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Ranolazine

  • 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 Ranolazine does in the body

Ranolazine blocks that leaking sodium current, so the calcium overload eases and the muscle relaxes.

When heart muscle is short of oxygen, a small leak of sodium into the cell fails to shut off properly. Sodium builds up, which forces calcium in behind it, and the overloaded muscle cannot relax properly between beats. A stiff, incompletely relaxing muscle squeezes its own small blood vessels and makes the oxygen shortage worse. That account is what the drug is named after; the prescribing information says the connection between blocking the current and relieving angina is uncertain.

Why people take it. Chest pain that continues despite usual medicines.

What happened in people

It added about 24 seconds of exercise and roughly half a chest-pain episode fewer each week.

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

Large studies did not show that it prevents major heart problems.

Where it acts
Cardiac myocyte membrane — the late sodium current during the plateau of the action potential, and the hERG potassium channel that repolarises it
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · A6IEZ5M406 · read 2026-08-29

  • Its recorded molecular formula is C24H33N3O4, weighing 427.54 g/mol.

    US prescribing information · 0cf58732-c242-49b0-8e3f-248778b4458d · 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 117 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.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

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.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Composite of cardiovascular death, myocardial infarction or recurrent ischaemia through end of study

The study did not show it

Who was studied
MERLIN-TIMI 36 (NCT00099788)
How many people
6560
Study design
Phase 3, randomised, double-blind, placebo-controlled, multinational
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
21.8% against 23.5%; hazard ratio 0.92 (95% CI 0.83 to 1.02), p=0.11 over a median 348 days
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. Recurrent ischaemia alone was reduced (HR 0.87, p=0.03), which is the component most vulnerable to ascertainment bias in an unblinded clinical setting. QTc prolongation requiring intravenous dose reduction occurred in 0.9% against 0.3%.

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

Form and route. Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets

Interval reported. 95% CI 0

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

Time to first ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation

The study did not show it

Who was studied
RIVER-PCI (NCT01442038)
How many people
2651
Study design
Phase 4, randomised, double-blind, placebo-controlled, event-driven
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
26% against 28%; hazard ratio 0.95 (95% CI 0.82 to 1.10), p=0.48 over a median 643 days
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. More patients stopped the study drug for an adverse event on ranolazine: 189 (14%) against 137 (11%), p=0.04. Funded by Gilead Sciences and Menarini.

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

Form and route. Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets

Interval reported. 95% CI 0

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

Change in trough treadmill exercise duration at 12 weeks, on background atenolol, amlodipine or diltiazem

The study showed what it set out to show

Who was studied
CARISA (JAMA 2004;291:309-316)
How many people
823
Study design
Phase 3, randomised, three-group parallel, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
+115.6 seconds from baseline in the pooled ranolazine groups against +91.7 seconds on placebo, p=0.01 — a between-group difference of about 24 seconds
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. The reported survival figures of 98.4% at one year and 95.9% at two come from the trial plus its open-label extension in 750 patients, with no control group.

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

Form and route. Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets

Interval reported. Not recorded in this summary

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

Average weekly number of anginal episodes over the last six weeks in patients with type 2 diabetes

The study showed what it set out to show

Who was studied
TERISA (NCT01425359)
How many people
949
Study design
Phase 4, randomised, double-blind, placebo-controlled, with placebo run-in
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
3.8 episodes (95% CI 3.6 to 4.1) against 4.3 (95% CI 4.0 to 4.5), p=0.008; weekly nitroglycerin 1.7 against 2.1 doses, p=0.003
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. A four-week single-blind placebo run-in preceded randomisation, which removes placebo responders and inflates the apparent drug effect relative to unselected practice. The absolute difference is about half an episode a week.

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

Form and route. Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets

Interval reported. 95% CI 3

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

What we know
RNAWiki holds 4 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.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  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.2 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

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

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

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

Where a source records it acting

  • Heart: At therapeutic levels can inhibit the cardiac late sodium current; the label records that the mechanism of the antianginal effect has not been determined and that the effects do not depend upon reductions in heart rate or blood pressure

    US prescribing information · 00979fb3-d70f-493d-94ca-2914cbadaa9d · read 2026-08-28

  1. Start

    Ranolazine

    What a person takes: Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets.

    The measurement behind this step

    The extended-release matrix exists because ranolazine has a short half-life and a dose-related QT effect, so a formulation that flattens the peak is doing safety work rather than convenience work. Clearance is dominated by CYP3A, which is why both inhibitors and inducers of that enzyme are contraindications rather than cautions.

  2. What it acts on

    A sodium leak that should have closed

    Heart muscle cells open sodium gates for a fraction of a second at the start of each beat. When the muscle is short of oxygen, a small fraction of those gates fail to shut and keep leaking.

