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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: 04 Sep 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

  • 11 Aug 2025 Denali Therapeutics align with US FDA for accelerated approval of DNL 126 for Mucopolysaccharidosis III
  • 11 Aug 2025 Denali Therapeutics plans phase-III trial for Mucopolysaccharidosis III
  • 07 May 2025 Denali Therapeutics and US FDA has collaboration and discussions with the FDA under the START program for DNL 126 in Mucopolysaccharidosis III

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