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Drugs / Pegaspargase
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Pegaspargase

also known as PEG Asparaginase · ONCASPAR · PEG-L-asparaginase · PEG-ASP · S95014 · Oncaspar (PEG-Asparaginase) · Oncospar · PEG-ASNASE · +3 more

Protein / enzyme biologic

Developed for
extranodal nasal NK/T cell lymphoma · acute lymphoblastic leukemia · leukemia · lymphoblastic lymphoma · mature T-cell and NK-cell non-Hodgkin lymphoma · lymphoma · B-cell childhood acute lymphoblastic leukemia · B-cell acute lymphoblastic leukemia
+25 more · T-cell acute lymphoblastic leukemia · T-lymphoblastic lymphoma · acute leukemia · adult acute lymphoblastic leukemia · B-cell adult acute lymphocytic leukemia · childhood acute lymphoblastic leukemia · precursor B-cell acute lymphoblastic leukemia · secondary hemophagocytic lymphohistiocytosis · B-lymphoblastic leukemia/lymphoma with hypodiploidy · B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2) · fallopian tube cancer · hematopoietic and lymphoid cell neoplasm · hemophagocytic syndrome · Hodgkins lymphoma · lymphoblastic leukemia, acute, with lymphomatous features · lymphoid leukemia · mixed phenotype acute leukemia · non-Hodgkin lymphoma · ovarian cancer · peripheral T-cell lymphoma, not otherwise specified · plasma cell myeloma · precursor lymphoblastic lymphoma/leukemia · primary peritoneal carcinoma · T-cell and NK-cell neoplasm · T-cell non-Hodgkin lymphoma
Investigated by
National Cancer Institute (NCI) · Sun Yat-sen University · Children's Oncology Group · St. Jude Children's Research Hospital · Dana-Farber Cancer Institute · Beijing Tongren Hospital
+99 more · Enzon Pharmaceuticals, Inc. · M.D. Anderson Cancer Center · Ruijin Hospital · Peking University Cancer Hospital & Institute · Rong Tao · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · ADIR, a Servier Group company · Chinese Academy of Medical Sciences · Deutsche Krebshilfe e.V., Bonn (Germany) · Eli Lilly and Company · Fudan University · Hebei Medical University Fourth Hospital · Hunan Cancer Hospital · Les Laboratoires Servier (L.L.S), Russia · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Mingzhi Zhang · Nordic Society for Pediatric Hematology and Oncology · Peking University · Peking University International Hospital · Servier · Servier · Shanxi Province Cancer Hospital · Shire · The First Affiliated Hospital with Nanjing Medical University · 307 Hospital of PLA · Alliance for Clinical Trials in Oncology · Amgen · Assistance Publique - Hôpitaux de Paris · Beijing Friendship Hospital · Beth Israel Deaconess Medical Center · Boston Children's Hospital · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Cancer Hospital of Guizhou Province · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · China Food and Drug Administration · Chinese PLA General Hospital · Danish Child Cancer Foundation · Duke University · Federal Research Institute of Pediatric Hematology, Oncology and Immunology · First Affiliated Hospital of Zhejiang University · First Hospital of China Medical University · GIMEMA Foundation · Genzyme, a Sanofi Company · Goethe University · Guangdong Provincial People's Hospital · Hoffmann-La Roche · Huiqiang Huang · Incyte Corporation · Institute of Hematology & Blood Diseases Hospital, China · Jazz Pharmaceuticals · Jiangxi Provincial Cancer Hospital · LIANG WANG · Leadiant Biosciences, Inc. · Lehigh Valley Health Network · Medac, Hamburg, Germany · Medical Research Council · Milton S. Hershey Medical Center · NCIC Clinical Trials Group · Nanfang Hospital, Southern Medical University · National Institute of General Medical Sciences (NIGMS) · National University of Singapore · Navy General Hospital, Beijing · OHSU Knight Cancer Institute · Ohio State University Comprehensive Cancer Center · Peking Union Medical College Hospital · People's Hospital of Guangxi Zhuang Autonomous Region · Pfizer · Qilu Hospital of Shandong University · Qingdao University · Rigshospitalet, Denmark · Second Hospital of Shanxi Medical University · Shandong Cancer Hospital and Institute · Shanxi Dayi Hospital · all 105 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) ONCASPAR — 2006-07-24 – 2019-01-03 fda.gov ↗
Approved EU (EMA) Oncaspar — 2016-01-14 europa.eu ↗
Approved US (FDA) ONCASPAR — 1994-02-01 fda.gov ↗

