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Ivabradine

  • 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 Ivabradine does in the body

Ivabradine blocks the specific channel that lets the charge in, so the build-up is slower and the heart beats less often.

Every heartbeat starts in a small cluster of cells that act as the heart natural pacemaker. Those cells slowly build up an electrical charge until they fire, and the speed of that build-up is what sets your resting pulse. It does nothing else: it does not weaken the beat, it does not lower blood pressure, and it does not change the electrical recovery of the pumping chambers. The same channel exists in the retina, which is why some people see brief flashes of brightness.

Why people take it. A weakened heart that keeps beating too fast.

What happened in people

It reduced heart-failure admissions in people with a weak, fast-beating heart, but did not reduce deaths.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

Many study participants were not taking the highest beta-blocker dose they could tolerate.

Where it acts
Sinoatrial node pacemaker cells — the HCN4 channel that sets the resting heart rate — and, incidentally, the retina
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • Its recorded molecular formula is C27H36N2O5·HCl, weighing 505.1.

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

A reviewer approved this sentence against this exact record and its sources.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 129 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.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What 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.

Results from the one trial this record names

  • In NCT02441218, Primary composite endpoint: first event among cardiovascular death (including death of unknown cause) or hospitalization for worsening heart failure was Ivabradine group: 793 participants with an event against Placebo group: 937 participants with an event in the comparison group at All over the study. The recorded difference is Hazard ratio 0.82 (95% two-sided CI 0.75 to 0.90; p<0.0001 (Cox proportional hazards regression, Wald test)).

    ClinicalTrials.gov record · NCT02441218 · read 2026-08-28

  • In NCT02441218, Secondary outcome measure: hospitalisation for worsening heart failure, a component of the primary composite endpoint was Ivabradine group: 514 participants with an event against Placebo group: 672 participants with an event in the comparison group at From the date of randomization to the date of first documented hospitalisation. The recorded difference is Hazard ratio 0.74 (95% two-sided CI 0.66 to 0.83; p< 0.0001 (Cox proportional hazards regression, Wald test)).

    ClinicalTrials.gov record · NCT02441218 · read 2026-08-28

Composite of cardiovascular death or hospital admission for worsening heart failure

The study showed what it set out to show

Who was studied
SHIFT (ISRCTN70429960)
How many people
6558
Study design
Phase 3, randomised, double-blind, placebo-controlled, parallel-group
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
24% against 29%; hazard ratio 0.82 (95% CI 0.75 to 0.90), p<0.0001 over a median 22.9 months
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. The effect was driven by heart failure admissions and heart failure deaths. Symptomatic bradycardia occurred in 150 (5%) against 32 (1%) and phosphenes in 89 (3%) against 17 (1%), both p<0.0001. Atrial fibrillation ran at 5.0% per patient-year against 3.9%.

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

Form and route. Oral tablet taken twice daily with food; an oral solution exists for paediatric use from six months of age

Interval reported. 95% CI 0

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

Composite of cardiovascular death, admission for acute myocardial infarction and admission for new or worsening heart failure

The study did not show it

Who was studied
BEAUTIFUL (NCT00143507)
How many people
10917
Study design
Phase 3, randomised, double-blind, placebo-controlled, parallel-group
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Hazard ratio 1.00 (95% CI 0.91 to 1.1), p=0.94 over a median 19 months
Repeated elsewhere
Failed to Replicate

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. The prespecified heart rate subgroup at or above 70 also failed on the primary endpoint (HR 0.91, p=0.17). Two secondary endpoints in that subgroup were positive, and it was those that generated the SIGNIFY hypothesis.

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

Form and route. Oral tablet taken twice daily with food; an oral solution exists for paediatric use from six months of age

Interval reported. 95% CI 0

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

Composite of death from cardiovascular causes or non-fatal myocardial infarction

The study did not show it

Who was studied
SIGNIFY (ISRCTN61576291)
How many people
19102
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
6.8% against 6.4%; hazard ratio 1.08 (95% CI 0.96 to 1.20), p=0.20 over a median 27.8 months
Repeated elsewhere
Failed to Replicate

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. Ivabradine increased the primary endpoint among the 12,049 patients with activity-limiting angina but not among those without it, p=0.02 for interaction. Bradycardia occurred in 18.0% against 2.3%, p<0.001, at a dose above the approved heart failure dose.

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

Form and route. Oral tablet taken twice daily with food; an oral solution exists for paediatric use from six months of age

Interval reported. 95% CI 0

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

What we know
RNAWiki holds 3 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 Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. 2 written-up studies measured this and did not show a benefit.
  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.6 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Dog. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it 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.

