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Ponatinib

  • 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 Ponatinib does in the body

ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy.

Ponatinib inhibited the in vitro tyrosine kinase activity of ABL and T315I mutant ABL with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. Ponatinib inhibited the in vitro activity of additional kinases with IC 50 concentrations between 0.1 nM and 20 nM, including members of the VEGFR, PDGFR, FGFR, EPH receptors and SRC families of kinases, and KIT, RET, TIE2, and FLT3. Ponatinib inhibited the in vitro viability of cells expressing native or mutant BCR::ABL, including T315I. In mice, treatment with ponatinib reduced the size of tumors expressing native or T315I mutant BCR::ABL when compared to controls.

Why people take it. ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy.

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 · 4340891KFS · read 2026-08-29

  • Its recorded molecular formula is C29H28ClF3N6O.

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · 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 165 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.

Overall survival

The study did not show it

Who was studied
NCT06860269
How many people
1200
Study design
Phase 2/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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Percentage of CP-CML Participants With Major Cytogenetic Response (MCyR)

The study did not show it

Who was studied
NCT01207440
How many people
449
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

OVERALL RESPONSE RATE (ORR)

The study did not show it

Who was studied
NCT04591431
How many people
400
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Overall survival (OS)

The study did not show it

Who was studied
NCT04530565
How many people
348
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Major Molecular Response (MMR) Rate at 12 Months

The study did not show it

Who was studied
NCT01650805
How many people
307
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Percentage of Participants With Molecular Response (MR2: <=1% Breakpoint Cluster Region-Abelson Transcript Level) as Measured by the International Scale (BCR-ABL1IS) at Month 12

The study did not show it

Who was studied
NCT02467270
How many people
283
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.

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot
  • Europe PMC · 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

No description of who was studied is recorded.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of ICLUSIG have not been established in pediatric patients.”

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · read 2026-08-30

  • On older people, the label states: “Of the 163 patients with Ph+ALL who received ICLUSIG in PhALLCON, 21% were 65 years and older and 7% were 75 years and older.”

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · read 2026-08-30

  • On people who are pregnant, the label states: “Data Animal Data Ponatinib was studied for effects on embryo-fetal development in pregnant rats given oral doses of 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day during organogenesis (25 rats per group).”

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of ponatinib in human milk, the effects on the breastfed child, or on milk production.”

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · read 2026-08-30

  • On people with reduced liver function, the label states: “Patients with hepatic impairment are more likely to experience adverse reactions compared to patients with normal hepatic function.”

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · 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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • 9 products list this as an active ingredient in the United States drug directory. 9 of them contain it and nothing else.

    FDA National Drug Code directory · 63020-533 · read 2026-08-29

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

    FDA National Drug Code directory · 63020-533 · read 2026-08-29

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

    FDA National Drug Code directory · 63020-533 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · read 2026-08-29

  • Iclusig is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets, film-coated: 10 mg of ponatinib: Oval, white to off-white, biconvex, debossed "NZ" on one side and plain on the other side 15 mg of ponatinib: Round, white, biconvex, debossed "A5"…, recorded as fda label in effect 2026-08-14 in the United States.

    US prescribing information · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · 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 Ponatinib 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 Ponatinib 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.

Where else this substance is registered

FDA substance identifier (UNII)
4340891KFS
CAS registry number
943319-70-8
PubChem compound
24826799
ChEMBL
CHEMBL1171837
ChEBI
78543
WHO international nonproprietary name list entry
9362
RxNorm concept
1364347
EMA substance identifier
100000141503
DrugBank
DB08901

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 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

  • 2 approved applications cover products containing this substance. The earliest was NDA203469, approved 20121214 to TAKEDA PHARMS USA.

    Drugs@FDA application register · NDA203469 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA203469 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20121214.

    FDA National Drug Code directory · 63020-533 · 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 Ponatinib label: indicated for what?

"ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission…": indications and usage on Ponatinib's label. DailyMed label · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · 2026-08-14

66 registered trials of Ponatinib — at which phases?

