From the FDA-approved label: Ibrutinib is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro .
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 1X70OSD4VX · read 2026-08-29
Its recorded molecular formula is C25H24N6O2.
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 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.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
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 people◇Read 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.
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
✗ The study did not show it
Who was studied
NCT06136559
How many people
1200
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Miminimal residual disease (MRD) negativity rate in peripheral blood (PB)
✗ The study did not show it
Who was studied
NCT02950051
How many people
926
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Failure Free Survival
✗ The study did not show it
Who was studied
NCT02858258
How many people
870
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
✗ The study did not show it
Who was studied
NCT01855750
How many people
838
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Maximum Tolerated Dose (MTD)
✗ The study did not show it
Who was studied
NCT03740529
How many people
803
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.8 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
progression free survival
progression free survival rate
progression free survival rate at 3 years
overall survival time
disease free survival
overall survival
rate of complete remission
failure free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (32)
clinical benefit response
overall response rate
incidence and severity of adverse events
affected by an adverse event
maximum tolerated dose
phase 2 overall response rate
objective response rate
overall response
recommended phase ii dose
qtc interval
adverse events
treatment emergent adverse event study cohort
who achieve a confirmed response
phase 1b/2 overall response rate of number of
severity of aes
response for cohorts 1 and 3
who are alive and progression free
treatment related adverse events as assessed by ctcae v4 0
disease control rate
incidence of adverse events
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 take◇Read 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.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
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.
How fast the body clears it. 4 hours hours
Read from the label, which states: “The half-life of ibrutinib is 4 hours to 6 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
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 unclear◇Read 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.
IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of IMBRUVICA have not been established for this indication in pediatric patients less than 1 year of age.”
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
On older people, the label states: “Of 992 patients in clinical studies of IMBRUVICA for B-cell malignancies or cGVHD, 62% were ≥ 65 years of age, while 22% were ≥ 75 years of age [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] .”
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary IMBRUVICA can cause fetal harm based on findings from animal studies.”
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of ibrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
On people with reduced liver function, the label states: “Adult Patients with B-cell Malignancies Avoid use of IMBRUVICA in patients with severe hepatic impairment (Child-Pugh class C).”
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read 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 take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4.
No source is stored against this line.
What is in the pack
Sold as suspension, tablet, capsule, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Ibrutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4111 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
atrial fibrillation — 1004 reaction mentions
pneumonia — 599 reaction mentions
haemorrhage — 500 reaction mentions
contusion — 414 reaction mentions
platelet count decreased — 386 reaction mentions
pleural effusion — 304 reaction mentions
epistaxis — 245 reaction mentions
white blood cell count increased — 242 reaction mentions
lymphadenopathy — 222 reaction mentions
haematoma — 195 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 unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
34 products list this as an active ingredient in the United States drug directory. 34 of them contain it and nothing else.
FDA National Drug Code directory · 82920-031 · read 2026-08-29
They are sold as capsule, powder, suspension and tablet, film coated, taken oral.
FDA National Drug Code directory · 82920-031 · read 2026-08-29
The regulator's established pharmacologic class for it is kinase inhibitor [epc] and protein kinase inhibitors [moa].
FDA National Drug Code directory · 82920-031 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-29
Imbruvica is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: Each 70 mg capsule is a yellow, opaque capsule marked with “ibr 70 mg” in black ink., recorded as fda label in effect 2025-10-21 in the United States.
US prescribing information · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Ibrutinib 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 unclear◇Read 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.
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 people◇Read 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.
Where else this substance is registered
FDA substance identifier (UNII)
1X70OSD4VX
RxNorm concept
1442986
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
10 approved applications cover products containing this substance. The earliest was NDA205552, approved 20131113 to PHARMACYCLICS LLC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 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.
The path through the body — 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.
Claims that go past the evidence — 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.
Recorded evidence blocks (13)
Q2
What did Ibrutinib's largest trial (1200 people) and its longest (19 years) measure?
