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Galafold(migalastat)
Galafold (migalastat) is a small molecule pharmaceutical. Migalastat was first approved as Galafold on 2016-05-25. It is used to treat fabry disease in the USA. It has been approved in Europe to treat fabry disease. It is known to target lysosomal alpha-glucosidase.
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SARS-CoV-2 Interaction
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
Galafold
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Migalastat hydrochloride
Tradename
Company
Number
Date
Products
GALAFOLDAmicus TherapeuticsN-208623 RX2018-08-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
galafoldNew Drug Application2021-02-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
fabry diseaseOrphanet_324D000795E75.21
Agency Specific
FDA
EMA
Expiration
Code
MIGALASTAT HYDROCHLORIDE, GALAFOLD, AMICUS THERAP US
2025-08-10ODE-205
2023-08-10NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Migalastat Hydrochloride, Galafold, Amicus Therap Us
116333882039-03-25U-2371
116229622039-03-17DP
116423342039-02-20U-2371
113577842039-02-06U-2371
102518732038-05-30U-2371
104710532038-05-30U-2371
107922782038-05-30U-2371
107922792038-05-30U-2371
107994912038-05-30U-2371
108067272038-05-30U-2371
108498892038-05-30U-2371
108498902038-05-30U-2371
108571412038-05-30U-2371
108571422038-05-30U-2371
108746552038-05-30U-2371
108746562038-05-30U-2371
108746572038-05-30U-2371
112785362038-05-30U-2371
112785372038-05-30U-2371
112785382038-05-30U-2371
112785392038-05-30U-2371
112785402038-05-30U-2371
113049402038-05-30DP
113577612038-05-30U-2371
113577622038-05-30U-2371
113577632038-05-30U-2371
113577642038-05-30DP
113577652038-05-30DP
113762442038-05-30DP
113894362038-05-30U-2371
113894372038-05-30U-2371
114263962038-05-30DP
114581282038-05-30U-2371
116125932038-05-30DP
116125942038-05-30DP
116333872038-05-30DP
100765142037-03-15U-2371
112349722037-03-15U-2371
RE486082029-02-12U-2371
85923622029-02-12U-2371
90955842029-02-12U-2371
108139212029-02-12U-2371
99996182028-04-28U-2372, U-2373
105250452028-04-28U-2371
109258662028-04-28U-2371
110335382028-04-28U-2371
90000112027-05-16U-2371
94806822027-05-16U-2371
99872632027-05-16U-2371
103838642027-05-16U-2371
104061432027-05-16U-2371
112414222027-05-16U-2371
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
— A16AX: Various alimentary tract and metabolism products
— A16AX14: Migalastat
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fabry diseaseD000795E75.214610—323
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMIGALASTAT
INNmigalastat
Description
Migalastat is a member of piperidines.
Classification
Small molecule
Drug classenzyme inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O
Identifiers
PDB—
CAS-ID108147-54-2
RxCUI2054252
ChEMBL IDCHEMBL110458
ChEBI ID—
PubChem CID176077
DrugBankDB05018
UNII IDC4XNY919FW (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GAA
GAA
Organism
Homo sapiens
Gene name
GAA
Gene synonyms
NCBI Gene ID
2548
Protein name
lysosomal alpha-glucosidase
Protein synonyms
Acid maltase, Aglucosidase alfa, glucosidase alpha, acid
Uniprot ID
Q8IWE7
Mouse ortholog
Gaa (14387)
lysosomal alpha-glucosidase (Q91Z45)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 546 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,215 adverse events reported
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