Elspar, Spectrila(asparaginase)
Elspar, Spectrila (asparaginase) is an enzyme pharmaceutical. Asparaginase was first approved as Elspar on 1978-01-10. It is used to treat cholelithiasis, lymphoma, and precursor cell lymphoblastic leukemia-lymphoma in the USA. It has been approved in Europe to treat precursor cell lymphoblastic leukemia-lymphoma.
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Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Asparaginase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Elspar | asparaginase | Recordati Rare Diseases, Inc. | N-101063 DISCN | 1978-01-10 | 1 products |
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Agency Specific
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Clinical
Clinical Trials
175 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 2 | 20 | 21 | — | 5 | 47 | |
| Lymphoma | D008223 | C85.9 | — | 6 | 7 | — | — | 13 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | 4 | 6 | — | — | 11 | |
| Myelodysplastic syndromes | D009190 | D46 | 1 | 1 | 5 | — | — | 7 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 3 | 1 | — | — | 5 | |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 1 | 2 | — | — | 3 |
| Megakaryoblastic leukemia acute | D007947 | C94.2 | — | — | 2 | — | — | 2 | |
| Monocytic leukemia acute | D007948 | — | — | 2 | — | — | 2 | ||
| Myelomonocytic leukemia acute | D015479 | C92.5 | — | — | 2 | — | — | 2 | |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| T-cell lymphoma | D016399 | 2 | 1 | — | — | 1 | 4 | ||
| Biphenotypic leukemia acute | D015456 | C95.0 | 1 | 4 | — | — | — | 4 | |
| Extranodal nk-t-cell lymphoma | D054391 | C86.0 | — | 1 | — | — | 1 | 2 | |
| Philadelphia chromosome | D010677 | 2 | 1 | — | — | — | 2 | ||
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | 1 | 1 | — | — | — | 2 | ||
| Hematologic neoplasms | D019337 | 1 | 1 | — | — | — | 2 | ||
| Inborn genetic diseases | D030342 | EFO_0000508 | — | 1 | — | — | — | 1 | |
| T-cell leukemia | D015458 | — | 1 | — | — | — | 1 | ||
| B-cell leukemia | D015448 | — | 1 | — | — | — | 1 | ||
| Neutropenia | D009503 | D70 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ASPARAGINASE |
| INN | crisantaspase |
| Description | Asparaginase is an enzyme that is used as a medication and in food manufacturing. As a medication, L-asparaginase is used to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). It is given by injection into a vein, muscle, or under the skin. A pegylated version is also available. In food manufacturing it is used to decrease acrylamide.
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| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
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Safety
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177 adverse events reported
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