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Nebivolol

  • 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 Nebivolol does in the body

High blood pressure.

Nebivolol blocks the beta-1 receptor that adrenaline uses on heart muscle, so the heart beats slower and less forcefully and the kidney releases less of the hormone that tightens arteries. Blood pressure falls. It is often described as also relaxing arteries directly by releasing nitric oxide, the same molecule that makes blood vessels dilate during exercise. The laboratory evidence for that is real; the drug regulator has not accepted it as the explanation, and the official label lists five possible contributors to the pressure drop without naming nitric oxide among them.

What happened in people

In older people with heart failure, combined deaths or heart admissions fell slightly, but deaths alone did not.

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

Its claimed artery-relaxing action is not established in its official prescribing information.

Where it acts
Beta-1 adrenergic receptor on cardiac myocytes; the claimed second site on the vascular endothelium is not in the United States label
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • 4 registered substances share the start of this name, which is why a search for it can return more than one thing.

    FDA substance registry · GMK2E335DQ · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

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

The four opening statements run to 114 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 was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Fertility and sexual healthNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
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 moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
insulin sensitivity index
Fertility and sexual health
female sexual function index
Cholesterol
myocardial triglyceride content

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
1 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 all-cause mortality or cardiovascular hospital admission, time to first event, in patients aged 70 or over with heart failure

The study showed what it set out to show

Who was studied
SENIORS (Eur Heart J 2005;26:215-225)
How many people
2128
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
31.1% against 35.3%; hazard ratio 0.86 (95% CI 0.74 to 0.99), p=0.039 over a mean 21 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. All-cause death alone was not significantly different: 15.8% against 18.1%, HR 0.88 (95% CI 0.71 to 1.08), p=0.21. The composite result sits at the edge of significance, and 35% of the enrolled population had an ejection fraction above 35%.

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

Form and route. Oral tablet at 2.5, 5, 10 and 20 mg of nebivolol base, taken once daily

Interval reported. 95% CI 0

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

Change from baseline in sitting blood pressure at 12 weeks

The study showed what it set out to show

Who was studied
Three 12-week placebo-controlled monotherapy hypertension trials (NDA 021742)
How many people
1802
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Blood pressure endpoints met; discontinuation for adverse reactions 2.8% on nebivolol against 2.2% on placebo across the placebo-controlled programme
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. These are blood pressure trials of twelve weeks. No cardiovascular outcome was measured, which is why the label states there are no controlled trials demonstrating risk reduction with the drug.

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

Form and route. Oral tablet at 2.5, 5, 10 and 20 mg of nebivolol base, taken once daily

Interval reported. Not recorded in this summary

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 Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.17 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 Drosophila (fruit fly), Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

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

What it 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

    Nebivolol

    What a person takes: Oral tablet at 2.5, 5, 10 and 20 mg of nebivolol base, taken once daily.

    The measurement behind this step

    Absorption resembles that of an oral solution and is unaffected by food; peak plasma concentration comes at about 1.5 to 4 hours. Absolute bioavailability has not been determined. The effective half-life of the active d-isomer is about 12 hours in extensive metabolisers and 19 hours in poor metabolisers, and active metabolites contribute to beta blockade.

  2. Getting in

    One tablet, two mirror-image molecules

    The tablet contains equal amounts of two forms of the same molecule. Only one of them meaningfully blocks the heart receptor; the other reaches higher levels in the blood and does much less.

    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

    A racemate of d-nebivolol (SRRR) and l-nebivolol (RSSS). The label states d-nebivolol beta receptor affinity is more than 1,000-fold higher and that l-nebivolol contributes little to activity despite higher exposure. Plasma protein binding is about 98%, and food does not alter the pharmacokinetics.

  3. Reaching the cell

    How fast your liver works decides your dose

    The active half is broken down by a liver enzyme that some people have little of. Those people end up with about ten times as much active drug from the same tablet.

    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

    Metabolism is predominantly direct glucuronidation with N-dealkylation and oxidation by CYP2D6. Poor metabolisers attain a 5-fold higher peak concentration and 10-fold higher area under the curve of d-nebivolol, with effective half-life rising from about 12 to 19 hours. Active metabolites, including the hydroxyl metabolite and glucuronides, contribute to beta blockade, which the label argues blunts the clinical importance of the difference.

