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DNL 126

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Drug Profile

DNL 126

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

Latest Information Update: 13 Mar 2025

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At a glance

  • Originator Denali Therapeutics Inc
  • Class 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

  • 28 Feb 2025 Denali Therapeutics announces intention align with US FDA for accelerated approval
  • 13 Jan 2025 DNL 126 receives Fast Track designation for Mucopolysaccharidosis III [IV] (In adolescents, In children) in USA, prior to January 2025
  • 13 Jan 2025 DNL 126 receives Orphan Drug status for Mucopolysaccharidosis III in USA, prior to January 2025

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