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A Phase 1/Phase 2 Open-label Single Arm Study With Dose Escalation (Part A), and Dose Expansion (Part B) Parts to Evaluate the Safety, Tolerability, and Efficacy of SAR446268, an Adeno-associated Viral Vector-mediated Gene Therapy in Participants 10 to 55 Years Old With Non-congenital Myotonic Dystrophy Type 1

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Trial Profile

A Phase 1/Phase 2 Open-label Single Arm Study With Dose Escalation (Part A), and Dose Expansion (Part B) Parts to Evaluate the Safety, Tolerability, and Efficacy of SAR446268, an Adeno-associated Viral Vector-mediated Gene Therapy in Participants 10 to 55 Years Old With Non-congenital Myotonic Dystrophy Type 1

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 May 2026

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At a glance

  • Drugs SAR 446268 (Primary)
  • Indications Myotonic dystrophy
  • Focus Adverse reactions; First in man
  • Sponsors Sanofi

Most Recent Events

  • 28 Apr 2026 Planned End Date changed from 28 Feb 2029 to 27 Apr 2032.
  • 28 Jan 2026 Planned End Date changed from 28 Feb 2030 to 28 Feb 2029.
  • 23 Sep 2025 According to Sanofi media release, first patient is planned for enrolment in late 2025.

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