    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 late component of the sodium current through Nav1.5 is small in healthy myocytes and enlarged by ischaemia, hypoxia, oxidative stress and several inherited channel variants. That difference in size between healthy and ischaemic tissue is the selectivity argument for a drug that targets it.

  3. The change it makes

    Sodium drags calcium in behind it

    The cell has an exchanger that normally pushes calcium out in return for letting sodium in. With sodium already high, that exchanger runs backwards and calcium accumulates.

    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

    Elevated intracellular sodium drives the sodium-calcium exchanger into reverse mode, loading the cytosol and the sarcoplasmic reticulum with calcium. This is the mechanistic chain proposed for the drug, and the label says the relationship between blocking the current and relieving angina is uncertain.

  4. The change it makes

    Overloaded muscle cannot let go between beats

    Calcium is what makes muscle contract, so too much of it left over means the muscle never fully relaxes. A stiff heart wall squeezes the small vessels running through it.

    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

    Calcium overload raises diastolic tension and left ventricular diastolic pressure, compressing intramural coronary vessels and reducing subendocardial perfusion — the proposed route by which a purely electrical abnormality becomes an ischaemic one.

  5. What that does for a person

    Blocking the leak, without touching rate or pressure

    Ranolazine blocks the leaking current. Unlike every other antianginal drug, it does this without slowing the heart or lowering blood pressure, which is the reason it exists.

    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

    The label records anti-ischaemic and antianginal effects that do not depend on reductions in heart rate or blood pressure, and no effect on the rate-pressure product at maximal exercise. That is an unusual and genuinely useful property in patients already at the floor of both.

  6. What that does for a person

    The same channel family produces the risk

    The drug also blocks a potassium channel that resets the heart electrically, which lengthens the QT interval on an ECG. That is the effect the label is confident about.

    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

    QT prolongation is attributed to inhibition of IKr, the hERG-carried rapid delayed rectifier, prolonging the ventricular action potential, and is dose-related. In the acute coronary syndrome population there was no increased risk of proarrhythmia or sudden death, and symptomatic documented arrhythmias were 3.0% against 3.1% on placebo.

  7. What that does for a person

    What the outcome trials measured

    Two large trials asked whether the drug prevents heart attacks and repeat procedures. Both missed. What is left is about twenty-four seconds more treadmill time and half an anginal episode a week.

    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

    MERLIN-TIMI 36: primary composite HR 0.92 (95% CI 0.83 to 1.02, p=0.11) in 6,560 patients. RIVER-PCI: primary composite HR 0.95 (0.82 to 1.10, p=0.48) in 2,651 patients. CARISA: trough exercise duration +115.6 seconds against +91.7 on placebo (p=0.01). TERISA: 3.8 against 4.3 weekly anginal episodes (p=0.008).

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.

  • seattle angina questionnaire
  • quality of life questionnaire

Measured

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

  • glycosylated hemoglobin at week 12
  • glycosylated hemoglobin at week 24
  • maximum observed plasma concentration of metformin

Meaningful

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

  • 6 minute walk test

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 (15)
  • exercise duration
  • assessment of platelet reaction
  • oxygen consumption at 6 weeks
  • pulmonary vascular resistance
  • troponin
  • peak oxygen consumption
  • coronary flow reserve
  • myocardial perfusion
  • nt pro bnp
  • hscrp
  • pharmacokinetic assessment
  • right ventricular ejection fraction
  • dose limiting toxicities
  • frequency of treatment emergent adverse events
  • muscle cramp frequency

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. 7 hours hours

    Read from the label, which states: “The apparent terminal half-life of ranolazine is 7 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 chronic angina, usually added to existing treatment rather than replacing it. Not people taking strong CYP3A inhibitors or CYP3A inducers, and not people with liver cirrhosis, 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 have not been established in pediatric patients.”

    US prescribing information · 0cf58732-c242-49b0-8e3f-248778b4458d · read 2026-08-30

  • On older people, the label states: “Of the chronic angina patients treated with ranolazine in controlled studies, 496 (48%) were ≥65 years of age, and 114 (11%) were ≥75 years of age.”

    US prescribing information · 0cf58732-c242-49b0-8e3f-248778b4458d · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no available data on ranolazine use in pregnant women to inform any drug-associated risks.”

    US prescribing information · 0cf58732-c242-49b0-8e3f-248778b4458d · read 2026-08-30

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

    US prescribing information · 0cf58732-c242-49b0-8e3f-248778b4458d · read 2026-08-30

Where the result stopped carrying

  • MERLIN-TIMI 36 missed its primary composite in 6,560 patients at p=0.11
  • RIVER-PCI missed its primary composite in 2,651 patients at p=0.48, with more discontinuations on the drug
  • The drug is contraindicated with both CYP3A inhibitors and CYP3A inducers, and in liver cirrhosis
  • Acute renal failure has been observed at creatinine clearance below 30 mL/min
  • 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

Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets

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

The extended-release matrix exists because ranolazine has a short half-life and a dose-related QT effect, so a formulation that flattens the peak is doing safety work rather than convenience work. Clearance is dominated by CYP3A, which is why both inhibitors and inducers of that enzyme are contraindications rather than cautions.

