YA-101 / National Taiwan University, Yoda Pharma - LARVOL DELTA

Esprit's new drug YA-101 for the treatment of MSA Phase II clinical trial approved in Japan [Google translation] (udn.com) - "Esprit Uda Pharmaceuticals-KY...announced on the 2nd that its subsidiary's application for the second phase clinical trial of its new drug YA-101 for the treatment of multisystem degenerative disease (MSA) has been approved by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan...The trial is a multi-national, multi-center, global Phase II clinical study....According to the trial plan, the overall case acceptance work is expected to be completed in 2026."

New P2 trial • CNS Disorders

Unveiling the Cognitive Enhancing Effects of RS-D7, a Novel NMDAR Modulator, on Hippocampus-Dependent Learning and Memory in Mice (CINP-AsCNP 2025) - "Our findings suggest that RS-D7 enhances hippocampus-dependent spatial learning and memory in mice. Electrophysiological data, which confirm improved synaptic function, along with neuromorphological changes in CA1 neurons, further support the observed behavioral enhancements. Ongoing data collection is expected to provide deeper insights into the underlying mechanisms by which RS-D7 modulates neurocognitive functions."

Preclinical • CNS Disorders • Cognitive Disorders • Mental Retardation • Psychiatry

Yoda Therapeutics Announces First Patient Dosed in Phase 2 Trial of YA-101 for Multiple System Atrophy (PRNewswire) - "Yoda Therapeutics Inc...announced the dosing of the first patient in the Phase 2 trial of YA-101 for Multiple System Atrophy (MSA) in the United States."

Trial status • Multiple System Atrophy

Pharmacokinetics And Safety Of YA-101, A Dual Inhibitors Of D-Amino Acid Oxidase (DAAO) And NLRP3 Inflammasome, In Healthy Subjects: A Double-Blind, Placebo-Controlled, Randomized, Single Dose and Multiple Dose Phase I Study (MDS Congress 2024) - "The Phase I trial of YA-101 successfully established a favorable safety and PK profile, supporting the potential of YA-101 as a novel therapeutic agent. Notably, the results validate the feasibility of YA-101 with twice-daily dosing regimens, paving the foundation of subsequent YA-101 clinical development for investigating efficacy and safety in MSA."

Clinical • P1 data • PK/PD data • CNS Disorders • Multiple System Atrophy • IL1B • NLRP3

S15 - Advancing Drug Discovery for Unmet Medical Needs in Schizophrenia: From Cell Lines, Brain Organoids, Mouse Models to Patients (CINP 2022) - "Professor Wen-Sung Lai at National Taiwan University will discuss the emerging role of NMDA receptor in schizophrenia and wrap up this symposium with the use of novel pharmaceutical agents (including lithium, sarcosine, and RS-D7) for the treatment of schizophrenia in preclinical and clinical studies (7-8). There is an urgent need in making good use of these preclinical models and advancing techniques for studying the complexity of schizophrenia and developing novel treatments for unmet medical needs in schizophrenia and other neuropsychiatric disorders."

Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Mental Retardation • Psychiatry • Schizophrenia

Efficacy of a N-Methyl-D-Aspartate Receptor (NMDAR) Modulator for the Treatment of Early Phase Alzheimer Disease (AAIC 2019) - "The preliminary results suggest RS-D7 prodrug may be efficacious for cognitive and functional improvement in subjects with aMCI or early AD."

Clinical