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Daunorubicin

  • 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 Daunorubicin does in the body

Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

From the FDA-approved label: Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. Daunorubicin forms complexes with DNA by intercalation between base pairs. It inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. Single strand and double strand DNA breaks result. Daunorubicin hydrochloride may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Daunorubicin hydrochloride possesses an antitumor effect against a wide spectrum of animal tumors, either grafted or spontaneous.

Why people take it. Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

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

  • 13 registered substances share the start of this name, which is why a search for it can return more than one thing.

    FDA substance registry · ZS7284E0ZP · read 2026-08-29

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 178 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.

Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization

The study did not show it

Who was studied
NCT01190930
How many people
9350
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. Injection

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

Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab

The study did not show it

Who was studied
NCT03914625
How many people
6720
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. Injection

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

The study did not show it

Who was studied
NCT01117441
How many people
6136
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. Injection

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

Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

The study did not show it

Who was studied
NCT00002582
How many people
6000
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. Injection

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

Post-induction 5-year event-free survival (EFS)

The study did not show it

Who was studied
NCT03959085
How many people
5951
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. Injection

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

DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone

The study did not show it

Who was studied
NCT02883049
How many people
5949
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. Injection

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.

  • Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

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 older people, the label states: “Elderly See CLINICAL PHARMACOLOGY, Special Populations , Geriatric Patients section.”

    US prescribing information · ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f · read 2026-08-30

  • On people who are pregnant, the label states: “Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman.”

    US prescribing information · ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether this drug is excreted in human milk.”

    US prescribing information · ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f · 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

Injection

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 injectable, powder, injectable, liposomal, injection, given by the injection, 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 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

Injection

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

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

    FDA National Drug Code directory · 53183-1447 · read 2026-08-29

  • They are sold as injection, injection, powder, lyophilized, for suspension, injection, solution and powder, taken intravenous.

    FDA National Drug Code directory · 53183-1447 · read 2026-08-29

  • The regulator's established pharmacologic class for it is anthracycline topoisomerase inhibitor [epc], anthracyclines [cs] and topoisomerase inhibitors [moa].

    FDA National Drug Code directory · 53183-1447 · read 2026-08-29

  • 5 published labels name it as an active ingredient. 4 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 227784a8-ce68-4dd4-8ac5-a65265969677 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 227784a8-ce68-4dd4-8ac5-a65265969677 · read 2026-08-29

  • daunorubicin hydrochloride is intravenous at HOW SUPPLIED Daunorubicin Hydrochloride Injection, 5 mg (base) per mL, is available as follows: NDC Daunorubicin Hydrochloride Injection 5 mg (base) per mL Package Factor 71288- 182 -05 20 mg (as base) per 4 mL Single-D…, recorded as fda label in effect 2025-05-21 in the United States.

    US prescribing information · ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f · 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 Daunorubicin 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 Daunorubicin are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Read from sources, not yet reviewed

No traced study record is stored for this substance.

Built from stored sources by fixed rules. No reviewer has signed it off.

How many documents were read

  • 4 documents were read for this substance.

    RNAWiki source record

  • 4 of them state the same halfLife, and they agree.

    RNAWiki source record

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4, S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 12 approved applications cover products containing this substance. The earliest was NDA050484, approved 19791219 to WYETH AYERST.

    Drugs@FDA application register · NDA050484 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA050484 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19940511.

    FDA National Drug Code directory · 53183-1447 · 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 (9)

On the Daunorubicin label: indicated for what?

"Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.": indications and usage on Daunorubicin's label. DailyMed label · ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f · 2025-05-21

262 registered trials of Daunorubicin — at which phases?

