SUVN-I6107 / Suven Life Sci - LARVOL DELTA

First-in-Human Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SUVN-I6107, a Pure M1 Positive Allosteric Modulator, in Healthy Human Subjects (CTAD 2026) - No abstract available

Clinical • First-in-human • P1 data • PK/PD data

Evaluation Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Suvn-i6107, A M1 Pam, In Healthy Human Subjects (AAIC 2026) - No abstract available

Clinical • PK/PD data

Suven Life Sciences announces successful completion and topline results of First-in-Human (FIH) Phase-1 clinical study of SUVN-I6107, a Muscarinic M1 Positive Allosteric Modulator (M1-PAM) and its advancement into Phase-2 clinical development (Suven Press Release) - "The completed FIH Phase-1 study (NCT06705088) was a two-part, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SUVN-I6107 in healthy human volunteers....SUVN-I6107 demonstrated a favorable safety and tolerability profile across all dose levels evaluated in the study. No predefined dose-escalation stopping criteria were met, and no treatment related adverse event led to study drug discontinuation or participant withdrawal....Detailed findings will be presented in future medical conference and/or peer-reviewed journal publications."

First-in-human • P1 data • Trial completion • CNS Disorders

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Suven Life Sciences Limited | Recruiting ➔ Completed

First-in-human • Trial completion

Biomarkers. (PubMed, Alzheimers Dement) - P1 | "Results from the non-clinical studies suggest SUVN-I6107 may have memory enhancing property in various forms of dementias. SUVN-I6107 is currently being studied in a Phase-1 study (NCT06705088) to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamic effects after single and repeated administrations in healthy human subjects."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • APP

SUVN-I6107, a True Positive Allosteric Modulator at Muscarinic M1 Receptor for Treatment of Cognitive Disorders, Update on the Development (CTAD 2025) - No abstract available

CNS Disorders • Cognitive Disorders • Developmental Disorders

Efficacy and Pharmacokinetics of SUVN-I6107, A Muscarinic 1 Receptor Positive Allosteric Modulator (M1 PAM) in Animal Models of Cognition (Neuroscience 2025) - P1 | "From the results, we conclude that SUVN-I6107 may have therapeutic utility in various cognitive disorders. SUVN-I6107 is currently being evaluated in a Phase 1 clinical trial (NCT06705088) to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy human subjects."

PK/PD data • Preclinical • CNS Disorders • Cognitive Disorders • APP

Suven doses first subjects in trial of SUVN-I6107 for cognitive disorders (Yahoo Finance) - "India-based Suven Life Sciences has announced the dosing of the first subjects in its Phase I clinical trial of SUVN-I6107 to treat cognitive disorders."

Trial status • CNS Disorders

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Suven Life Sciences Limited | Not yet recruiting ➔ Recruiting

Enrollment open

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Suven Life Sciences Limited

New P1 trial

Suven Life Sciences announces FDA acceptance of investigational new drug (Indian Pharma Post) - "Suven Life Sciences...has announced the acceptance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) and grant of 'Study may proceed Letter' to evaluate SUVN-I6107 in a first-in-human phase-1 clinical trial...Preclinical evidence has shown that treatment with SUVN-I6107 results in precognitive properties in diverse animal models. Additionally, SUVN-I6107 was devoid of cholinergic side effects at doses effective in animal models...We look forward to dosing the first subject with SUVN-I6107 during the H2-2024 with an expected data readout in the H1-2025...The primary endpoint will assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs."

IND • New P1 trial • CNS Disorders • Dementia

SUVN-I6107: A True Positive Allosteric Modulator (PAM) at Muscarinic M1 Receptors for the Treatment of Cognitive Disorders (AAIC 2023) - "It also attenuated scopolamine-induced memory deficit in the object recognition as well as contextual fear conditioning task. SUVN-I6107 enhanced cerebral blood flow, potentiated the effects of donepezil and promoted non-amyloidogenic amyloid precursor protein processing in rats... SUVN-I6107, a novel, potent and selective M1-PAM demonstrated efficacy in animal models and devoid of cholinergic side effects"

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • APP

SUVN-I6107: A True Positive Allosteric Modulator (PAM) at Muscarinic M1 Receptors for the Treatment of Cognitive Disorders (AAIC 2023) - "It also attenuated scopolamine-induced memory deficit in the object recognition as well as contextual fear conditioning task. SUVN-I6107 enhanced cerebral blood flow, potentiated the effects of donepezil and promoted non-amyloidogenic amyloid precursor protein processing in rats... SUVN-I6107, a novel, potent and selective M1-PAM demonstrated efficacy in animal models and devoid of cholinergic side effects"

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • APP

SUVN-I6107: A True Positive Allosteric Modulator (PAM) at Muscarinic M1 Receptors for the Treatment of Cognitive Disorders (AAIC 2023) - "It also attenuated scopolamine-induced memory deficit in the object recognition as well as contextual fear conditioning task. SUVN-I6107 enhanced cerebral blood flow, potentiated the effects of donepezil and promoted non-amyloidogenic amyloid precursor protein processing in rats... SUVN-I6107, a novel, potent and selective M1-PAM demonstrated efficacy in animal models and devoid of cholinergic side effects"

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • APP

SUVN-I6107: A True Positive Allosteric Modulator (PAM) at Muscarinic M1 Receptors for the Treatment of Cognitive Disorders (AAIC 2023) - "It also attenuated scopolamine-induced memory deficit in the object recognition as well as contextual fear conditioning task. SUVN-I6107 enhanced cerebral blood flow, potentiated the effects of donepezil and promoted non-amyloidogenic amyloid precursor protein processing in rats... SUVN-I6107, a novel, potent and selective M1-PAM demonstrated efficacy in animal models and devoid of cholinergic side effects"

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders • APP