Migalastat

Migalastat
Clinical data
Pronunciationmi GAL a stat
Trade namesGalafold
Other namesDDIG, AT1001, 1-deoxygalactonojirimycin
AHFS/Drugs.comMonograph
Pregnancy
category
  • AU: B3
Routes of
administration
By mouth
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • CA: ℞-only
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability75%
Protein bindingNone
MetabolitesO-glucuronides (<15%)
Elimination half-life3–5 hours (single dose)
ExcretionUrine (77%), feces (20%)
Identifiers
  • (2R,3S,4R,5S)-2-(Hydroxymethyl)-3,4,5-piperidinetriol
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC6H13NO4
Molar mass163.173 g·mol−1
3D model (JSmol)
  • C1[C@@H]([C@H]([C@H]([C@H](N1)CO)O)O)O
  • InChI=1S/C6H13NO4/c8-2-3-5(10)6(11)4(9)1-7-3/h3-11H,1-2H2/t3-,4+,5+,6-/m1/s1
  • Key:LXBIFEVIBLOUGU-DPYQTVNSSA-N

Migalastat, sold under the brand name Galafold, is a medication for the treatment of Fabry disease, a rare genetic disorder. It was developed by Amicus Therapeutics. The US Food and Drug Administration (FDA) granted it orphan drug status in 2004, and the European Commission followed in 2006. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) granted the drug a marketing approval under the name Galafold in May 2016.

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.