Suven Life Sciences Completes Patient Enrollment in Global Phase-3 Study of Masupirdine for Alzheimer's Dementia
Suven Life Sciences has completed patient enrollment for its global Phase-3 study of Masupirdine (SUVN-502) for Agitation Associated with Alzheimer’s Dementia (AAD). A total of 424 patients were randomized, exceeding the designed target of 375. Last Patient Last Visit is expected by December 2026, with topline results anticipated by May 2027.
This is a significant step in the drug development process, but the ultimate impact will depend on the topline results and subsequent regulatory approvals. Therefore, the impact is currently assessed as medium.
The completion of patient enrollment in a crucial Phase-3 clinical study is a significant positive milestone for a biopharmaceutical company, indicating progress towards potential drug approval and market entry.
Suven Life Sciences Limited has announced the successful completion of patient enrollment in its global Phase-3 clinical study for Masupirdine (SUVN-502), a drug aimed at treating agitation associated with Alzheimer's Dementia (AAD).
The study, conducted across sites in the USA and Europe, was designed to randomize 375 patients. However, due to the enrollment of several patients already undergoing screening when the target was reached, a total of 424 patients were ultimately randomized. The study is a multicenter, randomized, double-blind, placebo-controlled Phase-3 trial where patients receive Masupirdine (50 mg or 100 mg) or a placebo once daily for 12 weeks.
Key timelines for the study include the Last Patient Last Visit (LPLV) expected by the end of December 2026, targeted Database Lock (DBL) by the end of March 2027, and topline results anticipated by May 2027. Safety data is being continuously monitored with no concerns reported to date.
Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, expressed optimism about the completion of enrollment, highlighting the significant unmet need for new treatment options for AAD and thanking all participants and staff. Dr. Ramakrishna Nirogi, President and Chief Scientific Officer, elaborated on Masupirdine's differentiated pharmacological profile as a selective 5-HT6 receptor antagonist, noting its potential to overcome limitations of current treatments.
A plain-language summary of a public exchange filing by Suven Life Sciences Limited. Read the original for the full detail.