  4. What it acts on

    The heart receptor is blocked, mostly selectively

    The active half sits on the beta-1 receptor, which is mainly on the heart, and leaves the lung receptor largely alone — at ordinary strengths, in most people.

    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

    Competitive beta-1 antagonism without intrinsic sympathomimetic or membrane-stabilising activity at therapeutic concentrations. Preferential beta-1 selectivity holds in extensive metabolisers at 10 mg and below; in poor metabolisers and at higher doses both beta-1 and beta-2 are inhibited. There is no alpha-1 blockade at clinically relevant doses.

  5. The change it makes

    Pressure falls, by a route the label will not name

    Blood pressure comes down. The prescribing information lists five things that may be responsible and declines to say which, and never mentions nitric oxide.

    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

    Section 12.1 states the mechanism of the antihypertensive response has not been definitively established and lists decreased heart rate, decreased contractility, diminished tonic sympathetic outflow, renin suppression, and vasodilation with decreased peripheral resistance as possible contributors. The endothelial nitric oxide account rests on isolated tissue and forearm plethysmography work, not on anything the label endorses.

  6. What that does for a person

    In the elderly with heart failure, a marginal composite

    The only outcome trial found a small advantage on a combined measure of death or hospital admission. Deaths on their own were not different.

    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

    SENIORS: primary composite 31.1% against 35.3%, hazard ratio 0.86 (95% CI 0.74 to 0.99, p=0.039), in 2,128 patients aged 70 or over over a mean 21 months. All-cause death 15.8% against 18.1%, hazard ratio 0.88 (0.71 to 1.08, p=0.21).

  7. What that does for a person

    What has never been measured

    Nothing in hypertension. The label states there are no controlled trials showing this drug reduces cardiovascular risk, and it was never studied in angina or after a heart attack.

    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

    Section 1.1: "There are no controlled trials demonstrating risk reduction with BYSTOLIC." Section 5.2: the drug was not studied in patients with angina pectoris or recent myocardial infarction. The outcome evidence that exists, SENIORS, is in a heart failure population the United States label does not cover and in which decompensated failure is a contraindication.

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.

  • symptoms questionnaire derived

Measured

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

  • insulin sensitivity index
  • decrease in supine systolic blood pressure
  • exercise capacity
  • peripheral diastolic blood pressure
  • seated trough cuff systolic blood pressure at week 12
  • glycosylated hemoglobin at week 26
  • trough sitting diastolic blood pressure
  • central systolic blood pressure
  • systolic blood pressure during the night
  • stable blood pressure

and 8 more.

Meaningful

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

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (21)
  • bsa and age adjusted aortic root diameter
  • trough seated dbp at week 8
  • marker of fibrinolysis
  • peak exercise oxygen consumption
  • delta peak exercise oxygen consumption time 1 versus time 3
  • peak exercise minute ventilation
  • delta peak exercise minute ventilation time 1 versus time 3
  • female sexual function index
  • pulse wave velocity
  • resting systolic bp
  • exercise duration
  • metabolic equivalent level
  • aortic mean arterial pressure
  • aortic pulse pressure
  • aortic augmentation pressure
  • systolic and diastolic myocardial function
  • reduction of thin cap fibroatheromas as defined by vh ivus
  • forearm blood flow response to bq 123
  • fbf response to bq 123 + bq 788
  • fbf response to acetylcholine

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. 12 hours hours

    Read from the label, which states: “The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers (most people), and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers.”

  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 high blood pressure. Not people with decompensated heart failure, severe bradycardia, heart block beyond first degree or severe liver impairment, all of which are contraindications.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-30

  • On older people, the label states: “Of the 2800 patients in the U.S. sponsored placebo-controlled clinical hypertension studies, 478 patients were 65 years of age or older.”

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available data regarding use of Nebivolol Tablets in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes.”

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-30

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

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-30

Where the result stopped carrying

  • All-cause mortality in SENIORS, the only outcome trial, did not separate from placebo
  • Beta-1 selectivity is lost in CYP2D6 poor metabolisers and at doses above 10 mg, in exactly the people with highest exposure
  • The drug was never studied in angina or after myocardial infarction, and its label says so
  • The one outcome trial was conducted in heart failure, a condition the United States label does not cover and whose decompensated form is a contraindication
  • 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 at 2.5, 5, 10 and 20 mg of nebivolol base, taken once daily

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

5 to 4 hours. Absolute bioavailability has not been determined. The effective half-life of the active d-isomer is about 12 hours in extensive metabolisers and 19 hours in poor metabolisers, and active metabolites contribute to beta blockade.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to 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 severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without a pacemaker and severe hepatic impairment. Do not stop abruptly: severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported after abrupt beta-blocker withdrawal in coronary disease, and the label directs tapering over one to two weeks. In general, patients with bronchospastic disease should not receive beta-blockers. It may mask the symptoms of hypoglycaemia and alter glucose levels. Discontinuation for adverse reactions in placebo-controlled trials was 2.8% against 2.2% on placebo, most often for headache, nausea or bradycardia.