Where a source records it acting

  • Heart: Blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker current that regulates heart rate; the cardiac effects were most pronounced in the sinoatrial node

    US prescribing information · 236cc914-7eef-600c-e063-6394a90a4bd1 · read 2026-08-28

  • Eyes: Can also inhibit the retinal current I h, which is involved in curtailing retinal responses to bright light stimuli

    US prescribing information · 236cc914-7eef-600c-e063-6394a90a4bd1 · read 2026-08-28

  1. Start

    Ivabradine

    What a person takes: Oral tablet taken twice daily with food; an oral solution exists for paediatric use from six months of age.

    The measurement behind this step

    The dose is titrated to a resting heart rate between 50 and 60 beats per minute, which makes this one of the few drugs whose target is a number measured at each visit rather than a fixed strength. Clearance is dominated by CYP3A4, so strong inhibitors of that enzyme are a contraindication rather than a caution.

  2. What it acts on

    The pacemaker cell leaks itself up to threshold

    A small cluster of cells at the top of the heart starts every beat. Between beats they slowly let positive charge in until they reach a trigger point. How fast that happens is your resting pulse.

    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

    The funny current, carried mainly by HCN4 in the sinoatrial node, activates on hyperpolarisation rather than depolarisation — which is why it was named funny — and provides the slow diastolic depolarisation that determines cycle length. Cyclic AMP binding to the channel steepens that slope, which is how adrenaline speeds the heart.

  3. Reaching the cell

    The drug gets in through the open channel

    Ivabradine can only reach its target from inside the cell, and only while the channel is open. That means it blocks more when the heart is beating fast and less when it is already slow.

    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

    Block is current-dependent and requires channel opening for access from the intracellular side, giving a self-limiting profile: the faster the sinoatrial node fires, the more block accumulates. The label records cardiac effects most pronounced at the sinoatrial node, with some AH and PR interval prolongation.

  4. The change it makes

    The rate falls and nothing else changes

    The heart beats less often. It does not beat more weakly, blood pressure does not fall, and the electrical recovery of the pumping chambers is untouched. That combination is unique.

    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

    The label records no effect on ventricular repolarisation and no effect on myocardial contractility. In BEAUTIFUL the placebo-corrected heart rate reduction was 6 beats per minute at 12 months; in SIGNIFY, mean heart rate at three months was 60.7 against 70.6 on placebo.

  5. What that does for a person

    Fewer admissions in heart failure

    In patients with a weak heart beating over seventy times a minute, this reduced hospital admissions for worsening heart failure by about a quarter. Deaths from all causes were not reduced.

    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

    SHIFT primary composite 24% against 29%, HR 0.82 (95% CI 0.75 to 0.90, p<0.0001), driven mainly by heart failure admissions (HR 0.74, 0.66 to 0.83) and heart failure deaths (HR 0.74, 0.58 to 0.94). The United States indication is written as reducing hospitalisation risk and makes no mortality claim.

  6. What that does for a person

    The retina has the same channel

    A related channel in the retina normally damps the response to sudden bright light. Blocking part of it produces brief flashes of brightness in part of the visual field.

    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

    The label states that ivabradine can inhibit the retinal current Ih, which is involved in curtailing retinal responses to bright light, and that partial inhibition under rapid changes in luminosity may underlie the luminous phenomena. Phosphenes occurred in 2.8% against 0.5% on placebo.

  7. What that does for a person

    Where it did not work, and where it did harm

    In coronary disease without heart failure, two large trials found nothing. In the group with activity-limiting angina, the larger trial found outcomes were worse on the drug.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    BEAUTIFUL primary composite HR 1.00 (95% CI 0.91 to 1.1, p=0.94) in 10,917 patients. SIGNIFY primary composite HR 1.08 (0.96 to 1.20, p=0.20) in 19,102 patients, with a significant interaction (p=0.02) showing an increase in the primary endpoint among the 12,049 with activity-limiting angina.

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

What we know
The record describes 6 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.

  • systolic and diastolic blood pressure
  • heart rate
  • heart rate reduction
  • flow mediated dilation of the brachial artery
  • urinary albumin excretion
  • achieving target heart rate

Meaningful

Things that change how a life goes, not only a number.

  • event free survival

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 (14)
  • central arterial pressure
  • central and peripheral arterial and pulse wave velocity
  • maximal oxygen consumption
  • viscosity of the common carotid artery
  • vo2max
  • pharmacokinetic parameters
  • bioavailability parameters
  • serious adverse events
  • hemodynamic changes
  • amount of blood loss
  • nt pro bnp
  • neopterin
  • blood loss
  • duration of hospital stay

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. approximately 6 hours (effective half-life) hours

    Read from the label, which states: “Ivabradine plasma levels decline with a distribution half-life of 2 hours and an effective half-life of approximately 6 hours.”

