Suven Life Sciences Reports Positive Safety Review for Masupirdine in Alzheimer's Disease Agitation Study

Suven Life Sciences Reports Positive Safety Review for Masupirdine in Alzheimer's Disease Agitation Study​

Suven Life Sciences, a clinical-stage biopharmaceutical company specializing in therapeutic innovation for central nervous system (CNS) disorders, announced positive outcomes from an independent Data and Safety Monitoring Board (DSMB) review and a pre-specified interim analysis of its global Phase 3 study evaluating Masupirdine (SUVN-502). The trial is assessing the drug for agitation associated with Alzheimer's disease (AD).

The DSMB conducted a planned safety review after approximately 50% of randomized participants completed 12 weeks of treatment. Based on the comprehensive evaluation of unblinded safety data, the DSMB recommended that the trial continue as originally planned, noting that no safety concerns were identified requiring protocol modification or additional follow up.

In parallel, a pre-specified unblinded interim analysis was performed to assess sample size adequacy after approximately 50% of participants completed the 12 weeks of treatment period. This analysis led the DSMB to recommend that there be no need for an increase in sample size, supporting the continuation of the trial as originally designed.

The global Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled trial being conducted across approximately 80 sites spanning North America (USA) and Europe (Poland, Serbia, and Croatia). The study aims to enroll roughly 375 patients who will receive either Masupirdine 50 mg QD, 100 mg QD, or Placebo for 12 weeks. The primary endpoint under investigation is the change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items aligned with International Psychogeriatric Association (IPA) agitation criteria.

Study Status and Timeline​

Enrollment into the Masupirdine study continues strongly, with approximately 88% of the planned patient population enrolled as of the latest update. Based on current enrollment trends, Suven anticipates completing enrollment by September 2026. The last patient last visit is scheduled for January 2027, with database lock and top-line results expected in Q2-2027. The company noted that accelerated enrollment could potentially advance these timelines.

Key details regarding the Masupirdine agitation study:


Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, commented on the results, stating that the positive safety review marked a significant milestone in the program's development. He added that with over 88% of study participants enrolled, reflecting strong execution and sustained momentum, they remain committed to the program with patient enrolment currently on track for completion by the end of calendar year 2026.

SUVEN Stock Price Movement​

Suven Life Sciences Limited stock sheds 3.07% of its value as of 10:56 AM, with shares currently standing at ₹266.9 amid live trading. The equity has seen a volume of 442,056 shares traded so far in the ongoing session.