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

Where this came from

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 at 2.5, 5, 10 and 20 mg of nebivolol base, taken once daily

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

5 to 4 hours. Absolute bioavailability has not been determined. The effective half-life of the active d-isomer is about 12 hours in extensive metabolisers and 19 hours in poor metabolisers, and active metabolites contribute to beta blockade.

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

  • 110 products list this as an active ingredient in the United States drug directory. 110 of them contain it and nothing else.

    FDA National Drug Code directory · 0456-1420 · read 2026-08-29

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

    FDA National Drug Code directory · 0456-1420 · read 2026-08-29

  • The regulator's established pharmacologic class for it is adrenergic beta-antagonists [moa] and beta-adrenergic blocker [epc].

    FDA National Drug Code directory · 0456-1420 · read 2026-08-29

  • 43 published labels name it as an active ingredient. 43 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-29

  • nebivolol is oral at 3 DOSAGE FORMS AND STRENGTHS Nebivolol Tablets for oral administration containing nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol., recorded as fda label in effect 2025-02-14 in the United States.

    US prescribing information · 3f5766c0-e1fa-4805-a32c-523182310ad5 · read 2026-08-30

  • Recorded price in US: 0.11194–0.17833 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 97 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.

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

Questions worth asking

  • Which of the trials of Nebivolol 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 nebivolol works through nitric-oxide-mediated vasodilation — a phrase that appears nowhere in its United States label, which says the mechanism has not been definitively established

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 l-isomer supplies a clinically meaningful vasodilator effect, when the label states it contributes little to activity

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 drug reduces cardiovascular events in hypertension, which the label explicitly declines to claim

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 SENIORS demonstrated a mortality benefit, when all-cause death alone was not significantly different

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 Nebivolol 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.

