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.
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
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 | 2024-10-03 |
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
35 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 6 | 6 | 10 | — | 9 | 31 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
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 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Rare diseases | D035583 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
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 722 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
332 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use