Xenpozyme(olipudase alfa)
Xenpozyme (olipudase alfa) is an enzyme pharmaceutical. Olipudase alfa was first approved as Xenpozyme on 2022-06-24. It is used to treat lysosomal storage diseases in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Xenpozyme
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xenpozyme | Biologic Licensing Application | 2024-09-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lysosomal storage diseases | — | D016464 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
olipudase alfa, Xenpozyme, Genzyme Corporation | |||
| 2029-08-31 | Orphan excl. | ||
Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
8 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 |
|---|---|---|---|---|---|---|---|---|---|
| Niemann-pick diseases | D009542 | — | E75.24 | 3 | 3 | 1 | — | 3 | 8 |
| Type a niemann-pick disease | D052536 | EFO_1001380 | E75.240 | 3 | 3 | 1 | — | 3 | 8 |
| Type c niemann-pick disease | D052556 | Orphanet_646 | E75.242 | 3 | 3 | 1 | — | 3 | 8 |
| Lipidoses | D008064 | — | E75.6 | 1 | 3 | 1 | — | 1 | 4 |
Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pick disease of the brain | D020774 | EFO_0003096 | G31.01 | 1 | — | — | — | 1 | 2 |
| Frontotemporal dementia | D057180 | HP_0002145 | G31.0 | 1 | — | — | — | — | 1 |
| Primary progressive aphasia | D018888 | EFO_0009053 | G31.01 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Olipudase alfa |
| INN | olipudase alfa |
| Description | Olipudase alfa, sold under the brand name Xenpozyme, is a medication used for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) type A/B or type B.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707358 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12835 |
| UNII ID | 6D5766Q4OP (ChemIDplus, GSRS) |
Target
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 156 documents
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Safety
Black-box Warning
Black-box warning for: Xenpozyme
Adverse Events
Top Adverse Reactions
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52 adverse events reported
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