The nitric oxide story is not in the label
In plain words
Nebivolol is sold as the beta-blocker that also relaxes arteries by releasing nitric oxide. Its official prescribing information says the mechanism of the blood pressure effect has not been definitively established, and the phrase nitric oxide does not appear anywhere in the document.
What was measured
That nebivolol lowers blood pressure by nitric-oxide-mediated vasodilation — a mechanism supported in isolated tissue, absent from the label, and never linked to a clinical outcome
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.1 of the BYSTOLIC label reads: "The mechanism of action of the antihypertensive response of BYSTOLIC has not been definitively established." It lists five possible contributing factors — decreased heart rate, decreased myocardial contractility, diminished tonic sympathetic outflow, suppression of renin activity, and vasodilation with decreased peripheral vascular resistance — and does not attribute the fifth to nitric oxide or to any named pathway. Section 12 also states that at clinically relevant doses nebivolol does not demonstrate alpha-1 adrenergic blockade, closing off the other obvious vasodilator route, and that l-nebivolol contributes little to the drug activity because d-nebivolol beta receptor affinity is more than 1,000-fold higher. The laboratory literature on endothelial nitric oxide release by nebivolol is genuine and it has not translated into a mechanism the regulator will state, nor into an outcome the drug has been shown to produce.
Source
BYSTOLIC (nebivolol) United States prescribing information, sections 12 and 12.1 (NDA 021742)
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
The label says there are no controlled trials showing this drug reduces risk
In plain words
It lowers blood pressure. Whether it prevents strokes and heart attacks has not been tested, and the package insert says exactly that.
What was measured
That the blood pressure reduction measured with nebivolol converts into fewer cardiovascular events — a class-level inference the label declines to make for this molecule
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 1.1 reads: "There are no controlled trials demonstrating risk reduction with BYSTOLIC." The benefit is inferred from the general proposition that lowering blood pressure reduces fatal and nonfatal cardiovascular events, which the label states has been shown for drugs from a wide variety of pharmacologic classes including the one nebivolol belongs to. That inference is weaker for beta-blockers than for other classes: this is the class that has been demoted from first-line in most hypertension guidelines because, at equal blood pressure reduction, it prevented fewer strokes in the outcome trial record. Section 5.2 adds that the drug was not studied in patients with angina pectoris or recent myocardial infarction.
Source
BYSTOLIC (nebivolol) United States prescribing information, sections 1.1 and 5.2 (NDA 021742)
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
SENIORS: the composite was met, and deaths alone were not different
In plain words
The one outcome trial randomised over two thousand people aged seventy and above with heart failure. The combined measure of death or heart admission improved, just, at a p value of 0.039. Deaths on their own were no different.
What was measured
Composite of all-cause mortality or cardiovascular hospital admission in patients aged 70 and over
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SENIORS randomised 2,128 patients aged 70 or over with a history of heart failure — hospital admission within the previous year or known ejection fraction at or below 35% — to nebivolol titrated from 1.25 mg to 10 mg daily (n=1,067) or placebo (n=1,061), for a mean 21 months. Mean age was 76 and mean ejection fraction 36%, with 35% having ejection fraction above 35%. The primary composite of all-cause mortality or cardiovascular hospital admission occurred in 332 (31.1%) against 375 (35.3%), hazard ratio 0.86 (95% CI 0.74 to 0.99, p=0.039). Death from any cause occurred in 169 (15.8%) against 192 (18.1%), hazard ratio 0.88 (95% CI 0.71 to 1.08, p=0.21) — not significant. Age, sex and ejection fraction did not modify the effect. This is a real result at the edge of significance on a composite, in a population the drug is not licensed for in the United States, and it is the entire outcome evidence base for the molecule.
Source
Flather MD et al., Eur Heart J 2005;26:215-225 (SENIORS)
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 one outcome trial is in a condition the United States label does not cover
In plain words
SENIORS studied heart failure. In the United States, nebivolol is licensed only for blood pressure, and decompensated heart failure is a contraindication. The trial everyone cites is about a use the label does not authorise.
What was measured
Licensed indication against the population in which the only outcome trial was run
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The United States indication is hypertension alone. Contraindications include decompensated cardiac failure, severe bradycardia, heart block greater than first degree, cardiogenic shock, sick sinus syndrome without a pacemaker, and severe hepatic impairment at Child-Pugh above B. SENIORS enrolled 2,128 patients with a history of heart failure and reported the only outcome data the molecule has. Nebivolol carries heart failure indications in several European jurisdictions. So the outcome trial and the United States label describe different drugs in practice: the evidence that exists is for a use the label does not cover, and the use the label covers has no outcome evidence.
Source
BYSTOLIC United States prescribing information, sections 1.1 and 4 (NDA 021742); Flather MD et al., Eur Heart J 2005;26:215-225
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
Selectivity fails in the people who get the most drug
In plain words
Nebivolol is heart-selective in most people at ordinary strengths. In people who metabolise it slowly — who also end up with ten times the drug exposure — it blocks the lung receptors too.
What was measured
Beta-1 selectivity as a function of CYP2D6 metaboliser status and dose, from the label pharmacology section
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label states that in extensive metabolisers, most of the population, and at doses at or below 10 mg, nebivolol is preferentially beta-1 selective; in poor metabolisers and at higher doses it inhibits both beta-1 and beta-2 receptors. For the same dose, poor metabolisers attain a 5-fold higher peak concentration and a 10-fold higher area under the curve of the active d-isomer, and its effective half-life extends from about 12 to about 19 hours. The two failure modes therefore coincide: the people in whom selectivity is lost are the people carrying the most drug. Section 5.3 states that in general, patients with bronchospastic diseases should not receive beta-blockers.
Source
BYSTOLIC United States prescribing information, sections 12, 12.3 and 5.3 (NDA 021742)
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 racemate in which one isomer does almost nothing at the receptor
In plain words
The tablet contains equal amounts of two mirror-image molecules. One does the beta blocking. The other is present at higher levels in the blood and, according to the label, contributes little.
What was measured
That the l-isomer supplies a clinically meaningful vasodilator effect — asserted in the mechanistic literature, contradicted by the label statement that it contributes little to activity
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Nebivolol is a racemate of d-nebivolol (SRRR) and l-nebivolol (RSSS). The label states that exposure to l-nebivolol is higher than to d-nebivolol, but that l-nebivolol contributes little to the drug activity because d-nebivolol beta receptor affinity is more than 1,000-fold higher. Much of the published mechanistic work attributing nitric-oxide-mediated vasodilation to nebivolol assigns that activity to the l-isomer or to the racemate rather than to d-nebivolol. The label position — that the l-isomer contributes little and that the antihypertensive mechanism is not established — sits uneasily with a marketing account in which the l-isomer supplies the distinguishing pharmacology. Both statements cannot carry equal weight, and the label is the document with regulatory standing.
Source
BYSTOLIC United States prescribing information, sections 11, 12 and 12.3 (NDA 021742)
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