1200 people in Ibrutinib's largest registered study, 19 years in its longest registered window, measuring Overall Survival Time. ClinicalTrials.gov · 2026-09-01
183 phase2, 122 phase1, 44 phase3, 10 na or unstated, 3 phase4, 2 early phase1; NCT02514083; 2034-10-23; no ageing endpoint recorded. Last human test completed 2026, NCT03447808.
Interpretation These counts include studies where Ibrutinib was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
183
phase1
122
phase3
44
na or unstated
10
phase4
3
early phase1
2
1 more recorded row
Last recorded human testNCT03447808
2026-05-26
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Ibrutinib shown lifespan?
terminated; "Recruitment difficulties and toxicity"
NCT02269085
terminated; "slow accrual"
NCT02272686
terminated; "Slow Accrual"
14 further recorded trials
NCT02351037
terminated; "Study data do not support development in AML."
NCT02356458
terminated; "SAKK Board decision of 14th November 2020 due to financial reasons."
NCT02415608
terminated; "Slow accrual"
NCT02451111
terminated; "The premature termination is based on the decision by the SAKK board on November 14, 2020 due to the lack of further financial support for the follow up period."
NCT02548962
terminated; "After completing Phase 1, the Sponsor elected not to move forward with Phase 2."
NCT02611908
withdrawn; "No participants enrolled"
NCT02635074
terminated; "safety"
NCT02662296
withdrawn; "Low enrollment"
NCT02670317
terminated; "GA101-CHOP not advantage from rituximab-CHOP"
NCT02677948
withdrawn; "FDA has placed all trials involving Pacritinib on Full Clinical Hold"
NCT02703272
terminated; "IDMC recommended that enrolment be stoped, as the EFS hazard ratio and associated p-value crossed the futility boundary specified in protocol (July 2020)."
NCT02780830
withdrawn; "Study D2276C00001 was not started. No patients were enrolled. The sponsor decided to pursue an alternate design."
NCT02815059
withdrawn; "Termination of Investigator Initiated Studies using Ibrutinib"
NCT02914327
withdrawn; "Lack of enrollment"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Ibrutinib used TRU-016 10-20 mg/kg + ibrutinib — over how long?
8 recorded entries; human; also "TRU-016 10-20 mg/kg + ibrutinib", "Cirmtuzumab (2-16 kg/mg) plus Ibrutinib", "Cirmtuzumab (300mg) plus Ibrutinib"
Show the evidence
human
NCT01644253
TRU-016 10-20 mg/kg + ibrutinib
NCT03088878
Cirmtuzumab (2-16 kg/mg) plus Ibrutinib
NCT03088878
Cirmtuzumab (300mg) plus Ibrutinib
NCT03088878
Cirmtuzumab (600 mg) plus ibrutinib
NCT03190330
Ibrutinib 420 mg
NCT03190330
Ibrutinib 560 mg
2 more recorded rows
humanNCT03379428
Ibrutinib 840 mg
humanNCT03646461
Ibrutinib 560mg PO daily (Imbruvica)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Ibrutinib's half-life is 4 hours — which schedules were studied?
4 hours, the half-life Ibrutinib's label states. openfda-label · 0dfd0279-ff17-4ea9-89be-9803c71bab44 · 2026-08-30
bioavailability 2.9% %.
Show the evidence
half life
4 hours hours; The half-life of ibrutinib is 4 hours to 6 hours.
tmax
Ibrutinib is absorbed after oral administration with a median T max of 1 hour to 2 hours.
bioavailability
2.9% %; Absorption Absolute bioavailability of ibrutinib in fasted condition was 2.9% (90% CI: 2.1, 3.9) in healthy subjects.
metabolism
Metabolism Metabolism is the main route of elimination for ibrutinib.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of adverse events, affected by an adverse event and best overall response rate did Ibrutinib's trials measure?
adverse events, affected by an adverse event and best overall response rate lead 40 outcome terms across Ibrutinib's trials. ClinicalTrials.gov · 2026-09-01
incidence and severity of adverse events, affected by an adverse event, maximum tolerated dose, progression free survival rate, progression free survival rate at 3 years and phase 2 overall response rate follow.
