Pegaspargase
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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 109 · started per year
Also used as a comparator or background therapy in 88 trials
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-12-13 | Takeda | New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL) takeda.com ↗ |
| 2017-10-13 | Takeda | New Formulation of ONCASPAR® (pegaspargase) Receives Positive CHMP Opinion in Europe for Patients with Acute Lymphoblastic Leukemia (ALL) takeda.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 201 sources stand behind the page.
| Field | Value | Cited 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 ↗145“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 ↗ “During Cycle 1, participants will receive prednisone, vincristine, pegaspargase/calaspargase pegol-mknL, and daunorubicin.” NCT05326516 ↗ “Pegaspargase-modified risk-oriented program for adult acute lymphoblastic leukemia: results of the GIMEMA LAL1913 trial.” PMID 37276451 ↗ Aug 2023 “Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE Natural Killer /T-cell Lymphoma” NCT04366128 ↗ “Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy” NCT03936452 ↗ “Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.” NCT07495631 ↗ “Drug: Pegaspargase Pegaspargase(3750 IU) on day 2, every 3 weeks” NCT06953739 ↗ “Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15” NCT03817320 ↗ “pegaspargase 2500IU/m2 intramuscularly on day 1” NCT07000617 ↗ “* pegaspargase (a type of antineoplastic agent)” NCT07227584 ↗ “Pegaspargase (2000 U/m² intravenously, Day 2)” NCT07385989 ↗ “Pegaspargase 2500 international unit day 1” NCT02520479 ↗ “Pegaspargase :3750U/m2 im on days 8,22” NCT02396043 ↗ “Pegaspargase, 2500IU/m2/d im, day 4” NCT02764281 ↗ “Pegaspargase, 2000IU/m2/d IM, day 4” NCT02733458 ↗ “PEG-aspargase 6000iu/m2 day2, day4” NCT05775705 ↗ “pegaspargase 2000U/m2 im on day 1” NCT02560441 ↗ “Lyophilized Pegaspargase (S95014)” NCT04956666 ↗ “Pegaspargase, 2500U/m2, i.m. d1” NCT06069830 ↗ “Pegaspargase, 2500U/m2, IM, d1” NCT06573151 ↗ “Pegaspargase 3750U im D1;” NCT06824883 ↗ |
| 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 ↗ “Peg-asparaginase 2000 IU/m2 I.V. - D4 and D18” NCT06034561 ↗ “Drug: Pegaspargase (PEG) Asparaginase” NCT07525466 ↗ “Pegaspargase (PEG) Asparaginase” NCT07554482 ↗ “Pegaspargase (PEG) Asparaginase” NCT03860844 ↗ |
| 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 ↗ |
| 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-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 ↗ |
| 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 NCT01117441 ↗ |
| Known as | pegylated asparaginase | “Patients received induction chemotherapy with vincristine, prednisone, doxorubicin, and pegylated asparaginase.” PMID 27171984 ↗ May 2016 |
| Known as | Pegylated-L-asparaginase | “Pegylated-L-asparaginase is designed to get rid of an important building block of proteins in leukemia cells.” NCT00905034 ↗ |
| Known as | polyethylene | “Patients were treated with a combination of punctal dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate...” NCT06798025 ↗ |
| 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 ↗ |
| Known as | SHP674 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04067518 ↗ |
| 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 ↗ |