Date: September 03, 2026

Clinical Trial Update

Suven Life Sciences announced completion of patient enrollment in its global Phase-3 clinical study of Masupirdine (SUVN-502) for the treatment of Agitation associated with Alzheimer's Dementia (AAD).

Study Design Details

Trial Design: Multicenter, randomized, double-blind, placebo-controlled Phase-3 study conducted across sites in USA and Europe.

Randomization: Patients were randomized in 1:1:1 ratio to receive Masupirdine 50 mg, Masupirdine 100 mg, or placebo once daily for 12 weeks.

Primary Endpoint: Change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items corresponding to the International Psychogeriatric Association (IPA) agitation criteria.

Key Secondary Endpoint: Modified Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C) assessing agitation-related clinical change.

Clinical Trial Registrations: NCT05397639 (ClinicalTrials.gov) and 2021-003405-22 (EudraCT Number).

Enrollment Metrics

Original Target: 375 patients

Actual Enrollment: 424 patients randomized (exceeding target due to patients already undergoing screening when target was reached)

Geographic Scope: Sites in USA and Europe

Timeline Projections

Last Patient Last Visit (LPLV): Expected by end of December 2026

Database Lock (DBL): Targeted by end of March 2027

Topline Results: Expected by May 2027

Safety Monitoring

Safety data from the study is being monitored continuously, with no concerns observed to date.

Management Commentary

Venkat Jasti, Chairman and Managing Director: Highlighted the significant unmet need for new treatment options for agitation associated with Alzheimer's disease. Expressed gratitude to study participants, caregivers, investigators, and site staff. Stated optimism for completion of the study with definitive timelines.

Ramakrishna Nirogi, President and Chief Scientific Officer: Described Masupirdine as a highly selective 5-HT6 receptor antagonist with a differentiated pharmacological profile. Noted favorable efficacy and tolerability profile throughout non-clinical and clinical development. Highlighted limitations of current pharmacological approaches that rely on sedative mechanisms or antipsychotic agents with adverse-effect profiles including potential cardiac risks. Emphasized Masupirdine's potential to address these limitations with its distinct and novel mechanism of action.

Medical Context

Agitation in Alzheimer's Disease: Described as one of the most distressing and challenging symptoms for both patients and caregivers, contributing to early institutionalization, increased morbidity, caregiver burden, and functional impairment. Significant unmet need remains for effective and well-tolerated treatment options.

Drug Profile

Masupirdine: Potent and highly selective 5-HT6 receptor antagonist with favorable pharmacokinetic properties. In preclinical studies, attenuated aggressive behaviors and modulated neurotransmitter pathways implicated in neuropsychiatric symptoms. In clinical study, demonstrated reduction in agitation and aggression in patients with AD.

Company Pipeline Overview

Suven Life Sciences has a portfolio of advanced stage clinical candidates and research programs for CNS disorders:

  • Masupirdine (SUVN-502): For agitation in patients with dementia of the Alzheimer's type (Global Phase-3 study ongoing, enrollment completed)
  • Samelisant (SUVN-G3031): For excessive daytime sleepiness (EDS) in narcolepsy (Phase-2 study for EDS completed; pivotal Phase-3 AWAKE study for EDS initiated; Phase-2 study for Cataplexy in planning)
  • Ropanicant (SUVN-911): For MDD (Open-label Phase-2a study completed; Double blind randomized Placebo controlled Phase-2b study completed; Phase-3 study in planning)
  • Usmarapride (SUVN-D4010): For cognitive disorders (Phase-2 study in planning)
  • SUVN-I6107: For cognitive disorders (Phase-1 study completed; Phase-2 enabling safety studies in planning)

Additionally, the company has 7 projects in research pipeline across multiple indications. Suven owns all intellectual property rights for its assets in all major world markets.