This page shows what was measured, who it was measured in, and what that does not settle.
What Zanubrutinib does in the body
The treatment of adult patients
From the FDA-approved label: Zanubrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B-cell proliferation and reduced tumor growth.
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 · AG9MHG098Z · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 96 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.
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.
Incidence of Adverse Events (AEs)
✗ The study did not show it
Who was studied
NCT04170283
How many people
955
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
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
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
✗ The study did not show it
Who was studied
NCT05100862
How many people
799
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
Overall Response Rate (ORR) Assessed by the Investigator
✗ The study did not show it
Who was studied
NCT03734016
How many people
652
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
Cohort 1: Progression Free Survival (PFS）
✗ The study did not show it
Who was studied
NCT06073821
How many people
652
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
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)
✗ The study did not show it
Who was studied
NCT03336333
How many people
590
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
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.6 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 healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.5 registered measures of this kind.
■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. 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.
arm a maximum observed concentration
arm b maximum observed concentration
arm a time of the maximum observed concentration
arm b time of the maximum observed concentration
maximum observed plasma concentration
Meaningful
Things that change how a life goes, not only a number.
progression free survival
3 year progression free survival
event free survival
progression free survival rate at 3 years
2 year progression free survival
progression free survival 1
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 (29)
part 1 and part 2 number of adverse events
dose escalation maximum tolerated dose of tislelizumab
dose escalation rp2d of tislelizumab
overall response rate
overall response rate assessed by the investigator
orr assessed by the independent review committee
adverse events and serious adverse events
experiencing treatment emergent adverse events
experiencing serious adverse events
part 2 overall response rate
success rate
arm a apparent terminal elimination half life
arm b apparent terminal elimination half life
complete renal response
complete response rate
very good partial response or better rate
incidence of adverse events
rate of undetectable minimal residual disease
overall response
evaluation of treatment response
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. 2 to 4 hours hours
Read from the label, which states: “Elimination The mean half-life (t ½ ) of zanubrutinib is approximately 2 to 4 hours following a single oral zanubrutinib dose of 160 mg or 320 mg.”
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.
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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 of BRUKINSA in pediatric patients have not been established.”
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-30
On older people, the label states: “Of the 1729 patients with MCL, MZL, WM, CLL/SLL, and FL in clinical studies with BRUKINSA, 59% were ≥65 years of age, and 21% were ≥75 years of age.”
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings in animals, BRUKINSA can cause fetal harm when administered to pregnant women.”
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of zanubrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-30
On people with reduced liver function, the label states: “Dosage modification of BRUKINSA is recommended in patients with severe hepatic impairment [see Dosage and Administration (2.2) ] .”
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage modification is recommended in patients with mild, moderate, or severe renal impairment (CLcr ≥15 mL/min, estimated by Cockcroft-Gault).”
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · 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 capsule, tablet, 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.
Zanubrutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 115 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
anaemia — 15 reaction mentions
white blood cell count decreased — 15 reaction mentions
platelet count decreased — 14 reaction mentions
pneumonia — 12 reaction mentions
myelosuppression — 11 reaction mentions
febrile neutropenia — 10 reaction mentions
lymphocyte count decreased — 10 reaction mentions
neutropenia — 10 reaction mentions
neutrophil count decreased — 10 reaction mentions
disease progression — 8 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or 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
15 products list this as an active ingredient in the United States drug directory. 15 of them contain it and nothing else.
FDA National Drug Code directory · 17205-628 · read 2026-08-29
They are sold as capsule, capsule, gelatin coated, powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 17205-628 · read 2026-08-29
The regulator's established pharmacologic class for it is bruton's tyrosine kinase inhibitors [moa] and kinase inhibitor [epc].
FDA National Drug Code directory · 17205-628 · 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 · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · read 2026-08-29
BRUKINSA is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with "ZANU 80" in black ink., recorded as fda label in effect 2026-07-21 in the United States.
US prescribing information · 3e08fe23-d70e-424c-bc51-1222e320f902 · 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 Zanubrutinib 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.
