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Imatinib

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Imatinib does in the body

Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase (1.1)

From the FDA-approved label: Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML. Imatinib inhibits proliferation and induces apoptosis in BCR-ABL positive cell lines as well as fresh leukemic cells from Philadelphia chromosome positive chronic myeloid leukemia. Imatinib inhibits colony formation in assays using ex vivo peripheral blood and bone marrow samples from CML patients. In vivo , imatinib inhibits tumor growth of BCR-ABL transfected murine myeloid cells as well as BCR-ABL positive leukemia lines derived from CML patients in blast crisis.

Why people take it. Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase (1.1)

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 · 8A1O1M485B · read 2026-08-29

  • Its recorded molecular formula is C29H31N7O•CH3SO3H, weighing 589.71 g/mol.

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

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 171 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 peopleRead from sources, not yet reviewed

What happened in people

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

All-cause mortality

The study did not show it

Who was studied
NCT02735707
How many people
20000
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) for the whole protocol

The study did not show it

Who was studied
NCT04307576
How many people
6430
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

16 weeks clinical response

The study did not show it

Who was studied
NCT04817956
How many people
3000
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

Randomization WHO- Mortality

The study did not show it

Who was studied
NCT04330690
How many people
2900
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

Major molecular response (MMR) rate at 12 months

The study did not show it

Who was studied
NCT05367765
How many people
2400
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

Overall Survival

The study did not show it

Who was studied
NCT00002514
How many people
1929
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 is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase (1.1) Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy (1.2) Adult…

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 imatinib mesylate have been demonstrated in pediatric patients with newly diagnosed Ph+ chronic phase CML and Ph+ALL [see Clinical Studies ( 14.2 , 14.4 )].”

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

  • On older people, the label states: “In the CML clinical studies, approximately 20% of patients were older than 65 years.”

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Imatinib mesylate can cause fetal harm when administered to a pregnant woman based on human and animal data.”

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Imatinib and its active metabolite are excreted into human milk.”

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

  • On people with reduced liver function, the label states: “The effect of hepatic impairment on the pharmacokinetics of both imatinib and its major metabolite, CGP74588, was assessed in 84 patients with cancer with varying degrees of hepatic impairment at imatinib doses ranging from 100 mg to 800 mg.”

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

  • On people with reduced kidney function, the label states: “The effect of renal impairment on the pharmacokinetics of imatinib was assessed in 59 patients with cancer and varying degrees of renal impairment at single and steady state imatinib doses ranging from 100 to 800 mg/day.”

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · 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 takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied 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 takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

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 tablet, capsule, solution, 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 takeNothing 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 unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral

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

  • 70 products list this as an active ingredient in the United States drug directory. 70 of them contain it and nothing else.

    FDA National Drug Code directory · 65344-0020 · read 2026-08-29

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

    FDA National Drug Code directory · 65344-0020 · read 2026-08-29

  • The regulator's established pharmacologic class for it is bcr-abl tyrosine kinase inhibitors [moa], cytochrome p450 2d6 inhibitors [moa] and cytochrome p450 3a4 inhibitors [moa].

    FDA National Drug Code directory · 65344-0020 · read 2026-08-29

  • 25 published labels name it as an active ingredient. 25 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-29

  • Imatinib is oral at 3 DOSAGE FORMS AND STRENGTHS 100 mg film-coated tablets Yellow to brownish orange, round film coated tablets debossed with “1” on one side and score line on the other side. 400 mg film-coated tablets Yellow to brownish…, recorded as fda label in effect 2025-04-20 in the United States.

    US prescribing information · 559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 · read 2026-08-30

  • Recorded price in US: 0.61141–2.87642 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 30 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

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 Imatinib studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

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 Imatinib are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 25 documents were read for this substance.

    RNAWiki source record

  • 25 of them state the same bioavailability, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
8A1O1M485B
RxNorm concept
403878

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.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 19 approved applications cover products containing this substance. The earliest was NDA021335, approved 20010510 to NOVARTIS.

    Drugs@FDA application register · NDA021335 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA021335 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20010515.

