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An Open-label Study to Collect Safety and Effectiveness Information on Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy Who Have Completed Prior Studies With Vamorolone

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Trial Profile

An Open-label Study to Collect Safety and Effectiveness Information on Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy Who Have Completed Prior Studies With Vamorolone

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 07 Dec 2025

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At a glance

  • Drugs Vamorolone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Therapeutic Use
  • Acronyms GUARDIAN; The GUARDIAN Study
  • Sponsors Santhera Pharmaceuticals

Most Recent Events

  • 04 Nov 2025 Primary endpoint has been met. (Number of vertebral fractures per 1000 person-years based on X-ray central reading.)
  • 04 Nov 2025 According to Santhera Pharmaceuticals media release, Detailed results are being submitted for presentation at a major international scientific conference in Q1 2026.
  • 04 Nov 2025 Results presented in the Santhera Pharmaceuticals media release.

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