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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: 26 Apr 2022

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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

  • 18 Apr 2022 Amicus Therapeutics has patent protection for composition of matter for migalastat in USA
  • 08 Mar 2022 Phase III development for Fabry's disease (Monotherapy, In adolescents) is ongoing in USA (PO, Capsule) (NCT04049760)
  • 02 Aug 2021 The European Commission approves Migalastat for Fabry's disease (Monotherapy, In adolescents, aged 12 to 16 years) in the EU, Iceland, Norway and Liechtenstein
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