Drug Profile

Zeleciment Basivarsen - Dyne Therapeutics

Alternative Names: DYNE-101

Latest Information Update: 01 Aug 2025

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At a glance

Originator Dyne Therapeutics
Class Antibodies; Antisense oligonucleotides; Drug conjugates; Immunoconjugates; Immunoglobulin fragments
Mechanism of Action Gene silencing; Myotonin protein kinase expression inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Myotonic dystrophy
New Molecular Entity Yes

Highest Development Phases

Phase I/II Myotonic dystrophy

Most Recent Events

28 Jul 2025 Dyne Therapeutics plans to complete enrolment in its phase III ACHIEVE trial for Myotonic dystrophy in forth quarter of 2025
17 Jun 2025 DYNE 101 receives Breakthrough Therapy status for Myotonic dystrophy in USA
17 Jun 2025 Dyne Therapeutics plans a submission for U.S. Accelerated Approval in late 2026

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