Suven Life Sciences has completed patient enrollment in its global Phase 3 study of Masupirdine (SUVN-502) for agitation associated with Alzheimer’s dementia, with 424 patients randomized — well above the original target of 375.

 

The company said enrollment has been completed across clinical sites in the US and Europe, taking the drug into the final stages of its pivotal clinical development.

 

Suven expects the last patient last visit (LPLV) by the end of December 2026, followed by a targeted database lock by the end of March 2027. Topline results from the Phase 3 trial are expected by May 2027.

 

The randomized, double-blind, placebo-controlled study evaluated two doses of Masupirdine — 50 mg and 100 mg once daily — against placebo over 12 weeks. Patients were randomized in a 1:1:1 ratio.

 

The primary endpoint is the change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items corresponding to the International Psychogeriatric Association (IPA) agitation criteria. The key secondary endpoint is the modified Alzheimer’s Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C), assessing agitation-related clinical change.

 

The trial was initially designed to randomize approximately 375 patients. However, because several patients were already undergoing screening when the enrollment target was reached, those who subsequently met all eligibility criteria were allowed to proceed to randomization under the protocol. This pushed total enrollment to 424 patients.

 

Suven said safety data continue to be monitored and that no concerns have been observed to date.

 

“We are pleased to announce that we have completed the enrollment for our Masupirdine Phase-3 clinical study. The strong enrollment in the Masupirdine trial highlights the significant unmet need for new treatment options for the management of Agitation associated with Alzheimer's disease. 

 

"We are grateful for the enthusiasm and commitment of the study participants, caregivers, investigators, and site staff, whose dedication contributed to the efficient conduct of the trial. We remain very optimistic of completion of this study with definitive timelines and look forward to bring a new therapy to AAD” said Venkat Jasti, Chairman and Managing Director, Suven Life Sciences.

 

Masupirdine is a highly selective 5-HT6 receptor antagonist being developed as a potential treatment for agitation associated with Alzheimer’s dementia. The company says the drug's mechanism could offer an alternative to existing approaches that rely heavily on sedative or antipsychotic mechanisms.

 

“Masupirdine is a highly selective 5-HT6 receptor antagonist with a differentiated pharmacological profile and has demonstrated a favorable efficacy and tolerability profile throughout its non-clinical and clinical development. Current pharmacological approaches to the management of agitation associated with Alzheimer’s dementia rely predominantly on sedative mechanisms or antipsychotic agents. 

 

"Sedation and the adverse-effect profile associated with antipsychotics, including potential cardiac risks present significant limitations, particularly in this vulnerable patient population. 

 

"Masupirdine, with its distinct and novel mechanism of action, has the potential to address several of these limitations and provide meaningful differentiation from existing treatment options,” said Ramakrishna Nirogi, President and Chief Scientific Officer, Suven Life Sciences.