Idursulfase - Shire

Drug Profile

Idursulfase - Shire

Alternative Names: Elaprase; GC-1111 - Sanofi Genzyme; HGT-2310; Hunterase; I2S; Iduronate-2-sulfatase-gene-therapy; Idursulfase-beta; idursulfase-IT; Recombinant-iduronate-2-sulfatase - Shire; SHP-609

Latest Information Update: 22 Nov 2017

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At a glance

  • Originator Shire Pharmaceuticals Group
  • Developer Sanofi Genzyme; Shire
  • Class Iduronate sulfatases
  • 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

  • 06 Nov 2017 Shire completes the phase II/III AIM-IT trial in Mucopolysaccharidosis II (In adolescents, In children) in Spain, USA, Argentina, Mexico, United Kingdom, Australia, Canada, Colombia and France (Intrathecal) (NCT02055118)
  • 30 Sep 2016 Shire completes enrolment in a phase III trial in Mucopolysaccharidosis II (Hunter's syndrome) in Spain, USA, Argentina, Mexico, United Kingdom, Australia, Canada and Colombia
  • 05 Jan 2016 Shire plans a phase II/III trial for Hunter syndrome (Intrathecal)
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