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Agalsidase alfa - Takeda

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Drug Profile

Agalsidase alfa - Takeda

Alternative Names: Replagal; SMP 536; TAK-675; α-galactosidase A

Latest Information Update: 03 Dec 2024

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At a glance

  • Originator Shire
  • Developer Endo, Inc.; Medison Pharma; Orphan Australia; Samaritan Pharmaceuticals; Sumitomo Pharma; Takeda
  • Class Galactosidases; Isoenzymes
  • Mechanism of Action Alpha-galactosidase stimulants
  • 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

  • 03 Dec 2024 Phase III development is ongoing for Fabry's diseases (Treatment-naïve, In children, In adolescents, In adults) in China (IV, Infusion) (NCT04974749)
  • 17 Jun 2024 Takeda (Shire) terminates a phase III trial in Fabry's disease (Treatment-naive) in Greece, Sweden (IV) due to enrolment challenges (NCT04840667) (EudraCT2018-004689-32)
  • 23 Apr 2024 Endo International has been acquired and merged into Endo, Inc.

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