholesterol; 2026-09-01
  • biomarkers
    adverse events; 2026-09-01
  • biomarkers
    ldl c level at week 12; 2026-09-01
  • biomarkers
    pharmacokinetic parameter area under the curve; 2026-09-01
  • biomarkers
    pharmacokinetic parameter maximum observed concentration; 2026-09-01
  • biomarkers
    maximum observed concentration; 2026-09-01
  • biomarkers
    ldl c; 2026-09-01
  • biomarkers
    annualised change in percentage plaque burden; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 21 ± 11 hours; 2026-08-30
  • human trials at or under30
    3
  • smallest human trial
    16; NCT06021951; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED

Which of adverse events, annualised change in percentage plaque burden and calculated low density lipoprotein cholesterol did Bempedoic acid's trials measure?


adverse events, annualised change in percentage plaque burden and calculated low density lipoprotein cholesterol lead 21 outcome terms across Bempedoic acid's trials. ClinicalTrials.gov · 2026-09-01

low density lipoprotein cholesterol at week 12, low density lipoprotein cholesterol at week 6, low density lipoprotein cholesterol at month 2, major congenital malformations, fdg pet/ct endpoint and daily infant dose follow.

Show the evidence
  • calculated low density lipoprotein cholesterol
    1
  • ldl cholesterol
    1
  • treatment emergent adverse events
    1
  • low density lipoprotein cholesterol at week 12
    1
  • low density lipoprotein cholesterol at week 6
    1
  • low density lipoprotein cholesterol at month 2
    1
14 more recorded rows
  • major congenital malformations
    1
  • fdg pet/ct endpoint
    1
  • daily infant dose
    1
  • relative infant dose
    1
  • liver fat content
    1
  • low density lipoprotein cholesterol at day 56
    1
  • direct low density lipsprotein cholesterol
    1
  • adverse events
    1
  • ldl c level at week 12
    1
  • pharmacokinetic parameter area under the curve
    1
  • pharmacokinetic parameter maximum observed concentration
    1
  • maximum observed concentration
    1
  • ldl c
    1
  • annualised change in percentage plaque burden
    1

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

Which of Bempedoic acid's 11 ongoing trials reports first?


11 registered trials of Bempedoic acid are open; earliest completion 2025-10. ClinicalTrials.gov · 2026-09-01

Major congenital malformations (MCM); FDG PET/CT Endpoint; latest 2032-05

Show the evidence

Trial

  • NCT05103254
    "Bempedoic Acid Pregnancy Surveillance Program"; n 20; "Major congenital malformations (MCM)"; 2032-05
  • NCT05488431
    "Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)"; n 121; "FDG PET/CT Endpoint"; 2028-03-01
  • NCT06035874
    "Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes"; n 100; "The change in liver fat content"; 2025-10-01
  • NCT06686615
    "A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia"; n 2000; "Relative LDL-C change between untreated and 8 week after triple therapy start"; 2028-01-31
  • NCT06780410
    "A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid"; n 240; "Percentage change from baseline in LDL-C levels at Week 12"; 2025-10
  • NCT07239414
    "Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability"; n 690; "Percentage change in LDL-C"; 2027-02-21
5 further recorded trials
  • NCT07282821
    "Bempedoic Acid Therapy for Polycystic Kidney Disease"; n 120; "Safety as defined by rate of serious adverse events and adverse events of special interest (e.g., hyperuricemia, gout, liver transaminitis, and worsening anemia)."; 2030-03-31
  • NCT07374861
    "Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy"; n 1500; "Description of adherence to treatment with Bempedoic acid in a real-life Italian population"; 2028-12-31
  • NCT07474649
    "A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events"; n 103; "Annualised change in percentage plaque burden (Δ%PB)"; 2028-10-02
  • NCT07508254
    "Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome"; n 120; "Change in LDL cholesterol level"; 2026-10-31
  • NCT07623915
    "A Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid"; n 222; "Percentage change from baseline in LDL-C levels at Week 12"; 2027-08-28

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

Which 7 trials of Bempedoic acid posted no result?