Registered studies posting no result
46 of 66

66 registered studies of Ponatinib: 48 phase2, 10 na or unstated, 10 phase1, 5 phase3, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

60 with a PubMed record

Show the evidence
  • phase2
    48
  • na or unstated
    10
  • phase1
    10
  • phase3
    5
  • na
    1
  • completed
    19
8 more recorded rows
  • terminated
    14
  • recruiting
    10
  • active not recruiting
    8
  • unknown
    8
  • withdrawn
    4
  • approved for marketing
    1
  • no longer available
    1
  • not yet recruiting
    1

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

17 of Ponatinib's trials stopped: safety, accrual/recruitment, other?

safety (4), accrual/recruitment (7) and other (6): Ponatinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Closed due to slow accrual"; 17 of 66 registered studies

Show the evidence

Trial

  • NCT01570868
    terminated; "Closed due to slow accrual"
  • NCT01620216
    terminated; "Unable to recruit enough eligible subjects"
  • NCT01650805
    terminated; "Study terminated based on evaluation of safety data."
  • NCT01761747
    terminated; "FDA hold and toxicity associated with study drug"
  • NCT01838642
    terminated; "Recruiting halted prematurely and will not resume. New study to open soon."
  • NCT01888562
    withdrawn; "Could not obtain an IDE on the FGFR2 assay"
11 further recorded trials
  • NCT02398825
    terminated; "low enrollment rate"
  • NCT02448095
    terminated; "lack of interest"
  • NCT02627677
    terminated; "The study was stopped due to operational feasibility and not due to any safety concerns"
  • NCT03576547
    terminated; "The study was terminated early due to slow accrual and low level of interest both by the sponsor and by the department"
  • NCT03807479
    terminated; "less recruting"
  • NCT03838692
    withdrawn; "Closed by sponsor"
  • NCT03878524
    terminated; "Low accrual"
  • NCT04501614
    terminated; "Phase 1 enrollment was terminated due to dose-limiting toxicities, thus the study was terminated by Sponsor."
  • NCT04554459
    terminated; "slower recruitment rate;"
  • NCT04845035
    withdrawn; "The PI plans to revise the study design in a new protocol"
  • NCT05268003
    terminated; "\< 75% participation"

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

Human studies of Ponatinib used Ponatinib 30 mg QD — over how long?

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

7 recorded entries; human; also "Ponatinib 30 mg QD", "Ponatinib 15 mg QD", "Ponatinib 30 MG"

Show the evidence

human

  • NCT02627677
    Ponatinib 30 mg QD
  • NCT02627677
    Ponatinib 15 mg QD
  • NCT03171389
    Ponatinib 30 MG
  • NCT03704688
    Ponatinib 15 MG
  • NCT04554459
    Ponatinib 15 MG Oral Tablet
  • NCT04709731
    Ponatinib 15mg QD
1 more recorded row
  • human NCT04709731
    Ponatinib 30mg QD

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

Ponatinib's half-life is 28 days — which schedules were studied?

28 days, the half-life Ponatinib's label states: "Elimination The mean (range) terminal elimination half-life of ponatinib was approximately 24 (12 to 66) hours following ICLUSIG 45 mg orally once daily for 28 days in patients with cancer." DailyMed label · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · 2026-08-14

tmax 6 hours.

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  • half life pharmacokinetics
    28 days; Elimination The mean (range) terminal elimination half-life of ponatinib was approximately 24 (12 to 66) hours following ICLUSIG 45 mg orally once daily for 28 days in patients with cancer.
  • tmax pharmacokinetics
    6 hours; Peak concentrations of ponatinib are observed within 6 hours after ICLUSIG oral administration.
  • metabolism pharmacokinetics
    Metabolism At least 64% of a dose undergoes Phase I and Phase II metabolism.

recorded 2026-08-14 · last checked 2026-09-04

Which running trial of Ponatinib could settle lifespan?

NCT03739814 measures Event-free survival, reading out 2027-02-01.

4 open trials; n 84; "Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia"

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Trial

  • NCT03739814
    "Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia"; n 84; "Event-free survival"; 2027-02-01
  • NCT01424982
    "Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia"; n 88; "Event-free survival"; 2027-10-31
  • NCT04530565
    "Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults"; n 348; "Overall survival (OS)"; 2028-07-01
  • NCT06175702
    "Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL"; n 150; "Overall survival"; 2030-12-25

Which 4 trials of Ponatinib posted no result?

