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Pegaspargase

  • Biologic
  • Given by a clinician
  • 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 Pegaspargase does in the body

ALL and hypersensitivity to native forms of L-asparaginase

From the FDA-approved label: L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ONCASPAR is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.

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 · 7D96IR0PPM · 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 91 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. Intramuscular

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
  • FDA label (openFDA SPL) · 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. Intramuscular

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
  • FDA label (openFDA SPL) · 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. Intramuscular

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
  • FDA label (openFDA SPL) · 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. Intramuscular

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
  • FDA label (openFDA SPL) · 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. Intramuscular

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
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Event-free Survival (EFS) for SR-Average ALL Patients

The study did not show it

Who was studied
NCT00103285
How many people
5377
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. Intramuscular

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
  • FDA label (openFDA SPL) · 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.

  • ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for…

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 ONCASPAR in the treatment of ALL have been established in pediatric patients.”

    US prescribing information · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · read 2026-08-30

  • On older people, the label states: “Clinical studies of ONCASPAR did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.”

    US prescribing information · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · read 2026-08-30

  • On people who are pregnant, the label states: “Risk summary Based on published literature studies with L-asparaginase in pregnant animals, ONCASPAR can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · read 2026-08-30

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

    US prescribing information · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · 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

Given by a clinician

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

Intramuscular

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, S4.

No source is stored against this line.

What is in the pack

Sold as vial, injection, solution, given by the intramuscular, 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

Intramuscular

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 · 72694-954 · read 2026-08-29

  • They are sold as injection, solution, taken intramuscular and intravenous.

    FDA National Drug Code directory · 72694-954 · read 2026-08-29

  • The regulator's established pharmacologic class for it is asparaginase [cs] and asparagine-specific enzyme [epc].

    FDA National Drug Code directory · 72694-954 · 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 · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · read 2026-08-29

  • ONCASPAR is intramuscular at 3 DOSAGE FORMS AND STRENGTHS Injection: 3,750 International Units/5 mL (750 International Units/mL) clear, colorless solution in a single-dose vial., recorded as fda label in effect 2024-10-07 in the United States.

    US prescribing information · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · 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 Pegaspargase 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 Pegaspargase are recorded. Results from one form may not transfer to another.

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

What would answer it

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

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

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

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

What would answer it

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

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

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

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

Where else this substance is registered

FDA substance identifier (UNII)
7D96IR0PPM
RxNorm concept
213040

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, 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

  • 1 approved application covers products containing this substance. The earliest was BLA103411, approved 19940201 to SIGMA TAU.

    Drugs@FDA application register · BLA103411 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA103411 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20200102.

    FDA National Drug Code directory · 72694-954 · 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 Pegaspargase label: indicated for what?


"ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic…": indications and usage on Pegaspargase's label. DailyMed label · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · 2024-10-07

122 registered trials of Pegaspargase — at which phases?


Registered studies posting no result
80 of 122

122 registered studies of Pegaspargase: 65 phase2, 42 phase3, 20 phase1, 6 na, 1 early phase1, 1 na or unstated, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

58 with a PubMed record

Show the evidence
  • phase2
    65
  • phase3
    42
  • phase1
    20
  • na
    6
  • early phase1
    1
  • na or unstated
    1
8 more recorded rows
  • phase4
    1
  • completed
    54
  • unknown
    23
  • terminated
    14
  • active not recruiting
    13
  • recruiting
    12
  • not yet recruiting
    4
  • withdrawn
    2

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

14 of Pegaspargase's trials stopped: safety, accrual/recruitment, funding/business, other?


safety (2), accrual/recruitment (4), funding/business (2) and other (6): Pegaspargase's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Slow accrual"; 14 of 122 registered studies

Show the evidence

Trial

  • NCT00882206
    terminated; "Slow accrual"
  • NCT01005914
    terminated; "Increased rate of bacterial infections"
  • NCT01186328
    terminated; "Enzon Pharmaceuticals decided to end its development of EZN-3042."
  • NCT01483690
    terminated; "Toxicity"
  • NCT01878708
    terminated; "Slow accrual"
  • NCT02043587
    terminated; "Original investigator for the trial has left"
8 further recorded trials
  • NCT02359162
    terminated; "The study is out of date"
  • NCT02419469
    terminated; "Slow Accrual"
  • NCT02419755
    terminated; "Accrual goals were no longer feasible based on restrictions imposed by the DSMB."
  • NCT02518750
    terminated; "Due to slow accrual"
  • NCT02535806
    terminated; "Funding source discontinued"
  • NCT03808610
    terminated; "\<75% participation"
  • NCT05521087
    withdrawn; "Business Decision"
  • NCT06210750
    withdrawn; "Other - Protocol moved to Disapproved"

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

Pegaspargase's half-life is 1.7 days — which schedules were studied?


1.7 days, the half-life Pegaspargase's label states: "The mean half-life of absorption from the IM site was 1.7 days." DailyMed label · ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce · 2024-10-07

bioavailability 82 %.

