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Donidalorsen - Ionis Pharmaceuticals

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Drug Profile

Donidalorsen - Ionis Pharmaceuticals

Alternative Names: DAWNZERA; Donidalorsen sodium; IONIS-PKK-L Rx; ISIS 721744

Latest Information Update: 25 Aug 2025

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At a glance

  • Originator Ionis Pharmaceuticals
  • Developer Ionis Pharmaceuticals; Otsuka Pharmaceutical
  • Class Antisense oligonucleotides; Antisense RNA; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action Gene silencing; Plasma kallikrein expression inhibitors
  • Orphan Drug Status

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

    Yes - Hereditary angioedema
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Hereditary angioedema
  • Discontinued COVID 2019 infections

Most Recent Events

  • 25 Aug 2025 Discontinued - Phase-II for COVID-2019 infections in Brazil (SC)
  • 21 Aug 2025 Efficacy data from a phase III OASIS-Plus OLE trial in Hereditary angioedema released by Ionis Pharmaceuticals
  • 21 Aug 2025 Registered for Hereditary angioedema (Prevention, In adults, In the elderly, In adolescents) in USA (SC) - First global approval

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