Lupin Limited ((IN:LUPIN)) announced an update on their ongoing clinical study.
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Lupin Limited is conducting a clinical study titled ‘A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Once Daily Mexiletine PR During 26 Weeks of Treatment in Patients With Myotonic Dystrophy Type 1 and Type 2.’ This Phase 3 study aims to evaluate the safety and efficacy of Mexiletine PR in treating Myotonic Dystrophy, a significant step in addressing this rare neuromuscular disorder.
The study tests Mexiletine prolonged-release (PR), a drug designed to manage symptoms of Myotonic Dystrophy by stabilizing muscle cell membranes. The intervention includes Mexiletine PR granules for prolonged-release oral suspension and a matching placebo.
This interventional study is randomized and double-blind, with a parallel-group, placebo-controlled design. It involves a 26-week treatment phase following a 4-week screening period. Participants are randomly assigned to receive either Mexiletine or a placebo, with the primary goal of assessing treatment efficacy.
The study began on May 3, 2024, with primary completion expected by August 21, 2025. These dates are crucial for tracking progress and anticipating results that could influence market dynamics.
The outcome of this study could significantly impact Lupin Limited’s stock performance by potentially enhancing its portfolio with a new treatment option for Myotonic Dystrophy. This development is particularly relevant in the competitive pharmaceutical landscape, where advancements in rare disease treatments are highly valued.
The study is currently recruiting, with further details available on the ClinicalTrials portal.