Trials 105 · started per year

today
US approved 1994
EU approved 2016
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT01878708 Jul 2013 → Feb 2017 T-cell non-Hodgkin lymphoma Dana-Farber Cancer Institute Terminated No outcome recorded Stop: Enrollment
Phase 13 trials
Phase 1 NCT03962465 Jul 2022 → Jul 2023 overdue B-cell acute lymphoblastic leukemia University of Virginia Active not recruiting No outcome recorded
Phase 1 NCT00866307 Feb 2009 → Jun 2014 B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia Children's Oncology Group Completed No outcome recorded
Phase 1 NCT00363610 Jul 2006 → Nov 2007 lymphoma Enzon Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT07525466 Apr 2026 → Mar 2028 expected extranodal nasal NK/T cell lymphoma, secondary hemophagocytic lymphohistiocytosis Beijing Tongren Hospital Recruiting No outcome recorded
Phase 1/2 NCT06176027 Oct 2024 → Sep 2028 expected peripheral T-cell lymphoma, not otherwise specified Navy General Hospital, Beijing Recruiting No outcome recorded
Phase 1/2 NCT06559553 Sep 2024 → Dec 2026 expected T-cell and NK-cell neoplasm Mingzhi Zhang Recruiting No outcome recorded
Phase 1/2 NCT06376721 Apr 2024 → Oct 2026 expected T-lymphoblastic lymphoma, extranodal nasal NK/T cell lymphoma Beijing Tongren Hospital Recruiting No outcome recorded
Phase 1/2 NCT04509466 Sep 2020 → Jan 2022 extranodal nasal NK/T cell lymphoma CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 252 trials · 3 met primary
Phase 2 NCT07574528 May 2026 → Mar 2028 expected extranodal nasal NK/T cell lymphoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07227584 Apr 2026 → Jul 2030 expected acute lymphoblastic leukemia Dana-Farber Cancer Institute Not yet recruiting No outcome recorded
Phase 2 NCT07457177 Feb 2026 → Jan 2028 expected extranodal nasal NK/T cell lymphoma LIANG WANG Not yet recruiting No outcome recorded
Phase 2 NCT07000617 Mar 2025 → Dec 2026 expected mature T-cell and NK-cell non-Hodgkin lymphoma Peking University Cancer Hospital & Institute Recruiting No outcome recorded
Phase 2 NCT06573151 Sep 2024 → Jul 2027 expected lymphoma Ruijin Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06554626 Aug 2024 → Aug 2026 overdue precursor B-cell acute lymphoblastic leukemia First Affiliated Hospital of Zhejiang University Recruiting No outcome recorded
Phase 2 NCT06824883 May 2024 → May 2026 overdue extranodal nasal NK/T cell lymphoma Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 2 NCT06314334 Mar 2024 → Dec 2026 expected extranodal nasal NK/T cell lymphoma Fudan University Recruiting No outcome recorded
Phase 2 NCT04845035 Jan 2024 → Jan 2026 acute lymphoblastic leukemia University of Michigan Rogel Cancer Center Withdrawn No outcome recorded
Phase 2 NCT04676789 Sep 2021 → Sep 2024 extranodal nasal NK/T cell lymphoma Sun Yat-sen University Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03117751 Mar 2017 → Sep 2026 overdue lymphoblastic leukemia, acute, with lymphomatous features St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 326 trials · 1 missed
Phase 3 NCT07678229 Jul 2026 → Dec 2031 expected mature T-cell and NK-cell non-Hodgkin lymphoma Rong Tao Not yet recruiting No outcome recorded
Phase 3 NCT06953739 May 2025 → Dec 2027 expected mature T-cell and NK-cell non-Hodgkin lymphoma The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase 3 NCT04043494 Aug 2019 → Apr 2030 expected lymphoblastic lymphoma University Hospital Muenster Recruiting No outcome recorded
Phase 3 NCT03007147 Aug 2017 → Jun 2026 overdue B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, mixed phenotype acute leukemia Children's Oncology Group Active not recruiting No outcome recorded
Phase 3 NCT03020030 Mar 2017 → Nov 2026 expected childhood acute lymphoblastic leukemia Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 3 NCT02716233 Sep 2016 → Apr 2022 overdue acute lymphoblastic leukemia Assistance Publique - Hôpitaux de Paris Active not recruiting No outcome recorded
Phase 3 NCT02912702 Sep 2016 → Sep 2018 secondary hemophagocytic lymphohistiocytosis Beijing Friendship Hospital Unknown No outcome recorded
