This page shows what was measured, who it was measured in, and what that does not settle.
What Nilotinib does in the body
Nilotinib capsules are a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
From the FDA-approved label: Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro , nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. 7 nM).
Why people take it. Nilotinib capsules are a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
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
25 registered substances share the start of this name, which is why a search for it can return more than one thing.
FDA substance registry · J4WJ4450U9 · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 163 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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.
Accrual of patients to ComboMATCH treatment trials
✗ The study did not show it
Who was studied
NCT05564377
How many people
2900
Study design
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
Percentage of patients that are treated based on their molecular tumor profile
✗ The study did not show it
Who was studied
NCT02925234
How many people
1550
Study design
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
Changes From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 72 [ Time Frame: Baseline, Week 72]
✗ The study did not show it
Who was studied
NCT05143528
How many people
1275
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
Percentage of Participants With Molecular Response (MR4^0) at 18 Months
✗ The study did not show it
Who was studied
NCT01061177
How many people
1090
Study design
Phase 4
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
Induction Progression-Free Rate after induction treatment
✗ The study did not show it
Who was studied
NCT02029001
How many people
900
Study design
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
Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation
✗ The study did not show it
Who was studied
NCT00471497
How many people
846
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 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 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.
Nilotinib capsules are a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
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 nilotinib have been established in pediatric patients greater than or equal to 1 year of age with newly diagnosed and resistant or intolerant Ph+ CML in chronic phase [see Clinical Studies (14.5 )].”
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · read 2026-08-30
On older people, the label states: “In the clinical trials of nilotinib (patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP), approximately 12% and 30% of patients were 65 years or over, respectively.”
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and the mechanism of action, nilotinib can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ] .”
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of nilotinib or its metabolites in human milk or its effects on a breastfed child or on milk production.”
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · read 2026-08-30
On people with reduced liver function, the label states: “Reduce the nilotinib dosage in patients with hepatic impairment and monitor the QT interval closely in these patients [ see Dosage and Administration (2.7) , Clinical Pharmacology (12.3) ].”
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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, S6.
No source is stored against this line.
What is in the pack
Sold as capsule, tablet, tablet, orally disintegrating, 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.
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
54 products list this as an active ingredient in the United States drug directory. 54 of them contain it and nothing else.
FDA National Drug Code directory · 72205-239 · read 2026-08-29
They are sold as capsule, powder, tablet and tablet, orally disintegrating, taken oral.
FDA National Drug Code directory · 72205-239 · read 2026-08-29
The regulator's established pharmacologic class for it is bcr-abl tyrosine kinase inhibitors [moa], cytochrome p450 2b6 inducers [moa] and cytochrome p450 2c8 inducers [moa].
FDA National Drug Code directory · 72205-239 · read 2026-08-29
11 published labels name it as an active ingredient. 11 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · read 2026-08-29
nilotinib is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 50 mg light yellow opaque colour body and red opaque colour cap imprinted with “MN5” with black ink. 150 mg red opaque colour body and red opaque colour cap imprinted with“MN4” wit…, recorded as fda label in effect 2025-11-20 in the United States.
US prescribing information · 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 · 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 Nilotinib 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 Nilotinib 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.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
Built from stored sources by fixed rules. No reviewer has signed it off.
How many documents were read
11 documents were read for this substance.
RNAWiki source record
7 of them state the same bioavailability, and they agree.
RNAWiki source record
11 of them state the same proteinBinding, and they agree.
RNAWiki source record
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ 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, S6.
✓ 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
9 approved applications cover products containing this substance. The earliest was NDA022068, approved 20071029 to NOVARTIS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 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.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — 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 (11)
Q2
On the Nilotinib label: indicated for what?
"CAVHANZA is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that…": indications and usage on Nilotinib's label. DailyMed label · 98b197ea-bca4-427e-8737-97f70a3262bc · 2026-08-07
Q3
159 registered trials of Nilotinib — at which phases?
Registered studies posting no result
102 of 159
159 registered studies of Nilotinib: 74 phase2, 33 phase1, 28 phase3, 17 phase4, 16 na or unstated, 2 early phase1, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"This study was terminated due to limited enrollment."; 23 of 159 registered studies
Show the evidence
Trial
NCT00519090
terminated; "This study was terminated due to limited enrollment."
NCT00644878
terminated; "Slower than expected enrollment"
NCT00782834
terminated; "Stopped early for futility, unable to meet accrual goals"
NCT00905398
terminated; "The study was terminated due to excessive toxicity and low compliance to the protocol scheme."
NCT01089595
terminated; "Novartis is ending their research program for Nilotinib in GIST."
NCT01179737
terminated; "Study was terminated due to serious adverse event (SAE)"
14 further recorded trials
NCT01201538
terminated; "Study PI passed away We had trouble recruiting for the drug arm"
NCT01270893
withdrawn; "No particapnt recruitment."
NCT01670084
withdrawn; "No Accrual"
NCT01751425
terminated; "Per PI Request. 2) No additional benefit was noted with the addition of Ruxolitinib."
NCT01866553
terminated; "insufficient enrollment"
NCT02086487
terminated; "Because of many unseen obstacles resulted in poor accrual, study is terminated."
NCT02108951
terminated; "Study was terminated because of slow recruitment"
NCT02115386
terminated; "Study was terminated by Novartis"
NCT02174445
terminated; "very slow recruitment rate and a lot of pat. didn't fulfil BCR-ABL requirements"
NCT02225574
terminated; "Slow Accrual - Only 1 patient enrolled in Phase 1 - Study never went to Phase II"
NCT02627677
terminated; "The study was stopped due to operational feasibility and not due to any safety concerns"
NCT02709083
terminated; "Original principal investigator left institution"
NCT02774512
withdrawn; "none participant has been enrolled and recruited during the first year after competent autority autorisation."