Show the evidence
  • half life pharmacokinetics
    1.7 days; The mean half-life of absorption from the IM site was 1.7 days.
  • bioavailability pharmacokinetics
    82 %; The relative bioavailability was 82% following the first IM dose and 98% following repeat dosing.

recorded 2024-10-07 · last checked 2026-09-04

Which running trial of Pegaspargase could settle lifespan?


NCT02101853 measures Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients, reading out 2026-09-16.

15 open trials; n 669; "Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia"

Show the evidence

Trial

  • NCT02101853
    "Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia"; n 669; "Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients"; 2026-09-16
  • 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
  • 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
  • NCT06554626
    "Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL"; n 20; "Event free survival(EFS)"; 2027-08-01
  • 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
  • NCT03914625
    "A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia"; n 6720; "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"; 2027-09-30
9 further recorded trials
  • 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
  • NCT04365036
    "A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)"; n 207; "progression free survival (PFS)"; 2028-12-31
  • NCT05700448
    "Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma"; n 150; "Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification"; 2030-12
  • NCT06124157
    "A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)"; n 222; "Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)"; 2030-12-01
  • NCT02553460
    "Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I"; n 50; "Percentage of Treatment-related Mortality (TRM)"; 2031-10
  • NCT03959085
    "Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy"; n 5951; "Post-induction 5-year event-free survival (EFS)"; 2032-03-31
  • NCT07072585
    "Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)"; n 1708; "Event-free survival (EFS) in patients with newly diagnosed T-cell lymphoblastic leukemia (T-ALL)"; 2035-09-01
  • NCT07768943
    "GELAD-Based Response-Adapted Treatment for Early-Stage Extranodal NK/T-Cell Lymphoma"; n 620; "24-Month Progression-Free Survival Rate in PART A"; 2036-06-30

Which 14 trials of Pegaspargase posted no result?


Posted no result
14 of 14 completed trials
Registrations
NCT00002816, NCT00022126, NCT00002590, NCT00002744, NCT00002785 and NCT00005596, and 8 more
Completion dates
oldest 2006-04; newest 2024-05-20
Show the evidence

Trial

  • NCT00002816
    2006-04
  • NCT00022126
    2006-04
  • NCT00002590
    2007-03
  • NCT00002744
    2007-03
  • NCT00002785
    2007-03
  • NCT00005596
    2007-07
8 further recorded trials
  • NCT00005945
    2008-06
  • NCT00967057
    2011-12
  • NCT00819351
    2016-03-02
  • NCT02825147
    2017-07
  • NCT01324180
    2017-07-27
  • NCT01523977
    2018-11
  • NCT03349281
    2022-10-12
  • NCT06527781
    2024-05-20

At the median, Pegaspargase's trials enrolled 100 people — anything larger?


Median enrolment
100
Largest enrolment
9350
Registered trials counted
120

What do 3967 spontaneous reports say about Pegaspargase — 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.

Pegaspargase appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 3967 reaction mentions were counted: febrile neutropenia 1106; febrile bone marrow aplasia 497; pyrexia 486; neutropenia 345. FAERS via Open Targets · CHEMBL2108546 · 2026-06-24

Show the evidence
  • febrile neutropenia
    1106
  • febrile bone marrow aplasia
    497
  • pyrexia
    486
  • neutropenia
    345
  • hypertriglyceridaemia
    296
  • sepsis
    291
4 more recorded rows
  • hypersensitivity
    260
  • hypofibrinogenaemia
    247
  • pancreatitis
    225
  • hyperbilirubinaemia
    214

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

Which 10 reactions does Pegaspargase's label not list?


febrile bone marrow aplasia, febrile neutropenia and hyperbilirubinaemia and 7 more reported for Pegaspargase, absent from its label. FAERS via Open Targets · CHEMBL2108546 · 2026-06-24

2 label terms; 10 reported and unlisted; ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce

Show the evidence
  • febrile bone marrow aplasia
    count not stated
  • febrile neutropenia
    count not stated
  • hyperbilirubinaemia
    count not stated
  • hypersensitivity
    count not stated
  • hypertriglyceridaemia
    count not stated
  • hypofibrinogenaemia
    count not stated
4 more recorded rows
  • neutropenia
    count not stated
  • pancreatitis
    count not stated
  • pyrexia
    count not stated
  • sepsis
    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
CHEMBL2108546
CAS number
130167-69-0
RxCUI
34132
Also called
Asparaginase compd with polyethylene glycol, Asparaginase e. coli compd with polyethylene glycol, Peg-asparaginase, Pegaspargasa, asparaginase, erwinia asparaginase, l-asparaginase, peg-asp, peg-l-asparaginase, (MONOMETHOXYPOLYETHYLENE GLYCOL SUCCINIMIDYL)74-L-ASPARAGINASE, ASPARAGINASE COMPD WITH POLYETHYLENE GLYCOL [MI], ASPARAGINASE E. COLI COMPD WITH POLYETHYLENE GLYCOL 5000
Trade name
Oncaspar
Sources (5)

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: 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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