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Gilteritinib

  • 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 Gilteritinib does in the body

Adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test

From the FDA-approved label: Gilteritinib is a small molecule that inhibits multiple receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). Gilteritinib demonstrated the ability to inhibit FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, tyrosine kinase domain mutations (TKD) FLT3-D835Y and FLT3-ITD-D835Y, and it induced apoptosis in leukemic cells expressing FLT3-ITD.

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 · 5RZZ0Z1GJT · read 2026-08-29

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. 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 90 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.

Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment

The study did not show it

Who was studied
NCT03013998
How many people
3000
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

The study did not show it

Who was studied
NCT05564390
How many people
2000
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

Event-free survival (EFS)

The study did not show it

Who was studied
NCT04293562
How many people
1186
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

Overal survival (OS)

The study did not show it

Who was studied
NCT04027309
How many people
777
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

Number of patients with adverse events and serious adverse events in Phase 1

The study did not show it

Who was studied
NCT04988555
How many people
606
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Measurable residual disease recurrence-free survival (MRD-RFS)

The study did not show it

Who was studied
NCT07463651
How many people
594
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.

  • XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

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 in pediatric patients have not been established.”

    US prescribing information · b5ff59aa-9c0d-49a8-9053-1f179b482383 · read 2026-08-30

  • On older people, the label states: “Of the 319 patients in clinical studies of XOSPATA, 43% were age 65 years or older, and 13% were 75 years or older.”

    US prescribing information · b5ff59aa-9c0d-49a8-9053-1f179b482383 · read 2026-08-30

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

    US prescribing information · b5ff59aa-9c0d-49a8-9053-1f179b482383 · read 2026-08-30

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

    US prescribing information · b5ff59aa-9c0d-49a8-9053-1f179b482383 · 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, S6.

No source is stored against this line.

What is in the pack

Sold as tablet, 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

  • 3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.

    FDA National Drug Code directory · 54893-0120 · read 2026-08-29

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

    FDA National Drug Code directory · 54893-0120 · 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 · b5ff59aa-9c0d-49a8-9053-1f179b482383 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · b5ff59aa-9c0d-49a8-9053-1f179b482383 · read 2026-08-29

  • Xospata is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 40 mg as light yellow, round-shaped, film-coated tablets debossed with the Astellas logo and ‘235’ on the same side., recorded as fda label in effect 2022-01-01 in the United States.

    US prescribing information · b5ff59aa-9c0d-49a8-9053-1f179b482383 · 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 Gilteritinib 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 Gilteritinib 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)
5RZZ0Z1GJT
RxNorm concept
2105811

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, 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

  • 1 approved application covers products containing this substance. The earliest was NDA211349, approved 20181128 to ASTELLAS.

    Drugs@FDA application register · NDA211349 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA211349 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20181128.

    FDA National Drug Code directory · 54893-0120 · 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 Gilteritinib label: indicated for what?


"XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have…": indications and usage on Gilteritinib's label. DailyMed label · b5ff59aa-9c0d-49a8-9053-1f179b482383 · 2022-01-01

64 registered trials of Gilteritinib — at which phases?


Registered studies posting no result
51 of 64

64 registered studies of Gilteritinib: 33 phase1, 28 phase2, 9 phase3, 7 na or unstated, 3 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

29 with a PubMed record

Show the evidence
  • phase1
    33
  • phase2
    28
  • phase3
    9
  • na or unstated
    7
  • na
    3
  • recruiting
    24
9 more recorded rows
  • completed
    18
  • active not recruiting
    6
  • terminated
    4
  • not yet recruiting
    3
  • withdrawn
    3
  • no longer available
    2
  • unknown
    2
  • approved for marketing
    1
  • suspended
    1

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

8 of Gilteritinib's trials stopped: safety, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (1), accrual/recruitment (1), funding/business (2), sponsor decision unspecified (2) and other (2): Gilteritinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study terminated due to adverse events related to the combination therapy"; 8 of 64 registered studies

Show the evidence

Trial

  • NCT02495233
    terminated; "Study terminated due to adverse events related to the combination therapy"
  • NCT04240002
    terminated; "The study was terminated due to enrollment challenges."
  • NCT04336982
    terminated; "Business objectives have changed."
  • NCT04655391
    withdrawn; "Drug availability"
  • NCT05028751
    terminated; "Sponsor decision"
  • NCT05279859
    withdrawn; "Sponsor decision."
2 further recorded trials
  • NCT05330377
    withdrawn; "Sponsor withdrew funding"
  • NCT05955261
    suspended; "PI requests voluntary hold"

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

Human studies of Gilteritinib used Gilteritinib 40 MG Oral Tablet — over how long?


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

1 recorded entry; human; also "Gilteritinib 40 MG Oral Tablet"

Show the evidence
  • human NCT05330377
    Gilteritinib 40 MG Oral Tablet

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

Gilteritinib's half-life is 113 hours — which schedules were studied?


113 hours, the half-life Gilteritinib's label states: "Elimination The estimated half-life of gilteritinib is 113 hours, and the estimated apparent clearance is 14.85 L/h." DailyMed label · b5ff59aa-9c0d-49a8-9053-1f179b482383 · 2022-01-01

tmax 6 hours.

Show the evidence
  • half life pharmacokinetics
    113 hours; Elimination The estimated half-life of gilteritinib is 113 hours, and the estimated apparent clearance is 14.85 L/h.
  • tmax pharmacokinetics
    6 hours; Absorption The time to maximum gilteritinib concentration (t max ) observed is approximately between 4 and 6 hours post dose in the fasted state.
  • metabolism pharmacokinetics
    Metabolism Gilteritinib is primarily metabolized via CYP3A4 in vitro .

recorded 2022-01-01 · last checked 2026-09-04

Which running trial of Gilteritinib could settle lifespan?


