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An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Tideglusib for the Treatment of Congenital or Childhood Onset DM1 (REACH CDM X)

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Trial Profile

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Tideglusib for the Treatment of Congenital or Childhood Onset DM1 (REACH CDM X)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 07 Nov 2025

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At a glance

  • Drugs Tideglusib (Primary)
  • Indications Myotonic dystrophy
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms REACH CDM X
  • Sponsors AMO Pharma

Most Recent Events

  • 15 Sep 2025 According to an AMO Pharma media release, company has also submitted a protocol for a Phase 3 study in adult-onset myotonic dystrophy to the FDA and will share updates on this review, as well as on the outcomes of the upcoming FDA meeting and ongoing regulatory discussions.
  • 15 Sep 2025 According to an AMO Pharma media release, company has submitted these additional data for AMO-02 to the U.S. Food and Drug Administration (FDA) and plans to submit to Health Canada and the UK Medicines and Healthcare products Regulatory Agency (MHRA). and plans to meet with UK MHRA and Health Canada.
  • 15 Sep 2025 According to an AMO Pharma media release, as of August 2025, 45 participants remain on treatment, including 20 who have been receiving AMO-02 for more than three years. A total of 14 participants have discontinued treatment, with only one withdrawal due to an adverse event (elevated liver enzymes).

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