How many documents were read

  • 41 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

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: Reviewed first-read answer.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or 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

  • 22 approved applications cover products containing this substance. The earliest was NDA021742, approved 20071217 to ALLERGAN.

    Drugs@FDA application register · NDA021742 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA021742 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20071208.

    FDA National Drug Code directory · 0456-1420 · 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

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.
  • 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 beta-1 selective blocker marketed on nitric-oxide-mediated vasodilation that its own FDA label never mentions, whose only outcome trial — SENIORS, in 2,128 patients over 70 — met a composite of death or cardiovascular admission at 31.1% against 35.3% (p=0.039) while all-cause death alone did not differ (15.8% against 18.1%, p=0.21).

Recorded evidence blocks (14)

What did Nebivolol's largest trial (22213 people) and its longest (17 years) measure?


22213 people in Nebivolol's largest registered study, 17 years in its longest registered window, measuring Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis. ClinicalTrials.gov · 2026-09-01

44 phase4, 17 phase3, 13 na, 8 phase2, 5 na or unstated, 3 phase1, 2 early phase1; NCT03778554; 2035-12-10. Last human test completed 2025, NCT07397481.

Interpretation These counts include studies where Nebivolol 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
    44
  • phase3
    17
  • na
    13
  • phase2
    8
  • na or unstated
    5
  • phase1
    3
2 more recorded rows
  • early phase1
    2
  • Last recorded human test NCT07397481
    2025-06-01

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

From Drosophila to human: where has Nebivolol shown lifespan?


Drosophila: lifespan, mouse: lifespan, rat: mechanism-only and human: lifespan (89): the rungs where Nebivolol has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis — the recorded outcome words.

Yeast C. elegans Drosophila lifespanMouse lifespanRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • Drosophila
    lifespan
  • mouse
    lifespan
  • rat
    mechanism-only
  • human NCT00832442
    lifespan; Beta-blocker therapy improves overall mortality and morbidity in symptomatic heart failure in an individual patient meta-analysis; 89

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

10 of Nebivolol's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (7), funding/business (1) and other (2): Nebivolol's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Difficulty with recruiting willing participants."; 10 of 89 registered studies

Show the evidence

Trial

  • NCT00849810
    terminated; "Difficulty with recruiting willing participants."
  • NCT00893984
    terminated; "Lack of patient recruitment"
  • NCT01051947
    withdrawn; "Similar study already published"
  • NCT01076140
    withdrawn; "No participants enrolled"
  • NCT01206439
    terminated; "Slow enrollment"
  • NCT01441570
    terminated; "due to slow enrollment"
4 further recorded trials
  • NCT01605370
    terminated; "Difficulty in identifying subjects satisfying the inclusion criteria."
  • NCT01939990
    withdrawn; "Funding was discontinued."
  • NCT02053246
    terminated; "Study funding ended before recruitment completed."
  • NCT04130438
    terminated; "Low recruitment, insufficient funding"

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

Mouse studies of Nebivolol used 60 ppm — over how long?


Mouse studies of Nebivolol used "60 ppm". clinicaltrials.gov+jax-mpd-itp · 2026-09-04

4 recorded entries; mouse, human; also "Nebivolol 5 mg", "Zofenopril 30 mg + Nebivolol 5 mg", "Nebivolol 2.5 mg"

Show the evidence
  • mouse Nebivolol C2020
    60 ppm

human

  • NCT01044693
    Nebivolol 5 mg
  • NCT05257148
    Zofenopril 30 mg + Nebivolol 5 mg
  • NCT07397481
    Nebivolol 2.5 mg

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

Nebivolol's half-life is 12 hours — which schedules were studied?