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.

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 · 00979fb3-d70f-493d-94ca-2914cbadaa9d · read 2026-08-28

  • Initiation: 500 mg twice daily

    US prescribing information · 00979fb3-d70f-493d-94ca-2914cbadaa9d · read 2026-08-28

  • Increase as needed: 1000 mg twice daily — Based on clinical symptoms, as recorded in the label

    US prescribing information · 00979fb3-d70f-493d-94ca-2914cbadaa9d · 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 with strong CYP3A inhibitors, with CYP3A inducers and in liver cirrhosis. Blocks IKr and prolongs QTc dose-dependently, with little data above 1000 mg twice daily, alongside other QT-prolonging drugs, or in congenital or acquired long QT. Acute renal failure has been observed at creatinine clearance below 30 mL/min, and renal function should be monitored below 60 mL/min. Commonest reactions above 4% and more common than placebo are dizziness, headache, constipation and nausea; about 6% discontinued for an adverse event against 3% on placebo.

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.

Ranolazine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1021 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • dizziness — 222 reaction mentions
  • chest pain — 128 reaction mentions
  • drug interaction — 118 reaction mentions
  • syncope — 95 reaction mentions
  • angina pectoris — 92 reaction mentions
  • hypotension — 89 reaction mentions
  • electrocardiogram qt prolonged — 80 reaction mentions
  • bradycardia — 72 reaction mentions
  • tremor — 70 reaction mentions
  • coronary artery disease — 55 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

Extended-release oral tablet, taken twice daily; a sprinkle formulation exists for patients who cannot swallow tablets

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 CYP3A, which is why both inhibitors and inducers of that enzyme are contraindications rather than cautions.

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

  • 80 products list this as an active ingredient in the United States drug directory. 80 of them contain it and nothing else.

    FDA National Drug Code directory · 71610-518 · read 2026-08-29

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

    FDA National Drug Code directory · 71610-518 · read 2026-08-29

  • The regulator's established pharmacologic class for it is anti-anginal [epc], cytochrome p450 2d6 inhibitors [moa] and cytochrome p450 3a inhibitors [moa].

    FDA National Drug Code directory · 71610-518 · read 2026-08-29

  • 32 published labels name it as an active ingredient. 32 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · b2a8dc3e-a880-5241-e053-2995a90a933a · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · b2a8dc3e-a880-5241-e053-2995a90a933a · read 2026-08-29

  • Ranolazine is extended-release tablets at Extended-release tablets: 500 mg, 1000 mg, recorded as prescription product; fda label in effect 2026-01-29 in the United States.

    US prescribing information · 00979fb3-d70f-493d-94ca-2914cbadaa9d · 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 Ranolazine 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 ranolazine relieves angina by inhibiting the late sodium current — the label says that relationship is uncertain

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 reducing recurrent ischaemia in MERLIN-TIMI 36 amounts to a cardiovascular benefit, when the primary composite it belongs to was not met

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 98.4% one-year survival in the CARISA extension says anything about the drug, given there was no control group

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 HbA1c effect is clinically established — it is a prespecified analysis inside a trial that missed its primary endpoint, with a mechanism the authors describe as under investigation