Posted no result
4 of 4 completed trials
Registrations
NCT02981784, NCT00660920, NCT02779283 and NCT01641107
Completion dates
oldest 2015-12; newest 2021-09-30
Show the evidence

Trial

  • NCT02981784
    2015-12
  • NCT00660920
    2016-05
  • NCT02779283
    2018-09-20
  • NCT01641107
    2021-09-30

At the median, Ponatinib's trials enrolled 36.5 people — anything larger?

Median enrolment
36.5
Largest enrolment
1484
Registered trials counted
64

What do 1114 spontaneous reports say about Ponatinib — 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.

Ponatinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1114 reaction mentions were counted: rash 164; hypertension 143; pyrexia 139; thrombocytopenia 111. FAERS via Open Targets · CHEMBL1171837 · 2026-06-24

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  • rash
    164
  • hypertension
    143
  • pyrexia
    139
  • thrombocytopenia
    111
  • abdominal pain
    109
  • pleural effusion
    101
4 more recorded rows
  • constipation
    93
  • drug resistance
    89
  • neoplasm progression
    83
  • acute lymphocytic leukaemia recurrent
    82

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

Which 10 reactions does Ponatinib's label not list?

abdominal pain, acute lymphocytic leukaemia recurrent and constipation and 7 more reported for Ponatinib, absent from its label. FAERS via Open Targets · CHEMBL1171837 · 2026-06-24

2 label terms; 10 reported and unlisted; 16d804b6-4957-43ee-b18c-3b36ec37c5ac

Show the evidence
  • abdominal pain
    count not stated
  • acute lymphocytic leukaemia recurrent
    count not stated
  • constipation
    count not stated
  • drug resistance
    count not stated
  • hypertension
    count not stated
  • neoplasm progression
    count not stated
4 more recorded rows
  • pleural effusion
    count not stated
  • pyrexia
    count not stated
  • rash
    count not stated
  • thrombocytopenia
    count not stated

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

Ponatinib and CYP3A: shared by which compounds?

CYP3A appear in Ponatinib's recorded interaction sentences, 8 in all. DailyMed label · 16d804b6-4957-43ee-b18c-3b36ec37c5ac · 2026-08-14

CYP3A, CYP3A; 2 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Strong CYP3A Inhibitors : Avoid coadministration or reduce ICLUSIG dose if coadministration cannot be avoided.
  • drug_interactions
    ( 2.3 , 7.1 ) Strong CYP3A Inducers : Avoid coadministration.
  • drug_interactions
    ( 7.1 ) 7.1 Effects of Other Drugs on ICLUSIG Strong CYP3A Inhibitors Coadministration of ICLUSIG with a strong CYP3A inhibitor increases ponatinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may increase the risk of ICLUSIG adverse reactions.
  • drug_interactions
    Avoid coadministration of ICLUSIG with strong CYP3A inhibitors.
  • drug_interactions
    If coadministration of ICLUSIG with strong CYP3A inhibitors cannot be avoided, reduce the ICLUSIG dosage [see Dosage and Administration (2.3) ] .
  • drug_interactions
    Strong CYP3A Inducers Coadministration of ICLUSIG with a strong CYP3A inducer decreases ponatinib plasma concentrations [see Clinical Pharmacology (12.3) ] .
2 more recorded rows
  • Interaction statement drug_interactions
    Avoid coadministration of ICLUSIG with strong CYP3A inducers unless the benefit outweighs the risk of decreased ponatinib exposure.
  • Interaction statement drug_interactions
    Selection of concomitant medication with no or minimal CYP3A induction potential is recommended.

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

recorded 2026-08-14 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1171837
PubChem CID
24826799
CAS number
943319-70-8
RxCUI
1364347
InChIKey
PHXJVRSECIGDHY-UHFFFAOYSA-N
Development code
AP-24534, AP24534
Trade name
Iclusig
Also called
PONATINIB HYDROCHLORIDE, PONATINIB [MI], PONATINIB [USAN], PONATINIB [VANDF], Ponatinib [WHO-DD], ponatinib [INN]
Salt form
AP-24534 HCL, AP24534 HCL, Iclusig / Ponatinib Hydrochloride
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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: 3 required field(s) not terminal: 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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