August 24, 2026ManagementProducts

AGC and Neusignal Therapeutics Collaborate on the Development of Alzheimer’s Disease Drug Candidate “NTX-083”

-End-to-End Support from Development to Clinical Readiness-

AGC Inc. (Headquarters: Tokyo; President: Yoshinori Hirai; hereinafter “AGC”) highlights its end-to-end support capabilities as a small-molecule pharmaceutical CDMO as demonstrated by its collaboration with Neusignal Therapeutics, Inc. (Headquarters: Tokyo; CEO: Itaru Arimoto; hereinafter “NTX”).
In this collaboration, AGC provided integrated support for the drug substance of “NTX-083,” an Alzheimer’s disease drug candidate being developed by NTX, covering process development, GMP*1 manufacturing, and regulatory support from the early stages of development. In addition to establishing the manufacturing process for the drug substance, AGC completed the preparation of documentation required for an IND application*2 in the United States. NTX-083 is scheduled to enter clinical trials in the United States in 2026.

Process Development

Pharma Chemicals Chiba Site

Process Development Operations Exterior of AGC's Synthetic Pharmaceuticals Chiba Site

Alzheimer’s disease is one of the disorders with significant unmet medical needs*3, and the number of patients continues to increase worldwide. NTX is advancing the development of NTX-083 with the goal of providing a new treatment option for patients facing this challenge. In the process development and manufacturing of the NTX-083 drug substance, AGC supported a smooth transition from the early stages of development to the clinical stage through collaboration between its Yokohama Technical Center, a process development site, and its Chiba Site, a GMP manufacturing site. AGC also supported the preparation of CMC*4-related documentation required for the IND application.

Under its medium-term management plan, AGC plus-2026 , the AGC Group has identified three social values it aims to create through its products and technologies. One of these values, “Well-being” aims to contribute to safe, secure, and healthy lives through the stable supply of products and services essential to healthcare and everyday life. Through its pharmaceutical and agrochemical CDMO services, the Life Science business supports drug discovery and pharmaceutical development and contributes to improving people’s health and quality of life.


〈Notes〉

*1

GMP (Good Manufacturing Practice):
A quality standard that ensures the quality and safety of pharmaceutical products by controlling the entire manufacturing process, from raw material receipt through production and product release.

*2

IND (Investigational New Drug) Application:
An application submitted to the U.S. Food and Drug Administration (FDA) to obtain authorization to initiate clinical trials using an investigational drug.

*3

Unmet Medical Needs:
Medical needs that remain insufficiently addressed due to the absence of effective treatments or because existing therapies do not provide adequate outcomes.

*4

CMC (Chemistry, Manufacturing and Controls):
Information and documentation related to manufacturing processes and quality controls required to ensure the quality and safety of pharmaceutical products.

〈Reference Information〉
About Neusignal Therapeutics, Inc.

Neusignal Therapeutics, Inc. is a drug discovery startup originating from Tohoku University that focuses on the research and development of treatments for central nervous system disorders, including Alzheimer's disease. The company is advancing the development of “NTX-083,” a novel small-molecule oral drug candidate with a new mechanism of action that is expected to improve cognitive and psychiatric symptoms while also offering disease-modifying potential. In 2026, the company raised a total of ¥5.32 billion in its Series B financing round, including support from AMED’s Strengthening Program for Pharmaceutical Startup Ecosystem. The company is currently preparing to initiate a Phase 1b clinical trial in patients with Alzheimer's disease in the United States.
Contact: info@neusignal-tx.com

About the AGC Group
AGC Inc. is a global materials company operating across a wide range of products and industries. Founded in 1907 with flat glass production as its original business, AGC has expanded its operations in line with changing societal needs, providing materials and solutions based on its core material and production technologies. Today, the AGC Group operates in more than 30 countries and regions, with businesses spanning glass, electronics, chemicals, life science, and ceramics. Guided by its purpose, “AGC, an everyday essential part of our world,” the Group provides value to society through the pursuit of innovation. For more information, visit www.agc.com/en.

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