Show the evidence
clinical benefit response
1
overall response rate
1
progression free survival
1
incidence and severity of adverse events
1
affected by an adverse event
1
maximum tolerated dose
1
14 more recorded rows
progression free survival rate
1
progression free survival rate at 3 years
1
phase 2 overall response rate
1
objective response rate
1
overall survival time
1
overall response
1
recommended phase ii dose
1
qtc interval
1
adverse events
1
disease free survival
1
treatment emergent adverse event study cohort
1
who achieve a confirmed response
1
phase 1b/2 overall response rate of number of
1
severity of aes
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ibrutinib's 89 ongoing trials reports first?
Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.; Number of participants affected by an adverse event; latest 2035-08-30
Show the evidence
Trial
NCT01589302
"PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia"; n 154; "Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL."; 2026-10-31
NCT01804686
"A Long-term Extension Study of PCI-32765 (Ibrutinib)"; n 700; "Number of participants affected by an adverse event"; 2029-12-31
NCT01829568
"Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma"; n 33; "Maximally tolerated dose (MTD) of lenalidomide and ibrutinib for combination with rituximab"; 2027-06-06
NCT01841723
"Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia"; n 44; "Overall response rate (complete response [CR] and partial response [PR])"; 2029-12-31
NCT01849263
"Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma"; n 41; "Overall Response Rate"; 2027-03-19
NCT01880567
"Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell Lymphoma"; n 113; "Overall response (complete response and partial response), assessed by the International Workshop Standardized Response Criteria for non-Hodgkin lymphoma"; 2028-07-31
14 further recorded trials
NCT01886872
"Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia"; n 547; "Progression Free Survival (PFS)"; 2027-06-24
NCT01955499
"Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma"; n 39; "Maximum tolerated dose (MTD)"; 2027-05-06
NCT02007044
"Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia"; n 66; "Progression-free survival rate"; 2028-06-30
NCT02048813
"Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 529; "Progression-free Survival (PFS) Rate at 3 Years"; 2026-10-09
NCT02159755
"Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma"; n 28; "Recommended phase II dose of the combination of ibrutinib and palbociclib"; 2027-04-30
NCT02160015
"Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery"; n 12; "Recommended phase II dose of lenalidomide and ibrutinib with rituximab based on the maximum tolerated dose and the assessment of any clinically relevant toxicity"; 2027-08-19
NCT02203526
"Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma"; n 68; "safety and feasibility in untreated PCNSL patients"; 2027-12-01
NCT02251548
"A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia"; n 85; "Part I: Participants Who Achieve a Minimal Residual Disease (MRD) Negative Complete Response (CR) in the Bone Marrow at 2 Months Post FCR"; 2027-01
NCT02427451
"Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or Previously Untreated Chronic Lymphocytic Leukemia"; n 87; "Maximum Tolerated Dose of Bcl-2 Inhibitor GDC-0199 in Combination With Obinutuzumab and Ibrutinib (Phase Ib)"; 2027-04-15
NCT02427620
"Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma"; n 131; "Overall response rate (complete response + partial response)"; 2027-06-30
NCT02436707
"Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma"; n 129; "Measure overall response rate"; 2026-12-31
NCT02443077
"Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma"; n 94; "24-month Progression-free Survival (PFS), Defined as the Proportion of Patients Who Are Alive and Progression-free 2 Years From Randomization"; 2026-12-23
NCT02446236
"Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma"; n 27; "Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events"; 2026-07
NCT02477696
"Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)"; n 533; "Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment"; 2028-01-03
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Ibrutinib could settle lifespan?
NCT03478514 measures Progression free survival, reading out 2026-08-30.
