Tokyo, Japan – March 17, 2026 – Neusignal Therapeutics, Inc. (“NTX”) today announced the achievement of the last-subject-out (last subject visit completion) as scheduled in a company-sponsored Phase 1 trial of NTX-083, a drug candidate for Alzheimer’s disease. This trial was conducted to assess the safety, tolerability, and pharmacokinetics of NTX-083 following multiple-dose administration in Japanese and Caucasian healthy adults.
Regarding the safety assessment in this trial, no adverse drug reactions were reported, and the safety and tolerability of NTX‑083 following once-daily oral administration for seven days were confirmed. Additionally, both single oral administration and once-daily oral administration for seven days clearly showed a favorable PK profile.
Based on these positive results, NTX plans to initiate a Phase 1b trial in Alzheimer’s disease patients in the United States, as the next step. The development of NTX-083, including this trial, is progressing a few months ahead of the original schedule.
Background
NTX is a Tokyo-based company focused on commercializing early-stage drug discovery from Tohoku University. The development of NTX-083 is supported by the Japan Agency for Medical Research and Development (AMED) under its Strengthening Program for Pharmaceutical Startup Ecosystem (3rd round). NTX provided NTX-083 for the investigator-initiated clinical trial in healthy adults at the University of Tokyo Hospital, where the first-in-human administration of the drug was achieved on February 18, 2025. The trial announced today is the first company-sponsored trial for NTX-083 initiated on November 7, 2025, to assess the safety, tolerability, and pharmacokinetics of NTX-083 following multiple-dose administration. Development has been supported by Tohoku University Faculty of Pharmaceutical Sciences, the AMED Strengthening Program for Pharmaceutical Startup Ecosystem, investors, and other stakeholders. NTX remains committed to accelerating the development of NTX-083 to address the unmet needs in Alzheimer’s treatment.
This research and development program is supported by AMED under project number JP25qfb127005, “Development of KATP channel inhibitor NTX-083 for Alzheimer’s disease therapy.”
Company Overview
・ Established: April 2022
・ Location: 3-11-5 Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan
・ Representative Director: Itaru Arimoto, Ph.D.
・ Business activities: Research and development of treatments for dementia and psychiatric disorders, exploration of early-stage drug discovery for brain diseases
・ Website: https://neusignal-tx.com/