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

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

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

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

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults with reduced-ejection-fraction heart failure whose resting heart rate stays at or above 70 in sinus rhythm despite the maximum beta-blocker dose they can take, and children from six months old with dilated cardiomyopathy. Not people in atrial fibrillation, where the drug has no target.

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.

Who a named study recorded including and excluding

  • It included: Symptomatic Chronic heart failure (NYHA II, III or IV); Left ventricular systolic dysfunction (LVEF ≤ 35%); Sinus rhythm and resting heart rate ≥ 70 bpm; Optimal and unchanged CHF medications or dosages.

    ClinicalTrials.gov record · NCT02441218 · read 2026-08-28

  • It excluded: Unstable condition within previous 4 weeks; Myocardial infarction or coronary revascularisation within previous 2 months; Stroke or transient cerebral ischaemia within previous 4 weeks; Congenital heart disease; Severe valvular disease; Active myocarditis.

    ClinicalTrials.gov record · NCT02441218 · read 2026-08-28

What the label states about particular groups

  • On pediatric, the label states: “The safety and efficacy of ivabradine have not been established in patients less than 6 months of age.”

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

  • On older people, the label states: “No pharmacokinetic differences have been observed in elderly (≥ 65 years) or very elderly (≥ 75 years) patients compared to the overall population.”

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings in animals, ivabradine may cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

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

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is required in patients with mild or moderate hepatic impairment.”

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage adjustment is required for patients with creatinine clearance 15 to 60 mL/min.”

    US prescribing information · 53f15531-796d-442b-a73c-05f048218531 · read 2026-08-30

Where the result stopped carrying

  • BEAUTIFUL missed its primary endpoint with a hazard ratio of exactly 1.00 in 10,917 patients
  • SIGNIFY missed its primary endpoint in 19,102 patients and found a significant interaction indicating harm in the target angina population
  • A systematic review of 47 angina trials in 35,797 participants found no effect on mortality or quality of life and slightly more serious adverse events
  • The drug increases atrial fibrillation, the arrhythmia in which it stops working, and the label directs discontinuation if it develops
  • 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 tablet taken twice daily with food; an oral solution exists for paediatric use from six months of age

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S3.

No source is stored against this line.

What is in the pack

The dose is titrated to a resting heart rate between 50 and 60 beats per minute, which makes this one of the few drugs whose target is a number measured at each visit rather than a fixed strength.

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: Clearance is dominated by CYP3A4, so strong inhibitors of that enzyme are a contraindication rather than a caution.

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.

The recorded stepping schedule

  • What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.

    US prescribing information · 236cc914-7eef-600c-e063-6394a90a4bd1 · read 2026-08-28

  • Starting dose (adults): 2.5 mg (vulnerable adults) or 5 mg twice daily with food

    US prescribing information · 236cc914-7eef-600c-e063-6394a90a4bd1 · read 2026-08-28

  • After 2 weeks of treatment, adjusted on the basis of heart rate: Maximum dose 7.5 mg twice daily

    US prescribing information · 236cc914-7eef-600c-e063-6394a90a4bd1 · read 2026-08-28

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

Contraindicated in acute decompensated heart failure, clinically significant hypotension, sick sinus syndrome, sinoatrial block or third-degree AV block without a demand pacemaker, clinically significant bradycardia, severe hepatic impairment, pacemaker dependence, and with strong CYP3A4 inhibitors. It increases atrial fibrillation and the label directs discontinuation if it develops. Bradycardia, sinus arrest and heart block occur at 6.0% per patient-year. Phosphenes affected 2.8% against 0.5% on placebo. Animal studies showed embryo-fetal toxicity and cardiac teratogenic effects at one to three times human exposure, and effective contraception is directed.

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.

Ivabradine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 959 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • dyspnoea — 142 reaction mentions
  • bradycardia — 141 reaction mentions
  • hypotension — 119 reaction mentions
  • dizziness — 115 reaction mentions
  • cardiac failure — 89 reaction mentions
  • photopsia — 81 reaction mentions
  • chest pain — 79 reaction mentions
  • syncope — 72 reaction mentions
  • electrocardiogram qt prolonged — 63 reaction mentions
  • palpitations — 58 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 taken twice daily with food; an oral solution exists for paediatric use from six months of age

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

Clearance is dominated by CYP3A4, so strong inhibitors of that enzyme are a contraindication rather than a caution.

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 and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 33 products list this as an active ingredient in the United States drug directory. 33 of them contain it and nothing else.

    FDA National Drug Code directory · 72603-935 · read 2026-08-29

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

    FDA National Drug Code directory · 72603-935 · read 2026-08-29

  • The regulator's established pharmacologic class for it is hyperpolarization-activated cyclic nucleotide-gated channel antagonists [moa] and hyperpolarization-activated cyclic nucleotide-gated channel blocker [epc].