NCT03182244 measures Overall Survival (OS), reading out 2027-03-31.

5 open trials; n 276; "A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation"

Show the evidence

Trial

  • NCT03182244
    "A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation"; n 276; "Overall Survival (OS)"; 2027-03-31
  • NCT07131059
    "MRD-positive AML Clinical Study"; n 537; "relapse-free survival rate"; 2028-10-30
  • NCT04293562
    "A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations"; n 1186; "Event-free survival (EFS)"; 2029-06-30
  • NCT07463651
    "MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib"; n 594; "Measurable residual disease recurrence-free survival (MRD-RFS)"; 2030-03-31
  • NCT04027309
    "A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy"; n 777; "Overal survival (OS)"; 2033-06

Which 7 trials of Gilteritinib posted no result?


Posted no result
7 of 7 completed trials
Registrations
NCT02571816, NCT02181660, NCT02456883, NCT03964038, NCT02236013 and NCT03625505, and 1 more
Completion dates
oldest 2016-03-05; newest 2022-07-18
Show the evidence

Trial

  • NCT02571816
    2016-03-05
  • NCT02181660
    2016-06-27
  • NCT02456883
    2017-06-19
  • NCT03964038
    2019-07-16
  • NCT02236013
    2021-07-26
  • NCT03625505
    2021-08-31
  • 1 further recorded trial NCT04699877
    2022-07-18

At the median, Gilteritinib's trials enrolled 70 people — anything larger?


Median enrolment
70
Largest enrolment
3000
Registered trials counted
61

What do 430 spontaneous reports say about Gilteritinib — 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.

Gilteritinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 430 reaction mentions were counted: febrile neutropenia 58; platelet count decreased 55; pyrexia 53; pneumonia 47. FAERS via Open Targets · CHEMBL3301603 · 2026-06-24

Show the evidence
  • febrile neutropenia
    58
  • platelet count decreased
    55
  • pyrexia
    53
  • pneumonia
    47
  • myelosuppression
    43
  • cytopenia
    42
4 more recorded rows
  • acute myeloid leukaemia
    36
  • thrombocytopenia
    36
  • anaemia
    30
  • pancytopenia
    30

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

Which 10 reactions does Gilteritinib's label not list?


acute myeloid leukaemia, anaemia and cytopenia and 7 more reported for Gilteritinib, absent from its label. FAERS via Open Targets · CHEMBL3301603 · 2026-06-24

2 label terms; 10 reported and unlisted; b5ff59aa-9c0d-49a8-9053-1f179b482383

Show the evidence
  • acute myeloid leukaemia
    count not stated
  • anaemia
    count not stated
  • cytopenia
    count not stated
  • febrile neutropenia
    count not stated
  • myelosuppression
    count not stated
  • pancytopenia
    count not stated
4 more recorded rows
  • platelet count decreased
    count not stated
  • pneumonia
    count not stated
  • pyrexia
    count not stated
  • thrombocytopenia
    count not stated

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

Gilteritinib and CYP3A, P-GP and BCRP: shared by which compounds?


CYP3A, P-GP and BCRP appear in Gilteritinib's recorded interaction sentences, 8 in all. DailyMed label · b5ff59aa-9c0d-49a8-9053-1f179b482383 · 2022-01-01

CYP3A, CYP3A, BCRP, OCT1, P-gp, P-gp; 6 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    • Combined P-gp and Strong CYP3A Inducers: Avoid concomitant use.
  • drug_interactions
    ( 7.1 ) • Strong CYP3A Inhibitors: Consider alternative therapies.
  • drug_interactions
    If the concomitant use of strong CYP3A inhibitors cannot be avoided, monitor patients more frequently for XOSPATA adverse reactions.
  • drug_interactions
    ( 2.3 , 7.1 ) • P-gp, BCRP, OCT1 Substrates: Decrease the dose of the substrates when coadministered with gilteritinib and as clinically indicated.
  • drug_interactions
    ( 7.2 ) 7.1 Effect of Other Drugs on XOSPATA Combined P-gp and Strong CYP3A Inducers Concomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases gilteritinib exposure which may decrease XOSPATA efficacy [see Clinical Pharmacology ( 12.3 )] .
  • drug_interactions
    Avoid concomitant use of XOSPATA with combined P-gp and strong CYP3A inducers.
2 more recorded rows
  • Interaction statement drug_interactions
    Strong CYP3A Inhibitors Concomitant use of XOSPATA with a strong CYP3A inhibitor increases gilteritinib exposure [see Clinical Pharmacology ( 12.3 )] .
  • Interaction statement drug_interactions
    Consider alternative therapies that are not strong CYP3A inhibitors.

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
  • BCRP
    TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Deoxycholic acid, Golodirsen, Naldemedine, Eravacycline, Omadacycline
  • OCT1
    Ceftobiprole Medocaril, Deoxycholic acid, Sofpironium, Naldemedine, Eravacycline, Prucalopride, Chenodeoxycholic acid, Methylnaltrexone

P-gp

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2022-01-01 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3301603
PubChem CID
76970819
CAS number
1254053-84-3
RxCUI
2105823
InChIKey
GYQYAJJFPNQOOW-UHFFFAOYSA-N
Also called
GILTERITINIB FUMARATE, Gilteritinib hemifumarate, Asp-2215, GILTERITINIB FUMARATE [JAN], GILTERITINIB FUMARATE [ORANGE BOOK], GILTERITINIB FUMARATE [USAN], Gilteritinib fumarate [WHO-DD]
Development code
ASP2215 hemifumarate, ASP-2215 HEMIFUMARATE, ASP2215
Trade name
Xospata
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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