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Temozolomide

  • 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 Temozolomide does in the body

The treatment of adult patients

From the FDA-approved label: Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to DNA alkylation, mainly at the O 6 and N 7 positions of guanine, which causes DNA double strand breaks and results in programmed cell death. 2 Pharmacodynamics Temozolomide exposure-response relationships and the time course of pharmacodynamic response are unknown.

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 · YF1K15M17Y · read 2026-08-29

  • Its recorded molecular formula is C6H6N6O2, weighing 194.15.

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

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 93 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 (OS)

The study did not show it

Who was studied
NCT03970447
How many people
2250
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. Oral

Interval reported. Not recorded in this summary

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

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

Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone

The study did not show it

Who was studied
NCT00094653
How many people
1783
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Event Free Survival (RT2)

The study did not show it

Who was studied
NCT04625907
How many people
1672
Study design
Phase 1/Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Incidence of Adverse Events (AEs)

The study did not show it

Who was studied
NCT03899155
How many people
1500
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

Median Overall Survival Time

The study did not show it

Who was studied
NCT00304031
How many people
1173
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

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

safety and efficacy

The study did not show it

Who was studied
NCT01364064
How many people
1153
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. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

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 Temozolomide have not been established in pediatric patients.”

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

  • On older people, the label states: “In the Newly Diagnosed Glioblastoma trial, Study MK-7365-051, 15% of patients were 65 years and older.”

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

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

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating Temozolomide [see Use in Specific Populations (8.1) ].”

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage adjustment is recommended for patients with mild to moderate hepatic impairment (Child Pugh class Aand B) [see Clinical Pharmacology (12.3 ) ].”

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dosage adjustment is recommended for patients with creatinine clearance (CLcr) of 36 to 130 mL/min/m 2 [see Clinical Pharmacology (12.3) ].”

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

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

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4.

No source is stored against this line.

What is in the pack

Sold as capsule, powder, injection, powder, lyophilized, for solution, given by the oral, 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

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 84 products list this as an active ingredient in the United States drug directory. 84 of them contain it and nothing else.

    FDA National Drug Code directory · 72162-2659 · read 2026-08-29

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

    FDA National Drug Code directory · 72162-2659 · read 2026-08-29

  • The regulator's established pharmacologic class for it is alkylating activity [moa] and alkylating drug [epc].

    FDA National Drug Code directory · 72162-2659 · read 2026-08-29

  • 20 published labels name it as an active ingredient. 20 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 70996a9d-4a4f-4ed1-ab07-130486aa14ab · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 70996a9d-4a4f-4ed1-ab07-130486aa14ab · read 2026-08-29

  • temozolomide is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: - 5 mg: white opaque bodies with green opaque caps., recorded as fda label in effect 2021-11-28 in the United States.

    US prescribing information · 27e5a781-e4f2-4489-9def-7971d0b86d9c · read 2026-08-30

  • Recorded price in US: 0.87977–20.5332 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 38 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

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 Temozolomide studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

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

What would answer it

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

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

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

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

What would answer it

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

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

Formulation uncertainty

Several salts, forms or products of Temozolomide 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.

How many documents were read

  • 20 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 20 of them state the same tMax, and they agree.

    RNAWiki source record

  • 20 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
YF1K15M17Y
RxNorm concept
313209

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.

  • 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

  • 18 approved applications cover products containing this substance. The earliest was NDA021029, approved 19990811 to MERCK SHARP DOHME.

    Drugs@FDA application register · NDA021029 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA021029 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19990811.

    FDA National Drug Code directory · 72162-2659 · 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 (10)

On the Temozolomide label: indicated for what?


"1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules are an alkylating drug indicated for the treatment of adult patients with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.": indications and usage on Temozolomide's label. DailyMed label · 56245d21-4a42-471e-bbdc-80b129336e2f · 2026-08-11

819 registered trials of Temozolomide — at which phases?


Registered studies posting no result
587 of 819

819 registered studies of Temozolomide: 526 phase2, 317 phase1, 80 phase3, 19 early phase1, 15 na, 11 na or unstated, 4 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1071 with a PubMed record

Show the evidence
  • phase2
    526
  • phase1
    317
  • phase3
    80
  • early phase1
    19
  • na
    15
  • na or unstated
    11
9 more recorded rows
  • phase4
    4
  • completed
    381
  • recruiting
    106
  • terminated
    106
  • unknown
    96
  • active not recruiting
    78
  • not yet recruiting
    25
  • withdrawn
    24
  • suspended
    3