    FDA National Drug Code directory · 72603-935 · read 2026-08-29

  • 12 published labels name it as an active ingredient. 12 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 2e70f883-8c01-4ac2-815d-4a6d561c711a · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 2e70f883-8c01-4ac2-815d-4a6d561c711a · read 2026-08-29

  • Ivabradine is film-coated tablets at Tablets: 5 mg, 7.5 mg, recorded as prescription product; fda label in effect 2025-04-15 in the United States.

    US prescribing information · 236cc914-7eef-600c-e063-6394a90a4bd1 · read 2026-08-28

  • Recorded price in US: 0.66061–0.76447 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 16 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Ivabradine 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 ivabradine reduces death — the SHIFT effect was driven by admissions and heart failure deaths, and the United States indication claims only reduced hospitalisation

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 the SHIFT benefit belongs to ivabradine rather than to residual room for beta-blocker uptitration, which no trial has tested

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 heart rate reduction is beneficial in itself, which BEAUTIFUL and SIGNIFY tested directly and did not support outside heart failure

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 the myocardial infarction reduction in a BEAUTIFUL subgroup was real, when the confirmatory trial designed to test it found the opposite interaction

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 Ivabradine 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.

SHIFT: fewer admissions, and no reduction in death from any cause
In plain words
Six and a half thousand patients with a weak, fast-beating heart were randomised to ivabradine or a dummy tablet. The combined measure improved from 29% to 24%. Almost all of that came from fewer hospital admissions rather than fewer deaths.
What was measured
Composite of cardiovascular death or hospital admission for worsening heart failure
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SHIFT randomised 6,558 patients with symptomatic heart failure, ejection fraction at or below 35%, in sinus rhythm with heart rate at or above 70 beats per minute, admitted for heart failure within the previous year, on stable background therapy including a beta-blocker if tolerated. Median follow-up was 22.9 months. The primary composite of cardiovascular death or hospital admission for worsening heart failure occurred in 793 (24%) against 937 (29%), hazard ratio 0.82 (95% CI 0.75 to 0.90, p<0.0001). The published account states the effects were driven mainly by hospital admissions for worsening heart failure (672 [21%] placebo against 514 [16%] ivabradine; HR 0.74, 0.66 to 0.83, p<0.0001) and deaths due to heart failure (151 [5%] against 113 [3%]; HR 0.74, 0.58 to 0.94, p=0.014). The United States indication that followed is written narrowly, to reduce the risk of hospitalisation for worsening heart failure, and makes no mortality claim.
Source
Swedberg K et al., Lancet 2010;376:875-885 (SHIFT, ISRCTN70429960)
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
BEAUTIFUL: no effect at all in 10,917 patients with coronary disease
In plain words
A trial in almost eleven thousand patients with coronary disease and a weakened heart found the drug made no difference whatsoever to the main outcome. The hazard ratio was exactly 1.00.
What was measured
Composite of cardiovascular death, admission for acute myocardial infarction and admission for new or worsening heart failure
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
BEAUTIFUL screened 12,473 and enrolled 10,917 patients with coronary artery disease and ejection fraction below 40%, randomised to ivabradine (n=5,479) or placebo (n=5,438) in addition to appropriate cardiovascular medication; 87% were on beta-blockers. Median follow-up was 19 months. Ivabradine reduced heart rate by 6 beats per minute at 12 months, placebo-corrected. The primary composite of cardiovascular death, admission for acute myocardial infarction and admission for new or worsening heart failure was not affected: hazard ratio 1.00 (95% CI 0.91 to 1.1, p=0.94). In the prespecified subgroup with heart rate at or above 70, the primary composite was still not affected (HR 0.91, 95% CI 0.81 to 1.04, p=0.17), nor was cardiovascular death or admission for new or worsening heart failure; two secondary endpoints were reduced, admission for fatal and non-fatal myocardial infarction (HR 0.64, 0.49 to 0.84, p=0.001) and coronary revascularisation (HR 0.70, 0.52 to 0.93, p=0.016). Those two secondary results generated the hypothesis that SIGNIFY was designed to test.
Source
Fox K et al., Lancet 2008;372:807-816 (BEAUTIFUL, NCT00143507)
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
SIGNIFY: the confirmatory trial found harm in the group it was aimed at
In plain words
Nineteen thousand patients with coronary disease and a fast pulse were given ivabradine to confirm the earlier subgroup finding. There was no benefit. Among those whose angina limited their activity — the very group the trial targeted — outcomes were worse on the drug.
What was measured
That the myocardial infarction reduction seen in a BEAUTIFUL subgroup would confirm in a dedicated trial — it did not, and the confirmatory trial found a significant interaction pointing the other way in the target population
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SIGNIFY randomised 19,102 patients with stable coronary artery disease without clinical heart failure and heart rate at or above 70, including 12,049 with activity-limiting angina of Canadian Cardiovascular Society class II or above, to ivabradine at up to 10 mg twice daily or placebo, targeting a heart rate of 55 to 60. At three months, mean heart rate was 60.7 against 70.6. After a median 27.8 months there was no significant difference in the primary composite of cardiovascular death or non-fatal myocardial infarction: 6.8% against 6.4%, hazard ratio 1.08 (95% CI 0.96 to 1.20, p=0.20). Ivabradine was associated with an increase in the primary endpoint among patients with activity-limiting angina but not among those without it, p=0.02 for interaction. Bradycardia occurred in 18.0% against 2.3%, p<0.001. The dose tested was above the approved heart failure dose. European regulators subsequently restricted the drug angina labelling.
