From the FDA-approved label: Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). 6) recognizes human CD33 antigen. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker.
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 protein.
FDA substance registry · 8GZG754X6M · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 100 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 people◇Read 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.
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. Single-dose
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Overall survival
✗ The study did not show it
Who was studied
NCT00454480
How many people
2000
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. Single-dose
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Overall survival
✗ The study did not show it
Who was studied
NCT02272478
How many people
1600
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. Single-dose
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. Single-dose
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 at 3 Years
✗ The study did not show it
Who was studied
NCT00372593
How many people
1070
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. Single-dose
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
Overarching primary objective
✗ The study did not show it
Who was studied
NCT05994690
How many people
905
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. Single-dose
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 unclear◇Read 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.
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of MYLOTARG as a single agent in pediatric patients with newly-diagnosed AML have not been established.”
US prescribing information · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · read 2026-08-30
On older people, the label states: “Use of MYLOTARG in combination with daunorubicin and cytarabine in newly-diagnosed adult patients with de novo AML is supported by a randomized, controlled trial that included 50 patients greater than or equal to 65 years old.”
US prescribing information · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action and findings from animal studies [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] , MYLOTARG can cause embryo-fetal harm when administered to a pregnant woman.”
US prescribing information · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · 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 take◇Read 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 take◇Read 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
Withdrawn
❝ 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
Single-dose
✎ 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, S8.
No source is stored against this line.
What is in the pack
Sold as vial, injection, powder, lyophilized, for solution, given by the single-dose, intravenous 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 take∅Nothing 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 unclear◇Read 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
Single-dose
✎ 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
1 product lists this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.
FDA National Drug Code directory · 0008-4510 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, taken intravenous.
FDA National Drug Code directory · 0008-4510 · read 2026-08-29
The regulator's established pharmacologic class for it is cd33-directed antibody interactions [moa] and cd33-directed immunoconjugate [epc].
FDA National Drug Code directory · 0008-4510 · 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 · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · read 2026-08-29
Mylotarg is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution., recorded as fda label in effect 2025-12-19 in the United States.
US prescribing information · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · 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 take◇Read 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, withdrawn medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Gemtuzumab ozogamicin 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 unclear◇Read 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 Gemtuzumab ozogamicin 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 people◇Read 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)
8GZG754X6M
RxNorm concept
1944701
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, S8.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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.
Withdrawn in United States, 2010, for "greater number of deaths" (ChEMBL; Open Targets)
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA761060, approved 20170901 to WYETH PHARMS INC.
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 (13)
Q2
On the Gemtuzumab ozogamicin label: indicated for what?
"MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and…": indications and usage on Gemtuzumab ozogamicin's label. DailyMed label · 32fd2bb2-1cfa-4250-feb8-d7956c794e05 · 2025-12-19
Q3
94 registered trials of Gemtuzumab ozogamicin — at which phases?
Registered studies posting no result
74 of 94
94 registered studies of Gemtuzumab ozogamicin: 58 phase2, 27 phase1, 17 phase3, 5 na or unstated, 2 phase4, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
136 with a PubMed record
Show the evidence
phase2
58
phase1
27
phase3
17
na or unstated
5
phase4
2
early phase1
1
10 more recorded rows
completed
56
recruiting
14
terminated
11
unknown
5
active not recruiting
3
approved for marketing
1
no longer available
1
not yet recruiting
1
suspended
1
withdrawn
1
recorded 2026-09-01 · last checked 2026-09-04
Q4
Approved in 2000, withdrawn in 2010: what happened to Gemtuzumab ozogamicin in United States?
9 of Gemtuzumab ozogamicin's trials stopped: safety, accrual/recruitment, funding/business, other?
safety (2), accrual/recruitment (2), funding/business (2) and other (3): Gemtuzumab ozogamicin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"funding unavailable"; 9 of 94 registered studies
Show the evidence
Trial
NCT00577694
terminated; "funding unavailable"
NCT00660036
terminated; "due to new safety information"
NCT00669890
terminated; "PI left institution"
NCT03878927
terminated; "Dose limiting toxicities."
NCT03904251
terminated; "slow accrual"
NCT04326439
terminated; "Due to unforeseen circumstances, the study team was limited in enrolling patients on this trial; thus, it was terminated."
