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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: 23 Aug 2026

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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

  • 30 Jul 2026 Biogen completes the phase III ONWARD trial for Spinal muscular atrophy (In children, In adolescents, In adults, In the elderly) (Intrathecal) in USA, Brazil, Canada, Chile, China, Colombia, Estonia, Germany, Italy, Japan, Lebanon, Mexico, Russia, Saudi Arabia, Spain, Taiwan (NCT04729907) (EudraCT2020-004708-32)
  • 30 Mar 2026 US FDA approves high dose regimen of Nusinersen for treatment of Spinal muscular atrophy in the US
  • 16 Feb 2026 Nusinersen is covered by patent protection in USA and Europe

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