GEXVal Receives Formal PMDA Opinion Letter for Lead Program GXV-001

株式會社GEXVal
March 24, 2026

GEXVal Receives Formal PMDA Opinion Letter for Lead Program GXV-001
-Post-Operative Delirium: A Global Unmet Need, Addressed from Japan-

GEXVal Inc. (President & CEO: Juran Kato, PhD; Fujisawa, Kanagawa, Japan; hereinafter “GEXVal”) is pleased to announce that it has received the formal opinion letter from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) following a face-to-face regulatory consultation (Taimen Jogen)¹ regarding its lead drug candidate GXV-001.

GEXVal submitted a formal regulatory consultation request on January 26, 2026, and received PMDA’s formal opinion on March 24, 2026.  The consultation covered the initiation of an early Phase II trial in elderly subjects in Japan, following on Phase I and Proof of Mechanism (POM) studies conducted in Australia, and the appropriateness of the proposed trial design, on which GEXVal obtained PMDA's supportive opinion*. GEXVal will accelerate preparations for this domestic trial while continuing its dialogue with PMDA.

Target Disease Area
Post-Operative Delirium (POD) is an acute neurocognitive disorder affecting 15–50%+ of elderly surgical patients. Current pharmacological management of delirium is primarily focused on symptom control, while therapeutic options targeting POD onset and the progression remain limited, representing a substantial unmet medical need ^2,3. POD is not merely a transient complication. 
Emerging research indicates that patients who experience POD face a 2–3-fold increased risk of dementia within five years of surgery ^4,5. POD is now understood to represent the earliest stage of a neurocognitive continuum — progressing through delayed Neurocognitive Recovery (dNCR) to Major Neurocognitive Disorder (Major NCD; dementia) ⁶. 
Intervention at this earliest, still-reversible stage is considered key to preventing subsequent irreversible cognitive decline ^2,3, yet no approved drug currently exists to interrupt this trajectory.
Japan, home to the world's highest proportion of elderly citizens, is uniquely positioned to lead this effort. With more elderly surgical patients per capita than any other nation, Japan has accumulated unparalleled clinical expertise in perioperative care for aging populations. This depth of experience —reinforced by Japan's landmark Dementia Basic Act (enacted 2024) ⁷, which enshrines dementia research and prevention as a national imperative — positions Japan not merely as a development site, but as a global proving ground for solutions that aging societies worldwide urgently need.

[About GEXVal]
GEXVal strives to create and develop innovative pharmaceuticals for unmet medical needs, ensuring Treatment Reaches the Unreached with focus on rare diseases and underserved medical conditions. By leveraging our proprietary AI-powered pharmacoinformatics technology, we illuminate paths to breakthrough therapies, identifying hidden potential in drug candidates to deliver life-changing medicines that bring new hope to patients and their families.

1. PMDA Formal Consultation (Taimen Jogen): A formal regulatory procedure in which PMDA provides official written guidance on a company's drug development plans. Conceptually similar to EMA Scientific Advice (CHMP) in Europe and FDA End-of-Phase 1 Meeting in the United States.
2. Hatta et al. JAMA Psychiatry. 2014;71(4):397–403.
3. Japanese Society of Anesthesiologists Safety Committee. Practical Guide for the Prevention and Treatment of Postoperative Delirium in the Elderly, Section 4.4. December 20, 2024. (Japanese only)
4. Davis et al. JAMA Psychiatry. 2017;74(3):244–251.
5. Witlox et al. JAMA. 2010;304(4):443–451.
6. Evered et al. Anesthesiology. 2018;129(5):872–879.
7. Act for Promotion of Realization of an Inclusive Society through Awareness of Dementia (Dementia Basic Act), Act No. 65 of 2023 (effective January 1, 2024).English outline: Japanese Law Translation, Ministry of Justice of Japan.

*: This opinion is not binding on any future regulatory review or approval decision.

This press release contains forward-looking statements based on current expectations. Actual results may differ materially due to risks and uncertainties inherent in drug development.

有關本事宜請諮詢:
Head of Corporate Office
Atsushi Sugizaki
info@gexval.com