Formulation uncertainty
Several salts, forms or products of Zanubrutinib 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 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)
AG9MHG098Z
RxNorm concept
2262440
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
2 approved applications cover products containing this substance. The earliest was NDA213217, approved 20191114 to BEONE MEDICINES USA.
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
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Recorded evidence blocks (13)
Q2
What did Zanubrutinib's largest trial (15000 people) and its longest (15 years) measure?
15000 people in Zanubrutinib's largest registered study, 15 years in its longest registered window, measuring Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters. ClinicalTrials.gov · 2026-09-01
98 phase2, 28 phase1, 16 phase3, 7 na or unstated, 3 na, 2 phase4; NCT05976763; 2038-08-31; no ageing endpoint recorded. Last human test completed 2026, NCT07141511.
Interpretation These counts include studies where Zanubrutinib 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
98
phase1
28
phase3
16
na or unstated
7
na
3
phase4
2
1 more recorded row
Last recorded human testNCT07141511
2026-02-23
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Zanubrutinib shown biomarker?
1 recorded entry; human; also "Zanubrutinib 80 MG"
Show the evidence
humanNCT04602598
Zanubrutinib 80 MG
recorded 2026-09-01 · last checked 2026-09-04
Q6
Zanubrutinib's half-life is 2 to 4 hours — which schedules were studied?
2 to 4 hours, the half-life Zanubrutinib's label states. openfda-label · 3e08fe23-d70e-424c-bc51-1222e320f902 · 2026-08-30
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half life
2 to 4 hours hours; Elimination The mean half-life (t ½ ) of zanubrutinib is approximately 2 to 4 hours following a single oral zanubrutinib dose of 160 mg or 320 mg.
tmax
Absorption The median t max of zanubrutinib is 2 hours.
metabolism
Metabolism Zanubrutinib is primarily metabolized by cytochrome P450(CYP)3A.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 2 year progression free survival, 3 year progression free survival and adverse events did Zanubrutinib's trials measure?
2 year progression free survival, 3 year progression free survival and adverse events lead 40 outcome terms across Zanubrutinib's trials. ClinicalTrials.gov · 2026-09-01
Interpretation overall response rate, overall response rate assessed by the investigator, orr assessed by the independent review committee, adverse events and serious adverse events, experiencing treatment emergent adverse events and experiencing serious adverse events follow.
Show the evidence
part 1 and part 2 number of adverse events
1
dose escalation maximum tolerated dose of tislelizumab
1
dose escalation rp2d of tislelizumab
1
overall response rate
1
overall response rate assessed by the investigator
1
orr assessed by the independent review committee
1
14 more recorded rows
adverse events and serious adverse events
1
experiencing treatment emergent adverse events
1
experiencing serious adverse events
1
part 2 overall response rate
1
success rate
1
arm a maximum observed concentration
1
arm b maximum observed concentration
1
arm a time of the maximum observed concentration
1
arm b time of the maximum observed concentration
1
arm a apparent terminal elimination half life
1
arm b apparent terminal elimination half life
1
complete renal response
1
complete response rate
1
progression free survival
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Zanubrutinib's 92 ongoing trials reports first?
