masupirdine (SUVN-502) / Suven Life Sci - LARVOL DELTA

Masupirdine (SUVN-502): An Update on the Phase-3 Clinical Development Program Targeting Agitation in Patients with Dementia of Alzheimer's Type (AAN 2025) - P3 | "Results from the Phase-3 study will inform the utility of Masupirdine in treating agitation in patients with dementia of the Alzheimer's type."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Drug Development. (PubMed, Alzheimers Dement) - P2a, P3 | "Outcomes from animal models of aggression and subgroup analysis of the Phase-2 study suggest that masupirdine may alleviate agitation. The Phase-3 study results may inform the therapeutic utility of masupirdine for the treatment of Alzheimer's agitation. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Comparison of the efficacy of updated drugs for the treatment on the improvement of cognitive function in patients with Alzheimer 's disease: A systematic review and network meta- analysis. (PubMed, Neuroscience) - "Donanemab and Lecanemab showed good efficacy in ADCS-ADL and CDR-SB, respectively. GV-971 is the best choice to improve ADAS cogs and NPI."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Rationale and Study Design for the Phase-3 Clinical Development Program of Masupirdine (SUVN-502), a Pure 5-HT6 Receptor Antagonist, for the Treatment of Agitation in Patients with Dementia of Alzheimer’s Type (Neuroscience 2024) - P2a, P3 | "Cohen-Mansfield Agitation Inventory items score aligning to the IPA agitation criteria domains and the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change score as related to agitation are the primary and key secondary endpoints, respectively. The study is currently recruiting participants."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Psychiatry

Masupirdine (SUVN-502): Phase-3 Study for the Potential Treatment of Agitation in Patients with Dementia of the Alzheimer’s Type, an Update (AAIC 2024) - P2a, P3 | "Outcomes from animal models of aggression and subgroup analysis of the Phase-2 study suggest that masupirdine may alleviate agitation. The Phase-3 study results may inform the therapeutic utility of masupirdine for the treatment of Alzheimer's agitation. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Masupirdine (a pure 5-HT6 receptor antagonist) for the treatment of agitation in patients with dementia of Alzheimer’s type: Phase-3 study design (Neuroscience 2023) - P2a, P3 | "Subject enrolment is expected to be completed by Q3 2024. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Masupirdine (SUVN-502), a pure 5-HT6 receptor antagonist: Rationale for evaluation in patients with agitation in dementia of Alzheimer's type (Neuroscience 2023) - P2a, P3 | "In addition, masupirdine significantly modulated levels of dopamine and norepinephrine in brain at a dose of 10 mg/kg, s.c. The post hoc analysis of the Phase-2 study (NCT02580305) in patients with moderate AD suggested treatment with masupirdine at 50 mg and 100 mg significantly decreased the agitation/aggression score from Week 13 to Week 26 suggesting potential treatment effects of masupirdine on agitation/aggression symptoms. To explore the beneficial effects, masupirdine is currently being evaluated as a monotherapy in a global Phase-3 study for the potential treatment of agitation in participants with dementia of Alzheimer's type (NCT05397639)."

Clinical • Alzheimer's Disease • Behavior Disorders • CNS Disorders • Dementia • Psychiatry

Masupirdine (A Pure 5-HT6 Receptor Antagonist) for the Treatment of Agitation in Patients with Dementia of Alzheimer's Type - Rationale and Phase-3 Study Design (CTAD 2023) - P2a, P3 | "The Phase-3 study (NCT05397639) may provide evidence for the potential utility of masupirdine for the treatment of agitation in dementia of Alzheimer’s type. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Developmental Disorders • Psychiatry

Masupirdine (SUVN-502) for the Potential Treatment of Agitation in Patients with Dementia of the Alzheimer’s Type: Preliminary Efficacy and Phase-3 Study Design (AAIC 2023) - P2a, P3 | "The need for new treatments for the management of agitation is significant and unmet. The Phase-3 study results will inform the utility of masupirdine for the potential treatment of agitation in patients with dementia of Alzheimer’s type. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Masupirdine (SUVN-502) for the Potential Treatment of Agitation in Patients with Dementia of the Alzheimer’s Type: Preliminary Efficacy and Phase-3 Study Design (AAIC 2023) - P2a, P3 | "The need for new treatments for the management of agitation is significant and unmet. The Phase-3 study results will inform the utility of masupirdine for the potential treatment of agitation in patients with dementia of Alzheimer’s type. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Masupirdine (SUVN-502) for the Potential Treatment of Agitation in Patients with Dementia of the Alzheimer’s Type: Preliminary Efficacy and Phase-3 Study Design (AAIC 2023) - P2a, P3 | "The need for new treatments for the management of agitation is significant and unmet. The Phase-3 study results will inform the utility of masupirdine for the potential treatment of agitation in patients with dementia of Alzheimer’s type. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Masupirdine (SUVN-502) for the Potential Treatment of Agitation in Patients with Dementia of the Alzheimer’s Type: Preliminary Efficacy and Phase-3 Study Design (AAIC 2023) - P2a, P3 | "The need for new treatments for the management of agitation is significant and unmet. The Phase-3 study results will inform the utility of masupirdine for the potential treatment of agitation in patients with dementia of Alzheimer’s type. Phase-3 study data readout is anticipated in Q1/Q2 2025."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