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

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


safety (4), futility/efficacy (4), accrual/recruitment (51), funding/business (16), sponsor decision unspecified (5) and other (39): Temozolomide's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"slow accrual"; 119 of 819 registered studies

Show the evidence

Trial

  • NCT00003567
    terminated; "slow accrual"
  • NCT00004106
    terminated; "Per Data Monitoring Committee given the poor/inadequate accrual."
  • NCT00005812
    terminated; "No objective response documented, protocol terminated after 12 patients."
  • NCT00020839
    terminated; "low accrual"
  • NCT00021307
    withdrawn; "Study not activated."
  • NCT00034697
    terminated; "Slow Enrollment"
14 further recorded trials
  • NCT00109798
    withdrawn; "Sub-Investigator reloacted to another institution"
  • NCT00238277
    terminated; "Terminated - due to low accrual"
  • NCT00248534
    terminated; "slow accrual/lack of resources/low priority due to combining 2 consortia"
  • NCT00365222
    terminated; "IRB Study Closure"
  • NCT00376103
    terminated; "Loss of funding from sponsor"
  • NCT00385398
    withdrawn; "lack of funding and drug supply"
  • NCT00389090
    terminated; "AOI Pharma terminated the license agreement. IND Transferred to NCI"
  • NCT00436436
    terminated; "Study closed to accrual after the company chose to stop development of the drug."
  • NCT00437957
    terminated; "Lack of enrollment"
  • NCT00471653
    terminated; "low accrual"
  • NCT00505635
    terminated; "Slow accrual"
  • NCT00508456
    terminated; "Low Accrual"
  • NCT00512798
    terminated; "This study was terminated due to lack of efficacy"
  • NCT00515788
    terminated; "Study terminated due to slow accrual with no expansion to additional phase."

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

Human studies of Temozolomide used temozolomide(TMZ) 75mg — over how long?


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

8 recorded entries; human; also "temozolomide(TMZ) 75mg", "temozolomide 60 mg x 21 days", "temozolomide 75 mg x 21 days"

Show the evidence

human

  • NCT00267592
    temozolomide(TMZ) 75mg
  • NCT01026493
    temozolomide 60 mg x 21 days
  • NCT01026493
    temozolomide 75 mg x 21 days
  • NCT01026493
    Temozolomide 150 mg x 5 days
  • NCT02133677
    temozolomide 100mg
  • NCT04116411
    Temozolomide 120 mg
2 more recorded rows
  • human NCT04221035
    Temozolomide 100 MG
  • human NCT04984733
    Temozolomide 50mg/m2/day

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

Temozolomide's half-life is 1.8 hours — which schedules were studied?


1.8 hours, the half-life Temozolomide's label states: "Elimination Clearance of temozolomide is approximately 5.5 L/hr/m 2 and the mean elimination half-life is 1.8 hours." DailyMed label · 56245d21-4a42-471e-bbdc-80b129336e2f · 2026-08-11

tmax 1 hour.

Show the evidence
  • half life pharmacokinetics
    1.8 hours; Elimination Clearance of temozolomide is approximately 5.5 L/hr/m 2 and the mean elimination half-life is 1.8 hours.
  • tmax pharmacokinetics
    1 hour; Absorption The median T max is 1 hour.
  • metabolism pharmacokinetics
    Metabolism Temozolomide is spontaneously hydrolyzed at physiologic pH to the active species, MTIC and to temozolomide acid metabolite.

recorded 2026-08-11 · last checked 2026-09-04

Which running trial of Temozolomide could settle lifespan?


NCT05554003 measures Progression free survival (PFS)., reading out 2024-12-31.

84 open trials; n 46; "Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study"

