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Quizartinib

  • 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 Quizartinib does in the body

VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

Quizartinib is a small molecule inhibitor of the receptor tyrosine kinase FLT3. Quizartinib and its major active metabolite AC886 bind to the adenosine triphosphate (ATP) binding domain of FLT3 with comparable affinity, and both had 10-fold lower affinity towards FLT3-ITD mutation compared to FLT3 in a binding assay. Quizartinib and AC886 inhibited FLT3 kinase activity, preventing autophosphorylation of the receptor, thereby inhibiting downstream FLT3 receptor signaling and blocking FLT3-ITD-dependent cell proliferation. Quizartinib showed antitumor activity in a mouse model of FLT3-ITD-dependent leukemia.

Why people take it. VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

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 · WK7Q6ZIZ10 · read 2026-08-29

  • Its recorded molecular formula is C29H32N6O4S∙2HCl, weighing 633.6.

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · 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 195 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 (Arm A vs Arm B)

The study did not show it

Who was studied
NCT06578247
How many people
700
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
  • Europe PMC · a recorded source, not a stored snapshot
  • ClinicalTrials.gov · a recorded source, not a stored snapshot

Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

The study did not show it

Who was studied
NCT02668653
How many people
539
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
  • Europe PMC · a recorded source, not a stored snapshot
  • ClinicalTrials.gov · a recorded source, not a stored snapshot

Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only)

The study did not show it

Who was studied
NCT05735184
How many people
420
Study design
Phase 1
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
  • Europe PMC · a recorded source, not a stored snapshot
  • ClinicalTrials.gov · a recorded source, not a stored snapshot

Overall Survival

The study did not show it

Who was studied
NCT07478991
How many people
376
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
  • Europe PMC · a recorded source, not a stored snapshot
  • ClinicalTrials.gov · a recorded source, not a stored snapshot

Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

The study did not show it

Who was studied
NCT02039726
How many people
367
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
  • Europe PMC · a recorded source, not a stored snapshot
  • ClinicalTrials.gov · a recorded source, not a stored snapshot

Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)

The study did not show it

Who was studied
NCT00989261
How many people
333
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
  • Europe PMC · a recorded source, not a stored snapshot
  • ClinicalTrials.gov · 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 VANFLYTA have not been established in pediatric patients.”

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-30

  • On older people, the label states: “There were 533 patients with newly diagnosed AML in the clinical study; of the total number of VANFLYTA-treated patients, 69 (26%) were 65 years of age and older, while 1 (0.4%) was 75 years of age [see Clinical Studies (14) ] .”

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-30

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

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-30

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

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Class A or total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1 to 1.5 times ULN and any value for AST) or moderate hepatic impairment (Child-Pugh Class B or total bilirubin >1.5 to 3 times ULN and any value for AST).”

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage adjustment is recommended in patients with mild to moderate renal impairment (i.e., estimated creatinine clearance [CLcr] by Cockcroft-Gault equation: CLcr 30 to 89 mL/min).”

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · 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, S5, 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

  • 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 · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · read 2026-08-29

  • VANFLYTA is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 17.7 mg quizartinib, white, round, film-coated, debossed with "DSC511" 26.5 mg quizartinib, yellow, round, film-coated, debossed with "DSC512" Tablets: 17.7 mg or 26.5 mg of quizart…, recorded as fda label in effect 2026-04-16 in the United States.

    US prescribing information · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · 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 Quizartinib 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.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Quizartinib 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)
WK7Q6ZIZ10
RxNorm concept
2643054

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, S5, S6.

  • Passed

    Canonical metadata present

    slug and display name present

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

10 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.
  • How this medicine reached us — 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 Quizartinib label: indicated for what?

"VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication…": indications and usage on Quizartinib's label. DailyMed label · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · 2026-04-16

42 registered trials of Quizartinib — at which phases?

