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Tividenofusp alfa - Denali Therapeutics

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Drug Profile

Tividenofusp alfa - Denali Therapeutics

Alternative Names: DNL-310; ETV:IDS

Latest Information Update: 13 Feb 2025

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At a glance

  • Originator Denali Therapeutics Inc
  • Class Iduronate sulfatases; Recombinant fusion proteins; Recombinant proteins
  • 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 No
  • Available For Licensing Yes

Highest Development Phases

  • Phase II/III Mucopolysaccharidosis II

Most Recent Events

  • 06 Feb 2025 Adverse events data from a Phase I/II clinical trials in Mucopolysaccharidosis II released by Denali Therapeutics
  • 13 Jan 2025 Denali Therapeutics announces intention to launch tividenofusp alfa (DNL310) for the treatment of MPS II (Hunter syndrome) in USA in late 2025 or early 2026
  • 08 Jan 2025 Tividenofusp alfa - Denali Therapeutics receives Breakthrough Therapy status for Mucopolysaccharidosis II in USA

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