Pegaspargase clinical trials
Pegaspargase is named as an intervention in 25 current clinical trials in our China, Canada, Israel, Australia, Mexico, Germany, Italy, Switzerland, Austria, Czechia, France, Netherlands, Belgium and Sweden registers. 13 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is National Cancer Institute (NCI) (6). The most-studied condition is B Acute Lymphoblastic Leukemia. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Pegaspargase is approved
All regulators →Of the three regulators tracked here, the first to approve Pegaspargase was the US, on 1 Feb 1994. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Pegaspargase
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Pegaspargase works
All drug targets →- B-cell acute lymphoblastic leukemiaPhase 3
- Chronic myeloid leukemiaPhase 3
- Extranodal nasal NK/T cell lymphomaPhase 3
- Hemophagocytic syndromePhase 3
- LeukemiaPhase 3
- Lymphoblastic lymphomaPhase 3
- Lymphoid leukemiaPhase 3
- Non-Hodgkin lymphomaPhase 3
- B-cell adult acute lymphocytic leukemiaPhase 2/3
- B-cell childhood acute lymphoblastic leukemiaPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108546, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Pegaspargase
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Pegaspargase. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Pegaspargase for treating acute lymphoblastic leukaemia NICE TA408 | Optimised | 28 Sep 2016 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Pegaspargase
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: OncasparEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Pegaspargase
- ATC code
- L01XX24
- ChEMBL
- CHEMBL2108546
- DrugBank
- DB00059
- CAS number
- 130167-69-0
- FDA UNII
- 7D96IR0PPM
- Wikidata
- Q7160547
- Wikipedia
- Pegaspargase
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Pegaspargase
25 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Pegaspargase in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Pegaspargase. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
AIEOP-BFM ALL 2025 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
2025-522190-11-01 · Neoplasms
|
Phase 3 | Authorised | Universitaetsklinikum Schleswig-Holstein AöR | Germany |
|
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 - A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group - IntReALL BCP 2020
2023-509392-17-00 · CTIS ↗ · Hemic and Lymphatic Diseases
|
Phase 3 | Ongoing | Charite Universitaetsmedizin Berlin KöR | Netherlands, Czechia, Italy + 9 more |
Pegaspargase across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Pegaspargase on the HPRA medicines list.
- Oncaspar 750 U/ml powder for solution for injection/infusionLes Laboratoires Servier · EU/1/15/1070/002
Supply shortages
No entry for Pegaspargase in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Pegaspargase
31 conditionsAll 31 conditions
| Condition (as registered) | Trials |
|---|---|
| B Acute Lymphoblastic Leukemia | 5 |
| Acute Lymphoblastic Leukemia | 4 |
| Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type | 3 |
| Recurrent B Acute Lymphoblastic Leukemia | 3 |
| NKTCL | 2 |
| Mixed Phenotype Acute Leukemia | 2 |
| Acute Lymphoblastic Leukemia, Pediatric | 2 |
| Down Syndrome | 2 |
| B Lymphoblastic Lymphoma | 2 |
| Precursor B-Cell Lymphoblastic Leukemia | 1 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | 1 |
| NK/T Cell Lymphoma Nos | 1 |
| T-lymphoblastic Lymphoma | 1 |
| Natural Killer/T-cell Lymphoma | 1 |
| Selinexor | 1 |
| Hematological Neoplasms | 1 |
| NK-T-Cell Lymphoma, Extranodal | 1 |
| T Acute Lymphoblastic Leukemia | 1 |
| B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | 1 |
| Central Nervous System Leukemia | 1 |
| Adult T Acute Lymphoblastic Leukemia | 1 |
| Ann Arbor Stage II Adult Lymphoblastic Lymphoma | 1 |
| Ann Arbor Stage II Childhood Lymphoblastic Lymphoma | 1 |
| Ann Arbor Stage III Adult Lymphoblastic Lymphoma | 1 |
| B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | 1 |
| B Acute Lymphoblastic Leukemia, BCR-ABL1-Like | 1 |
| Lymphoblastic Lymphoma | 1 |
| Acute Lymphoblastic Lymphoma | 1 |
| Recurrent B Lymphoblastic Lymphoma | 1 |
| Refractory B Acute Lymphoblastic Leukemia | 1 |
| Refractory B Lymphoblastic Lymphoma | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Pegaspargase trials
How many clinical trials are testing Pegaspargase?
25 current trials in our China, Canada, Israel, Australia, Mexico, Germany, Italy, Switzerland, Austria, Czechia, France, Netherlands, Belgium and Sweden registers name Pegaspargase as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Pegaspargase trials recruiting patients?
Yes. 13 of the 25 trials are recruiting: 9 with sites in China, 3 with sites in Canada, 3 with sites in Israel, 4 with sites in Australia, 2 with sites in Mexico, 1 with sites in Germany, 1 with sites in Italy, 1 with sites in Switzerland, 1 with sites in Austria and 1 with sites in Czechia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pegaspargase clinical trials?
National Cancer Institute (NCI) (6), Children's Oncology Group (4), Sun Yat-sen University (3) and Fudan University (2), among 13 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Pegaspargase licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Pegaspargase, for example Oncaspar 750 U/ml powder for solution for injection/infusion (Les Laboratoires Servier). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Pegaspargase shortage?
Not in the lists we track: Pegaspargase has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pegaspargase works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pegaspargase works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pegaspargase (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.