19 open trials; n 39; "Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma"
Show the evidence
Trial
NCT03478514
"Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma"; n 39; "Progression free survival"; 2026-08-30
NCT02048813
"Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 529; "Progression-free Survival (PFS) Rate at 3 Years"; 2026-10-09
NCT01589302
"PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia"; n 154; "Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL."; 2026-10-31
NCT02443077
"Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma"; n 94; "24-month Progression-free Survival (PFS), Defined as the Proportion of Patients Who Are Alive and Progression-free 2 Years From Randomization"; 2026-12-23
NCT03737981
"Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia"; n 465; "Progression-free Survival (PFS)"; 2026-12-29
NCT04421560
"Pembrolizumab, Ibrutinib and Rituximab in PCNSL"; n 37; "Progression-free survival rate 6 months (PFS6)"; 2027-01-05
13 further recorded trials
NCT01886872
"Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia"; n 547; "Progression Free Survival (PFS)"; 2027-06-24
NCT03731234
"Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance"; n 75; "Progression-free survival (PFS) (1st time point of assessment)"; 2027-07
NCT04608318
"Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)"; n 897; "Investigator-assessed progression-free survival (PFS)"; 2027-09
NCT02477696
"Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)"; n 533; "Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment"; 2028-01-03
NCT03282396
"Ibrutinib in Treating Participants With Untreated High Risk Smoldering Mantle Cell Lymphoma"; n 20; "Progression free survival"; 2028-02-28
NCT04662255
"Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)"; n 500; "To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)"; 2028-04
NCT03701282
"Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia"; n 720; "Progression-free survival"; 2028-05-07
NCT02007044
"Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia"; n 66; "Progression-free survival rate"; 2028-06-30
NCT03964090
"Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)"; n 48; "Progression-free survival (PFS)"; 2028-07-01
NCT05998642
"Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma"; n 30; "One year progression-free survival (PFS)"; 2028-12-31
NCT03462719
"A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)"; n 211; "Progression Free Survival (PFS)"; 2029-04-05
NCT06482684
"CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma"; n 150; "Failure Free Survival"; 2031-12-31
NCT07377578
"A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma"; n 394; "Progression-free survival (PFS) assessed by IRC"; 2033-01-30
Q10
Which 48 trials of Ibrutinib posted no result?
Posted no result
48 of 48 completed trials
Registrations
NCT01626651, NCT01674322, NCT01599949, NCT02271438, NCT02390609 and NCT02013128, and 42 more
Completion dates
oldest 2012-08; newest 2024-06-24
Show the evidence
Trial
NCT01626651
2012-08
NCT01674322
2012-09
NCT01599949
2015-05
NCT02271438
2015-05
NCT02390609
2015-11
NCT02013128
2015-12
14 further recorded trials
NCT02638116
2016-03
NCT01779791
2016-05-18
NCT02381080
2016-06-24
NCT02841150
2016-08
NCT02877225
2016-11-11
NCT02169180
2016-12
NCT02219737
2017-05-11
NCT02556892
2018-08-20
NCT02582320
2018-10-03
NCT03301207
2018-12-04
NCT02950220
2019-01-03
NCT02345863
2019-03-29
NCT02352558
2019-05-16
NCT03476655
2019-05-31
Q11
At the median, Ibrutinib's trials enrolled 37 people — anything larger?
Median enrolment
37
Largest enrolment
1200
Registered trials counted
311
Q12
What do 4111 spontaneous reports say about Ibrutinib — 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.
Ibrutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4111 reaction mentions were counted: atrial fibrillation 1004; pneumonia 599; haemorrhage 500; contusion 414. open-targets-adr · CHEMBL1873475 · 2026-06-24
Show the evidence
atrial fibrillation
1004
pneumonia
599
haemorrhage
500
contusion
414
platelet count decreased
386
pleural effusion
304
4 more recorded rows
epistaxis
245
white blood cell count increased
242
lymphadenopathy
222
haematoma
195
recorded 2026-06-24 · last checked 2026-09-04
Q13
Ibrutinib and BCRP, P-GP and CYP1A2: shared by which compounds?
BCRP, P-GP and CYP1A2 appear in Ibrutinib's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
In Vitro Studies Effect of Ibrutinib on CYP Substrates: In vitro studies suggest that ibrutinib and PCI-45227 are unlikely to inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 3A at clinical doses.
pharmacokinetics
Both ibrutinib and PCI-45227 are unlikely to induce CYP1A2, CYP2B6 or CYP3A at clinical doses.
CYP2B6pharmacokinetics
Both ibrutinib and PCI-45227 are unlikely to induce CYP1A2, CYP2B6 or CYP3A at clinical doses.