Source
Fox K et al., N Engl J Med 2014;371:1091-1099 (SIGNIFY, ISRCTN61576291)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
A systematic review of 47 trials found no benefit on any patient-important outcome
In plain words
Pooling every randomised trial of ivabradine in angina — forty-seven trials and nearly thirty-six thousand people — found no effect on deaths or quality of life, and slightly more serious side effects.
What was measured
All-cause mortality, quality of life and serious adverse events pooled across 47 randomised trials in 35,797 participants
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Maagaard and colleagues systematically reviewed randomised trials of ivabradine against placebo or no intervention in angina from coronary artery disease, including 47 trials with 35,797 participants; all trials and outcomes were judged at high risk of bias. Ivabradine had no effect on all-cause mortality (RR 1.04, 95% CI 0.96 to 1.13), quality of life (standardised mean difference -0.05, 95% CI -0.11 to 0.01), cardiovascular mortality (RR 1.07, 95% CI 0.97 to 1.18) or myocardial infarction (RR 1.03, 95% CI 0.91 to 1.16). After removal of outliers it appeared to increase serious adverse events (RR 1.07, 95% CI 1.03 to 1.11), including bradycardia, prolonged QT interval, photopsia, atrial fibrillation and hypertension, and non-serious adverse events (RR 1.13, 95% CI 1.11 to 1.16). Angina frequency and stability scores favoured ivabradine — mean differences of 2.06 (95% CI 0.82 to 3.30) and 1.48 (0.07 to 2.89) — but the authors state the effect sizes seemed minimal and possibly without relevance to patients, with methodological limitations questioning their validity. Their conclusion is that guidelines need reassessment and the use of ivabradine for angina should be reconsidered. This review covers angina, not the heart failure indication SHIFT established.
Source
Maagaard M, Nielsen EE, Sethi NJ, et al. Effects of adding ivabradine to usual care in patients with angina pectoris: a systematic review with meta-analysis and Trial Sequential Analysis. Open Heart 2020;7:e001288
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
It causes the arrhythmia that makes it useless
In plain words
Ivabradine only works in a heart beating in normal rhythm. It also makes the commonest abnormal rhythm more likely, and the label directs stopping the drug if that rhythm develops.
What was measured
Atrial fibrillation rate per patient-year and adverse reaction rates in SHIFT
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label states that ivabradine increases the risk of atrial fibrillation, with a rate of 5.0% per patient-year against 3.9% on placebo in SHIFT, and directs regular cardiac rhythm monitoring and discontinuation if atrial fibrillation develops. In the SHIFT adverse reaction table, atrial fibrillation was reported in 8.3% against 6.6%, bradycardia in 10% against 2.2%, hypertension or increased blood pressure in 8.9% against 7.8%, and phosphenes in 2.8% against 0.5%. Symptomatic bradycardia in the published trial occurred in 150 (5%) against 32 (1%), p<0.0001. The drug has no effect on ventricular rate in atrial fibrillation, because the funny current no longer sets it, so the adverse event and the loss of indication arrive together.
Source
CORLANOR (ivabradine) United States prescribing information, sections 5.2, 5.3 and 6.1 (NDA 206143); Swedberg K et al., Lancet 2010;376:875-885
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 comparison that would settle it has never been run
In plain words
The drug is licensed for patients whose heart rate stays high on the maximum beta-blocker dose they can tolerate. In the trial, only a minority were on a full beta-blocker dose, so the question of whether more beta-blocker would have done the same job was never asked.
What was measured
That the SHIFT benefit is attributable to ivabradine rather than to residual room for beta-blocker uptitration — plausible, assumed by the indication, and never tested against an uptitration arm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States indication requires that patients be on maximally tolerated doses of beta-blockers or have a contraindication to them, and the label records that SHIFT patients had to be clinically stable for at least four weeks on an optimised regimen including maximally tolerated beta-blocker doses. Maximally tolerated is not the same as target dose, and in SHIFT a minority of patients were at the target dose of their beta-blocker. Since beta-blockers lower heart rate and reduce mortality, while ivabradine lowers heart rate and did not reduce mortality, the untested question is whether the benefit measured in SHIFT belongs to ivabradine or to insufficient beta-blockade. No randomised trial has compared uptitration of a beta-blocker against the addition of ivabradine, and the drug regulatory position depends on the assumption that the beta-blocker was already maximal.
Source
CORLANOR United States prescribing information, sections 1.1 and 14.1 (NDA 206143); Swedberg K et al., Lancet 2010;376:875-885
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
A list of contraindications that is mostly the drug own mechanism
In plain words
Almost everything the drug must not be used in is a version of the same thing: a heart that is already too slow, or a pacemaker system that cannot be slowed further, or anything that raises the drug level.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Contraindications are acute decompensated heart failure, clinically significant hypotension, sick sinus syndrome, sinoatrial block or third-degree AV block without a functioning demand pacemaker, clinically significant bradycardia, severe hepatic impairment, pacemaker dependence where the heart rate is maintained exclusively by the pacemaker, and concomitant use of strong CYP3A4 inhibitors. Second-degree AV block is listed as not recommended. Fetal toxicity is a warning: embryo-fetal toxicity and cardiac teratogenic effects were observed in rats treated during organogenesis at exposures one to three times the human exposure at the maximum recommended dose, and effective contraception is directed. Bradycardia, sinus arrest and heart block have occurred, at a rate of 6.0% per patient-year.
Source
CORLANOR United States prescribing information, sections 4, 5.1 and 5.3 (NDA 206143)
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

