Suven Life Sciences has completed patient enrollment in its global Phase 3 clinical trial of masupirdine for the treatment of Agitation associated with Alzheimer’s Dementia (AAD), marking a key milestone in the development of the company’s CNS therapy.

The multicentre, randomised, double-blind, placebo-controlled study is being conducted across clinical sites in the US and Europe. Participants were randomised in a 1:1:1 ratio to receive masupirdine 50 mg, masupirdine 100 mg or placebo, administered once daily for 12 weeks.

The trial was initially designed to enroll approximately 375 patients. However, patients who were already undergoing screening when the enrollment target was reached and subsequently met all eligibility criteria were allowed to proceed with randomisation under the study protocol. As a result, 424 patients were ultimately randomised.

Suven said the strong enrollment reflects the significant unmet need for new treatment options for managing agitation associated with Alzheimer’s disease. The company expects the ongoing study to provide further evidence on masupirdine’s potential in addressing this neuropsychiatric symptom.

Masupirdine is being developed as part of Suven Life Sciences’ focus on innovative therapies for central nervous system disorders.