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A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

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Trial Profile

A Randomized, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Dec 2025

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At a glance

  • Drugs Zeleciment Basivarsen (Primary)
  • Indications Myotonic dystrophy
  • Focus Adverse reactions; First in man; Registrational
  • Acronyms ACHIEVE
  • Sponsors Dyne Therapeutics

Most Recent Events

  • 05 Nov 2025 According to a Dyne Therapeutics media release, Dyne intends to use data from the REC and from the already enrolled patients in the multiple ascending dose (MAD) and ongoing long-term extension portions of the ACHIEVE trial to support a potential submission for Accelerated Approval in the U.S. in early Q3 2027.
  • 05 Nov 2025 According to a Dyne Therapeutics media release, U.S. sites activated in the trial with patient enrollment and dosing was initiated in October. Completion of enrollment now expected in early Q2 2026 -
  • 06 Oct 2025 According to a Dyne Therapeutics media release, data from the trial were presented at the 30th Annual International Congress of the World Muscle Society (WMS), held virtually and in Vienna, Austria, October 7-11, 2025.

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