How many documents were read

  • 11 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 11 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
TP19837BZK
CAS registry number
155974-00-8
PubChem compound
132999
RxNorm concept
1649479

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • 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

  • 8 approved applications cover products containing this substance. The earliest was NDA206143, approved 20150415 to AMGEN INC.

    Drugs@FDA application register · NDA206143 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA206143 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20131231.

    FDA National Drug Code directory · 72603-935 · 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.

This order is fixed in code and does not count clicks or time on the page.

What is not here

4 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 was measured, goal by goal — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

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.

A pure heart-rate-lowering drug that reduced the composite of cardiovascular death or heart failure admission from 29% to 24% in 6,558 patients in SHIFT, driven by admissions rather than deaths — and which failed its primary endpoint in 10,917 patients in BEAUTIFUL and in 19,102 patients in SIGNIFY, where the subgroup with activity-limiting angina did worse on the drug than on placebo.

Recorded evidence blocks (12)

What did Ivabradine's largest trial (19102 people) and its longest (6.7 years) measure?


19102 people in Ivabradine's largest registered study, 6.7 years in its longest registered window, measuring Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite. ClinicalTrials.gov · 2026-09-01

29 phase4, 19 phase3, 12 na, 11 phase2, 3 na or unstated, 3 phase1, 1 early phase1; NCT02973594; 2023-06-30. Last human test completed 2025, NCT06305806.

Interpretation These counts include studies where Ivabradine 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
  • phase4
    29
  • phase3
    19
  • na
    12
  • phase2
    11
  • na or unstated
    3
  • phase1
    3
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT06305806
    2025-12-17

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

From mouse to human: where has Ivabradine shown biomarker?


mouse: mechanism-only, rat: mechanism-only, dog: mechanism-only and human: biomarker (75): the rungs where Ivabradine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat mechanism-onlyDog mechanism-onlyNon-human primate Human biomarker
Show the evidence
  • mouse
    mechanism-only
  • rat
    mechanism-only
  • dog
    mechanism-only
  • human NCT01804010
    biomarker; Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite; 75

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

7 of Ivabradine's trials stopped: accrual/recruitment, funding/business, sponsor decision unspecified, other?


accrual/recruitment (1), funding/business (4), sponsor decision unspecified (1) and other (1): Ivabradine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Difficulty recruit pts with PSHF HR \> 70 \& high BNP."; 7 of 75 registered studies

Show the evidence

Trial

  • NCT00757055
    withdrawn; "Difficulty recruit pts with PSHF HR \> 70 \& high BNP."
  • NCT02507050
    withdrawn; "Funding not yet achieved"
  • NCT03105219
    withdrawn; "Shortfall in funding"
  • NCT03137537
    terminated; "Funding terminated"
  • NCT03168529
    terminated; "Lack of patient enrollment"
  • NCT03619187
    withdrawn; "Sponsor decision"
  • 1 further recorded trial NCT03631654
    withdrawn; "Unable to obtain funding"

