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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: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 09 Sep 2026

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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

  • 09 Mar 2026 According to Santhera Pharmaceuticals media release, the company presented full results from long-term real-world comparative analyses, including baseline data from the ongoing GUARDIAN study at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference 2026 in a poster session on Sunday, March 8, 2026 at Orlando, Florida.
  • 09 Mar 2026 Results presented in the Santhera Pharmaceuticals media release.
  • 15 Dec 2025 Status changed from recruiting to active, no longer recruiting.

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