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A Phase 1/2, Multicenter, Open-Label Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL310 in Pediatric Participants With Hunter Syndrome

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Trial Profile

A Phase 1/2, Multicenter, Open-Label Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL310 in Pediatric Participants With Hunter Syndrome

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 May 2025

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At a glance

  • Drugs Tividenofusp alfa (Primary)
  • Indications Mucopolysaccharidosis II
  • Focus Adverse reactions; First in man; Proof of concept; Registrational; Therapeutic Use
  • Sponsors Denali Therapeutics Inc

Most Recent Events

  • 06 May 2025 According to a Denali Therapeutics Inc media release, company announced completion of submission of a Biologics License Application (BLA) for tividenofusp alfa under the U.S. Food and Drug Administrations (FDAs) accelerated approval pathway based on data from the Phase 1/2 study in participants with Hunter syndrome.
  • 02 Apr 2025 According to a Denali Therapeutics Inc media release, the company initiated a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
  • 06 Feb 2025 According to a Denali Therapeutics Inc media release, data from the study were presented at the 21st Annual WORLDSymposium™ conference in San Diego, California.

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