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 Ranolazine 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 label says the mechanism has not been determined
In plain words
Ranolazine is universally described as a late sodium current inhibitor, and that is where its whole scientific story comes from. Its own prescribing information says the mechanism of the antianginal effect has not been determined and that the link between blocking that current and relieving angina is uncertain.
What was measured
That ranolazine relieves angina by inhibiting the cardiac late sodium current — the label states the relationship between that inhibition and angina symptoms is uncertain
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.1 reads: "The mechanism of action of ranolazine’s antianginal effects has not been determined. Ranolazine has anti-ischemic and antianginal effects that do not depend upon reductions in heart rate or blood pressure. It does not affect the rate-pressure product, a measure of myocardial work, at maximal exercise. Ranolazine at therapeutic levels can inhibit the cardiac late sodium current (INa). However, the relationship of this inhibition to angina symptoms is uncertain." The one mechanism the label does assert is the unwanted one: QT prolongation is attributed to inhibition of IKr. So the drug is named and taught by a mechanism the regulator will not endorse, while the mechanism the regulator does endorse is the safety liability.
Source
Ranolazine extended-release tablets United States prescribing information, section 12.1
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
MERLIN-TIMI 36: the outcome trial missed, in 6,560 patients
In plain words
Six and a half thousand patients admitted with an acute coronary syndrome were randomised to ranolazine or placebo and followed for about a year. The main measure — cardiovascular death, heart attack or recurrent ischaemia — was not significantly better.
What was measured
Composite of cardiovascular death, myocardial infarction or recurrent ischaemia through end of study
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
MERLIN-TIMI 36 randomised 6,560 patients within 48 hours of ischaemic symptoms to intravenous then oral extended-release ranolazine 1000 mg twice daily (n=3,279) or matching placebo (n=3,281), followed for a median 348 days. The primary composite of cardiovascular death, myocardial infarction or recurrent ischaemia occurred in 696 (21.8%) against 753 (23.5%), hazard ratio 0.92 (95% CI 0.83 to 1.02, p=0.11). The major secondary composite was 18.7% against 19.2% (HR 0.96, 0.86 to 1.08, p=0.50). Cardiovascular death or myocardial infarction was 10.4% against 10.5% (HR 0.99, 0.85 to 1.15, p=0.87). Recurrent ischaemia alone was reduced: 13.9% against 16.1% (HR 0.87, 0.76 to 0.99, p=0.03). QTc prolongation requiring a reduction in intravenous dose occurred in 0.9% against 0.3%. Symptomatic documented arrhythmias did not differ (3.0% against 3.1%) and total mortality did not differ (HR 0.99, 0.80 to 1.22). The published conclusion is that adding ranolazine to standard treatment for acute coronary syndrome was not effective in reducing major cardiovascular events, and that the findings support its safety and efficacy as antianginal therapy.
Source
Morrow DA et al., JAMA 2007;297:1775-1783 (MERLIN-TIMI 36, NCT00099788)
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
RIVER-PCI: the second outcome trial missed too, and more patients stopped the drug
In plain words
Patients whose stent procedure left some narrowings untreated were given ranolazine or placebo. Repeat procedures and hospital admissions for ischaemia were no less common, and more people on the drug stopped it because of side effects.
What was measured
Time to first ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
RIVER-PCI randomised 2,651 patients at 245 centres in 15 countries with a history of chronic angina and incomplete revascularisation after percutaneous coronary intervention, defined as one or more lesions with at least 50% diameter stenosis in a vessel of at least 2 mm, to ranolazine 1000 mg twice daily (n=1,332) or placebo (n=1,319). After a median follow-up of 643 days, the primary composite of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation occurred in 345 (26%) against 364 (28%), hazard ratio 0.95 (95% CI 0.82 to 1.10, p=0.48). Neither component differed significantly. Discontinuation for an adverse event occurred in 189 (14%) on ranolazine against 137 (11%) on placebo, p=0.04. The trial was funded by Gilead Sciences and Menarini.
Source
Weisz G et al., Lancet 2016;387:136-145 (RIVER-PCI, NCT01442038)
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
CARISA: about 24 seconds more exercise than placebo
In plain words
In the trial that supported approval, patients walked longer on a treadmill before the pain started. The difference against the dummy tablet was about twenty-four seconds, and angina attacks fell by roughly one a week.
What was measured
