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Bosutinib

  • 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 Bosutinib does in the body

Chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy

From the FDA-approved label: Bosutinib is a TKI. Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL kinase expressed in murine myeloid cell lines. Bosutinib did not inhibit the T315I and V299L mutant cells.

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

  • Its recorded molecular formula is C26H29Cl2N5O3·2H2O, weighing 566.48.

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 83 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.

Objective response rate defined as the number of patients with complete response or partial response

The study did not show it

Who was studied
NCT03297606
How many people
720
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

Number of Participants With Dose Limiting Toxicity (DLT)

The study did not show it

Who was studied
NCT00261846
How many people
571
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 Participants With Major Molecular Response (MMR) at Month 12

The study did not show it

Who was studied
NCT02130557
How many people
536
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 Complete Cytogenetic Response (CCyR) at Year 1

The study did not show it

Who was studied
NCT00574873
How many people
502
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 Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI

The study did not show it

Who was studied
NCT04971226
How many people
405
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

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

The study did not show it

Who was studied
NCT04877522
How many people
347
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
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.

  • Bosutinib tablets are indicated for the treatment of: Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1, 14.2 )]. Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2 )].

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 bosutinib in pediatric patients younger than 1 year of age with newly diagnosed CP Ph+ CML, pediatric patients younger than 1 year of age with CP Ph+ CML that is resistant or intolerant to prior therapy, and pediatric patients with AP Ph+ CML or BP Ph+ CML have not been established.”

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-30

  • On older people, the label states: “In the single-arm study in patients with CML who were resistant or intolerant to prior therapy of bosutinib in patients with Ph+ CML, 20% were age 65 and over, 4% were 75 and over.”

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-30

  • On people who are pregnant, the label states: “R isk Summary Based on findings from animal studies and its mechanism of action, bosutinib can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ].”

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Based on findings from animal studies, bosutinib can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ].”

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-30

  • On people with reduced liver function, the label states: “Reduce the bosutinib dosage in patients with hepatic impairment (Child-Pugh A, B, or C) [see Dosage and Administration (2.3, 2.5) and Clinical Pharmacology (12.3) ].”

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Reduce the bosutinib starting dose in patients with moderate (creatinine clearance [CL cr ] 30 to 50 mL/min, estimated by Cockcroft-Gault (C-G)) and severe (CL cr less than 30 mL/min, C-G) renal impairment at baseline.”

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · 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, tablet, film coated, given by the oral, film coated 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

  • 16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.

    FDA National Drug Code directory · 0069-0504 · read 2026-08-29

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

    FDA National Drug Code directory · 0069-0504 · read 2026-08-29

  • The regulator's established pharmacologic class for it is bcr-abl tyrosine kinase inhibitors [moa] and kinase inhibitor [epc].

    FDA National Drug Code directory · 0069-0504 · read 2026-08-29

  • 5 published labels name it as an active ingredient. 5 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · read 2026-08-29

  • Bosutinib is oral at 3 DOSAGE FORMS AND STRENGTHS 400 mg: orange, oval, biconvex, film-coated tablets debossed with ''400'' on one side and “B” on other side., recorded as fda label in effect 2026-05-25 in the United States.

    US prescribing information · cb7a8d1d-07c0-462d-960f-214d44705e76 · 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 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 Bosutinib 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 Bosutinib 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.

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

  • 5 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 2 of them state the same tMax, and they agree.

    RNAWiki source record

  • 5 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: 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 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

  • 5 approved applications cover products containing this substance. The earliest was NDA203341, approved 20120904 to PF PRISM CV.

    Drugs@FDA application register · NDA203341 · read 2026-08-29

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

    Drugs@FDA application register · NDA203341 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20120904.

    FDA National Drug Code directory · 0069-0504 · 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 (10)

On the Bosutinib label: indicated for what?


"BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients…": indications and usage on Bosutinib's label. DailyMed label · d5929f91-6496-4c0e-97e8-0bd524e15763 · 2026-05-28

66 registered trials of Bosutinib — at which phases?


Registered studies posting no result
39 of 66

66 registered studies of Bosutinib: 32 phase1, 26 phase2, 6 na or unstated, 5 phase3, 2 phase4, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

70 with a PubMed record

Show the evidence
  • phase1
    32
  • phase2
    26
  • na or unstated
    6
  • phase3
    5
  • phase4
    2
  • na
    1
6 more recorded rows
  • completed
    46
  • terminated
    8
  • active not recruiting
    4
  • recruiting
    4
  • unknown
    3
  • withdrawn
    1

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

7 of Bosutinib's trials stopped: safety, accrual/recruitment, other?


safety (1), accrual/recruitment (1) and other (5): Bosutinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"See termination reason in detailed description."; 7 of 66 registered studies

Show the evidence

Trial

  • NCT00793546
    terminated; "See termination reason in detailed description."
  • NCT00880009
    terminated; "See termination reason in detailed description."
  • NCT02782403
    terminated; "Terminated per PI's request at the time of CR. Study was closed due to low/slow accrual due to other competing studies."
  • NCT02906696
    terminated; "Terminated per PI's request due to competing priorities."
  • NCT04006847
    terminated; "Product complaint"
  • NCT04655391
    withdrawn; "Drug availability"
  • 1 further recorded trial NCT04793399
    terminated; "The study has been prematurely terminated due to the onset of 2 dose limiting toxicities in 2 patients."