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

Human studies of Ivabradine used Ivabradine 5 mg — over how long?


studies of Ivabradine used the recorded amount. ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; also "Ivabradine 5 mg", "Procoralan 5 mg film-coated tablets", "Ivabradine 7.5Mg Tab"

Show the evidence

human

  • NCT03718273
    Ivabradine 5 mg
  • NCT04448899
    Procoralan 5 mg film-coated tablets
  • NCT05594342
    Ivabradine 7.5Mg Tab
  • NCT06505668
    Ivabradine 10mg
  • NCT07268170
    Ivabradine 7.5/15 mg

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

Which of achieving target heart rate, amount of blood loss and bioavailability parameters did Ivabradine's trials measure?


achieving target heart rate, amount of blood loss and bioavailability parameters lead 21 outcome terms across Ivabradine's trials. ClinicalTrials.gov · 2026-09-01

Interpretation maximal oxygen consumption, heart rate, event free survival, heart rate reduction, viscosity of the common carotid artery and flow mediated dilation of the brachial artery follow.

Show the evidence
  • systolic and diastolic blood pressure
    1
  • central arterial pressure
    1
  • central and peripheral arterial and pulse wave velocity
    1
  • maximal oxygen consumption
    1
  • heart rate
    1
  • event free survival
    1
14 more recorded rows
  • heart rate reduction
    1
  • viscosity of the common carotid artery
    1
  • flow mediated dilation of the brachial artery
    1
  • urinary albumin excretion
    1
  • vo2max
    1
  • pharmacokinetic parameters
    1
  • bioavailability parameters
    1
  • serious adverse events
    1
  • hemodynamic changes
    1
  • amount of blood loss
    1
  • nt pro bnp
    1
  • neopterin
    1
  • blood loss
    1
  • achieving target heart rate
    1

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

Which of Ivabradine's 5 ongoing trials reports first?


5 registered trials of Ivabradine are open; earliest completion 2026-04-22. ClinicalTrials.gov · 2026-09-01

Percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48; MINS; latest 2028-09-30

Show the evidence

Trial

  • NCT04031573
    "Ivabradine for Heart Rate Control In Septic Shock"; n 429; "Percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48"; 2026-04-22
  • NCT05279651
    "Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)"; n 2146; "MINS"; 2026-06-30
  • NCT05882708
    "Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis"; n 172; "The difference of a reduction in heart rate"; 2027-05-31
  • NCT07268170
    "Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease"; n 350; "Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography"; 2028-09-30
  • NCT07717710
    "Ivabradine for Heart Rate Reduction During Exercise in Healthy Adults"; n 20; "Heart rate, peak"; 2026-12

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

Which 25 trials of Ivabradine posted no result?


Posted no result
25 of 25 completed trials
Registrations
NCT00202579, NCT00202566, NCT01804010, NCT01022463, NCT01365286 and NCT00815100, and 19 more
Completion dates
oldest 2006-02; newest 2024-02-01
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Trial

  • NCT00202579
    2006-02
  • NCT00202566
    2007-10
  • NCT01804010
    2007-11
  • NCT01022463
    2010-10
  • NCT01365286
    2011-01
  • NCT00815100
    2011-09-07
14 further recorded trials
  • NCT01373619
    2012-01
  • NCT01699776
    2012-02
  • NCT01039389
    2013-03
  • NCT02354573
    2014-01
  • NCT02681978
    2015-07
  • NCT04285736
    2016-05
  • NCT02294292
    2016-08-31
  • NCT01657136
    2016-09
  • NCT03866395
    2017-03-07
  • NCT03710057
    2017-05-15
  • NCT03485482
    2018-03-23
  • NCT02584439
    2019-07-15
  • NCT03987204
    2019-09-17
  • NCT04448899
    2021-02-05

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


Median enrolment
50
Largest enrolment
19102
Registered trials counted
74

What do 959 spontaneous reports say about Ivabradine — 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.

Ivabradine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 959 reaction mentions were counted: dyspnoea 142; bradycardia 141; hypotension 119; dizziness 115. open-targets-adr · CHEMBL2145077 · 2026-06-24

Show the evidence
  • dyspnoea
    142
  • bradycardia
    141
  • hypotension
    119
  • dizziness
    115
  • cardiac failure
    89
  • photopsia
    81
4 more recorded rows
  • chest pain
    79
  • syncope
    72
  • electrocardiogram qt prolonged
    63
  • palpitations
    58

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

Ivabradine and CYP3A4 and OCT2: shared by which compounds?