CYP2D6pharmacokinetics
It is metabolized to several metabolites primarily by cytochrome P450 (CYP) 3A and to a minor extent by CYP2D6.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Ibrutinib and mTOR?
"Ibrutinib induces cardiotoxicity by targeting BTK/EGFR and inhibiting the downstream EGFR/PI3K/Akt/mTOR pathway, providing a mechanistic framework for clinical safety management of BTK inhibitors." — where Ibrutinib and mTOR appear together. Europe PMC · pathway abstract search · 2026-07-23
"Ibrutinib induces cardiotoxicity by targeting BTK/EGFR and inhibiting the downstream EGFR/PI3K/Akt/mTOR pathway, providing a mechanistic framework for clinical safety management of BTK inhibitors."
PMID 42373252
"We assessed the <i>in vitro</i> cytotoxicity of ibrutinib, idelalisib (PI3K inhibitor), and everolimus (mTOR inhibitor) across characterized LBCL cell lines."
PMID 41952319
"Furthermore, ibrutinib inhibited PI3K/AKT/mTOR cell survival signalling in some but not all OCCC cell lines, suggesting that this drug functions on additional pathways."
autophagy
PMID 38812314
"Hydroxychloroquine as an autophagy inhibitor was administered to rescue ibrutinib-induced Cx43 and Cx40 degradation."
PMID 38812314
"The off-target effect of ibrutinib on the PI3K-AKT-mTOR signaling pathway caused connexin degradation and atrial arrhythmia via promoting autophagy."
PMID 40134198
"The increased expression of LC3-Ⅱ protein in BIM-knockdown cell lines (<i>P</i><0.01) suggested that reduction of BIM may mediate autophagy activation. <b>Conclusion:</b> Downregulation of BIM may be a key factor in promoting ibrutinib resistance in CLL by activating protective autophagy."
AMPK
PMID 38842296
"We also found lower abundance and phosphorylation of myocardial AMPK (5'-adenosine monophosphate-activated protein kinase), indicating reduced AMPK activity in hearts after ibrutinib treatment."
PMID 38842296
"An acute treatment with the AMPK activator 5-aminoimidazole-4-carboxamide-1-β-D-ribofuranoside ameliorated abnormalities in action potential and Ca<sup>2+</sup> dynamics, and significantly reduced VA inducibility (37.1%±13.4% versus 72.2%±6.3% in the absence of 5-aminoimidazole-4-carboxamide-1-β-D-ribofuranoside, <i>P</i><0.05) in hearts from ibrutinib-treated rats."
PMID 38842296
"Pharmacological activation of AMPK may be a protective strategy against ibrutinib-induced cardiotoxicity."
IGF-1
PMID 37655217
"Ibrutinib is capable of inhibiting PI3K/Akt signaling in neonatal rat ventricular cardiomyocytes when stimulated with insulin-like growth factor 1 (IGF-1)."
PMID 37655217
"We therefore hypothesized that Ibrutinib might disrupt IGF-1-mediated activation of intracellular Ca handling in adult mouse cardiomyocytes by inhibiting PI3K/Akt signaling."
PMID 37655217
"Acalabrutinib induced similar effects on Ca handling in IGF-1 treated cultured myocytes as Ibrutinib in regard to decreased Ca transient amplitude and slowed Ca transient decay, hence implying a functional class effect of BTK inhibitors in cardiac myocytes."
NAD+
PMID 27287071
"Loss of function studies suggested a potential oncogenic role of Nampt in Waldenström macroglobulinemia cells, and BTK-inhibitor ibrutinib and FK866 resulted in a significant and synergistic anti-Waldenström macroglobulinemia cell death, regardless of MYD88 and CXCR4 mutational status."
PMID 27287071
"Our results show intracellular NAD<sup>+</sup> level as crucial for proliferation and survival of Waldenström macroglobulinemia cells, and provides the mechanistic preclinical rationale for targeting Nampt, either alone or with Ibrutinib, to overcome drug resistance and improve patient outcome in Waldenström macroglobulinemia."
recorded 2026-07-23 · last checked 2026-09-04
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