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

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type (clinicaltrials.gov) - P3 | N=375 | Active, not recruiting | Sponsor: Suven Life Sciences Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Dementia

Suven Life Sciences announces completion of patient enrollment in global phase 3 study of masupirdine (Pharmabiz) - "This multicenter, randomized, double-blind, placebo-controlled Phase 3 study was conducted across sites in USA and Europe. Patients were randomized in a 1:1:1 ratio to receive masupirdine 50 mg, masupirdine 100 mg, or placebo once daily for 12 weeks...Consequently, a total of 424 patients were randomized into the study."

Enrollment closed • Alzheimer's Disease

Masupirdine (a pure 5-HT6 receptor antagonist): Baseline demographic and clinical characteristics of the phase-3 clinical study targeting agitation in patients with dementia of Alzheimer's type (CTAD 2026) - No abstract available

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

Masupirdine (A Pure 5-HT6 Antagonist): Updates From The Phase-3 Clinical Trial Program Targeting Agitation In Alzheimer's Dementia (AAIC 2026) - No abstract available

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

Suven Life clears key safety review for Alzheimer's drug, Phase 3 on track (TradingView) - "An independent Data and Safety Monitoring Board (DSMB), after reviewing unblinded safety data from roughly half the patients who completed 12 weeks of treatment, flagged no safety concerns and recommended that the study proceed as planned...In parallel, a pre-specified interim analysis assessing whether the trial needs a larger patient pool concluded that the current sample size is adequate. The DSMB advised against any increase, effectively endorsing the study design and statistical assumptions, the company said....Enrollment in the trial has reached about 88 percent and remains on track for completion by September, with top-line results expected in the second quarter of 2027."

DSMB • Enrollment status • P3 data: top line • Alzheimer's Disease

Suven Life Sciences Reaches 76% Enrollment Milestone in Global Phase 3 Masupirdine Trial for Alzheimer's Agitation (Scanx) - "...targeting Last Patient In by September 2026 and data readout by April 2027. The 375-patient trial spans approximately 80 sites across North America and Europe, with management confirming full enrollment completion by end of calendar 2026."

Enrollment status • P3 data: top line • Alzheimer's Disease

Masupirdine (A Pure 5-HT6 Receptor Antagonist): Clinical Development Program Targeting Agitation in Alzheimer’s Dementia – Phase-3 Study Updates (AAN 2026) - P3 | "Conclusions Approximately 45% of the total study population have been enrolled. Results from the Phase-3 study will inform the utility of Masupirdine in treating agitation in Alzheimer's dementia."

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

Synthesis and preliminary assessment of fluorescent probes based on the competitive GPCR antagonists vismodegib and masupirdine. (PubMed, RSC Adv) - "In contrast, a masupirdine-naphthalimide conjugate showed a rapid and pronounced staining of the lysosomes, at 25 nM probe concentrations within 15 minutes. The anionic conjugates based on Alexa-532 and cyanine-5 fluorophores showed no cell uptake and bound more weakly to a non-specific protein, as required for their potential use as fluorescent probes that target the GPCRs."

Journal • CDKN1A

Network meta-analysis of the efficacy of nine drugs for cognitive function in patients with Alzheimer's disease. (PubMed, J Alzheimers Dis Rep) - "We systematically searched randomized controlled trials published up to May 2025 that evaluated aducanumab, lecanemab, donanemab, gosuranemab, semorinemab, tilavonemab, zagotenemab, masupirdine, or sodium oligomannate in AD. Tau-targeted antibodies (semorinemab, tilavonemab) display modest but non-significant promise, whereas aducanumab's apparent benefit is likely confounded by publication bias. Further large, rigorous randomized controlled trials and improved preclinical models are essential."

Journal • Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Masupirdine, a Selective Serotonin 5‑HT6 Receptor Antagonist for Alzheimer's Disease. (PubMed, ACS Pharmacol Transl Sci) - "Masupirdine is an oral, small, and safe molecule, readily available by a robust, two-step synthetic scheme, showing a potent, selective serotonin 5-HT6 receptor antagonist profile, pro-cognitive effects in various behavioral animal models in Phase 3 clinical trials for the treatment of agitation in patients with Alzheimer's dementia."

Journal • Alzheimer's Disease • CNS Disorders • Dementia

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type (clinicaltrials.gov) - P3 | N=375 | Recruiting | Sponsor: Suven Life Sciences Limited | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia

Drug Development. (PubMed, Alzheimers Dement) - P2a, P3 | "The non-clinical and clinical data support further evaluation of Masupirdine for the management of agitation in AD. A global Phase-3, double-blind, randomized, placebo-controlled study to establish the efficacy, safety, tolerability, and pharmacokinetics of Masupirdine in patients with agitation in dementia of the Alzheimer's type (NCT05397639 and EudraCT 2021-003405-22) is in progress."

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

Masupirdine (A Pure 5-HT6 Receptor Antagonist): Update on the Phase-3 Clinical Study Targeting Agitation in Patients with Dementia of Alzheimer's Type (CTAD 2025) - No abstract available

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

Phase 3 Trial to Uncover Therapeutic Potential of 5-HT6 Antagonist Masupirdine to Treat Alzheimer Agitation (NeurologyLive) - "Presented as a poster at the 18th Clinical Trials on Alzheimer’s Disease Conference (CTAD), held December 1-4, in San Diego, California, the study’s primary endpoint analyzes change in Cohen-Mansfield Agitation Inventory (CMAI) item scores aligned with the International Psychogeriatric Association (IPA) agitation criteria domains from baseline to week 12. In addition, the study’s secondary endpoint evaluates the proportion of participants considered to be improved on the modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) scale for agitation....In the study, participants will receive masupirdine orally once daily from day 1 through day 85."

Trial status • Alzheimer's Disease

Masupirdine (SUVN-502), a Pure 5-HT6 Receptor Antagonist: Phase-3 Study for the Treatment of Agitation in Patients with Dementia of Alzheimer's Type (Neuroscience 2025) - P2a, 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. Phase-3 study data readout is anticipated in 2026."

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

Divergent late stage functionalisation of luminescent europium(III) complexes for targeting and imaging applications. (PubMed, Chem Commun (Camb)) - "An efficient approach to six functionalised europium(III) complexes based on a common alkyne intermediate is exemplified by syntheses with morpholino and triphenylphosphonium moieties exhibiting a dominant lysosomal localisation profile, two dye conjugates showing intramolecular energy transfer, and two competitive antagonists, including vismodegib that binds to a G-protein coupled receptor in the Hedgehog signalling pathway and masupirdine, designed to target the serotonin GPCR."

Journal

Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type (clinicaltrials.gov) - P3 | N=375 | Recruiting | Sponsor: Suven Life Sciences Limited | Trial completion date: Jan 2025 ➔ Dec 2025 | Trial primary completion date: Jan 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia

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