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR); establish the rate of minimum residual disease (MRD) undetectable response; latest 2039-11-01
Show the evidence
Trial
NCT03336333
"A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL"; n 590; "Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)"; 2027-10-31
NCT03824483
"Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)"; n 230; "establish the rate of minimum residual disease (MRD) undetectable response"; 2027-02
NCT04002297
"A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation"; n 510; "Progression-free survival (PFS) determined by independent central review"; 2031-09-30
NCT04170283
"A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib"; n 955; "Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)"; 2026-12-31
NCT04271956
"Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment With or Without Sonrotoclax for Patients With Richter Transformation"; n 83; "Overall response rate (ORR) after induction therapy according to the refined Lugano Classification (Cheson et al, 2016)"; 2027-08
NCT04277637
"Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies"; n 437; "Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)"; 2027-05-31
14 further recorded trials
NCT04458610
"Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma"; n 60; "Success rate"; 2027-05-26
NCT04515238
"Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL"; n 42; "Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by multi-color flow cytometry"; 2027-02
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
NCT04840602
"Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma"; n 92; "Very good partial response or better (VGPR or better) rate"; 2028-03-31
NCT04850495
"Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma"; n 38; "Incidence of adverse events"; 2026-12-15
NCT05100862
"A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma"; n 799; "Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)"; 2030-06
NCT05168930
"Zanubrutinib and Venetoclax in CLL (ZANU-VEN)"; n 45; "Rate of undetectable minimal residual disease (uMRD)"; 2028-10-28
NCT05199909
"Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia"; n 10; "Proportion of subjects with a platelet count ≥ 30 × 10^9/L and 50×10^9/L at week 12(Day 85)"; 2025-06-30
NCT05202782
"Zanubrutinib and CAR T-cell Therapy for the Treatment of Recurrent or Refractory Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma"; n 24; "Change in 6-month complete response rates"; 2029-10-09
NCT05214391
"A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune Thrombocytopenia"; n 30; "Proportion of subjects with a platelet count ≥ 30 × 10^9/L and 50×10^9/L at week 12(Day 85)"; 2025-12-31
NCT05326308
"Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma"; n 705; "Medical resource utilization"; 2028-08
NCT05389293
"A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma"; n 152; "Rate of Complete Respons/CR"; 2027-12
NCT05635162
"Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma"; n 50; "Event free survival"; 2028-10
NCT05640102
"Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia"; n 111; "Major Response Rate (MRR)"; 2027-12
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Zanubrutinib could settle lifespan?
NCT07012980 measures progression-free survival (PFS) rate, reading out 2026-07-31.
24 open trials; n 38; "Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL"
Show the evidence
Trial
NCT07012980
"Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL"; n 38; "progression-free survival (PFS) rate"; 2026-07-31
NCT03336333
"A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL"; n 590; "Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)"; 2027-10-31
NCT06136351
"A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma"; n 23; "2-year Progression-Free Survival"; 2027-11-01
NCT06669143
"Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission"; n 19; "2-year recurrence-free survival"; 2027-12
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
NCT06468943
"Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL"; n 20; "Progression-free Survival（PFS）"; 2028-05-01
14 further recorded trials
NCT06341556
"A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma"; n 52; "2-year progression-free survival (PFS)"; 2028-06
NCT05635162
"Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma"; n 50; "Event free survival"; 2028-10
NCT06803693
"Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL"; n 152; "Progression-free survival（by IRC）"; 2028-12-31
NCT05890352
"Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment"; n 227; "Progression-free survival (PFS)"; 2029-01
NCT05735834
"Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients"; n 122; "Progression Free Survival (PFS) rate at 3 years"; 2029-05
NCT06973811
"ZR-MTX for PIOL Phase II Trial"; n 47; "2 years progression-free survival"; 2029-10-30
NCT07594899
"AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL"; n 178; "Progression-free survival"; 2029-12-31
NCT07717177
"AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL"; n 112; "Progression-free survival"; 2029-12-31
NCT05100862
"A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma"; n 799; "Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)"; 2030-06
NCT06367374
"MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL"; n 66; "4-Year Progressive Free Survival (PFS) Rate"; 2030-07-30
NCT04002297
"A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation"; n 510; "Progression-free survival (PFS) determined by independent central review"; 2031-09-30
NCT07277231
"A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia"; n 500; "Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)"; 2031-11
NCT06742996
"A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)"; n 300; "Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)"; 2032-03-30
NCT06073821
"Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)"; n 652; "Cohort 1: Progression Free Survival (PFS）"; 2032-12
Q10
Which 7 trials of Zanubrutinib posted no result?
Posted no result
7 of 7 completed trials
Registrations
NCT04163523, NCT03465059, NCT05279872, NCT05547399, NCT05767398 and NCT05320575, and 1 more
Completion dates
oldest 2016-07-21; newest 2024-08-26
Show the evidence
Trial
NCT04163523
2016-07-21
NCT03465059
2018-10-19
NCT05279872
2022-10-30
NCT05547399
2022-12-07
NCT05767398
2023-04-28
NCT05320575
2023-08-01
1 further recorded trialNCT04643470
2024-08-26
Q11
At the median, Zanubrutinib's trials enrolled 50.5 people — anything larger?