12 hours, the half-life Nebivolol's label states. openfda-label · 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 · 2026-08-30

Show the evidence
  • half life
    12 hours hours; The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers (most people), and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers.
  • metabolism
    In extensive metabolizers (most of the population) and at doses less than or equal to 10 mg, nebivolol is preferentially β 1 selective.

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

Could one person measure Nebivolol's effect on insulin sensitivity index?


Insulin sensitivity index: measured in Nebivolol's trials.

Interpretation insulin sensitivity index is the recorded endpoint.

Show the evidence

biomarkers

  • insulin sensitivity index; 2026-09-01
  • decrease in supine systolic blood pressure; 2026-09-01
  • exercise capacity; 2026-09-01
  • symptoms questionnaire derived; 2026-09-01
  • peripheral diastolic blood pressure; 2026-09-01
  • bsa and age adjusted aortic root diameter; 2026-09-01
14 more recorded rows
  • biomarkers
    seated trough cuff systolic blood pressure at week 12; 2026-09-01
  • biomarkers
    glycosylated hemoglobin at week 26; 2026-09-01
  • biomarkers
    trough seated dbp at week 8; 2026-09-01
  • biomarkers
    marker of fibrinolysis; 2026-09-01
  • biomarkers
    trough sitting diastolic blood pressure; 2026-09-01
  • biomarkers
    central systolic blood pressure; 2026-09-01
  • biomarkers
    peak exercise oxygen consumption; 2026-09-01
  • biomarkers
    delta peak exercise oxygen consumption time 1 versus time 3; 2026-09-01
  • biomarkers
    peak exercise minute ventilation; 2026-09-01
  • biomarkers
    delta peak exercise minute ventilation time 1 versus time 3; 2026-09-01
  • biomarkers
    female sexual function index; 2026-09-01
  • biomarkers
    pulse wave velocity; 2026-09-01
  • biomarkers
    systolic blood pressure during the night; 2026-09-01
  • biomarkers
    stable blood pressure; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 12 hours; 2026-08-30
  • human trials at or under30
    24
  • smallest human trial
    0; NCT01051947; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of aortic augmentation index for heart rate, aortic augmentation pressure and aortic diastolic blood pressure did Nebivolol's trials measure?


aortic augmentation index for heart rate, aortic augmentation pressure and aortic diastolic blood pressure lead 40 outcome terms across Nebivolol's trials. ClinicalTrials.gov · 2026-09-01

symptoms questionnaire derived, peripheral diastolic blood pressure, bsa and age adjusted aortic root diameter, seated trough cuff systolic blood pressure at week 12, glycosylated hemoglobin at week 26 and trough seated dbp at week 8 follow.

Show the evidence
  • insulin sensitivity index
    1
  • decrease in supine systolic blood pressure
    1
  • exercise capacity
    1
  • symptoms questionnaire derived
    1
  • peripheral diastolic blood pressure
    1
  • bsa and age adjusted aortic root diameter
    1
14 more recorded rows
  • seated trough cuff systolic blood pressure at week 12
    1
  • glycosylated hemoglobin at week 26
    1
  • trough seated dbp at week 8
    1
  • marker of fibrinolysis
    1
  • trough sitting diastolic blood pressure
    1
  • central systolic blood pressure
    1
  • peak exercise oxygen consumption
    1
  • delta peak exercise oxygen consumption time 1 versus time 3
    1
  • peak exercise minute ventilation
    1
  • delta peak exercise minute ventilation time 1 versus time 3
    1
  • female sexual function index
    1
  • pulse wave velocity
    1
  • systolic blood pressure during the night
    1
  • stable blood pressure
    1

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

Which of Nebivolol's 5 ongoing trials reports first?


5 registered trials of Nebivolol are open; earliest completion 2026-12. ClinicalTrials.gov · 2026-09-01

A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including…; Intracranial aneurysm growth; latest 2035-12-10

Show the evidence

Trial

  • NCT03778554
    "Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction"; n 2760; "A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin."; 2035-12-10
  • NCT06249802
    "Beta-blockade in Unruptured Intracranial Aneurysm"; n 100; "Intracranial aneurysm growth"; 2030-01-01
  • NCT06424834
    "Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries"; n 150; "Seattle Angina Questionnaire summary score"; 2026-12
  • NCT07233499
    "Evaluation of the Cardioprotective Effect of Nebivolol on Trastuzumab-Induced Cardiotoxicity in Breast Cancer Patients"; n 56; "Measurement of Left ventricular ejection fraction by Echocardiography"; 2027-02-01
  • NCT07568574
    "Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes"; n 60; "The incidence and severity of Treatment-related adverse events (TRAEs), including adverse events (AEs) and serious adverse events (SAEs), as assessed by the study physicians from baseline to 5.5 years after enrollment."; 2033-03-01

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

Which running trial of Nebivolol could settle lifespan?


