Drugs / asparaginase
asparaginase
also known as
L-Asparaginase · ASP · NSC-109229 · E. coli asparaginase · asparaginase (E. Coli) · E-coli L-asparaginase · Kidrolase · L-ASA · +10 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Spectrila | — | 2016-01-14 | europa.eu ↗ |
| Approved | US (FDA) | ELSPAR | — | 1978-01-10 | fda.gov ↗ |
Trials 67 · started per year
today
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EU approved 2016
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Also used as a comparator or background therapy in 51 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00028899 Background | Jul 2002 → Sep 2006 | leukemia, myelodysplastic syndrome | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07585734 Background | Apr 2025 → Apr 2026 | T-cell acute lymphoblastic leukemia | Institute of Hematology & Blood Diseases Hospital, China | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03246750 Background | Jan 2019 → Apr 2024 | extranodal nasal NK/T cell lymphoma | The Thai Lymphoma Study Group | Completed | No outcome recorded |
| Phase 1/2 | NCT00098839 Background | Feb 2005 → Apr 2011 | childhood acute lymphoblastic leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1/2 | NCT00061945 Background | Jun 2003 → Dec 2007 | B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell adult acute lymphocytic leukemia, T-cell childhood acute lymphocytic leukemia +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT06099366 Background | Mar 2024 → Dec 2033 expected | childhood acute lymphoblastic leukemia | Hee Young Ju | Recruiting | No outcome recorded |
| Phase 2 | NCT04440267 Background | Jul 2020 → Jun 2026 overdue | acute leukemia of ambiguous lineage | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06336395 Background | Mar 2020 → Mar 2030 expected | B-cell acute lymphoblastic leukemia | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT03860844 Background | Aug 2019 → Sep 2022 | acute lymphoblastic leukemia, acute myeloid leukemia | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT00873093 Background | Mar 2009 → Sep 2014 | B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell adult acute lymphocytic leukemia, T-cell childhood acute lymphocytic leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00262925 Background | Jun 2006 → Oct 2012 | adult acute lymphoblastic leukemia | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00458848 Background | Oct 2004 → Mar 2014 | leukemia | GIMEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT00195871 Background | Feb 2004 → Jun 2014 | lymphoblastic lymphoma | Centre Henri Becquerel | Unknown | No outcome recorded |
| Phase 2 | NCT00070174 Background | Dec 2003 → Sep 2006 | leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00022126 Background | Nov 2002 → Jan 2005 | leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00131053 Background | Sep 2002 → May 2011 | acute lymphoblastic leukemia | Japan Adult Leukemia Study Group | Unknown | No outcome recorded |
| Phase 2 | NCT00176462 Background | Feb 2001 → Sep 2008 | acute lymphoblastic leukemia | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| Phase 2 | NCT00002785 Background | Jul 1996 → Aug 2000 | leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00002756 Background | Jun 1996 → Sep 2007 | leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00002704 Background | Jan 1996 → Jun 2004 | leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00002471 Background | Feb 1990 → Jan 2003 | leukemia, lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02451774 Comparator | Jan 2015 → Dec 2019 | childhood acute lymphoblastic leukemia | Ramón Óscar González-Ramella, Ph.D | Unknown | No outcome recorded |
| Phase 2/3 | NCT01518517 Comparator | Dec 2009 → Sep 2014 | acute lymphoblastic leukemia | ERYtech Pharma | Completed | No outcome recorded |
