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Drug ReportsAgalsidase alfa
Agalsidase alfa
Replagal (agalsidase alfa) is an enzyme pharmaceutical. Agalsidase alfa was first approved as Replagal on 2001-08-03. It has been approved in Europe to treat fabry disease.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
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YTD
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Events
FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB03: Agalsidase alfa
HCPCS
No data
Clinical
Clinical Trials
70 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fabry diseaseD000795Orphanet_324E75.217131592565
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
Irritable bowel syndromeD043183EFO_0000555K581———12
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.6————11
Renal dialysisD006435EFO_0010690Z99.2————11
Abdominal painD015746HP_0002027R10.9————11
ColicD003085HP_0011848R10.83————11
FlatulenceD005414—R14.3————11
Hypertrophic cardiomyopathyD002312EFO_0000538I42.1————11
Lysosomal storage diseasesD016464——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAgalsidase alfa
INNagalsidase alfa
Description
Replagal (agalsidase alfa) is an enzyme pharmaceutical. Agalsidase alfa was first approved as Replagal on 2001-08-03. It has been approved in Europe to treat fabry disease.
Classification
Enzyme
Drug classenzymes
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB1R46, 1R47
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108214
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID2HLC17MX9G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Replagal – Takeda
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Replagal – Shire
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,618 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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151 adverse events reported
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