CYP3A4 and OCT2 appear in Ivabradine's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

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CYP3A4

  • pharmacokinetics
    Ivabradine is extensively metabolized in the liver and intestines by CYP3A4-mediated oxidation.
  • pharmacokinetics
    The N-desmethylated derivative is also metabolized by CYP3A4.
  • pharmacokinetics
    Drug Interactions The effects of coadministered drugs (CYP3A4 inhibitors, substrates, inducers, and other concomitantly administered drugs) on the pharmacokinetics of ivabradine were studied in several single-and multiple-dose studies.

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

Was Ivabradine studied with exercise?


exercise is named in Ivabradine's label sentences: "The effect of ivabradine on exercise tolerance in patients with heart failure with reduced ejection fraction (HFrEF) on standard drug therapies remains unclear. <b><i>Methods and Results:</i></b> This multicenter interventional trial of patients with HFrEF and a resting heart rate ≥75 beats/min in…" openfda-label+europepmc · 2026-08-30

1 recorded statement; exercise

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  • exercise
    The effect of ivabradine on exercise tolerance in patients with heart failure with reduced ejection fraction (HFrEF) on standard drug therapies remains unclear. <b><i>Methods and Results:</i></b> This multicenter interventional trial of patients with HFrEF and a resting heart rate ≥75 beats/min in sinus rhythm treated with standard drug therapies will consist of 2 periods: a 12-week open-label,…

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

What is recorded about Ivabradine and mTOR?


"Low (10 mg/kg) and high (20 mg/kg) doses of ivabradine were orally given once daily to each group for 6 weeks concurrently with TAA injection. <b>Results</b>: TAA caused marked elevations in liver enzymes, increased MDA, depletion of antioxidant defenses, activation of NF-κB p65 and pro-inflammatory cytokines, dysregulation of apoptotic…" — where Ivabradine and mTOR appear together. Europe PMC · pathway abstract search · 2026-03-19

mTOR, autophagy; PMID 41901349, 38230890, 34087391

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mTOR

  • PMID 41901349
    "Low (10 mg/kg) and high (20 mg/kg) doses of ivabradine were orally given once daily to each group for 6 weeks concurrently with TAA injection. <b>Results</b>: TAA caused marked elevations in liver enzymes, increased MDA, depletion of antioxidant defenses, activation of NF-κB p65 and pro-inflammatory cytokines, dysregulation of apoptotic markers, and upregulation of the PI3K/AKT/mTOR and TGF-β…"
  • PMID 41901349
    "Ivabradine produced dose-dependent improvements in biochemical markers of liver function, restored oxidant/antioxidant balance, suppressed NF-κB p65/TNF-α, normalized Bax/Bcl-2/caspase-3 expression, and inhibited PI3K/AKT/mTOR as well as TGF-β signaling, leading to significant attenuation of fibrosis. <b>Conclusions</b>: The current findings indicate that ivabradine exerts potent antioxidant,…"
  • autophagy PMID 38230890
    "This review aims to summarize and discuss the reported cardioprotective mechanisms of ivabradine beyond heart rate modulation in myocardial infarction through various molecular mechanisms including the prevention of reactive oxygen species-induced mitochondrial damage, improvement of autophagy system, modulation of intracellular calcium cycling, modification of ventricular electrophysiology, and…"
  • mTOR PMID 34087391
    "This study aims to explain the neuroprotective effect of nano-formulated ivabradine (nano IVA) in enhancing behavioral changes related to 3-NP model and to identify the involvement of ras homolog enriched striatum (Rhes)/mammalian target of rapamycin (m-Tor) mediated autophagy pathway."
  • autophagy PMID 34087391
    "This study aims to explain the neuroprotective effect of nano-formulated ivabradine (nano IVA) in enhancing behavioral changes related to 3-NP model and to identify the involvement of ras homolog enriched striatum (Rhes)/mammalian target of rapamycin (m-Tor) mediated autophagy pathway."

recorded 2026-03-19 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2145077
PubChem CID
3045381
CAS number
148849-67-6
RxCUI
1649479
InChIKey
ACRHBAYQBXXRTO-OAQYLSRUSA-N
Development code
S 16257, S-16257-2, AMG 998
Also called
IVABRADINE HYDROCHLORIDE, Corlentor, Ivabradina, IVABRADINE HYDROCHLORIDE [EMA EPAR], IVABRADINE HYDROCHLORIDE [JAN], IVABRADINE HYDROCHLORIDE [MI], IVABRADINE HYDROCHLORIDE [ORANGE BOOK], IVABRADINE HYDROCHLORIDE [USAN], Ivabradine hydrochloride [WHO-DD]
Trade name
Corlanor, Ivabradine accord, Ivabradine anpharm, Ivabradine jensonr, Ivabradine zentiva, Procoralan
Salt form
Ivabradine hcl
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

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

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