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Elaprase(idursulfase)
Elaprase (idursulfase) is an enzyme pharmaceutical. Idursulfase was first approved as Elaprase on 2006-07-24. It is used to treat mucopolysaccharidosis II in the USA. It has been approved in Europe to treat mucopolysaccharidosis II.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Elaprase
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)
Idursulfase
Tradename
Proper name
Company
Number
Date
Products
ElapraseidursulfaseTakedaN-125151 RX2006-07-24
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
elapraseBiologic Licensing Application2020-08-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mucopolysaccharidosis ii—D016532E76.1
Agency Specific
FDA
EMA
Expiration
Code
idursulfase, Elaprase, Takeda Pharmaceuticals U.S.A., Inc.
2113-07-24Orphan excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB09: Idursulfase
— A16AB16: Idursulfase beta
HCPCS
Code
Description
J1743
Injection, idursulfase, 1 mg
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis iiD016532E76.13974217
Mucopolysaccharidosis iD008059E76.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis iiiD009084E76.22—11——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIDURSULFASE
INNidursulfase
Description
Idursulfase (brand name Elaprase), manufactured by Takeda, is a drug used to treat Hunter syndrome (also called MPS-II). It is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)IDURSULFASE
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB5FQL, 6IOZ
CAS-ID50936-59-9
RxCUI644101
ChEMBL IDCHEMBL1201826
ChEBI ID—
PubChem CID—
DrugBankDB01271
UNII ID5W8JGG2651 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Elaprase - Takeda
$
€
£
₣
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Elaprase - Shire
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 606 documents
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Safety
Black-box Warning
Black-box warning for: Elaprase
Adverse Events
Top Adverse Reactions
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1,358 adverse events reported
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