Registered studies posting no result
199 of 262

262 registered studies of Daunorubicin: 114 phase2, 92 phase3, 53 phase1, 13 na, 13 phase4, 5 na or unstated, 1 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

652 with a PubMed record

Show the evidence
  • phase2
    114
  • phase3
    92
  • phase1
    53
  • na
    13
  • phase4
    13
  • na or unstated
    5
9 more recorded rows
  • early phase1
    1
  • completed
    147
  • recruiting
    41
  • unknown
    28
  • active not recruiting
    19
  • terminated
    16
  • withdrawn
    6
  • not yet recruiting
    4
  • suspended
    1

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

20 of Daunorubicin's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?

safety (3), futility/efficacy (2), accrual/recruitment (4), funding/business (1), sponsor decision unspecified (1) and other (9): Daunorubicin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Withdrawn due to "toxicity" problems"; 20 of 262 registered studies

Show the evidence

Trial

  • NCT00124644
    terminated; "Withdrawn due to "toxicity" problems"
  • NCT00275106
    terminated; "Withdrawn due to an excess of toxic deaths"
  • NCT00427414
    terminated; "Terminated due to slow accrual."
  • NCT00814164
    terminated; "Sponsor withdrew support"
  • NCT01794169
    terminated; "Poor recruitment"
  • NCT02043587
    terminated; "Original investigator for the trial has left"
14 further recorded trials
  • NCT02198482
    terminated; "development program of study drug volasertib was stopped by Boehringer Ingelheim due to manufacturing problems"
  • NCT02419469
    terminated; "Slow Accrual"
  • NCT02472626
    withdrawn; "Drug Supply Issues"
  • NCT02954653
    terminated; "The study was terminated due to a change in sponsor prioritization."
  • NCT03135028
    terminated; "No signal of efficacy with Entospletinib"
  • NCT03444649
    withdrawn; "IMP will not be further developed"
  • NCT03724084
    terminated; "Other - Study agent no longer available"
  • NCT03850535
    terminated; "Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2."
  • NCT03860844
    terminated; "Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns."
  • NCT04326439
    terminated; "Due to unforeseen circumstances, the study team was limited in enrolling patients on this trial; thus, it was terminated."
  • NCT04778397
    terminated; "Study discontinued due to futility."
  • NCT05955261
    suspended; "PI requests voluntary hold"
  • NCT06210750
    withdrawn; "Other - Protocol moved to Disapproved"
  • NCT07052994
    withdrawn; "PI requested"

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

Daunorubicin's half-life is 45 minutes — which schedules were studied?

45 minutes, the half-life Daunorubicin's label states: "Thereafter, plasma levels decline slowly with a half-life of 45 minutes in the initial phase and 18.5 hours in the terminal phase." DailyMed label · ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f · 2025-05-21

Show the evidence
  • half life pharmacokinetics
    45 minutes; Thereafter, plasma levels decline slowly with a half-life of 45 minutes in the initial phase and 18.5 hours in the terminal phase.
  • metabolism pharmacokinetics
    Metabolism and Elimination Daunorubicin hydrochloride is extensively metabolized in the liver and other tissues, mainly by cytoplasmic aldo-keto reductases, producing daunorubicinol, the major metabolite which has antineoplastic activity.

recorded 2025-05-21 · last checked 2026-09-04

Which running trial of Daunorubicin could settle lifespan?

NCT02112916 measures Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients, reading out 2026-09-16.

28 open trials; n 847; "Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma"

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Trial

  • NCT02112916
    "Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma"; n 847; "Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients"; 2026-09-16
  • NCT03701308
    "Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy"; n 267; "Event-free Survival (EFS)"; 2026-10-26
  • NCT02003222
    "Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia"; n 488; "Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy"; 2027-02-25
  • NCT02835222
    "Selinexor With Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients"; n 57; "Overall survival"; 2027-04-18
  • NCT03897127
    "Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics"; n 882; "Overall survival (OS) in the restricted set of de novo patients"; 2027-06
  • NCT02521493
    "Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome"; n 280; "Event-free Survival (EFS)"; 2027-06-30
14 further recorded trials
  • NCT03150693
    "Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia"; n 303; "Event-free survival (EFS)"; 2027-08
  • NCT03007147
    "Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia"; n 352; "Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)"; 2027-08-14
  • NCT04440267
    "Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage"; n 50; "Overall survival (OS)"; 2027-12-20
  • NCT04801797
    "Venetoclax + Azacitidine vs. Induction Chemotherapy in AML"; n 172; "Event free survival"; 2028-01-01
  • NCT06744556
    "HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML"; n 41; "Event-free survival (EFS)"; 2028-06-01
  • NCT03643276
    "Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017"; n 5000; "Event-free survival"; 2028-07-14
  • NCT03117751
    "Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma"; n 790; "Event-free survival of ALL patients (EFS)"; 2028-09-30
  • NCT06635681
    "Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML"; n 380; "Event-free survival (EFS)"; 2028-10-01
  • 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
  • NCT06529250
    "Intermediate-dose HAD Regimen for CEBPA Double-mutated AML"; n 148; "Event-free survival (EFS)"; 2029-09-01
  • NCT07754799
    "A Randomized Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia"; n 320; "Event-free survival (EFS)"; 2029-09-30
  • NCT06744504
    "Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1"; n 284; "overall survival"; 2029-12-01
  • NCT05959720
    "Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil"; n 180; "Overall survival (OS)"; 2030-06