    FDA National Drug Code directory · 65344-0020 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

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)

On the Imatinib label: indicated for what?


"Imatinib mesylate is a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase ( 1.1 ) • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis…": indications and usage on Imatinib's label. DailyMed label · 7c037022-7fc8-4b6e-9db3-427206c572b4 · 2026-08-04

469 registered trials of Imatinib — at which phases?


Registered studies posting no result
336 of 469

469 registered studies of Imatinib: 291 phase2, 106 phase1, 76 phase3, 21 na or unstated, 18 phase4, 6 na, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1126 with a PubMed record

Show the evidence
  • phase2
    291
  • phase1
    106
  • phase3
    76
  • na or unstated
    21
  • phase4
    18
  • na
    6
11 more recorded rows
  • early phase1
    3
  • completed
    279
  • terminated
    75
  • unknown
    51
  • recruiting
    27
  • active not recruiting
    18
  • withdrawn
    10
  • not yet recruiting
    6
  • enrolling by invitation
    1
  • no longer available
    1
  • suspended
    1

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

72 of Imatinib's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (4), futility/efficacy (2), accrual/recruitment (38), funding/business (2), sponsor decision unspecified (5) and other (21): Imatinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Poor accrual"; 72 of 469 registered studies

Show the evidence

Trial

  • NCT00021229
    terminated; "Poor accrual"
  • NCT00038649
    terminated; "Sponsor discontinued providing study drug."
  • NCT00042952
    terminated; "Administratively complete."
  • NCT00114959
    terminated; "Poor enrollment"
  • NCT00115739
    terminated; "Study was closed early due to slow accrual"
  • NCT00124748
    terminated; "This study was prematurely discontinued because no improvement was observed in the 800mg dose compared to 400mg dose"
14 further recorded trials
  • NCT00159016
    withdrawn; "the PI is no longer work at Hadassah"
  • NCT00230334
    terminated; "terminated by PI due to insufficient accrual"
  • NCT00245128
    terminated; "Per PI, results from another similar study were published prior to study analysis. Negative study results were published therefore analysis was not completed"
  • NCT00281996
    terminated; "Closed to accrual to allow enrollment on another more promising trial."
  • NCT00290771
    terminated; "Lack of efficacy"
  • NCT00320190
    terminated; "Terminated due to slow participant accrual"
  • NCT00323063
    terminated; "Slow accrual"
  • NCT00323362
    terminated; "Toxicity"
  • NCT00323791
    terminated; "slow accrual"
  • NCT00324987
    terminated; "The trial failed to accrue"
  • NCT00354523
    terminated; "Study closed following Phase I portion, insufficient activity to continue to Phase II."
  • NCT00362466
    terminated; "Insufficient Enrollment"
  • NCT00372567
    terminated; "See termination reason in detailed description."
  • NCT00402662
    terminated; "unexpected level of toxicity"

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

Human studies of Imatinib used STI571 400 mg — over how long?


studies of Imatinib used the recorded amount. ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; tablet; also "STI571 400 mg", "STI571 600 mg", "Imatinib mesylate 400 mg"

Show the evidence

human

  • NCT00171249
    STI571 400 mg
  • NCT00171249
    STI571 600 mg
  • NCT00219739
    Imatinib mesylate 400 mg
  • NCT00219739
    Imatinib mesylate 600 mg
  • NCT00219739
    Imatinib 400 mg + Peg-Interferon
  • NCT00219739
    Imatinib mesylate 400 mg + Cytarabine
14 more recorded rows
  • human NCT00514488
    STI571 (400 mg/day; or 800 mg/day)
  • human NCT00845221
    Imatinib mesylate 100 mg (Glivec)
  • human NCT01270984
    tablet; Glivec 100mg film coated tablet
  • human NCT01275222
    Imatinib 600mg/day (Glevec is the brand name for imatinib)
  • human NCT01275222
    Imatinib 800mg/day (Glevec is the brand name for imatinib)
  • human NCT01504984
    Imatinib 400mg
  • human NCT01504984
    Glivec film coated tab 4T(400mg)
  • human NCT01504984
    Imatinib 100mg
  • human NCT01827930
    Imatinib Mesylate 600 MG Oral Tablet
  • human NCT01827930
    Imatinib Mesylate 400 MG Oral Tablet
  • human NCT02103322
    Imatinib Mesylate Tablets, 400 mg
  • human NCT03131999
    Imatinib Mesylate 400Mg Capsule
  • human NCT03862768
    Imatinib 400 MG
  • human NCT03906292
    Imatinib 400 mg QD and asciminib 60 mg QD

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

Imatinib's half-life is 40 hours — which schedules were studied?


