Trial intelligence / Profile preview

ACHILLES study of prolonged-release versus immediate-release mexiletine in non-dystrophic myotonias

2024-514970-27-00Phase 3Authorised

Sponsor
Lupin Atlantis Holdings
Start
Sep 2025
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Countries
5
01

Overview

Phase 3, randomised, open-label trial of fresolimumab and mexiletine in non-dystrophic myotonia (NDM) (2 arms), sponsored by Lupin Atlantis Holdings. Primary endpoint: Incidence of treatment-emergent adverse events and discontinuation. Planned start Sep 2025; status: authorised.

02

Drugs

fresolimumabmexiletine
03

Conditions

non-dystrophic myotonia (NDM)

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