Phase 3 NCT02881086 Aug 2016 → Dec 2024 acute lymphoblastic leukemia, lymphoblastic lymphoma Goethe University Completed No outcome recorded
Phase 3 NCT02359162 May 2015 → Jun 2017 extranodal nasal NK/T cell lymphoma Sun Yat-sen University Terminated No outcome recorded
Phase 3 NCT02085655 Apr 2013 → Dec 2022 extranodal nasal NK/T cell lymphoma Huiqiang Huang Unknown No outcome recorded
Phase 45 trials · 1 met primary
Phase 4 NCT04999878 May 2021 → Jun 2023 hemophagocytic syndrome, mature T-cell and NK-cell non-Hodgkin lymphoma Zhengzhou University Unknown No outcome recorded
Phase 4 NCT03844360 Jan 2016 → Dec 2025 overdue hematopoietic and lymphoid cell neoplasm Wei Zhao Recruiting No outcome recorded
Phase 4 NCT01501149 Jan 2011 → Dec 2015 extranodal nasal NK/T cell lymphoma Mingzhi Zhang Unknown Met primary
Phase 4 NCT00192673 Jun 2005 → Dec 2013 acute lymphoblastic leukemia Nordic Society for Pediatric Hematology and Oncology Unknown No outcome recorded
Phase 4 NCT00222612 Oct 2003 → Aug 2013 acute lymphoblastic leukemia University of Oxford Unknown No outcome recorded
Phase not applicable11 trials
— NCT07495631 Apr 2026 → Mar 2028 expected adult acute lymphoblastic leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
— NCT06069830 Dec 2023 → Oct 2026 expected extranodal nasal NK/T cell lymphoma Ruijin Hospital Recruiting No outcome recorded
— NCT05426824 Jul 2022 → Jul 2024 extranodal nasal NK/T cell lymphoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
— NCT05058755 Sep 2021 → Dec 2022 extranodal nasal NK/T cell lymphoma Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
— NCT04366128 Apr 2020 → Dec 2021 extranodal nasal NK/T cell lymphoma Rong Tao Unknown No outcome recorded
— NCT02733458 Mar 2016 → Apr 2021 extranodal nasal NK/T cell lymphoma Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
— NCT02764281 Apr 2015 → Feb 2020 extranodal nasal NK/T cell lymphoma Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
— NCT01953770 Feb 2008 → Jan 2015 childhood acute lymphoblastic leukemia Federal Research Institute of Pediatric Hematology, Oncology and Immunology Unknown No outcome recorded
— NCT00096135 Nov 2004 → Sep 2013 leukemia Children's Oncology Group Completed No outcome recorded
— NCT00343369 Jan 2003 → ? leukemia University Medical Center Hamburg-Eppendorf Unknown No outcome recorded
Phase not stated1 trial · 1 missed
— NCT01085617 Dec 2010 → Feb 2025 leukemia, mouth disorder, mucositis University College, London Completed Missed primary
Comparator or background therapy86 trials
Phase 1 NCT05521087 Background Dec 2025 → Sep 2026 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia Janssen Research & Development, LLC Withdrawn No outcome recorded Stop: Business
Phase 1 NCT06527781 Comparator Nov 2023 → May 2024 acute lymphoblastic leukemia, lymphoblastic lymphoma Chongqing Peg-Bio Biopharm Co., Ltd. Completed No outcome recorded
Phase 1 NCT05157971 Background Mar 2022 → Apr 2027 expected B-lymphoblastic leukemia/lymphoma, BCR-ABL1–like City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1 NCT05326516 Background Mar 2022 → Jul 2024 acute lymphoblastic leukemia, acute undifferentiated leukemia, mixed phenotype acute leukemia Syndax Pharmaceuticals Completed No outcome recorded
Phase 1 NCT03571321 Background May 2019 → Sep 2026 overdue childhood acute lymphoblastic leukemia University of Chicago Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2017-12-13 Takeda Regulatory New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL) takeda.com ↗
Zug, Switzerland – December 13, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, today announced that the European Commission (EC) granted Marketing Authorization for lyophilized ONCASPAR (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients.
2017-10-13 Takeda Regulatory New Formulation of ONCASPAR® (pegaspargase) Receives Positive CHMP Opinion in Europe for Patients with Acute Lymphoblastic Leukemia (ALL) takeda.com ↗
The CHMP's positive opinion will be submitted to the European Commission (EC), which is responsible for granting marketing authorizations for medicines in the EU.

