Overview
Asparaginase derived from Escherichia coli (L-asparagine amidohydrolase, EC 3.5.1.1) is an enzyme responsible for the metabolism of L-asparagine, by catalyzing L-asparagine into L-aspartic acid and ammonia. It also facilitates the production of oxaloacetate which is needed for general cellular metabolism. Asparaginase from E. coli has clinically shown to exhibit antitumor actions in models of leukaemias . L-asparaginase of E. coli is marketed under several different trade names, including Elspar, for the treatment of acute lymphoblastic leukemia (ALL) as part of a multi-agent chemotherapeutic regimen. It is available as intramuscular or intravenous injections. Therapeutic L-asparaginase from E. coli works by depleting the levels of non-essential amino acid, asparagine, in lymphoblastic leukemic cells thus promoting apoptotic cell death . For patients who develop hypersensitivity to E. coli-derived formulations of L-asparaginase, the use of PEGylated or non-PEGylated Asparaginase Erwinia chrysanthemi is recommended .
Indication
Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL).
Associated Conditions
- Acute Lymphoblastic Leukaemias (ALL)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/06 | Not Applicable | Completed | Chang Gung Memorial Hospital | ||
2024/03/28 | Phase 2 | Recruiting | |||
2020/06/19 | Phase 2 | Not yet recruiting | wang, jianxiang | ||
2020/01/18 | Phase 1 | Withdrawn | National Cancer Centre, Singapore | ||
2019/12/05 | N/A | Completed | Aarhus University Hospital | ||
2019/01/25 | Phase 1 | Active, not recruiting | Therapeutic Advances in Childhood Leukemia Consortium | ||
2018/09/12 | Phase 2 | Terminated | |||
2018/08/09 | Phase 3 | UNKNOWN | |||
2017/09/18 | Phase 2 | Recruiting | National Hospital Organization Nagoya Medical Center | ||
2017/05/23 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Jazz Pharmaceuticals, Inc. | 68727-900 | INTRAMUSCULAR | 20 mg in 1 mL | 6/30/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/14/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LEUNASE FOR INJECTION 10,000 iu/vial | SIN01989P | INJECTION, POWDER, FOR SOLUTION | 10000 iu/vial | 6/23/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Asparaginase (Escherichia) for Injection | 国药准字H20065348 | 化学药品 | 注射剂(冻干粉针剂) | 8/9/2021 | |
| Asparaginase (Escherichia) for Injection | 国药准字H20057369 | 化学药品 | 注射剂(冻干粉针剂) | 12/29/2020 | |
| Asparaginase (Escherichia) for Injection | 国药准字H37022254 | 化学药品 | 注射剂 | 1/27/2021 | |
| Asparaginase (Escherichia) for Injection | 国药准字H20023613 | 化学药品 | 注射剂 | 6/15/2020 | |
| Asparaginase (Escherichia) for Injection | 国药准字H19993914 | 化学药品 | 注射剂 | 3/9/2020 | |
| Asparaginase (Escherichia) for Injection | 国药准字H19993445 | 化学药品 | 注射剂 | 9/5/2020 | |
| Asparaginase (Escherichia) for Injection | 国药准字H19993107 | 化学药品 | 注射剂 | 6/15/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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