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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Commercial
Therapeutic Areas
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Drug Products
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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)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lymphoma | — | D008223 | C85.9 |
| precursor cell lymphoblastic leukemia-lymphoma | — | D054198 | C91.0 |
| cholelithiasis | EFO_0004799 | D002769 | K80 |
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Clinical
Clinical Trials
303 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 40 | 99 | 72 | 14 | 25 | 227 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 37 | 97 | 67 | 16 | 32 | 227 |
| Lymphoid leukemia | D007945 | — | C91 | 36 | 87 | 57 | 13 | 22 | 195 |
| Lymphoma | D008223 | — | C85.9 | 10 | 44 | 20 | 4 | 7 | 81 |
| T-cell lymphoma | D016399 | — | — | 5 | 15 | 2 | 3 | 4 | 27 |
| T-cell lymphoma peripheral | D016411 | — | — | 4 | 13 | 2 | 3 | 4 | 24 |
| Philadelphia chromosome | D010677 | — | — | 4 | 5 | 4 | 2 | — | 13 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 5 | 21 | 12 | — | 1 | 38 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 7 | 9 | — | — | 20 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 5 | 11 | 6 | — | — | 18 |
| Myeloid leukemia | D007951 | — | C92 | 3 | 6 | 8 | — | — | 17 |
| Recurrence | D012008 | — | — | 6 | 9 | 2 | — | 1 | 15 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | 2 | 9 | 1 | — | 3 | 13 |
| Syndrome | D013577 | — | — | 2 | 1 | 6 | — | — | 9 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | 6 | — | — | 9 |
| Acute disease | D000208 | — | — | 3 | 3 | 2 | — | — | 8 |
| Preleukemia | D011289 | — | — | 2 | — | 6 | — | — | 8 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 4 | — | — | — | 5 |
| Hematologic neoplasms | D019337 | — | — | 2 | 2 | — | — | — | 4 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | 1 | — | — | 2 | 4 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | 1 | 1 | — | — | 1 | 2 |
| T-cell leukemia | D015458 | — | — | 1 | 2 | — | — | — | 2 |
| Precursor b-cell lymphoblastic leukemia-lymphoma | D015452 | — | — | 1 | 2 | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | — | 1 | — | — | 1 | 2 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Prolymphocytic leukemia t-cell | D015461 | — | C91.6 | 1 | — | — | — | — | 1 |
| Prolymphocytic leukemia | D015463 | — | — | 1 | — | — | — | — | 1 |
| Blast crisis | D001752 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 2 | 2 |
| Ataxia | D001259 | — | R27.0 | — | — | — | — | 1 | 1 |
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | — | — | — | — | 1 | 1 |
| Telangiectasis | D013684 | — | — | — | — | — | — | 1 | 1 |
| Cerebellar ataxia | D002524 | — | — | — | — | — | — | 1 | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | — | — | — | — | 1 | 1 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | — | — | 1 | 1 |
| Hyperlipoproteinemias | D006951 | — | — | — | — | — | — | 1 | 1 |
| Thromboembolism | D013923 | — | — | — | — | — | — | 1 | 1 |
| Residual neoplasm | D018365 | — | — | — | — | — | — | 1 | 1 |
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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.
|
| 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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11,077 adverse events reported
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