Change in trough treadmill exercise duration and weekly angina frequency against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CARISA randomised 823 adults with symptomatic chronic angina who still had angina and ischaemia at low workloads despite standard doses of atenolol, amlodipine or diltiazem, to placebo or one of two ranolazine doses twice daily, at 118 outpatient sites. Trough exercise duration — measured 12 hours after dosing — increased by 115.6 seconds from baseline in the pooled ranolazine groups against 91.7 seconds on placebo, p=0.01. The between-group difference is therefore about 24 seconds. Times to angina and to electrocardiographic ischaemia also increased, more at peak than at trough. Ranolazine reduced angina attacks and nitroglycerin use by about one per week against placebo (p<0.02), independent of changes in blood pressure, heart rate or background therapy, and the effect persisted through 12 weeks. Survival among 750 patients in the trial or its open-label extension was 98.4% at one year and 95.9% at two, which is an uncontrolled observation and not a comparison.
Source
Chaitman BR et al., JAMA 2004;291:309-316 (CARISA)
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
TERISA: half an anginal episode a week in patients with diabetes
In plain words
In nearly a thousand patients with type 2 diabetes and stable angina, the drug reduced weekly angina from 4.3 episodes to 3.8 and nitroglycerin use from 2.1 doses to 1.7. Both differences were statistically clear and both are small.
What was measured
Average weekly number of anginal episodes over the last six weeks of treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
TERISA randomised 949 patients with type 2 diabetes, coronary artery disease and stable angina despite one or two antianginal agents, across 104 centres in 14 countries, to eight weeks of ranolazine at a target of 1000 mg twice daily or placebo after a four-week single-blind placebo run-in. Mean age was 64, mean diabetes duration 7.5 years and mean baseline HbA1c 7.3%. Weekly angina frequency over the last six weeks was 3.8 episodes (95% CI 3.6 to 4.1) against 4.3 (95% CI 4.0 to 4.5), p=0.008; weekly sublingual nitroglycerin use was 1.7 doses (1.6 to 1.9) against 2.1 (1.9 to 2.3), p=0.003. Electronic diary capture was 98% in both groups. Serious adverse events did not differ. The absolute effect is about half an episode and 0.4 doses per week.
Source
Kosiborod M et al., J Am Coll Cardiol 2013;61:2038-2045 (TERISA, NCT01425359)
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
It lowers HbA1c substantially, and was never developed as a diabetes drug
In plain words
A prespecified analysis inside the failed outcome trial found that ranolazine lowered long-term blood sugar by an amount comparable to a real diabetes drug, without causing low blood sugar. Twenty years later it is still an angina drug and the mechanism is still described as under investigation.
What was measured
That an HbA1c reduction of this size in a cardiovascular trial would translate into a diabetes indication — it has not, and the effect remains an unexploited finding inside a trial that missed its primary endpoint
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A prospective evaluation within MERLIN-TIMI 36 compared HbA1c in 4,918 randomised patients. Ranolazine reduced HbA1c at four months against placebo: 5.9% against 6.2%, change from baseline -0.30 against -0.04, p<0.001. In patients with diabetes, HbA1c fell from 7.5% to 6.9%, a change of -0.64 (p<0.001); 59% against 49% reached HbA1c below 7% at four months (p<0.001); and 14.2% against 20.6% had a rise of at least 1% by one year (HR 0.63, 95% CI 0.51 to 0.77, p<0.001). Recurrent ischaemia was reduced in diabetic patients (HR 0.75, 95% CI 0.61 to 0.93, p=0.008). In patients without diabetes at baseline, new fasting glucose above 110 mg/dL or HbA1c at or above 6% occurred in 31.8% against 41.2% (HR 0.68, 95% CI 0.53 to 0.88, p=0.003). Reported hypoglycaemia did not increase. The authors state the mechanism of this effect is under investigation. A 0.64 percentage point HbA1c reduction is within the range achieved by approved oral antidiabetic agents, and no ranolazine diabetes programme followed.
Source
Morrow DA et al. Evaluation of the glycometabolic effects of ranolazine in patients with and without diabetes mellitus in the MERLIN-TIMI 36 randomized controlled trial. Circulation 2009;119:2032-2039
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
Contraindicated in both directions on the same enzyme
In plain words
Drugs that slow the enzyme clearing ranolazine push its level up, which lengthens the QT interval. Drugs that speed the enzyme up push its level down until it does nothing. Both are contraindications.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Ranolazine is contraindicated in patients taking strong CYP3A inhibitors such as ketoconazole, clarithromycin and nelfinavir, in patients taking CYP3A inducers such as rifampin, phenobarbital and St John wort, and in liver cirrhosis. It blocks IKr and prolongs QTc in a dose-related manner; the label records little experience above 1000 mg twice daily, with other QT-prolonging drugs, with potassium channel variants producing long QT, or in congenital or acquired QT prolongation, while noting that the acute coronary syndrome population showed no increased risk of proarrhythmia or sudden death. Acute renal failure has been observed in some patients with creatinine clearance below 30 mL/min, and the label directs monitoring below 60 mL/min and discontinuation if acute renal failure develops. About 6% of angina patients discontinued for an adverse event against about 3% on placebo, most often dizziness (1.3% against 0.1%) and nausea (1% against 0%).
Source
Ranolazine extended-release tablets United States prescribing information, sections 4, 5.1, 5.2 and 6.1
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