Which 69 trials of Daunorubicin posted no result?

Posted no result
69 of 69 completed trials
Registrations
NCT00002691, NCT00004215, NCT00018954, NCT00002471, NCT00015860 and NCT00002665, and 63 more
Completion dates
oldest 2000-06; newest 2024-02
Show the evidence

Trial

  • NCT00002691
    2000-06
  • NCT00004215
    2000-08
  • NCT00018954
    2002-10
  • NCT00002471
    2003-01
  • NCT00015860
    2003-10
  • NCT00002665
    2003-12
14 further recorded trials
  • NCT00187122
    2004-06
  • NCT00005863
    2004-12
  • NCT00526305
    2005-04
  • NCT00589082
    2005-11
  • NCT00003436
    2005-12
  • NCT00199056
    2005-12
  • NCT00004217
    2006-03
  • NCT00022126
    2006-04
  • NCT00613457
    2006-07
  • NCT00005793
    2006-11
  • NCT00002590
    2007-03
  • NCT00002744
    2007-03
  • NCT00002785
    2007-03
  • NCT00003783
    2007-03

At the median, Daunorubicin's trials enrolled 151.5 people — anything larger?

Median enrolment
151.5
Largest enrolment
6136
Registered trials counted
246

What do 30 spontaneous reports say about Daunorubicin — 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.

Daunorubicin appears in spontaneous reports to regulators. Across the 5 most-reported reaction terms, 30 reaction mentions were counted: febrile neutropenia 8; neoplasm recurrence 7; cardiac failure 6; febrile bone marrow aplasia 5. FAERS via Open Targets · CHEMBL1200475 · 2026-06-24

Show the evidence
  • febrile neutropenia
    8
  • neoplasm recurrence
    7
  • cardiac failure
    6
  • febrile bone marrow aplasia
    5
  • posterior reversible encephalopathy syndrome
    4

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

Which 5 reactions does Daunorubicin's label not list?

cardiac failure, febrile bone marrow aplasia and febrile neutropenia and 2 more reported for Daunorubicin, absent from its label. FAERS via Open Targets · CHEMBL1200475 · 2026-06-24

3 label terms; 5 reported and unlisted; ff6b9bd4-8a9f-400f-a0b9-70e25fa8a28f

Show the evidence
  • cardiac failure
    count not stated
  • febrile bone marrow aplasia
    count not stated
  • febrile neutropenia
    count not stated
  • neoplasm recurrence
    count not stated
  • posterior reversible encephalopathy syndrome
    count not stated

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200475
PubChem CID
9961878
CAS number
371770-68-2
RxCUI
221087
InChIKey
STQGQHZAVUOBTE-VGBVRHCVSA-N
Development code
NSC-83142, RP 13057, FI 6339 [AS THE BASE], NDC 0082-4155, NSC-82151, RP 13057 [AS THE BASE), FI 6339
Also called
DAUNORUBICIN CITRATE, Daunorubicin liposomal, liposomal daunorubicin, DAUNORUBICIN HYDROCHLORIDE, dnr, doxorubicin, Daunomycin, Daunorubicina, Daunorubicine, Valrubicin impurity, daunorubicin, anthracycline, cpx-351
Salt form
Daunorubicin citrate liposome, Daunorubicin hcl, FI 6339 HYDROCHLORIDE, RP 13057 HYDROCHLORIDE, Epirubicin hydrochloride impurity, daunorubicin-, Daunorubicin Hydrochloride / Cerubidine / Daunoxome
Trade name
Daunoxome, Cerubidine, Daunorubicin component of vyxeos, Vyxeos liposomal (previously Vyxeos)
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: 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: 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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