| Phase 2/3 | NCT00720109 Background | Jul 2008 → Dec 2014 | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), acute lymphoblastic leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT02665065 Comparator | Jun 2016 → Jun 2022 overdue | acute myeloid leukemia | Actinium Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02101853 Comparator | Dec 2014 → Jun 2021 overdue | B-cell acute lymphoblastic leukemia | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01371981 Background | Jul 2011 → Mar 2019 | myeloid sarcoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00557193 Background | Jan 2008 → Sep 2017 | T-cell childhood acute lymphocytic leukemia, acute undifferentiated leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00381680 Background | Mar 2007 → Mar 2016 | B-cell childhood acute lymphoblastic leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00408005 Comparator | Jan 2007 → Sep 2017 | T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00372593 Background | Aug 2006 → Aug 2013 | leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00400946 Comparator | Apr 2005 → Aug 2014 | leukemia, poisoning | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 3 | NCT00275106 Background | Sep 2004 → Dec 2009 | lymphoma | Children's Cancer and Leukaemia Group | Terminated | No outcome recorded |
| Phase 3 | NCT00022737 Background | Oct 2002 → Oct 2006 | childhood acute lymphoblastic leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00967057 Background | Oct 2002 → Jan 2010 | acute leukemia | Children's Cancer and Leukaemia Group | Completed | No outcome recorded |
| Phase 3 | NCT00131027 Background | Sep 2002 → Mar 2011 | acute lymphoblastic leukemia | Japan Adult Leukemia Study Group | Unknown | No outcome recorded |
| Phase 3 | NCT00136084 Background | Aug 2002 → Jul 2008 | acute myeloid leukemia | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00019409 Background | Oct 1999 → Jul 2001 | leukemia | National Institutes of Health Clinical Center (CC) | Withdrawn | No outcome recorded |
| Phase 3 | NCT00003437 Background | Jan 1997 → ? | leukemia | Medical Research Council | Unknown | No outcome recorded |
| Phase 3 | NCT01230983 Background | Jun 1996 → Sep 2001 | acute leukemia, chemotherapy-induced toxicity, lymphoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002744 Background | May 1996 → Mar 2007 | leukemia | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002700 Background | Aug 1995 → Mar 2004 | acute leukemia, lymphoma | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 3 | NCT00002514 Background | May 1993 → Dec 2006 | leukemia | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT01358253 Background | Dec 2010 → Dec 2012 | adult acute lymphoblastic leukemia | Ruijin Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00199004 Background | Apr 2004 → Mar 2009 | adult acute lymphoblastic leukemia | Johann Wolfgang Goethe University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00198991 Background | Apr 2003 → Jun 2011 | adult acute lymphoblastic leukemia | Goethe University | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT03390387 Comparator | Nov 2015 → Nov 2020 | childhood acute lymphoblastic leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| — | NCT01953770 Comparator | Feb 2008 → Jan 2015 | childhood acute lymphoblastic leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| — | NCT00550992 Background | Jan 2006 → Dec 2020 | leukemia | Dutch Childhood Oncology Group | Unknown | No outcome recorded |
| — | NCT00049569 Background | Jan 2003 → Mar 2006 | T-cell childhood acute lymphocytic leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| — | NCT00016302 Background | Apr 2001 → Jul 2007 | T-cell childhood acute lymphocytic leukemia | National Cancer Institute (NCI) | Completed | No outcome recorded |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 122 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Asparaginase | “Asparaginase 10,000 U/m2/dose IM days 2, 4, 6, 8, 10, 12” NCT00187057 ↗72“ASPARAGINASE 20.000 u/m2 i.m. day 22” NCT00526409 ↗ |
