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Drug ReportsCalaspargase pegol-mknl
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
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Asparlas
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
asparlasBiologic Licensing Application2023-12-06
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
calaspargase pegol, Asparlas, Servier Pharmaceuticals LLC
2101-02-01Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code
Description
J9118
Injection, calaspargase pegol-mknl, 10 units
Clinical
Clinical Trials
24 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
LeukemiaD007938—C956127—123
Precursor cell lymphoblastic leukemia-lymphomaD054198——4127—121
Lymphoid leukemiaD007945—C913126——18
LymphomaD008223—C85.9282——11
Precursor t-cell lymphoblastic leukemia-lymphomaD054218———32——5
Acute diseaseD000208——121——4
Philadelphia chromosomeD010677————2——2
Central nervous system neoplasmsD016543————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.915———6
Myeloid leukemia acuteD015470—C92.031———4
RecurrenceD012008——12———3
T-cell lymphomaD016399——11———2
T-cell lymphoma peripheralD016411——11———2
Myeloid leukemiaD007951—C9211———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
T-cell leukemiaD015458——1————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
AdenocarcinomaD000230——1————1
Myelodysplastic syndromesD009190—D461————1
Hematologic neoplasmsD019337——1————1
PreleukemiaD011289——1————1
SyndromeD013577——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCalaspargase pegol
INNcalaspargase 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 classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID941577-06-6
RxCUI—
ChEMBL IDCHEMBL2108728
ChEBI ID—
PubChem CID—
DrugBankDB14730
UNII IDT9FVH03HMZ (ChemIDplus, GSRS)
Target
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 90 documents
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Safety
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Top Adverse Reactions
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347 adverse events reported
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