NCT03778554 measures A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin., reading out 2035-12-10.

1 open trial; n 2760; "Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction"

Show the evidence
  • Trial NCT03778554
    "Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction"; n 2760; "A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin."; 2035-12-10

Which 20 trials of Nebivolol posted no result?


Posted no result
20 of 20 completed trials
Registrations
NCT00200460, NCT00200473, NCT00158093, NCT00145236, NCT00200499 and NCT00200434, and 14 more
Completion dates
oldest 2003-03; newest 2021-07-27
Show the evidence

Trial

  • NCT00200460
    2003-03
  • NCT00200473
    2003-03
  • NCT00158093
    2003-07
  • NCT00145236
    2003-08
  • NCT00200499
    2003-09
  • NCT00200434
    2003-10
14 further recorded trials
  • NCT01248338
    2009-12
  • NCT00517725
    2010-05
  • NCT00999752
    2010-05
  • NCT01077661
    2011-01
  • NCT01358409
    2013-02-11
  • NCT01679652
    2013-09
  • NCT00223717
    2017-01
  • NCT01996085
    2017-12
  • NCT02467400
    2018-04-01
  • NCT03930433
    2019-03-31
  • NCT03655964
    2019-08-20
  • NCT04467931
    2020-12-31
  • NCT01648634
    2021-07-20
  • NCT04888728
    2021-07-27

At the median, Nebivolol's trials enrolled 54 people — anything larger?


Median enrolment
54
Largest enrolment
22213
Registered trials counted
89

Nebivolol and CYP2D6: shared by which compounds?


CYP2D6 appear in Nebivolol's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics, clinical_pharmacology

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CYP2D6

  • pharmacokinetics
    12.3 Pharmacokinetics Nebivolol is metabolized by a number of routes, including glucuronidation and hydroxylation by CYP2D6.
  • pharmacokinetics
    The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers (most people), and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers.
  • clinical_pharmacology
    Fluoxetine: Fluoxetine, a CYP2D6 inhibitor, administered at 20 mg per day for 21 days prior to a single 10 mg dose of nebivolol to 10 healthy adults, led to an 8-fold increase in the AUC and 3-fold increase in C max for d-nebivolol [see Drug Interactions ( 7 )].
  • clinical_pharmacology
    No studies have been conducted in patients on dialysis [see Dosage and Administration ( 2.1 )]. 12.5 Drug-Drug Interactions Drugs that inhibit CYP2D6 can be expected to increase plasma levels of nebivolol.

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

Was Nebivolol studied with fasting, caloric restriction and exercise?


fasting, caloric restriction and exercise are named in Nebivolol's label sentences: "In this multicenter trial, the effects of nebivolol added to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) were assessed in patients with hypertension (diastolic blood pressure [DBP] 80-110 mm Hg) and prediabetes (fasting blood glucose 100-125 mg/dL…" openfda-label+europepmc · 2026-08-30

3 recorded statements; fasting, caloric restriction, exercise

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  • fasting
    In this multicenter trial, the effects of nebivolol added to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) were assessed in patients with hypertension (diastolic blood pressure [DBP] 80-110 mm Hg) and prediabetes (fasting blood glucose 100-125 mg/dL and/or 2-hour oral glucose tolerance test [OGTT] 140-199 mg/dL).
  • caloric restriction
    To address this, 45 men and women (age 40-75 years) with stage I hypertension were randomized to receive either nebivolol (NB; forced titration to 10 mg OD; n = 15; age 57.2 ± 11.4 years; body mass index [BMI] 30.8 ± 5.8 kg/m(2)), lifestyle modification (LM; 5-10% weight loss via calorie restriction and physical activity; n = 15; age 52.7 ± 8.5 years; BMI 33.9 ± 7.2 kg/m(2)) or nebivolol plus…
  • exercise
    To assess the long-term effects of administration of nebivolol, compared to placebo, on the clinical symptoms, exercise capacity and parameters of left ventricular (LV) function in patients with HFPEF.

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

What is recorded about Nebivolol and mTOR?


