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Nusinersen - Biogen/Ionis Pharmaceuticals

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Drug Profile

Nusinersen - Biogen/Ionis Pharmaceuticals

Alternative Names: BIIB-058; IONIS-SMNRx; ISIS-396443; ISIS-SMNRx; Spinraza

Latest Information Update: 03 Jul 2025

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At a glance

  • Originator Cold Spring Harbor Laboratory; Isis Pharmaceuticals
  • Developer Biogen; Ionis Pharmaceuticals
  • Class Antisense oligonucleotides
  • Mechanism of Action RNA interference; Survival of motor neuron 2 protein expression stimulants
  • Orphan Drug Status

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

    Yes - Spinal muscular atrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Spinal muscular atrophy

Most Recent Events

  • 27 Jun 2025 Efficacy and adverse events data from a phase II/III DEVOTE trial in Spinal muscular atrophy released by Biogen
  • 27 Jun 2025 Efficacy and safety data from a phase II NURTURE trial in Spinal muscular atrophy released by Biogen
  • 12 Feb 2025 FDA assigns PDUFA action date of 22/09/2025 for Nusinersen for Spinal muscular atrophy

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