Posted no result
7 of 7 completed trials
Registrations
NCT01485146, NCT01607294, NCT01779453, NCT01941836, NCT02072161 and NCT02659397, and 1 more
Completion dates
oldest 2012-01-25; newest 2022-11-17
Show the evidence

Trial

  • NCT01485146
    2012-01-25
  • NCT01607294
    2012-10
  • NCT01779453
    2013-08
  • NCT01941836
    2014-11
  • NCT02072161
    2015-01
  • NCT02659397
    2016-07
  • 1 further recorded trial NCT05546398
    2022-11-17

At the median, Bempedoic acid's trials enrolled 121 people — anything larger?


Median enrolment
121
Largest enrolment
13970
Registered trials counted
39

What do 198 spontaneous reports say about Bempedoic 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.

Bempedoic acid appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 198 reaction mentions were counted: myalgia 47; muscle spasms 27; pain in extremity 27; arthralgia 25. open-targets-adr · CHEMBL3545313 · 2026-06-24

Show the evidence
  • myalgia
    47
  • muscle spasms
    27
  • pain in extremity
    27
  • arthralgia
    25
  • gout
    18
  • blood creatine phosphokinase increased
    16
4 more recorded rows
  • blood triglycerides increased
    13
  • muscular weakness
    9
  • blood uric acid increased
    8
  • hepatic enzyme increased
    8

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

Bempedoic acid and CYP2C9, OAT3 and OATP1B1: shared by which compounds?


CYP2C9, OAT3 and OATP1B1 appear in Bempedoic acid's recorded interaction sentences, 2 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

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CYP2C9

  • pharmacokinetics
    Warfarin In vitro studies indicate that bempedoic acid is not an inhibitor or inducer of CYP2C9.
  • pharmacokinetics
    Because warfarin is primarily eliminated through CYP2C9, its pharmacokinetics is not expected to be altered by bempedoic acid.

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

Was Bempedoic acid studied with fasting?


fasting is named in Bempedoic acid's label sentences: "In patients with diabetes or prediabetes, bempedoic acid significantly (P < .0001) reduced HbA1c by -0.12% and -0.06%, respectively, and did not worsen fasting glucose versus placebo." openfda-label+europepmc · 2026-08-30

1 recorded statement; fasting

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  • fasting
    In patients with diabetes or prediabetes, bempedoic acid significantly (P < .0001) reduced HbA1c by -0.12% and -0.06%, respectively, and did not worsen fasting glucose versus placebo.

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

What is recorded about Bempedoic acid and AMPK?


"This study aimed to investigate the role of bempedoic acid, a novel antihyperlipidemic drug, in attenuating hypertension-induced cardiac remodelling in rats by modulating Ang II-induced damage and activating the AMPK signalling pathway." — where Bempedoic acid and AMPK appear together. Europe PMC · pathway abstract search · 2023-07-19

AMPK; PMID 37473803, 36931497

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AMPK

  • PMID 37473803
    "This study aimed to investigate the role of bempedoic acid, a novel antihyperlipidemic drug, in attenuating hypertension-induced cardiac remodelling in rats by modulating Ang II-induced damage and activating the AMPK signalling pathway."
  • PMID 37473803
    "These findings indicate the cardioprotective and antihypertrophic activity of bempedoic acid, which are suggested to result from energy-independent AMPK downstream signalling activation."
  • PMID 36931497
    "We also studied the modulation of multiple AMPK signalling pathways by bempedoic acid in a chronic hypertension model in rats."

recorded 2023-07-19 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3545313
PubChem CID
10472693
CAS number
738606-46-7
RxCUI
2282403
InChIKey
HYHMLYSLQUKXKP-UHFFFAOYSA-N

Relations

Also called
Acide bempedoique, Acido bempedoico, Bempedoic acid [INN], Bempedoic acid [JAN], Bempedoic acid [MI], Bempedoic acid [ORANGE BOOK], Bempedoic acid [USAN], Bempedoic acid [WHO-DD]
Trade name
Bempedoic acid component of nexlizet, Nexletol, Nilemdo, Nexlizet component bempedoic acid, Nustendi
Development code
ESP-55016, ETC-1002, ETC1002
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • 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 pathway abstract search ·
  • Europe PMC search ·
5 more sources

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
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  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
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