"Nebivolol exerts a multi-targeted hepatoprotective effect against NASH, mainly mediated through the modulation of AMPK/mTOR and TGF-β1/α-SMA pathways, besides restoration of NO and eNOS signaling." — where Nebivolol and mTOR appear together. Europe PMC · pathway abstract search · 2026-04-24

mTOR, AMPK, NAD+, autophagy; PMID 40682968, 42030279, 39335471, 35678673

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  • mTOR PMID 40682968
    "Nebivolol exerts a multi-targeted hepatoprotective effect against NASH, mainly mediated through the modulation of AMPK/mTOR and TGF-β1/α-SMA pathways, besides restoration of NO and eNOS signaling."
  • AMPK PMID 40682968
    "Nebivolol exerts a multi-targeted hepatoprotective effect against NASH, mainly mediated through the modulation of AMPK/mTOR and TGF-β1/α-SMA pathways, besides restoration of NO and eNOS signaling."

mTOR

  • PMID 42030279
    "Furthermore, nebivolol attenuated AKT/mTOR/4EBP1 signaling cascade activation, thereby impeding GBM malignant proliferation."
  • PMID 42030279
    "This study delineates a novel dual mechanism whereby nebivolol exerts anti-GBM effects through concurrent modulation of mitochondrial bioenergetics and AKT/mTOR/4EBP1 signaling transduction."
  • NAD+ PMID 39335471
    "The study drugs were administered intragastrically-new drug Hypertril (1-(β-phenylethyl)-4-amino-1,2,4-triazolium bromide)-3.5 mg/kg, Metoprolol-15 mg/kg, Nebivolol -10 mg/kg, Carvedilol 50 mg/kg, and Bisoprolol, 10 mg/kg. In the myocardium, the main indices of energy metabolism were determined-ATP, ADP, AMP, malate, lactate, pyruvate, succinate dehydrogenase (SDH) activity, and NAD-dependent…"

AMPK

  • PMID 35678673
    "In compliance with these data, the inhibition of eNOS by L-N⁵-(1-Iminoethyl) ornithine (LNIO) and its upstream regulator AMP-activated kinase (AMPK) with compound C in the presence of nebivolol showed effects similar to those of the L-NAME plus nebivolol combination on Ang II-mediated signaling."
  • PMID 35678673
    "In conclusion, our data indicate that the rise in NO bioavailability caused by nebivolol via the stimulation of AMPK/eNOS signaling is key for its anti-inflammatory and antioxidant properties but not for its antihypertrophic response upon Ang II stimulation."
  • NAD+
    "The study drugs were administered intragastrically – new drug Hypertril (1-(β-phenylethyl)-4-amino-1,2,4-triazolium bromide)-3.5 mg/kg, metoprolol - 15 mg/kg, Nebivolol -10 mg/kg, Carvedilol 50 mg/kg, Bisoprolol, 10 mg/kg. In the myocardium, the main indices of energy metabolism were determined - ATP, ADP, AMP, malate, lactate, pyruvate, succinate dehydrogenase (SDH) activity, NAD-dependent…"

autophagy

  • PMID 31082961
    "Nebivolol attenuated NLRP3 inflammasome activation and suppressed autophagy."
  • PMID 27686325
    "In vitro, nebivolol treatment of palmitate-incubated H9C2 cells suppressed autophagy, restored mitochondrial biogenesis, leading to decreased mitochondrial reactive oxygen species (mtROS) generation, and suppressed NLRP3 inflammasome activation."
  • NAD+ PMID 16330685
    "The effects of nebivolol were dose-dependent and not observed with atenolol; similar effects were observed with apocynin, an NAD(P)H oxidase inhibitor."

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

Where it is registered
Identifiers, relations and other names

The exact record

PubChem CID
189562
CAS number
118457-15-1
InChIKey
KOHIRBRYDXPAMZ-YHBROIRLSA-N
Salt form
Nebivolol Hydrochloride, NEBIBOLOL
Trade name
Bystolic
Also called
D-NEBIVOLOL, Dexnebivolol, Dexnebivolol [WHO-DD], SRRR-Nebivolol, dexnebivolol [INN]
Development code
R-67138
Sources (11)

Sources

  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • clinicaltrials.gov+jax-mpd-itp clinicaltrials.gov+jax-mpd-itp ·
  • 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 · NIA ITP via the JAX Mouse Phenome Database · 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

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