Otsuka Holdings (4578) Centanafadine Phase 3b data released; data on ADHD with comorbid anxiety likely to differentiate centanafadine from other products

Research evidence excerpt

Otsuka Holdings (4578) Centanafadine Phase 3b data released; data on ADHD with comorbid anxiety likely to differentiate centanafadine from other products

J P M O R G A N Asia Pacific Equity Research

25 June 2026

Otsuka Holdings (4578)

Centanafadine Phase 3b data released; data on ADHD Overweight

with comorbid anxiety likely to differentiate 4578.T, 4578 JP

centanafadine from other products Price (25 Jun 26):¥10,840

Price Target (Dec-26):¥14,000

Otsuka Holdings announced at 15:15 on June 25 that it had obtained solid results Japan Equity Research

for centanafadine from the Phase 3b study in adult ADHD patients with comorbid

Biotechnology & Pharmaceuticals/

anxiety. The primary endpoint of the Adult Investigator Symptom Rating Scale Medical Technologies & Services

(AISRS) demonstrated statistically significant and clinically relevant AC Seiji Wakao, Ph.D.

improvements versus placebo (inter-group difference: -5.87; p<0.0001), with

(81-3) 6736-8612

efficacy observed from week 1. Anxiety (measured by the Hamilton Anxiety seiji.wakao@jpmorgan.com

Rating Scale, HAM-A) also showed statistically significant improvements (inter- Yugo R. Kamimura, Ph.D.

group difference: -1.92; p=0.02). The safety profile was consistent with previous (81-3) 6736-8635

results. Centanafadine is a norepinephrine, dopamine, and serotonin reuptake yugo.kamimura@jpmorgan.com

inhibitor (NDSRI), and a priority review is ongoing in the US based on four Phase Naoko Saito

3 studies that are separate from the one for which results were just announced (81-3) 6736-8693

(PDUFA date: July 24, 2026). naoko.saito@jpmorgan.com

JPMorgan Securities Japan Co., Ltd.

We view this study as a study for marketing purposes, and these results seem likely