A 2023 update on the advancements in the treatment of agitation in Alzheimer’s disease. (PubMed, Expert Opin Pharmacother) - "Several agents were identified for promise in treating agitation, including: brexpiprazole, cannabinoids, dexmedetomidine, dextromethorphan, escitalopram, masupirdine, and prazosin. Clinical trials remain underway utilizing both novel and repurposed agents to address symptoms of agitation in AD. With increasing understanding of the neurobiological mechanisms that fuel the development of agitation in AD, the use of enhanced trial design and conduct, advanced statistical approaches, and accelerated pathways for regulatory approval, we are advancing closer to having safe and efficacious treatment options for agitation in AD."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Progress in Investigational Agents Targeting Serotonin-6 Receptors for the Treatment of Brain Disorders. (PubMed, Biomolecules) - "Several 5-HT receptor antagonists (idalopirdine, intepirdine and latrepirdine) showed efficacy in alleviating cognitive deficits associated with AD in the proof-of-concept clinical studies; however, the outcomes of the subsequent phase 3 studies were largely disappointing...Masupirdine, a selective 5-HT receptor antagonist, reduced agitation/aggression-like behaviors in animal models, and a post hoc analysis of a phase 2 trial suggested potential beneficial effects on agitation/aggression and psychosis in AD. This agent will be assessed in additional trials, and the outcome of the trials will inform the use of 5-HT receptor antagonists in the treatment of agitation in dementia of the Alzheimer's type."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Psychiatry • Schizophrenia

Phase-3 Study of Masupirdine (SUVN-502), a 5-HT6 Receptor Antagonist, For the Potential Treatment of Agitation in Participants with Dementia of Alzheimer’s Type (CTAD 2022) - No abstract available

P3 data • Alzheimer's Disease • CNS Disorders • Dementia

Suven starts Phase 3 trial for first home-grown Alzheimer's drug (Business Standard) - "Hyderabad-based Suven Life Sciences (Suven) has started recruiting patients for the Phase 3 trial of this novel drug that could possibly slow cognitive decline....Suven said on Wednesday it has started randomisation of the first patient in the Phase 3 global clinical trial of its drug Masupirdine for the treatment of agitation in patients with dementia of the Alzheimer’s type....'The study will enrol approximately 375 patients who will be randomised in a 1:1:1 ratio to receive Masupirdine'...Top-line data from the trial is expected to be available by early 2025."

P3 data: top line • Trial status • Alzheimer's Disease • CNS Disorders • Dementia

Masupirdine (SUVN-502): A Pure 5-HT6 Receptor Antagonist for the Treatment of Agitation/Aggression and Psychosis (Neuroscience 2022) - P2a, P3 | "Further exploration is warranted to confirm the beneficial effects of masupirdine in AD patients. Masupirdine is currently being evaluated as a monotherapy in a Phase-3 study for the potential treatment of agitation in participants with dementia of Alzheimer’s type (NCT05397639)."

Alzheimer's Disease • CNS Disorders • Dementia • Mood Disorders • Psychiatry • Sleep Disorder

Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses. (PubMed, Int J Geriatr Psychiatry) - "Further research is warranted to explore the potential beneficial effects of masupirdine on NPS."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Psychiatry

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type (clinicaltrials.gov) - P3 | N=375 | Recruiting | Sponsor: Suven Life Sciences Limited | Initiation date: Jun 2022 ➔ Sep 2022

Trial initiation date • Alzheimer's Disease • CNS Disorders • Dementia

Effects of Masupirdine (SUVN-502) on Agitation/Aggression and Psychosis in Patients with Probable Alzheimer’s Disease: A Post Hoc Analysis (AAIC 2022) - No abstract available

Clinical • Retrospective data • Alzheimer's Disease • CNS Disorders • Psychiatry

Effect of Concurrent Use of Memantine on The Efficacy of Masupirdine (SUVN-502): A Post-hoc Analysis of a Phase-2 Randomized Placebo-Controlled Study (AAIC 2022) - No abstract available

Clinical • P2 data • Retrospective data

Effect of Concurrent Use of Memantine on the Efficacy of Masupirdine (SUVN-502): A Post Hoc Analysis of a Phase 2 Randomized Placebo-Controlled Study. (PubMed, Neurol Ther) - P2a | "Although prespecified study endpoints of the phase 2 study were not met, these exploratory post hoc subgroup observations are hypothesis-generating and suggest that the efficacy of masupirdine was adversely affected by concurrent therapy with memantine. Further assessment of masupirdine to determine its potential role as a treatment option for cognitive deficits associated with AD is warranted."

Journal • P2 data • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Effect of masupirdine (SUVN-502) on cognition in patients with moderate Alzheimer's disease: A randomized, double-blind, phase 2, proof-of-concept study. (PubMed, Alzheimers Dement (N Y)) - P2a | "Possible reasons for the observed trial results are discussed. Masupirdine was evaluated in moderate Alzheimer's disease patients.First trial in class with background treatment of donepezil and memantine.Masupirdine was generally safe and well tolerated.Possible reasons for the observed trial results are discussed."

Clinical • Journal • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type (clinicaltrials.gov) - P3 | N=375 | Recruiting | Sponsor: Suven Life Sciences Limited

New P3 trial • Alzheimer's Disease • CNS Disorders • Dementia

Masupirdine (SUVN-502), A Serotonin Receptor Sub-Type 6 Antagonist for the Potential Treatment of Agitation and Psychosis in Patients with Dementia of Alzheimer’s Type (AAN 2022) - P2a | "Further exploration of masupirdine is warranted to confirm the beneficial effects on agitation and psychosis. Currently, a Phase-3 study evaluating the effect of masupirdine on agitation in patients with dementia of the Alzheimer's type is in progress."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry