Vimizim(elosulfase alfa)
Vimizim (elosulfase alfa) is an enzyme pharmaceutical. Elosulfase alfa was first approved as Vimizim on 2014-02-14. It is used to treat mucopolysaccharidosis IV in the USA. It has been approved in Europe to treat mucopolysaccharidosis IV.
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Commercial
Trade Name
FDA
EMA
Vimizim
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)
Elosulfase alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Vimizim | elosulfase alfa | BioMarin Pharmaceutical | N-125460 RX | 2014-02-14 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vimizim | Biologic Licensing Application | 2025-10-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mucopolysaccharidosis iv | — | D009085 | E76.210 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
elosulfase alfa, Vimizim, BioMarin Pharmaceutical Inc. | |||
| 2121-02-14 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1322 | Injection, elosulfase alfa, 1 mg |
Clinical
Clinical Trials
292 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 |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | 2 | 5 | 3 | — | 4 | 12 |
| Lysosomal storage diseases | D016464 | — | — | 2 | 5 | 1 | — | 1 | 7 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | 1 | 1 | 3 | — | 1 | 6 |
| Mucopolysaccharidosis vi | D009087 | — | — | 1 | 1 | 2 | — | — | 4 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
| 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 | Elosulfase alfa |
| INN | elosulfase alfa |
| Description | Elosulfase alfa, sold under the brand name Vimizim, is a medication used for the treatment of Morquio syndrome which is caused by a deficiency in the enzyme N-acetylgalactosamine-6-sulfatase. Elosulfase alfa is a synthetic version of this enzyme.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108676 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09051 |
| UNII ID | ODJ69JZG85 (ChemIDplus, GSRS) |
Target
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Vimizim – BioMarin Pharmaceutical
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Additional graphs summarizing 8,400 documents
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Safety
Black-box Warning
Black-box warning for: Vimizim
Adverse Events
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5,143 adverse events reported
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