By: IPP Bureau
Last updated : June 05, 2026 9:37 am
Independent DSMB recommends continuation of Masupirdine without modifications as enrollment reaches 88% in global trial
Suven Life Sciences, a clinical-stage biopharmaceutical company has announced positive outcomes from an independent Data and Safety Monitoring Board (DSMB) review and a pre-specified interim analysis of its ongoing global Phase 3 clinical trial evaluating Masupirdine (SUVN-502) for the treatment of agitation associated with Alzheimer’s disease.
The DSMB conducted a planned safety review after approximately 50% of randomized participants had completed the 12-week treatment period.
Following a comprehensive assessment of unblinded safety data, the board recommended that the study continue as planned, with no changes to the protocol, study design, or trial conduct. The review identified no safety concerns and did not recommend any additional follow-up measures.
In parallel, the DSMB reviewed results from a pre-specified unblinded interim analysis designed to assess the adequacy of the study’s sample size after approximately half of the participants had completed treatment.
Based on the findings, the board concluded that no increase in sample size was required, supporting continuation of the trial according to the original development plan.
Patient enrollment continues to advance steadily, with approximately 88% of the targeted study population enrolled to date. Suven expects to complete enrollment by September 2026. The company anticipates the last patient’s final visit to occur in January 2027, followed by database lock and the release of top-line results in the second quarter of 2027.
Management noted that ongoing enrollment momentum could potentially accelerate these timelines further.
Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, said, “We are pleased to report another positive safety review for Masupirdine, with the DSMB recommending continuation of the trial without modification, marking a key milestone in its development.”
“To date, over 88% of study participants have been enrolled, reflecting strong execution and sustained momentum. We remain fully committed to the program, with patient enrolment on track for completion by the end of calendar year 2026,” added Jasti.