  • 32 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
A6IEZ5M406
CAS registry number
95635-55-5
PubChem compound
56959
RxNorm concept
35829

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

  • 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

  • 30 approved applications cover products containing this substance. The earliest was NDA021526, approved 20060127 to MENARINI INTL.

    Drugs@FDA application register · NDA021526 · read 2026-08-29

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

    Drugs@FDA application register · NDA021526 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20060127.

    FDA National Drug Code directory · 71610-518 · 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.

An antianginal that works without lowering heart rate or blood pressure, adding about 24 seconds of exercise time over placebo in 823 patients in CARISA and about half an anginal episode a week in 949 diabetic patients in TERISA — and which missed its primary endpoint in both of its cardiovascular outcome trials, in 6,560 and 2,651 patients.

Recorded evidence blocks (14)

What did Ranolazine's largest trial (6560 people) and its longest (5.9 years) measure?


6560 people in Ranolazine's largest registered study, 5.9 years in its longest registered window, measuring Maximum observed plasma concentration (Cmax) of metformin. ClinicalTrials.gov · 2026-09-01

27 phase4, 23 phase2, 16 phase3, 10 na, 9 phase1, 2 na or unstated; NCT01648205; 2018-07-20; no ageing endpoint recorded. Last human test completed 2022, NCT03472950.

Interpretation These counts include studies where Ranolazine 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
    27
  • phase2
    23
  • phase3
    16
  • na
    10
  • phase1
    9
  • na or unstated
    2
1 more recorded row
  • Last recorded human test NCT03472950
    2022-12-09

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

Ranolazine was tested only in human — what did it show?


human: biomarker (84): the rungs where Ranolazine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Maximum observed plasma concentration (Cmax) of metformin — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT01546558
    biomarker; Maximum observed plasma concentration (Cmax) of metformin; 84

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

17 of Ranolazine's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?


futility/efficacy (1), accrual/recruitment (10), funding/business (3) and other (3): Ranolazine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"no funding"; 17 of 84 registered studies

Show the evidence

Trial

  • NCT00574756
    terminated; "no funding"
  • NCT00657514
    withdrawn; "Insufficient enrollment"
  • NCT00832572
    terminated; "Lack of enrollment"
  • NCT01349491
    terminated; "low recruitement rates"
  • NCT01352416
    terminated; "lack of enrollment"
  • NCT01590979
    terminated; "The study was terminated due to slow rate of accrual resulting in a sample size."
11 further recorded trials
  • NCT01675973
    terminated; "Study met stopping criteria specified within protocol."
  • NCT01705509
    terminated; "Study terminated due to lack of resources."
  • NCT01767987
    terminated; "Sponsor terminated study due to lack of enrollment"
  • NCT01887353
    terminated; "Difficultly in enrolling"
  • NCT02147834
    terminated; "due to futility"
  • NCT02156336
    terminated; "Not enough patients met study criteria for enrollment."
  • NCT02239926
    terminated; "Difficulty in enrolling subjects"
  • NCT02423265
    withdrawn; "slow recruitment; local new issues with CMR after study start"
  • NCT02687269
    withdrawn; "Inability to produce placebo tablets similar to the drug tested"
  • NCT03257683
    withdrawn; "Lack of funding"
  • NCT04456517
    terminated; "Low accrual and subject engagement"

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

Human studies of Ranolazine used Ranolazine 500 mg — over how long?


Human studies of Ranolazine used "Ranolazine 500 mg". ClinicalTrials.gov · 2026-09-01

4 recorded entries; human; tablet; also "Ranolazine 500 MG", "Ranolazine 1000 MG", "Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die"

Show the evidence

human

  • NCT01562041
    Ranolazine 500 mg
  • NCT03472950
    Ranolazine 500 MG
  • NCT03472950
    Ranolazine 1000 MG
  • NCT03953989
    tablet; Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die

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

Ranolazine's half-life is 7 hours — which schedules were studied?


7 hours, the half-life Ranolazine's label states. openfda-label · 90c5a0c2-542c-467e-9c0c-ef320534c560 · 2026-08-28

bioavailability 73% of the dose systemically available as ranolazine or metabolites %.

Show the evidence
  • half life
    7 hours hours; The apparent terminal half-life of ranolazine is 7 hours.
  • bioavailability
    73% of the dose systemically available as ranolazine or metabolites %; After oral administration of 14 C-ranolazine as a solution, 73% of the dose is systemically available as ranolazine or metabolites. The bioavailability of ranolazine from ranolazine extended-release tablet relative to that from a solution of ranolazine is 76%.
  • metabolism
    12.3 Pharmacokinetics Ranolazine is extensively metabolized in the gut and liver and its absorption is highly variable.

recorded 2026-08-28 · last checked 2026-09-04

Could one person measure Ranolazine's effect on glycosylated hemoglobin at week 12?


Glycosylated hemoglobin at week 12: measured in Ranolazine's trials.

glycosylated hemoglobin at week 12 is the recorded endpoint.

Show the evidence

biomarkers

  • glycosylated hemoglobin at week 12; 2026-09-01
  • 6 minute walk test; 2026-09-01
  • exercise duration; 2026-09-01
  • seattle angina questionnaire; 2026-09-01
  • quality of life questionnaire; 2026-09-01
  • glycosylated hemoglobin at week 24; 2026-09-01
14 more recorded rows
  • biomarkers
    assessment of platelet reaction; 2026-09-01
  • biomarkers
    oxygen consumption at 6 weeks; 2026-09-01
  • biomarkers
    maximum observed plasma concentration of metformin; 2026-09-01
  • biomarkers
    pulmonary vascular resistance; 2026-09-01
  • biomarkers
    troponin; 2026-09-01
  • biomarkers
    peak oxygen consumption; 2026-09-01
  • biomarkers
    coronary flow reserve; 2026-09-01
  • biomarkers
    myocardial perfusion; 2026-09-01
  • biomarkers
    nt pro bnp; 2026-09-01
  • biomarkers
    hscrp; 2026-09-01
  • biomarkers
    pharmacokinetic assessment; 2026-09-01
  • biomarkers
    right ventricular ejection fraction; 2026-09-01
  • biomarkers
    dose limiting toxicities; 2026-09-01
  • biomarkers
    frequency of treatment emergent adverse events; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 7 hours; 2026-08-28
  • human trials at or under30
    49
  • smallest human trial
    0; NCT00657514; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 6 minute walk test, assessment of platelet reaction and coronary flow reserve did Ranolazine's trials measure?


6 minute walk test, assessment of platelet reaction and coronary flow reserve lead 21 outcome terms across Ranolazine's trials. ClinicalTrials.gov · 2026-09-01

seattle angina questionnaire, quality of life questionnaire, glycosylated hemoglobin at week 24, assessment of platelet reaction, oxygen consumption at 6 weeks and maximum observed plasma concentration of metformin follow.

Show the evidence
  • glycosylated hemoglobin at week 12
    1
  • 6 minute walk test
    1
  • exercise duration
    1
  • seattle angina questionnaire
    1
  • quality of life questionnaire
    1
  • glycosylated hemoglobin at week 24
    1
14 more recorded rows
  • assessment of platelet reaction
    1
  • oxygen consumption at 6 weeks
    1
  • maximum observed plasma concentration of metformin
    1
  • pulmonary vascular resistance
    1
  • troponin
    1
  • peak oxygen consumption
    1
  • coronary flow reserve
    1
  • myocardial perfusion
    1
  • nt pro bnp
    1
  • hscrp
    1
  • pharmacokinetic assessment
    1
  • right ventricular ejection fraction
    1
  • dose limiting toxicities
    1
  • frequency of treatment emergent adverse events
    1

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

Which of Ranolazine's 3 ongoing trials reports first?


3 registered trials of Ranolazine are open; earliest completion 2026-06. ClinicalTrials.gov · 2026-09-01

Frequency of Treatment-Emergent Adverse Events; The proportion of eligible participants approached that consent; latest 2028-07

Show the evidence

Trial

  • NCT06527222
    "A Study of Ranolazine in ALS"; n 72; "Frequency of Treatment-Emergent Adverse Events"; 2028-07
  • NCT06570473
    "Feasibility Trial for a Right Ventricular Failure Platform Trial"; n 30; "The proportion of eligible participants approached that consent"; 2026-12
  • NCT07380919
    "Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study"; n 100; "Preservation of the coronary microcirculation"; 2026-06

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

Which 12 trials of Ranolazine posted no result?


Posted no result
12 of 12 completed trials
Registrations
NCT00091429, NCT00099788, NCT00998218, NCT01163734, NCT01546558 and NCT01546597, and 6 more
Completion dates
oldest 2005-02; newest 2020-03-06
Show the evidence

Trial

  • NCT00091429
    2005-02
  • NCT00099788
    2007-02
  • NCT00998218
    2010-12
  • NCT01163734
    2011-02
  • NCT01546558
    2012-03
  • NCT01546597
    2012-03
6 further recorded trials
  • NCT01843127
    2013-09
  • NCT01757808
    2015-01
  • NCT02133911
    2016-04-02
  • NCT02251457
    2017-12-18
  • NCT03401502
    2019-03-31
  • NCT03953989
    2020-03-06

At the median, Ranolazine's trials enrolled 25 people — anything larger?


Median enrolment
25
Largest enrolment
6560
Registered trials counted
84

What do 1021 spontaneous reports say about Ranolazine — 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.

Ranolazine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1021 reaction mentions were counted: dizziness 222; chest pain 128; drug interaction 118; syncope 95. open-targets-adr · CHEMBL1404 · 2026-06-24

Show the evidence
  • dizziness
    222
  • chest pain
    128
  • drug interaction
    118
  • syncope
    95
  • angina pectoris
    92
  • hypotension
    89
4 more recorded rows
  • electrocardiogram qt prolonged
    80
  • bradycardia
    72
  • tremor
    70
  • coronary artery disease
    55

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

Ranolazine and CYP2D6, P-GP and OCT2: shared by which compounds?