3 further recorded trials
NCT04849910
terminated; "Lack of Funding"
NCT05716009
terminated; "Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML"
NCT05955261
suspended; "PI requests voluntary hold"
recorded 2026-09-01 · last checked 2026-09-04
Q6
Human studies of Gemtuzumab ozogamicin used Gemtuzumab Ozogamicin 3 mg/m^2 — over how long?
studies of Gemtuzumab ozogamicin used the recorded amount. ClinicalTrials.gov · 2026-09-01
2 recorded entries; human; also "Gemtuzumab Ozogamicin 3 mg/m^2", "Gemtuzumab Ozogamicin 2 mg/m^2"
Show the evidence
human
NCT03848754
Gemtuzumab Ozogamicin 3 mg/m^2
NCT03848754
Gemtuzumab Ozogamicin 2 mg/m^2
recorded 2026-09-01 · last checked 2026-09-04
Q7
Gemtuzumab ozogamicin's half-life is 62 hours — which schedules were studied?
62 hours; The terminal plasma half-life (t ½ ) for hP67.6 was 62 hours after the first dose and 90 hours after the second dose.
metabolismpharmacokinetics
Metabolism In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolized, primarily via nonenzymatic reduction of the disulfide moiety.
recorded 2025-12-19 · last checked 2026-09-04
Q8
Which running trial of Gemtuzumab ozogamicin could settle lifespan?
NCT04793919 measures Event Free Survival (EFS) probability, reading out 2027-10-10.
4 open trials; n 89; "Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia"
Show the evidence
Trial
NCT04793919
"Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia"; n 89; "Event Free Survival (EFS) probability"; 2027-10-10
NCT01409161
"Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia"; n 151; "Event free survival"; 2027-12-18
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
NCT05183035
"Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)"; n 130; "Overall Survival (OS)"; 2031-04
Q9
Which 31 trials of Gemtuzumab ozogamicin posted no result?
Posted no result
31 of 31 completed trials
Registrations
NCT00003673, NCT00003131, NCT00008151, NCT00037596, NCT00037583 and NCT00304447, and 25 more
Completion dates
oldest 1999-03; newest 2024-06-29
Show the evidence
Trial
NCT00003673
1999-03
NCT00003131
2002-02
NCT00008151
2002-07
NCT00037596
2003-04
NCT00037583
2003-09
NCT00304447
2004-01
14 further recorded trials
NCT00044733
2004-09
NCT00006265
2005-05
NCT00089050
2006-03
NCT00017589
2006-05
NCT00038831
2006-10
NCT00005962
2007-06
NCT00962767
2007-12
NCT00195000
2008-02
NCT00233909
2008-03
NCT00143975
2009-06
NCT00049179
2010-10
NCT02182596
2011-01
NCT00476541
2012-01
NCT00052299
2012-02
Q10
At the median, Gemtuzumab ozogamicin's trials enrolled 50 people — anything larger?
Median enrolment
50
Largest enrolment
2000
Registered trials counted
86
Q11
What do 922 spontaneous reports say about Gemtuzumab ozogamicin — 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.
Gemtuzumab ozogamicin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 922 reaction mentions were counted: febrile neutropenia 259; pyrexia 116; thrombocytopenia 86; venoocclusive liver disease 82. FAERS via Open Targets · CHEMBL1201506 · 2026-06-24
Show the evidence
febrile neutropenia
259
pyrexia
116
thrombocytopenia
86
venoocclusive liver disease
82
sepsis
79
platelet count decreased
71
4 more recorded rows
neutropenia
65
white blood cell count decreased
59
alanine aminotransferase increased
55
chills
50
recorded 2026-06-24 · last checked 2026-09-04
Q12
Which 10 reactions does Gemtuzumab ozogamicin's label not list?
In Vitro Studies At clinically relevant concentrations, gemtuzumab ozogamicin had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
pharmacokinetics
At clinically relevant concentrations, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2B6 , CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
pharmacokinetics
• Induce CYP450 Enzymes : CYP1A2, CYP2B6, and CYP3A4.
• Inhibit Drug Transporters : P-gp (P-glycoprotein), breast cancer resistance protein (BCRP), organic anion transporter (OAT)1 and OAT3, organic cation transporter (OCT)2, and organic anion transporting polypeptide (OATP)1B1 and OATP1B3.
clinical_pharmacology
In Vitro Studies At clinically relevant concentrations, gemtuzumab ozogamicin had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
2 more recorded rows
Interaction statementclinical_pharmacology
At clinically relevant concentrations, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2B6 , CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5.
Interaction statementclinical_pharmacology
• Induce CYP450 Enzymes : CYP1A2, CYP2B6, and CYP3A4.
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
✗ 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: 7 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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