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: 18 Aug 2025

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At a glance

17 Jun 2025 According to a Dyne Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation toDYNE-101 for the treatment of Myotonic Dystrophy Type 1.
17 Jun 2025 Results presented in the Dyne Therapeutics the Media Release
17 Jun 2025 According to a Dyne Therapeutics media release, the company reported updated safety and tolerability data from 56 patients enrolled through the 6.8 mg/kg Q8W cohort from this trial.

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