NCT02973711
withdrawn; "lack of funding"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Nilotinib used Nilotinib 300mg BID — over how long?
studies of Nilotinib used the recorded amount. ClinicalTrials.gov · 2026-09-01
13 recorded entries; human; oral; also "Nilotinib 300mg BID", "Nilotinib (400 mg BID)", "Nilotinib 300 mg."
Show the evidence
human
NCT01856283
Nilotinib 300mg BID
NCT02029001
Nilotinib (400 mg BID)
NCT02086487
Nilotinib 300 mg.
NCT02086487
Tasigna 300 mg
NCT02627677
Nilotinib 400 mg BID
NCT03079505
oral; Nilotinib 150mg oral capsule [Tasigna]
7 more recorded rows
humanNCT03764215
Nilotinib 150 MG
humanNCT03906292
Nilotinib 300 mg
humanNCT03906292
Nilotinib 300 mg BID and asciminib 20 mg BID or 40 mg QD
humanNCT04903119
Nilotinib 100mg
humanNCT04903119
Nilotinib 200mg
humanNCT04903119
Nilotinib 300mg
humanNCT04903119
Nilotinib 400mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Nilotinib's half-life is 13.6 h — which schedules were studied?
13.6 h, the half-life Nilotinib's label states: "Elimination The geometric mean (coefficient of variation) apparent first-order terminal elimination half-life was 13.6 h (36.4%) for a single 160 mg dose of CAVHANZA." DailyMed label · 98b197ea-bca4-427e-8737-97f70a3262bc · 2026-08-07
tmax 2 hours.
Show the evidence
half lifepharmacokinetics
13.6 h; Elimination The geometric mean (coefficient of variation) apparent first-order terminal elimination half-life was 13.6 h (36.4%) for a single 160 mg dose of CAVHANZA.
tmaxpharmacokinetics
2 hours; The median time (range) to reach maximal plasma concentration (T max ) of nilotinib is 2 hours (1-8 hours) in the fasted state after oral administration.
metabolismpharmacokinetics
Metabolism Nilotinib is primarily metabolized via CYP3A4-mediated oxidation and to a minor extent by CYP2C8.
recorded 2026-08-07 · last checked 2026-09-04
Q7
Which running trial of Nilotinib could settle lifespan?
NCT04626024 measures Molecular relapse (MR) free survival, reading out 2028-11-15.
2 open trials; n 17; "Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population"
Show the evidence
Trial
NCT04626024
"Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population"; n 17; "Molecular relapse (MR) free survival"; 2028-11-15
NCT07493408
"Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML"; n 45; "Morphological relapse-free survival (M-RFS)"; 2037-12-31
Q8
Which 42 trials of Nilotinib posted no result?
Posted no result
42 of 42 completed trials
Registrations
NCT00264160, NCT01126892, NCT00732888, NCT01110668, NCT00976612 and NCT00786812, and 36 more
Completion dates
oldest 2009-08; newest 2024-05-29
Show the evidence
Trial
NCT00264160
2009-08
NCT01126892
2011-04
NCT00732888
2011-09
NCT01110668
2011-09
NCT00976612
2011-12
NCT00786812
2012-01
14 further recorded trials
NCT01206088
2012-09
NCT01261429
2013-04
NCT00718562
2013-07
NCT01819389
2013-08
NCT01155817
2013-12
NCT01223898
2013-12
NCT01220648
2014-01
NCT02068898
2014-05
NCT00769327
2014-10-10
NCT01252017
2014-11
NCT01289054
2015-03
NCT01099514
2015-06
NCT00809211
2016-02
NCT01810718
2016-03
Q9
At the median, Nilotinib's trials enrolled 42 people — anything larger?
Median enrolment
42
Largest enrolment
2900
Registered trials counted
153
Q10
What do 3681 spontaneous reports say about Nilotinib — 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.
Nilotinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3681 reaction mentions were counted: rash 821; electrocardiogram qt prolonged 494; pleural effusion 394; myocardial infarction 373. FAERS via Open Targets · CHEMBL1201740 · 2026-06-24
Show the evidence
rash
821
electrocardiogram qt prolonged
494
pleural effusion
394
myocardial infarction
373
thrombocytopenia
322
platelet count decreased
284
4 more recorded rows
drug intolerance
282
pancreatitis
254
drug resistance
231
blood bilirubin increased
226
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Nilotinib's label not list?
Strong CYP3A Inhibitors: Avoid concomitant use with CAVHANZA or reduce CAVHANZA dose if concomitant use cannot be avoided.
drug_interactions
( 7.1 ) Strong CYP3A Inducers: Avoid concomitant use with CAVHANZA.
drug_interactions
( 7.1 ) 7.1 Effect of Other Drugs on CAVHANZA Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with CAVHANZA.
drug_interactions
Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )].
drug_interactions
Concomitant use with a strong CYP3A inhibitor increases nilotinib exposure [see Clinical Pharmacology ( 12.3 )], which may increase the risk of CAVHANZA adverse reactions.
drug_interactions
Strong CYP3A Inducers Avoid concomitant use of strong CYP3A inducers with CAVHANZA.
2 more recorded rows
Interaction statementdrug_interactions
Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )].
Interaction statementdrug_interactions
Concomitant use with a strong CYP3A inducer decreases nilotinib exposure [see Clinical Pharmacology ( 12.3 )] which may reduce CAVHANZA efficacy.
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.