Calaspargase pegol
Asparlas (calaspargase pegol) is an enzyme pharmaceutical. Calaspargase pegol was first approved as Asparlas on 2018-12-20. It is used to treat precursor cell lymphoblastic leukemia-lymphoma in the USA.
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Trade Name
FDA
EMA
Asparlas
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Calaspargase pegol
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Asparlas | calaspargase pegol-mknl | Servier | N-761102 RX | 2018-12-20 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| asparlas | Biologic Licensing Application | 2020-07-01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
calaspargase pegol, Asparlas, Servier Pharmaceuticals LLC | |||
| 2101-02-01 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J9118 | Injection, calaspargase pegol-mknl, 10 units |
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 2 | — | — | — | — | 2 | |
| T-cell lymphoma | D016399 | 1 | — | — | — | — | 1 | ||
| T-cell lymphoma peripheral | D016411 | C84.9 | 1 | — | — | — | — | 1 | |
| T-cell leukemia | D015458 | 1 | — | — | — | — | 1 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Recurrence | D012008 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CALASPARGASE PEGOL |
| INN | calaspargase pegol |
| Description | Calaspargase pegol, sold under the brand name Asparlas, is a medication for the treatment of acute lymphoblastic leukemia (ALL). It is approved in the United States as a component of a multi-agent chemotherapeutic regimen for ALL in pediatric and young adult patients aged one month to 21 years.
|
| Classification | Enzyme |
| Drug class | enzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 941577-06-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108728 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14730 |
| UNII ID | T9FVH03HMZ (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 61 documents
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Safety
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Adverse Events
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0 adverse events reported
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