Registered studies posting no result
27 of 42

42 registered studies of Quizartinib: 26 phase1, 18 phase2, 5 phase3, 2 na or unstated, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

38 with a PubMed record

Show the evidence
  • phase1
    26
  • phase2
    18
  • phase3
    5
  • na or unstated
    2
  • early phase1
    1
  • completed
    22
6 more recorded rows
  • recruiting
    9
  • active not recruiting
    4
  • terminated
    3
  • unknown
    2
  • no longer available
    1
  • withdrawn
    1

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

4 of Quizartinib's trials stopped: accrual/recruitment, funding/business, other?

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

"This study was terminated based on a business decision by the Sponsor."; 4 of 42 registered studies

Show the evidence

Trial

  • NCT03552029
    terminated; "This study was terminated based on a business decision by the Sponsor."
  • NCT03735875
    terminated; "This study was terminated early due to other competing trials, therefore did not go on to the Phase II portion of the study."
  • NCT04209725
    terminated; "Closed due to slow enrollment"
  • NCT04676243
    withdrawn; "Study turned out no longer feasible"

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

Quizartinib's half-life is 81 hours — which schedules were studied?

81 hours, the half-life Quizartinib's label states: "The mean (SD) effective half-lives (t 1/2 ) in patients with newly diagnosed AML for quizartinib and AC886 during maintenance therapy are 81 hours (±73) and 136 hours (±113), respectively." DailyMed label · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · 2026-04-16

tmax 4 hours; bioavailability 71 %.

Show the evidence
  • half life pharmacokinetics
    81 hours; The mean (SD) effective half-lives (t 1/2 ) in patients with newly diagnosed AML for quizartinib and AC886 during maintenance therapy are 81 hours (±73) and 136 hours (±113), respectively.
  • tmax pharmacokinetics
    4 hours; After oral administration under fasted conditions, time to peak concentration (median T max ) of quizartinib and AC886 measured post dose was approximately 4 hours (range 2 to 8 hours) and 5 to 6 hours (range 4 to 120 hours), respectively, in healthy subjects.
  • bioavailability pharmacokinetics
    71 %; Table 8: Pharmacokinetic Properties of Quizartinib and AC886 Quizartinib AC886 General Information Steady state exposure following 35.4 mg VANFLYTA once daily during induction therapy in patients with newly diagnosed AML C max 140 ng/mL (71%) 163 ng/mL (52%) AUC 0-24h 2,680 ng∙h/mL (85%) 3,590 ng∙h/mL (51%) Steady state exposure following 35.4 mg VANFLYTA once daily during consolidation therapy…
  • metabolism pharmacokinetics
    Metabolism In vitro quizartinib is primarily metabolized via oxidation by CYP3A4/5 and AC886 is formed and metabolized by CYP3A4/5.

recorded 2026-04-16 · last checked 2026-09-04

Which running trial of Quizartinib could settle lifespan?

NCT04047641 measures Event free survival (EFS), reading out 2027-12-31.

3 open trials; n 80; "Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome"

Show the evidence

Trial

  • NCT04047641
    "Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome"; n 80; "Event free survival (EFS)"; 2027-12-31
  • NCT07478991
    "Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)"; n 376; "Overall Survival"; 2030-04
  • NCT06578247
    "Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML"; n 700; "Overall Survival (Arm A vs Arm B)"; 2030-06-26

Which 6 trials of Quizartinib posted no result?

Posted no result
6 of 6 completed trials
Registrations
NCT01236144, NCT01390337, NCT01468467, NCT01576185, NCT02675478 and NCT03723681
Completion dates
oldest 2014-01; newest 2022-03-03
Show the evidence

Trial

  • NCT01236144
    2014-01
  • NCT01390337
    2015-02
  • NCT01468467
    2015-03
  • NCT01576185
    2016-05
  • NCT02675478
    2018-11-13
  • NCT03723681
    2022-03-03

At the median, Quizartinib's trials enrolled 44 people — anything larger?

Median enrolment
44
Largest enrolment
700
Registered trials counted
41

What do 28 spontaneous reports say about Quizartinib — 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.

Quizartinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 28 reaction mentions were counted: electrocardiogram qt prolonged 4; adrenal insufficiency 3; angiopathy 3; cardiomyopathy 3. FAERS via Open Targets · CHEMBL2105709 · 2026-06-24

Show the evidence
  • electrocardiogram qt prolonged
    4
  • adrenal insufficiency
    3
  • angiopathy
    3
  • cardiomyopathy
    3
  • febrile neutropenia
    3
  • hyperglycaemia
    3
4 more recorded rows
  • osteonecrosis
    3
  • arterial stenosis
    2
  • cardiac ventricular thrombosis
    2
  • coronary artery stenosis
    2

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

Which 10 reactions does Quizartinib's label not list?

adrenal insufficiency, angiopathy and arterial stenosis and 7 more reported for Quizartinib, absent from its label. FAERS via Open Targets · CHEMBL2105709 · 2026-06-24

2 label terms; 10 reported and unlisted; 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86

Show the evidence
  • adrenal insufficiency
    count not stated
  • angiopathy
    count not stated
  • arterial stenosis
    count not stated
  • cardiac ventricular thrombosis
    count not stated
  • cardiomyopathy
    count not stated
  • coronary artery stenosis
    count not stated
4 more recorded rows
  • electrocardiogram qt prolonged
    count not stated
  • febrile neutropenia
    count not stated
  • hyperglycaemia
    count not stated
  • osteonecrosis
    count not stated

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

Quizartinib and CYP3A and BCRP: shared by which compounds?

CYP3A and BCRP appear in Quizartinib's recorded interaction sentences, 8 in all. DailyMed label · 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 · 2026-04-16

CYP3A, CYP3A, BCRP; 3 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Table 7: Effect of Other Drugs on VANFLYTA Strong CYP3A Inhibitors Clinical Impact VANFLYTA is a CYP3A substrate.
  • drug_interactions
    Concomitant use of VANFLYTA with a strong CYP3A inhibitor increases quizartinib systemic exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of VANFLYTA adverse reactions.
  • drug_interactions
    Strong or Moderate CYP3A Inducers Clinical Impact Concomitant use of VANFLYTA with strong or moderate CYP3A inducers decreases quizartinib systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce VANFLYTA efficacy.
  • drug_interactions
    Prevention or Management Avoid concomitant use of VANFLYTA with strong or moderate CYP3A inducers [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Breast Cancer Resistant Protein (BCRP) Substrates Clinical Impact Concomitant use of VANFLYTA with BCRP substrates may increase the risk of BCRP substrate-associated adverse reactions [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Prevention or Management Avoid concomitant use of VANFLYTA with drugs that are BCRP substrates where possible.
2 more recorded rows
  • Interaction statement drug_interactions
    If concomitant use is unavoidable, monitor patients more frequently for BCRP substrate-associated adverse reactions and decrease the BCRP substrates dosage(s) in accordance with the respective Prescribing Information.
  • Interaction statement drug_interactions
    Strong CYP3A Inhibitors: Reduce the VANFLYTA dose.

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

recorded 2026-04-16 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2105709
PubChem CID
25184035
CAS number
1132827-21-4
RxCUI
2643054
InChIKey
CVWXJKQAOSCOAB-UHFFFAOYSA-N
Also called
QUIZARTINIB DIHYDROCHLORIDE, Quizartinib monohydrochloride, asp2689, AC-010220, AC010220, AC 220, AC708, ASP-2689, QUIZARTINIB [MI], QUIZARTINIB [USAN], Quizartinib [WHO-DD], UREA, N-(5-(1,1-DIMETHYLETHYL)-3-ISOXAZOLYL)-N'-(4-(7-(2-(4-MORPHOLINYL)ETHOXY) IMIDAZO(2,1-B)BENZOTHIAZOL-2-YL)PHENYL)-
Development code
AC010220 2HCL, AC-010220 DIHYDROCHLORIDE, AC220, AC220 2HCL, AC-220 DIHYDROCHLORIDE
Salt form
Quizartinib hydrochloride
Trade name
Vanflyta
Sources (5)

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: 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: 5 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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