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ATLAS open-label extension of once-daily mexiletine PR in myotonic dystrophy
2024-511178-66-00Phase 3Authorised
- Sponsor
- Lupin Limited
- Start
- Sep 2025
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
- Countries
- 6
01
Overview
Phase 3, open-label, single-arm trial of mexiletine in myotonic dystrophy type 1 (DM1) and myotonic dystrophy type 2 (DM2), sponsored by Lupin Limited. Primary endpoints: Treatment-emergent adverse events, Clinical laboratory and safety examinations and 2 more. Planned start Sep 2025; status: authorised.
02
Drugs
mexiletine
03
Conditions
myotonic dystrophy type 1 (DM1)myotonic dystrophy type 2 (DM2)
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