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Olipudase alfa - Sanofi

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Drug Profile

Olipudase alfa - Sanofi

Alternative Names: Acid sphingomyelinase Niemann Pick disease type B - Sanofi; Acid-sphingomyelinase - Sanofi; GZ-402665; Recombinant human acid sphingomyelinase - Sanofi; rhASM - Sanofi; Sphingomyelinase-C (synthetic human) - Sanofi; Synthetic human sphingomyelinase-C - Sanofi; XENPOZYME; Xenpozyme

Latest Information Update: 06 May 2025

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At a glance

  • Originator Genzyme Corporation
  • Developer Sanofi
  • Class Recombinant proteins; Sphingomyelin phosphodiesterases
  • Mechanism of Action Sphingomyelin phosphodiesterase replacements
  • Orphan Drug Status

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

    Yes - Niemann-Pick diseases
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Niemann-Pick diseases

Most Recent Events

  • 08 Apr 2025 Sanofi completes phase II clinical trials in Niemann-Pick diseases in France (NCT06949358)
  • 08 Nov 2024 Olipudase alfa - Sanofi receives Orphan Drug status for Niemann-Pick diseases in Japan (Sanofi pipeline, November 2024)
  • 05 Mar 2024 Launched for Niemann-Pick diseases (In adolescents, In children, In adults) in United Kingdom, Cyprus, Italy, Austria, Germany (IV)

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