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

Human studies of Bosutinib used Bosutinib 400 MG Monotherapy — over how long?


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

2 recorded entries; human; also "Bosutinib 400 MG Monotherapy", "Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection"

Show the evidence

human

  • NCT04793399
    Bosutinib 400 MG Monotherapy
  • NCT04793399
    Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection

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

Which running trial of Bosutinib could settle lifespan?


NCT04626024 measures Molecular relapse (MR) free survival, reading out 2028-11-15.

1 open trial; 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

Which 26 trials of Bosutinib posted no result?


Posted no result
26 of 26 completed trials
Registrations
NCT00434486, NCT00406406, NCT00499538, NCT00725426, NCT00777530 and NCT00721474, and 20 more
Completion dates
oldest 2007-03; newest 2024-07-31
Show the evidence

Trial

  • NCT00434486
    2007-03
  • NCT00406406
    2007-08
  • NCT00499538
    2007-09
  • NCT00725426
    2008-08
  • NCT00777530
    2008-08
  • NCT00721474
    2008-09
14 further recorded trials
  • NCT00757341
    2008-12
  • NCT01001936
    2008-12
  • NCT00759837
    2009-05
  • NCT00914121
    2009-08
  • NCT00934674
    2009-08
  • NCT00952913
    2009-10
  • NCT01080365
    2010-03
  • NCT01374139
    2011-10
  • NCT01233882
    2012-06
  • NCT02102633
    2014-06
  • NCT02192294
    2014-10
  • NCT02445742
    2019-06-27
  • NCT05363488
    2019-11-01
  • NCT02638467
    2020-02

At the median, Bosutinib's trials enrolled 45 people — anything larger?


Median enrolment
45
Largest enrolment
1484
Registered trials counted
65

What do 2621 spontaneous reports say about Bosutinib — 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.

Bosutinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2621 reaction mentions were counted: diarrhoea 862; nausea 397; fatigue 260; rash 236. FAERS via Open Targets · CHEMBL2095206 · 2026-06-24

Show the evidence
  • diarrhoea
    862
  • nausea
    397
  • fatigue
    260
  • rash
    236
  • vomiting
    213
  • pleural effusion
    183
4 more recorded rows
  • drug intolerance
    155
  • abdominal pain
    129
  • neoplasm progression
    116
  • drug resistance
    70

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

Which 10 reactions does Bosutinib's label not list?


abdominal pain, diarrhoea and drug intolerance and 7 more reported for Bosutinib, absent from its label. FAERS via Open Targets · CHEMBL2095206 · 2026-06-24

2 label terms; 10 reported and unlisted; d5929f91-6496-4c0e-97e8-0bd524e15763

Show the evidence
  • abdominal pain
    count not stated
  • diarrhoea
    count not stated
  • drug intolerance
    count not stated
  • drug resistance
    count not stated
  • fatigue
    count not stated
  • nausea
    count not stated
4 more recorded rows
  • neoplasm progression
    count not stated
  • pleural effusion
    count not stated
  • rash
    count not stated
  • vomiting
    count not stated

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

Bosutinib and CYP3A: shared by which compounds?


CYP3A appear in Bosutinib's recorded interaction sentences, 8 in all. DailyMed label · d5929f91-6496-4c0e-97e8-0bd524e15763 · 2026-05-28

CYP3A, CYP3A, CYP3A; 3 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    • Strong and Moderate CYP3A Inhibitors: Avoid concomitant use with BOSULIF.
  • drug_interactions
    ( 7.1 ) • Strong CYP3A Inducers: Avoid concomitant use with BOSULIF.
  • drug_interactions
    ( 7.1 ) 7.1 Effect of Other Drugs on BOSULIF Strong or Moderate CYP3A Inhibitors Avoid the concomitant use of strong or moderate CYP3A inhibitors with BOSULIF.
  • drug_interactions
    Bosutinib is a CYP3A substrate.
  • drug_interactions
    Concomitant use with a strong or moderate CYP3A inhibitor increases bosutinib C max and AUC [see Clinical Pharmacology (12.3) ] which may increase the risk of toxicities.
  • drug_interactions
    Strong CYP3A Inducers Avoid the concomitant use of strong CYP3A inducers with BOSULIF.
2 more recorded rows
  • Interaction statement drug_interactions
    Bosutinib is a CYP3A substrate.
  • Interaction statement drug_interactions
    Concomitant use with a strong CYP3A inducer decreases bosutinib C max and AUC [see Clinical Pharmacology (12.3) ] which may reduce BOSULIF efficacy.

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

recorded 2026-05-28 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2095206
PubChem CID
11990828
CAS number
918639-08-4
RxCUI
1314319
InChIKey
UBPYILGKFZZVDX-UHFFFAOYSA-N
Also called
BOSUTINIB MONOHYDRATE, BOSUTINIB (AS MONOHYDRATE) [EMA EPAR], BOSUTINIB HYDRATE [JAN], BOSUTINIB MONOHYDRATE [ORANGE BOOK], Bosutinib monohydrate [WHO-DD]
Trade name
Bosulif
Salt form
Bosutinib hydrate, SKI-606 MONOHYDRATE
Development code
SK-606, SKI-606
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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