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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| asparlas | Biologic Licensing Application | 2024-10-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| precursor cell lymphoblastic leukemia-lymphoma | — | D054198 | — |
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
25 clinical trials
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Indications Phases 4
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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 | 6 | 13 | 7 | — | 1 | 24 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 4 | 13 | 7 | — | 1 | 22 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 13 | 6 | — | — | 19 |
| Lymphoma | D008223 | — | C85.9 | 2 | 8 | 2 | — | — | 11 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | — | 3 | 2 | — | — | 5 |
| Acute disease | D000208 | — | — | 1 | 2 | 1 | — | — | 4 |
| Philadelphia chromosome | D010677 | — | — | — | — | 2 | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 5 | — | — | — | 6 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 3 | 1 | — | — | — | 4 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 3 |
| T-cell lymphoma | D016399 | — | — | 1 | 1 | — | — | — | 2 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | 1 | — | — | — | 2 |
| Myeloid leukemia | D007951 | — | C92 | 1 | 1 | — | — | — | 2 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| T-cell leukemia | D015458 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Preleukemia | D011289 | — | — | 1 | — | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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
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Variants
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Financial
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Trends
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Additional graphs summarizing 95 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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347 adverse events reported
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