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
Trade Name
FDA
EMA
Elaprase
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elaprase | Biologic Licensing Application | 2025-04-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mucopolysaccharidosis ii | — | D016532 | E76.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
idursulfase, Elaprase, Takeda Pharmaceuticals U.S.A., Inc. | |||
| 2113-07-24 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1743 | Injection, idursulfase, 1 mg |
Clinical
Clinical Trials
35 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 ii | D016532 | — | E76.1 | 7 | 14 | 11 | 4 | 10 | 33 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | 6 | 10 | 6 | 3 | 6 | 22 |
| Syndrome | D013577 | — | — | 1 | 5 | 6 | 2 | 6 | 15 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | — | — | — | 1 | 1 | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | 3 | 2 | — | — | 3 |
| Mucopolysaccharidosis iii | D009084 | — | E76.22 | 1 | 3 | 2 | — | — | 3 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | 1 | 1 | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lysosomal storage diseases | D016464 | — | — | 2 | 1 | — | — | — | 2 |
| Sudden infant death | D013398 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | 1 | — | — | — | — | 1 |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | — | 1 |
| Wolman disease | D015223 | Orphanet_75233 | E75.5 | 1 | — | — | — | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Umbilical hernia | D006554 | — | K42 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Idursulfase |
| INN | idursulfase |
| 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 class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 5FQL, 6IOZ |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201826 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01271 |
| UNII ID | 5W8JGG2651 (ChemIDplus, GSRS) |
Target
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Financial
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 826 documents
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Safety
Black-box Warning
Black-box warning for: Elaprase
Adverse Events
Top Adverse Reactions
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4,698 adverse events reported
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