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Migalastat - Amicus Therapeutics

Drug Profile

Migalastat - Amicus Therapeutics

Alternative Names: AT-1001-Amicus-Therapeutics; GALAFOLD; Galafold; GR181413A; GR181413A/AT1001; HGT-3310; Migalastat hydrochloride

Latest Information Update: 06 Aug 2019

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At a glance

  • Originator Amicus Therapeutics
  • Class Imino sugars; Pharmacological chaperones; Piperidines; Small molecules
  • Mechanism of Action Alpha-galactosidase A transport stimulants; Protein folding stabiliser
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Fabry's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Fabry's disease

Most Recent Events

  • 08 Aug 2019 Amicus Therapeutics plans a phase III trial for Fabry disease (Monotherapy, In Adolescents) in Spain and USA (PO) in October 2019 (NCT04049760)
  • 05 Aug 2019 Registered for Fabry's disease (Monotherapy, In adolescents, In adults) in Argentina (PO)
  • 18 Jul 2019 Amicus Therapeutics plans a phase III trial for Fabry disease in USA, Belgium, France, Italy, Spain and United Kingdom, in September 2019 (NCT04020055)
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