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Zafinofusp alfa - Denali Therapeutics

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Drug Profile

Zafinofusp alfa - Denali Therapeutics

Alternative Names: DNL-126; ETV:N-sulphoglucosamine sulphohydrolase; ETV:SGSH; Recombinant sulphoglucosamine sulphohydrolase - Denali Therapeutics

Latest Information Update: 20 Aug 2026

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At a glance

  • Originator Denali Therapeutics Inc
  • Class Hydrolases; Recombinant fusion proteins
  • Mechanism of Action N-sulfoglucosamine sulfohydrolase replacements
  • Orphan Drug Status

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

    Yes - Mucopolysaccharidosis III
  • New Molecular Entity Yes
  • Available For Licensing Yes - Mucopolysaccharidosis III

Highest Development Phases

  • Phase I/II Mucopolysaccharidosis III

Most Recent Events

  • 06 Feb 2026 Denali expects a BLA submission for Zafinofusp alfa for MPS IIIA in 2027
  • 06 Feb 2026 Denali expects approval for Zafinofusp alfa for MPS IIIA in 2027
  • 05 Feb 2026 Efficacy, pharmacodynamics and adverse events data from phase I/II trial in Mucopolysaccharidosis III A released by Denali Therapeutics

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