Show the evidence

Trial

  • NCT05554003
    "Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study"; n 46; "Progression free survival (PFS)."; 2024-12-31
  • NCT03709680
    "Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors"; n 128; "Phase 2 open-label, randomized: Event-free survival (EFS) based on Investigator assessment."; 2025-10-18
  • NCT04195139
    "Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM"; n 103; "Overall survival outcomes"; 2025-12-31
  • NCT04737889
    "Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma"; n 30; "2-year progression-free survival"; 2026-01-13
  • NCT02685605
    "Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme"; n 314; "Median Progression-Free Survival"; 2026-06
  • NCT02455557
    "SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma"; n 66; "Progression-free Survival (PFS)"; 2026-09-02
14 further recorded trials
  • NCT04200443
    "Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma"; n 96; "Progression-free Survival (PFS)"; 2026-09-10
  • NCT03581292
    "Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations"; n 38; "Event Free Survival (EFS)"; 2026-10-16
  • NCT01824875
    "Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors"; n 144; "Progression-free Survival"; 2026-12
  • NCT05440786
    "CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma"; n 46; "Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis"; 2026-12
  • NCT02152982
    "Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme"; n 447; "Overall Survival (OS)"; 2026-12-26
  • NCT00978458
    "Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma"; n 540; "Progression-free survival (PFS)"; 2026-12-31
  • NCT02179086
    "Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma"; n 624; "Median Survival Time (Within Center Group)"; 2026-12-31
  • NCT04623931
    "Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas"; n 40; "Progression free survival (PFS)"; 2026-12-31
  • NCT04959500
    "Newly Diagnosed Glioblastoma"; n 150; "Progression Free Survival (PFS) assessed by IRC"; 2026-12-31
  • NCT06105619
    "A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN)."; n 84; "Overall survival(OS)"; 2026-12-31
  • NCT05432791
    "Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working"; n 74; "Progression Free Survival (PFS) (Phase II)"; 2027-01-30
  • NCT05685004
    "Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)"; n 120; "Survival"; 2027-03
  • NCT05463848
    "Surgical Pembro +/- Olaparib w TMZ for rGBM"; n 52; "6-month Progression-Free Survival (PFS6)"; 2027-03-01
  • NCT01638546
    "Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer"; n 97; "Progression-free Survival, Calculated as the Proportion of Patients Alive and Without Evidence of Disease"; 2027-03-25

Which 180 trials of Temozolomide posted no result?


Posted no result
180 of 180 completed trials
Registrations
NCT00003708, NCT00003465, NCT00004113, NCT00006043, NCT00012116 and NCT00005955, and 174 more
Completion dates
oldest 2000-05; newest 2024-07-28
Show the evidence

Trial

  • NCT00003708
    2000-05
  • NCT00003465
    2001-02
  • NCT00004113
    2001-10
  • NCT00006043
    2001-11
  • NCT00012116
    2002-04
  • NCT00005955
    2002-09
14 further recorded trials
  • NCT00014261
    2002-11
  • NCT00004068
    2003-04
  • NCT00005954
    2003-06
  • NCT00003464
    2003-08
  • NCT00006877
    2003-09
  • NCT00014092
    2003-12
  • NCT00022711
    2004-01
  • NCT00003176
    2004-01-06
  • NCT00005815
    2004-08
  • NCT00006474
    2004-08
  • NCT00049361
    2004-12-07
  • NCT00027742
    2005-06
  • NCT00783393
    2005-06-17
  • NCT00003466
    2005-07

At the median, Temozolomide's trials enrolled 43.5 people — anything larger?


Median enrolment
43.5
Largest enrolment
2250
Registered trials counted
794

What do 3910 spontaneous reports say about Temozolomide — 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.

Temozolomide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3910 reaction mentions were counted: thrombocytopenia 756; nausea 577; disease progression 481; vomiting 435. FAERS via Open Targets · CHEMBL810 · 2026-06-24

Show the evidence
  • thrombocytopenia
    756
  • nausea
    577
  • disease progression
    481
  • vomiting
    435
  • neutropenia
    333
  • pancytopenia
    302
4 more recorded rows
  • malignant neoplasm progression
    289
  • platelet count decreased
    269
  • febrile neutropenia
    245
  • pulmonary embolism
    223

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

Which 10 reactions does Temozolomide's label not list?


disease progression, febrile neutropenia and malignant neoplasm progression and 7 more reported for Temozolomide, absent from its label. FAERS via Open Targets · CHEMBL810 · 2026-06-24

2 label terms; 10 reported and unlisted; 56245d21-4a42-471e-bbdc-80b129336e2f

Show the evidence
  • disease progression
    count not stated
  • febrile neutropenia
    count not stated
  • malignant neoplasm progression
    count not stated
  • nausea
    count not stated
  • neutropenia
    count not stated
  • pancytopenia
    count not stated
4 more recorded rows
  • platelet count decreased
    count not stated
  • pulmonary embolism
    count not stated
  • thrombocytopenia
    count not stated
  • vomiting
    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
CHEMBL810
PubChem CID
5394
CAS number
85622-93-1
RxCUI
37776
InChIKey
BPEGJWRSRHCHSN-UHFFFAOYSA-N
Development code
CCRG-81045, M-39831, M&B 39831, NSC-362856, SCH 52365
Also called
Methazolastone, Mk-7365, Temozolomida, captem, dit, metronomic temozolomide, tem, temo, tmz, 3,4-Dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide
Trade name
Temodal, Temodar, Temomedac, Temozolomide accord, Temozolomide hexal, Temozolomide sandoz, Temozolomide sun, Temozolomide teva, Kizfizo
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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