Lupin Limited ((IN:LUPIN)) announced an update on their ongoing clinical study.
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Study Overview: Lupin Limited is conducting an open-label extension study titled ‘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 the MEX-DM-302 Study (ATLAS Study).’ The study aims to assess the long-term safety and efficacy of mexiletine PR in patients with myotonic dystrophy types 1 and 2, following their participation in the MEX-DM-302 study. This research is significant as it seeks to provide a prolonged treatment option for managing myotonia symptoms in these patients.
Intervention/Treatment: The study tests mexiletine granules for prolonged-release oral suspension, a drug intended to manage symptoms of myotonia in patients with myotonic dystrophy types 1 and 2. Mexiletine PR is administered once daily in varying dosages.
Study Design: This is an interventional, open-label, single-group study with no masking. It is designed to evaluate the treatment effects of mexiletine PR over an 18-month period. Patients who completed the MEX-DM-302 study and meet eligibility criteria are invited to continue in this extension study.
Study Timeline: The study was first submitted on May 9, 2024, and the last update was submitted on July 30, 2025. These dates are crucial as they mark the progression and current status of the study, which is not yet recruiting participants.
Market Implications: The update on this study could positively influence Lupin Limited’s stock performance and investor sentiment, as successful results may lead to an expanded market for mexiletine PR. This could position Lupin favorably against competitors in the treatment of myotonic dystrophy, potentially increasing its market share.
The study is ongoing, with further details available on the ClinicalTrials portal.