CYP2D6, P-GP and OCT2 appear in Ranolazine's recorded interaction sentences, 7 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP2D6

  • pharmacokinetics
    Metabolism and Excretion Ranolazine is metabolized mainly by CYP3A and, to a lesser extent, by CYP2D6.
  • pharmacokinetics
    CYP2D6 Substrates Ranolazine extended-release tablets 750 mg twice daily increases the plasma concentrations of a single dose of immediate release metoprolol (100 mg), a CYP2D6 substrate, by 80% in extensive CYP2D6 metabolizers with no need for dose adjustment of metoprolol.
  • pharmacokinetics
    In extensive metabolizers of dextromethorphan, a substrate of CYP2D6, ranolazine inhibits partially the formation of the main metabolite dextrorphan.
  • pharmacokinetics
    CYP2D6 Inhibitors Paroxetine 20 mg once daily increased ranolazine concentrations by 20% in healthy volunteers receiving ranolazine extended-release tablets 1000 mg twice daily.
  • pharmacokinetics
    Effect of Ranolazine on Other Drugs In vitro ranolazine and its O-demethylated metabolite are weak inhibitors of CYP3A and moderate inhibitors of CYP2D6 and P-gp.
  • pharmacokinetics
    No dose adjustment of ranolazine extended-release tablets is required in patients treated with CYP2D6 inhibitors.
1 more recorded row
  • CYP2D6 pharmacokinetics
    Drug Interactions Effect of Other Drugs on Ranolazine In vitro data indicate that ranolazine is a substrate of CYP3A and, to a lesser degree, of CYP2D6.

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

Was Ranolazine studied with fasting and exercise?


fasting and exercise are named in Ranolazine's label sentences: "A systematic search of seven databases was conducted to identify all randomised controlled trials that compared the effect of ranolazine versus placebo on haemoglobin A1c (HbA1c) and/or fasting plasma glucose (FPG) and/or incidence of hypoglycaemia." openfda-label+europepmc · 2026-08-30

2 recorded statements; fasting, exercise

Show the evidence
  • fasting
    A systematic search of seven databases was conducted to identify all randomised controlled trials that compared the effect of ranolazine versus placebo on haemoglobin A1c (HbA1c) and/or fasting plasma glucose (FPG) and/or incidence of hypoglycaemia.
  • exercise
    The endpoint is to compare the change from the baseline of the exercise treadmill test (ETT) performing duration between add-on ranolazine and placebo at week 12.

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

What is recorded about Ranolazine and AMPK?


"As AMP-activated protein kinase (AMPK) has been shown to be involved in the cellular response to ischemic injury, in this context, the present animal study evaluated the modulating role of ranolazine in the AMPK expression in isoprenaline-induced myocardial ischemic rat model." — where Ranolazine and AMPK appear together. Europe PMC · pathway abstract search · 2019-06-03

AMPK, mTOR, NAD+; PMID 31157553, 27208652, 7503762

Show the evidence

AMPK

  • PMID 31157553
    "As AMP-activated protein kinase (AMPK) has been shown to be involved in the cellular response to ischemic injury, in this context, the present animal study evaluated the modulating role of ranolazine in the AMPK expression in isoprenaline-induced myocardial ischemic rat model."
  • PMID 31157553
    "Ranolazine administration revealed effectiveness in attenuating the severity of isoprenaline-induced myocardial injury in both nondiabetic and diabetic rats as revealed by ECG signs, histopathological score, and apoptotic markers via abrogating the increments in the inflammatory and oxidative stress markers and modulating AMPK expression."
  • PMID 31157553
    "Therefore, the current cardioprotective effect of ranolazine was, at least in part, mediated through inhibition of apoptosis and modulation of AMPK expression, encouraging considering the utility of ranolazine in protection from acute myocardial infarction."

mTOR

  • PMID 27208652
    "Furthermore, the activated Akt/mTOR signaling pathway induced by AF was further activated by ranolazine."
  • PMID 27208652
    "The present study confirms the effects of ranolazine on AF rats induced by ACh-CaCl2, and provides evidence that the anti-AF effects are associated with the restoration of mitochondrial function and activation of the Akt/mTOR signaling pathway in atrial tissue."
  • NAD+ PMID 7503762
    "In studies to investigate its action further, using isolated rat heart mitochondria, ranolazine was found to weakly inhibit (pIC50 values > 300 microM) respiration by coupled mitochondria provided with NAD(+)-linked substrates but not with succinate."

recorded 2019-06-03 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1404
PubChem CID
56959
CAS number
95635-55-5
RxCUI
35829
InChIKey
XKLMZUWKNUAPSZ-UHFFFAOYSA-N
Also called
Aspruzyo, Ran d, Ranolazina, 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-, RAN4, Ranolazine [EMA EPAR], Ranolazine [INN], Ranolazine [MART.]
Trade name
Aspruzyo sprinkle, Ranexa, Ranexa / Aspruzyo Sprinkle
Development code
CVT-303, NSC-759100, RS-43285-003
Sources (11)

Sources

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

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

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

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