Fabrazyme(agalsidase beta)
Fabrazyme (agalsidase beta) is an enzyme pharmaceutical. Agalsidase beta was first approved as Fabrazyme on 2001-08-03. It is used to treat fabry disease in the USA. It has been approved in Europe to treat fabry disease.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
Fabrazyme
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fabrazyme | Biologic Licensing Application | 2024-07-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fabry disease | Orphanet_324 | D000795 | E75.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
agalsidase beta, Fabrazyme, Genzyme Corporation | |||
| 2028-03-11 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0180 | Injection, agalsidase beta, 1 mg |
Clinical
Clinical Trials
89 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fabry disease | D000795 | Orphanet_324 | E75.21 | 8 | 16 | 19 | 13 | 30 | 81 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | 1 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | — | — | — | 1 | 2 |
| Syndrome | D013577 | — | — | 1 | — | — | — | 1 | 2 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Hyperglycemia | D006943 | — | R73.9 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Proteinuria | D011507 | — | R80 | — | — | — | — | 2 | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 2 | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 2 | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | — | — | — | 1 | 1 |
| Alopecia | D000505 | — | L64 | — | — | — | — | 1 | 1 |
| Abdominal pain | D015746 | EFO_0003766 | R10.9 | — | — | — | — | 1 | 1 |
| Colic | D003085 | — | R10.83 | — | — | — | — | 1 | 1 |
| Flatulence | D005414 | — | R14.3 | — | — | — | — | 1 | 1 |
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Agalsidase beta |
| INN | agalsidase beta |
| Description | Fabrazyme (agalsidase beta) is an enzyme pharmaceutical. Agalsidase beta was first approved as Fabrazyme on 2001-08-03. It is used to treat fabry disease in the USA. It has been approved in Europe to treat fabry disease. |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108888 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | RZD65TSM9U (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Fabrazyme – Sanofi
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 9,311 documents
View more details
Safety
Black-box Warning
Black-box warning for: Fabrazyme
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
9,846 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use