mexiletine prolonged release / Lupin - LARVOL DELTA

The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 (clinicaltrials.gov) - P3 | N=176 | Recruiting | Sponsor: Lupin Ltd. | Trial completion date: Apr 2026 ➔ Jun 2027 | Trial primary completion date: Mar 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

Design of ACHILLES Phase 3 Randomised Study: Mexiletine PR vs. Mexiletine IR in Non-Dystrophic Myotonia (ICNMD 2026) - "Mexiletine PR has been developed with the intention of reducing the number and impact of GI events experienced by patients. It provides a QD regimen that aims to simplify mexiletine administration, thereby improving patients' treatment experiences and quality of life, especially for those with dysphagia. Enrolment in ACHILLES is expected to complete in summer 2026"

Clinical • P3 data • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Myotonic Dystrophy

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study. (clinicaltrials.gov) - P3 | N=176 | Enrolling by invitation | Sponsor: Lupin Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: Lupin Ltd. | Trial completion date: Oct 2026 ➔ Feb 2027 | Trial primary completion date: Jul 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Myotonic Dystrophy

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR (clinicaltrials.gov) - P3 | N=24 | Recruiting | Sponsor: Lupin Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Myotonic Dystrophy

The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 (clinicaltrials.gov) - P3 | N=176 | Recruiting | Sponsor: Lupin Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study. (clinicaltrials.gov) - P3 | N=176 | Not yet recruiting | Sponsor: Lupin Ltd. | Trial completion date: Jun 2027 ➔ Jul 2028 | Trial primary completion date: Apr 2027 ➔ May 2028

Trial completion date • Trial primary completion date • Genetic Disorders • Muscular Dystrophy • Myotonic Dystrophy