40 hours, the half-life Imatinib's label states: "Following oral administration in healthy volunteers, the elimination half-lives of imatinib and its major active metabolite, the N-demethyl derivative (CGP74588), are approximately 18 and 40 hours, respectively." DailyMed label · 7c037022-7fc8-4b6e-9db3-427206c572b4 · 2026-08-04

bioavailability 98 %.

Show the evidence
  • half life pharmacokinetics
    40 hours; Following oral administration in healthy volunteers, the elimination half-lives of imatinib and its major active metabolite, the N-demethyl derivative (CGP74588), are approximately 18 and 40 hours, respectively.
  • bioavailability pharmacokinetics
    98 %; Mean absolute bioavailability is 98%.
  • metabolism pharmacokinetics
    Elimination Metabolism CYP3A4 is the major enzyme responsible for metabolism of imatinib.

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

Which running trial of Imatinib could settle lifespan?


NCT03007147 measures Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients), reading out 2027-08-14.

12 open trials; n 352; "Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia"

Show the evidence

Trial

  • NCT03007147
    "Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia"; n 352; "Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)"; 2027-08-14
  • NCT05152472
    "A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments"; n 110; "Progression-Free Survival (PFS)"; 2027-10
  • NCT02735707
    "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02
  • 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
  • NCT04933669
    "Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors"; n 122; "Progression free survival(PFS)"; 2029-12-31
  • NCT06336395
    "Ma-Spore ALL 2020 Study"; n 500; "Overall survival (OS)"; 2030-03
6 further recorded trials
  • NCT06124157
    "A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)"; n 222; "Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)"; 2030-12-01
  • NCT06175702
    "Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL"; n 150; "Overall survival"; 2030-12-25
  • NCT07585266
    "A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)"; n 800; "Progression-Free Survival (PFS) as assessed by Blinded independent central review (BICR)"; 2032-09-28
  • NCT02413736
    "Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST"; n 255; "Recurrence-free survival"; 2033-06
  • NCT04307576
    "A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia"; n 6430; "Event-free survival (EFS) for the whole protocol"; 2033-06
  • 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

Which 148 trials of Imatinib posted no result?


Posted no result
148 of 148 completed trials
Registrations
NCT00006475, NCT00006053, NCT00015860, NCT00045422, NCT00027586 and NCT00045669, and 142 more
Completion dates
oldest 2002-12; newest 2024-05-29
Show the evidence

Trial

  • NCT00006475
    2002-12
  • NCT00006053
    2003-03
  • NCT00015860
    2003-10
  • NCT00045422
    2003-10
  • NCT00027586
    2005-01
  • NCT00045669
    2005-01
14 further recorded trials
  • NCT00081133
    2005-02
  • NCT00053248
    2005-06
  • NCT00154336
    2005-08
  • NCT00004932
    2005-09
  • NCT00038194
    2005-09
  • NCT00066326
    2005-09
  • NCT00030667
    2005-12
  • NCT00156286
    2006-04
  • NCT00047502
    2006-04-10
  • NCT00110058
    2006-07
  • NCT00093639
    2006-08
  • NCT00010049
    2006-08-15
  • NCT00422825
    2006-09
  • NCT00088231
    2006-10

At the median, Imatinib's trials enrolled 42 people — anything larger?


Median enrolment
42
Largest enrolment
20000
Registered trials counted
449

What do 4998 spontaneous reports say about Imatinib — 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.

Imatinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4998 reaction mentions were counted: drug resistance 657; malignant neoplasm progression 653; drug intolerance 574; pleural effusion 556. FAERS via Open Targets · CHEMBL1642 · 2026-06-24

Show the evidence
  • drug resistance
    657
  • malignant neoplasm progression
    653
  • drug intolerance
    574
  • pleural effusion
    556
  • muscle spasms
    521
  • second primary malignancy
    510
4 more recorded rows
  • oedema peripheral
    484
  • oedema
    386
  • chronic myeloid leukaemia
    337
  • pancytopenia
    320

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

Which 10 reactions does Imatinib's label not list?


chronic myeloid leukaemia, drug intolerance and drug resistance and 7 more reported for Imatinib, absent from its label. FAERS via Open Targets · CHEMBL1642 · 2026-06-24

2 label terms; 10 reported and unlisted; 7c037022-7fc8-4b6e-9db3-427206c572b4

Show the evidence
  • chronic myeloid leukaemia
    count not stated
  • drug intolerance
    count not stated
  • drug resistance
    count not stated
  • malignant neoplasm progression
    count not stated
  • muscle spasms
    count not stated
  • oedema
    count not stated
4 more recorded rows
  • oedema peripheral
    count not stated
  • pancytopenia
    count not stated
  • pleural effusion
    count not stated
  • second primary malignancy
    count not stated

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

Imatinib and CYP3A4, CYP3A and CYP2C9: shared by which compounds?


CYP3A4, CYP3A and CYP2C9 appear in Imatinib's recorded interaction sentences, 8 in all. DailyMed label · 7c037022-7fc8-4b6e-9db3-427206c572b4 · 2026-08-04

CYP2C9, CYP2D6, CYP3A, CYP3A, CYP3A4, CYP3A4; 7 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    • CYP3A4 inducers may decrease imatinib mesylate C max and area under curve (AUC).
  • drug_interactions
    ( 2.12 , 7.1 , 12.3 ) • CYP3A4 inhibitors may increase imatinib mesylate C max and AUC.
  • drug_interactions
    ( 7.2 , 12.3 ) • Imatinib mesylate is an inhibitor of CYP3A4 and CYP2D6 which may increase the C max and AUC of other drugs.
  • drug_interactions
    ( 7.5 ) 7.1 Agents Inducing CYP3A Metabolism Concomitant administration of imatinib mesylate tablets and strong CYP3A4 inducers may reduce total exposure of imatinib; consider alternative agents [see Clinical Pharmacology ( 12.3 )] .
  • drug_interactions
    7.2 Agents Inhibiting CYP3A Metabolism Concomitant administration of imatinib mesylate tablets and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase.
  • drug_interactions
    7.3 Interactions With Drugs Metabolized by CYP3A4 Imatinib mesylate will increase plasma concentration of CYP3A4 metabolized drugs (e.g., triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, etc.).
2 more recorded rows
  • Interaction statement drug_interactions
    Use caution when administering imatinib mesylate tablets with CYP3A4 substrates that have a narrow therapeutic window.
  • Interaction statement drug_interactions
    Because warfarin is metabolized by CYP2C9 and CYP3A4, use low-molecular weight or standard heparin instead of warfarin in patients who require anticoagulation [see Clinical Pharmacology ( 12.3 )] .
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1642
PubChem CID
123596
CAS number
220127-57-1
RxCUI
284924
InChIKey
KTUFNOKKBVMGRW-UHFFFAOYSA-N
Also called
IMATINIB MESYLATE, Imatinib accord, Imatinib medac, Imatinib mesilate, Imatinib methane sulfonate, Imatinib methanesulfonate, Qti571, csti571, im, CGP057148B, CGP-57148B, Glamox
Trade name
Gleevec, Glivec, Imatinib actavis, Imatinib koanaa, Imatinib teva, Imatinib teva b.v., Imkeldi
Development code
NSC-716051, QTI-571, STI 571, STI571
Salt form
Imatinib Mesylate 400 Mg, IMATINIB ORAL, Gleevec / Imkeldi / Imatinib Mesylate 400 Mg
Sources (6)

Sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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

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