| Known as | 106977 (Erwinia) | “ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia)” NCT00002704 ↗ |
| Known as | ASNase | “three currently used asparaginase (ASNase) preparations” PMID 20108339 ↗ Jul 2010 |
| Known as | ASP | “asparaginase (ASP) IV over 30 minutes or intramuscularly on days 17-28.” NCT00002514 ↗8“ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia)” NCT00002704 ↗ “asparaginase (ASP) IV over 1 hour or intramuscularly (IM)” NCT00550992 ↗ “Asparaginase (E. coli), ASP, NSC-109229” NCT00002471 ↗ “asparaginase (ASP) IV over 30 minutes” NCT00002531 ↗ “asparaginase (ASP) on days 12-33” NCT00613457 ↗ “asparaginase (ASP) on days 12-33” NCT00430118 ↗ “Asparaginase, ASP, NSC-109229” NCT00002499 ↗ “ASP Asparaginase, NSC-109229” NCT00002691 ↗ |
| Known as | asparaginase (E. Coli) | “Asparaginase (E. coli), ASP, NSC-109229” NCT00002471 ↗ |
| Known as | Asparaginase medac | “native E.coli asparaginase (Asparaginase medac).” PMID 29727043 ↗ May 2018 |
| Known as | E-coli L-asparaginase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03286634 ↗ |
| Known as | E. coli asparaginase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00165178 ↗ |
| Known as | EC-Asnase | “We assessed the toxicity and efficacy of dexamethasone and a novel dosing method of Escherichia coli L-asparaginase (EC-Asnase) in children and adolescents with newly diagnosed...” PMID 23358966 ↗ Jan 2013 |
| Known as | Erwinase | “L - Asparaginase (Erwinase)” NCT03860844 ↗ |
| Known as | ERYASPASE | “The investigational product ERYASPASE is a dispersion for infusion of homologous red blood cells (RBC) encapsulating E. coli L-asparaginase.” NCT01910428 ↗ |
| Known as | Escherichia coli L-asparaginase | “We assessed the toxicity and efficacy of dexamethasone and a novel dosing method of Escherichia coli L-asparaginase (EC-Asnase) in children and adolescents with newly diagnosed...” PMID 23358966 ↗ Jan 2013 |
| Known as | Kidrolase | “L -asparaginase ( L -ASA ) of E. coli ( Kidrolase ® ) : 10,000 IU/m2 , iv , 16-20 , 23-27 .” NCT02036489 ↗ |
| Known as | L-ASA | “L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.” NCT00526175 ↗1“L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13” NCT00526305 ↗ |
| Known as | L-Asparaginase | “VDCLP regimen (vincristine, daunorubicin, cyclophosphamide, L-asparaginase, and prednisone) combined with CM313 at the RP2D during induction therapy.” NCT07585734 ↗38“L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23” NCT02451774 ↗ “SMILE (dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide) chemotherapy” PMID 35708709 ↗ Jul 2022 “fixed-dose MAD (Methotrexate, L-asparaginase and Dexamethasone) chemotherapy” NCT03246750 ↗ “L-asparaginase 6,000 IU/m2(days 2-4 start, total 9 doses for 3 weeks)” NCT05827549 ↗ “L-asparaginase (SPECTRILA) : 5000 units/m² IV at D2, 5, 8, 11” NCT03599960 ↗ “L-asparaginase (10 000 U/m2, i.m., weekly)” NCT03390387 ↗ “L-Asparaginase” NCT02665065 ↗ |
| Known as | native E coli L-asparaginase | “intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses” NCT00400946 ↗ |
| Known as | NSC-109229 | “ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia)” NCT00002704 ↗3“Asparaginase (E. coli), ASP, NSC-109229” NCT00002471 ↗ “Asparaginase, ASP, NSC-109229” NCT00002499 ↗ “ASP Asparaginase, NSC-109229” NCT00002691 ↗ |
| Known as | Oncospar | “Patients on Oncospar” NCT03668392 ↗ |
| Known as | SPECTRILA | “L-asparaginase (SPECTRILA) : 5000 units/m² IV at D2, 5, 8, 11” NCT03599960 ↗ |
| Modality | Protein / enzyme biologic | “Asparaginase is a therapeutic enzyme used to treat leukemia and lymphoma” PMID 24970932 ↗ Jun 2014 |
| Route | Intramuscular | “asparaginase (ASP) IV over 30 minutes or intramuscularly” NCT00002514 ↗ |
| Route | Intravenous | “asparaginase (ASP) IV over 30 minutes or intramuscularly” NCT00002514 ↗ |