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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Commercial
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 |
|---|---|---|---|---|
| GALAFOLD | Amicus Therapeutics | N-208623 RX | 2018-08-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| galafold | New Drug Application | 2025-08-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fabry disease | Orphanet_324 | D000795 | E75.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MIGALASTAT HYDROCHLORIDE, GALAFOLD, AMICUS THERAP US | |||
| 2025-08-10 | ODE-205 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Migalastat Hydrochloride, Galafold, Amicus Therap Us | |||
| 11833164 | 2042-01-11 | U-2371 | |
| 11633388 | 2039-03-25 | U-2371 | |
| 11622962 | 2039-03-17 | DP | |
| 11642334 | 2039-02-20 | U-2371 | |
| 11826360 | 2039-02-16 | DP | |
| 11357784 | 2039-02-06 | U-2371 | |
| 11903938 | 2038-08-17 | DP | U-2371 |
| 10251873 | 2038-05-30 | U-2371 | |
| 10471053 | 2038-05-30 | U-2371 | |
| 10792278 | 2038-05-30 | U-2371 | |
| 10792279 | 2038-05-30 | U-2371 | |
| 10799491 | 2038-05-30 | U-2371 | |
| 10806727 | 2038-05-30 | U-2371 | |
| 10849889 | 2038-05-30 | U-2371 | |
| 10849890 | 2038-05-30 | U-2371 | |
| 10857141 | 2038-05-30 | U-2371 | |
| 10857142 | 2038-05-30 | U-2371 | |
| 10874655 | 2038-05-30 | U-2371 | |
| 10874656 | 2038-05-30 | U-2371 | |
| 10874657 | 2038-05-30 | U-2371 | |
| 11278536 | 2038-05-30 | U-2371 | |
| 11278537 | 2038-05-30 | U-2371 | |
| 11278538 | 2038-05-30 | U-2371 | |
| 11278539 | 2038-05-30 | U-2371 | |
| 11278540 | 2038-05-30 | U-2371 | |
| 11304940 | 2038-05-30 | DP | |
| 11357761 | 2038-05-30 | U-2371 | |
| 11357762 | 2038-05-30 | U-2371 | |
| 11357763 | 2038-05-30 | U-2371 | |
| 11357764 | 2038-05-30 | DP | |
| 11357765 | 2038-05-30 | DP | |
| 11376244 | 2038-05-30 | DP | |
| 11389436 | 2038-05-30 | U-2371 | |
| 11389437 | 2038-05-30 | U-2371 | |
| 11426396 | 2038-05-30 | DP | |
| 11458128 | 2038-05-30 | U-2371 | |
| 11612593 | 2038-05-30 | DP | |
| 11612594 | 2038-05-30 | DP | |
| 11633387 | 2038-05-30 | DP | |
| 11666564 | 2038-05-30 | U-2371 | |
| 11786516 | 2038-05-30 | DP | |
| 11813255 | 2038-05-30 | U-2371 | |
| 10076514 | 2037-03-15 | U-2371 | |
| 11234972 | 2037-03-15 | U-2371 | |
| RE48608 | 2029-02-12 | U-2371 | |
| 8592362 | 2029-02-12 | U-2371 | |
| 9095584 | 2029-02-12 | U-2371 | |
| 10813921 | 2029-02-12 | U-2371 | |
| 9999618 | 2028-04-28 | U-2372, U-2373 | |
| 10525045 | 2028-04-28 | U-2371 | |
| 10925866 | 2028-04-28 | U-2371 | |
| 11033538 | 2028-04-28 | U-2371 | |
| 9000011 | 2027-05-16 | U-2371 | |
| 9480682 | 2027-05-16 | U-2371 | |
| 9987263 | 2027-05-16 | U-2371 | |
| 10383864 | 2027-05-16 | U-2371 | |
| 10406143 | 2027-05-16 | U-2371 | |
| 11241422 | 2027-05-16 | U-2371 | |
HCPCS
No data
Clinical
Clinical Trials
37 clinical trials
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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 disease | D000795 | Orphanet_324 | E75.21 | 5 | 6 | 8 | — | 7 | 26 |
| Lysosomal storage diseases | D016464 | — | — | 1 | — | 1 | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Migalastat |
| INN | migalastat |
| Description | Migalastat is a member of piperidines. |
| Classification | Small molecule |
| Drug class | enzyme 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-ID | 108147-54-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL110458 |
| ChEBI ID | — |
| PubChem CID | 176077 |
| DrugBank | DB05018 |
| UNII ID | C4XNY919FW (ChemIDplus, GSRS) |
Target
Variants
No data
Financial
Revenue by drug
$
€
£
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Galafold – Amicus Therapeutics
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 841 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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462 adverse events reported
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