Cerezyme(imiglucerase)
Cerezyme (imiglucerase) is an enzyme pharmaceutical. Imiglucerase was first approved as Cerezyme on 1994-05-23. It is used to treat gaucher disease, liver diseases, and splenic diseases in the USA. It has been approved in Europe to treat gaucher disease.
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Target
Variants
Financial
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Safety
Events Timeline
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Events
FDA approval date
EMA approval date
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Study first post date
Last update post date
Start date
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Completion date
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Commercial
Trade Name
FDA
EMA
Cerezyme (discontinued: Cerezyme)
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cerezyme | Biologic Licensing Application | 2024-07-12 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
imiglucerase, Cerezyme, Genzyme Corporation | |||
| 2101-05-23 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1786 | Injection, imiglucerase, 10 units |
| S9357 | Home infusion therapy, enzyme replacement intravenous therapy; (e.g., imiglucerase); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem |
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 11 | 12 | 17 | 4 | 13 | 51 |
| Lipidoses | D008064 | — | E75.6 | — | 1 | — | 2 | 1 | 4 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | 1 | — | 2 | 1 | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | 1 | 2 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 5 | — | — | 9 | 14 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood platelet disorders | D001791 | — | — | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Lysosomal storage diseases | D016464 | — | — | — | — | — | — | 1 | 1 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | — | — | — | 1 | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Imiglucerase |
| INN | imiglucerase |
| Description | Cerezyme (imiglucerase) is an enzyme pharmaceutical. Imiglucerase was first approved as Cerezyme on 1994-05-23. It is used to treat gaucher disease, liver diseases, and splenic diseases in the USA. It has been approved in Europe to treat gaucher disease. |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 1OGS, 1Y7V, 2F61, 2J25, 2NSX, 2NT0, 2NT1, 2V3D, 2V3E, 2V3F, 2WKL, 2XWD, 2XWE, 3GXD, 3GXF, 3GXI, 3GXM, 3KE0, 3KEH, 3RIK, 3RIL, 5LVX, 6MOZ, 6Q6K, 6Q6L, 6Q6N, 6TJJ, 6TJK, 6TJQ, 6TN1, 6YTP, 6YTR, 6YUT, 6YV3, 6Z39, 6Z3I, 7NWV |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201632 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00053 |
| UNII ID | Q6U6J48BWY (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Cerezyme – Sanofi
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,238 documents
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Safety
Black-box Warning
Black-box warning for: Cerezyme
Adverse Events
Top Adverse Reactions
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5,245 adverse events reported
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