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 195 sources stand behind the page.

FieldValueCited text
Known as pegaspargase “Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1;...” NCT06176027 ↗
144

“The purpose of this research study is for the study's sponsor, Enzon Pharmaceuticals, Inc. ("Enzon"), to learn more about its drug pegaspargase. Pegaspargase is the drug's...” NCT00363610 ↗

“with varied cycles, including Daunorubicin, Vincristine, Prednisone, Pegaspargase, Rituximab, Cytarabine, Mercaptopurine, Cyclophosphamide, Methotrexate, Doxorubicin,...” NCT04845035 ↗

“Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA...” NCT05192889 ↗

“A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)” NCT04954326 ↗

“gemcitabine ：1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days” NCT02080234 ↗

“Gemcitabine 1.0 g/m² on day 1, etoposide 60 mg/m² on days 1-3, pegaspargase 2000 IU/m² on day 4, and dexamethasone 40 mg on days 1-4, repeated every 21 days for 1 cycle.” NCT07678229 ↗

“Multi-agent chemotherapy including vincristine, prednisone, daunorubicin, cyclophosphamide, pegaspargase, cytarabine, 6-MP, MTX, and dexamethasone per protocol phases.” NCT07454226 ↗

“The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works differently from standard chemotherapy, has been approved to treat leukemia” NCT01313078 ↗

“Treatment comprised up to eight 21-day cycles of sintilimab 200 mg (day 1), pegaspargase 2500 IU/m2 (day 1), and anlotinib 8 mg (days 1-14)” PMID 41774854 ↗ Mar 2026

“Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip” NCT06583083 ↗

Show 134 more sources
Known as ONCASPAR “Pegaspargase is the drug's scientific or generic name. Because it is already approved by the Food and Drug Administration (FDA), it also has a brand name - ONCASPAR®.” NCT00363610 ↗
6

“The pharmacokinetics of the polyethylene glycol (PEG)-conjugated asparaginase Oncaspar® are characterized by an increase in elimination over time.” PMID 28349335 ↗ Dec 2017

“Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native ASNase.” NCT02716233 ↗

NCT00363610 ↗

NCT01251809 ↗

NCT01574274 ↗

NCT00837200 ↗
Known as Oncaspar (PEG-Asparaginase) “Oncaspar (PEG-Asparaginase)” NCT00819351 ↗
Known as Oncospar “PEG-Asparaginase (also called Oncospar), which remains in the body for about two weeks” NCT00184041 ↗
Known as PEG Asparaginase “Patients received a maximum of 2 cycles of the intravenous (IV) 5-drug regimen (clofarabine, etoposide,cyclophosphamide, PEG-asparaginase, and vincristine) plus intrathecal...” NCT00991133 ↗
39

“Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2...” NCT01667302 ↗

“Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available),...” NCT04501614 ↗

“PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)” NCT00819351 ↗

“Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase” NCT03236857 ↗

“native Escherichia coli asparaginase, polyethylene glycol linked to asparaginase (PEG-asparaginase)” NCT02013167 ↗

“The ALLR3 chemotherapy regimen (vincristine, mitoxantrone, dexamethasone, and PEG-asparaginase” NCT05748171 ↗

“peg-asparaginase (or other form of asparaginase, per local standard of care (intravenous)” NCT03181126 ↗

“Pegylated E coli asparaginase (PEG-asparaginase) has a longer half-life” NCT00400946 ↗

“Augmented consolidation: vincristine, Peg-asparaginase.” NCT00222612 ↗

“PEG-Asparaginase 2500 U/m2/day IM Days 8, 15, 22, 29” NCT00187083 ↗

Show 29 more sources
Known as PEG-ASNASE “intensive exposure to pegylated L-asparaginase (PEG-ASNASE, 2,500 IU/sqm once a week × 4)” PMID 38096462 ↗ Dec 2023
Known as PEG-ASP “pegaspargase (PEG-ASP) IV over 1 hour or IM” NCT00550992 ↗
1

“Pegylated Asparaginase (Peg-ASP)” NCT02067143 ↗
Known as PEG-L-ASP “pegylated L-asparaginase (PEG-L-ASP) on days 12 and 26” NCT01117441 ↗
Known as PEG-L-asparaginase ClinicalTrials.gov intervention name — accepted as the source's own label NCT00187005 ↗
6

NCT01953770 ↗

NCT02419755 ↗

NCT01878708 ↗

NCT01117441 ↗

NCT00549848 ↗

NCT00137111 ↗
Known as pegylated asparaginase “Patients received induction chemotherapy with vincristine, prednisone, doxorubicin, and pegylated asparaginase.” PMID 27171984 ↗ May 2016
Known as polyethylene glycol (PEG)-asparaginase “Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available),...” NCT04501614 ↗
Known as S95014 “A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)” NCT04954326 ↗
1

“Lyophilized Pegaspargase (S95014)” NCT04956666 ↗
Action Inhibit “blocking some of the enzymes needed for cell growth” NCT00866307 ↗
Modality Protein / enzyme biologic “PEG-asparaginase, has a longer half-life and is potentially less immunogenic than native E coli L-asparaginase” NCT00400946 ↗
Route Intramuscular “pegaspargase IV or intramuscularly (IM) on day 1” NCT00002766 ↗
Route Intravenous “pegaspargase IV or intramuscularly (IM) on day 1” NCT00002766 ↗