Naglazyme , Naglazyme(galsulfase)
Naglazyme (galsulfase) is an enzyme pharmaceutical. Galsulfase was first approved as Naglazyme on 2005-05-31. It is used to treat mucopolysaccharidosis VI in the USA. It has been approved in Europe to treat mucopolysaccharidosis VI.
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Commercial
Trade Name
FDA
EMA
Naglazyme
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)
Galsulfase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Naglazyme | galsulfase | BioMarin Pharmaceutical | N-125117 RX | 2005-05-31 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| naglazyme | Biologic Licensing Application | 2024-09-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mucopolysaccharidosis vi | — | D009087 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
galsulfase , Naglazyme , BioMarin Pharmaceutical Inc. | |||
| 2112-05-31 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1458 | Injection, galsulfase, 1 mg |
Clinical
Clinical Trials
8 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 vi | D009087 | — | — | 1 | 1 | 2 | 1 | 2 | 7 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | 1 | 1 | 2 | 1 | 1 | 6 |
| Syndrome | D013577 | — | — | — | — | — | 1 | 1 | 2 |
Indications Phases 3
No data
Indications Phases 2
No data
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 | 2 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Osteochondrodysplasias | D010009 | Orphanet_800 | G71.13 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Galsulfase |
| INN | galsulfase |
| Description | Naglazyme (galsulfase) is an enzyme pharmaceutical. Galsulfase was first approved as Naglazyme on 2006-01-23. It is used to treat mucopolysaccharidosis vi in the USA. It has been approved in Europe to treat mucopolysaccharidosis vi. |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201822 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01279 |
| UNII ID | 59UA429E5G (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Naglazyme – BioMarin Pharmaceutical
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 291 documents
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Safety
Black-box Warning
Black-box warning for: Naglazyme
Adverse Events
Top Adverse Reactions
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3,599 adverse events reported
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