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Idursulfase - Takeda

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Drug Profile

Idursulfase - Takeda

Alternative Names: DRX 006A; Elaprase; GC-1111 - Sanofi Genzyme; HGT-2310; I2S; Iduronate-2-sulfatase-gene-therapy; Idursulfase-beta; idursulfase-IT; Recombinant-iduronate-2-sulfatase - Takeda; SHP-609; TAK 609

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Shire Pharmaceuticals Group
  • Developer Sanofi; Takeda
  • Class Iduronate sulfatases; Recombinant proteins
  • Mechanism of Action Iduronate sulfatase replacements
  • Orphan Drug Status

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

    Yes - Mucopolysaccharidosis II
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Mucopolysaccharidosis II

Most Recent Events

  • 11 Sep 2023 Takeda plans a phase II/III open-label extension trial for Mucopolysaccharidosis II (In children, In adolescents) in Canada and France (Intrathecal, Injection, once monthly) (NCT06031259)
  • 03 Apr 2023 Takeda initiates a post-trial, expanded access program for Idursulfase in Mucopolysaccharidosis II (In children, In adolescent) (IV) (NCT05795361)
  • 11 May 2022 Discontinued - Phase-II/III for Mucopolysaccharidosis II (In adolescents, In children) in Spain, France, Canada, Colombia, Australia, United Kingdom, USA, Mexico, Argentina (Intrathecal)
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