Median enrolment
50.5
Largest enrolment
15000
Registered trials counted
144
Q12
What do 115 spontaneous reports say about Zanubrutinib — 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.
Zanubrutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 115 reaction mentions were counted: anaemia 15; white blood cell count decreased 15; platelet count decreased 14; pneumonia 12. open-targets-adr · CHEMBL3936761 · 2026-06-24
Show the evidence
anaemia
15
white blood cell count decreased
15
platelet count decreased
14
pneumonia
12
myelosuppression
11
febrile neutropenia
10
4 more recorded rows
lymphocyte count decreased
10
neutropenia
10
neutrophil count decreased
10
disease progression
8
recorded 2026-06-24 · last checked 2026-09-04
Q13
Zanubrutinib and P-GP, BCRP and CYP2B6: shared by which compounds?
P-GP, BCRP and CYP2B6 appear in Zanubrutinib's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2B6pharmacokinetics
In Vitro Studies CYP Enzymes : Zanubrutinib is an inducer of CYP2B6 and CYP2C8.
CYP2C19pharmacokinetics
CYP2C19 Substrates : Coadministration of multiple doses of zanubrutinib decreased omeprazole (CYP2C19 substrate) C max by 20% and AUC by 36%.
CYP2C8pharmacokinetics
In Vitro Studies CYP Enzymes : Zanubrutinib is an inducer of CYP2B6 and CYP2C8.
CYP2C9pharmacokinetics
Other CYP Substrates : No clinically significant differences were observed with warfarin (CYP2C9 substrate) pharmacokinetics when coadministered with zanubrutinib.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Zanubrutinib and mTOR?
"B-cell lymphoma cells Daudi were proportionally co-cultured with CD19 CAR T and intervened using different concentrations of zanubrutinib, and the changes of cell viability, apoptosis, autophagy, and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT)/mechanistic target of rapamycin (mTOR) pathway-related factors were assessed using…" — where Zanubrutinib and mTOR appear together. Europe PMC · pathway abstract search · 2026-03-12
mTOR, autophagy; PMID 41836029
Show the evidence
mTORPMID 41836029
"B-cell lymphoma cells Daudi were proportionally co-cultured with CD19 CAR T and intervened using different concentrations of zanubrutinib, and the changes of cell viability, apoptosis, autophagy, and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT)/mechanistic target of rapamycin (mTOR) pathway-related factors were assessed using the Cell Counting Kit-8 (CCK-8) assay, flow cytometry,…"
autophagyPMID 41836029
"B-cell lymphoma cells Daudi were proportionally co-cultured with CD19 CAR T and intervened using different concentrations of zanubrutinib, and the changes of cell viability, apoptosis, autophagy, and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT)/mechanistic target of rapamycin (mTOR) pathway-related factors were assessed using the Cell Counting Kit-8 (CCK-8) assay, flow cytometry,…"
mTORPMID 41836029
"The results showed that zanubrutinib increased the sensitivity of B-cell lymphoma to CD19 CAR T-cells, promoted apoptosis and autophagy, and inhibited BTK phosphorylation and the PI3K/AKT/mTOR signaling pathway."
autophagyPMID 41836029
"The results showed that zanubrutinib increased the sensitivity of B-cell lymphoma to CD19 CAR T-cells, promoted apoptosis and autophagy, and inhibited BTK phosphorylation and the PI3K/AKT/mTOR signaling pathway."
mTORPMID 41836029
"Zanubrutinib can promote the killing of B-cell lymphoma by CD19 CAR T. Collectively, zanubrutinib enhances CD19 CAR T killing of B-cell lymphoma by inhibiting BTK phosphorylation, regulating PI3K/AKT/mTOR pathway, and promoting autophagy."
autophagyPMID 41836029
"Zanubrutinib can promote the killing of B-cell lymphoma by CD19 CAR T. Collectively, zanubrutinib enhances CD19 CAR T killing of B-cell lymphoma by inhibiting BTK phosphorylation, regulating PI3K/AKT/mTOR pathway, and promoting autophagy."
recorded 2026-03-12 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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