Mexiletine - Lupin
Alternative Names: Mexiletine hydrochloride - Lupin; NamusclaLatest Information Update: 30 Apr 2026
At a glance
- Originator Temmler Pharma
- Developer Lupin
- Class Class Ib antiarrhythmics; Local anaesthetics; Phenyl ethers; Propylamines; Small molecules
- Mechanism of Action Sodium channel antagonists
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Orphan Drug Status
Yes - Musculoskeletal disorders
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Myotonic disorders
- Phase III Myotonic dystrophy
Most Recent Events
- 26 Mar 2026 Preregistration for Myotonic disorders (In adolescents, In children) in European Union (PO)
- 26 Mar 2026 The CHMP adopts positive opinion recommending approval for mexiletine for Myotonic disorders in children and adolescents
- 01 Oct 2025 Phase-III clinical trials in Myotonic dystrophy in Belgium (PO, Capsule) (NCT07097701)