Otsuka’s daily attention-deficit/hyperactivity disorder (ADHD) candidate has shown benefit in a Phase IIIb trial.
In the study (NCT06973577), centanafadine XR 280mg once daily was investigated in adults with ADHD and comorbid anxiety. Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).
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The trial met its primary endpoint by demonstrating improvements from baseline on the Adult Investigator Symptom Rating Scale (AISRS) total score compared to placebo after eight weeks.
Adult patients with ADHD and comorbid anxiety receiving centanafadine demonstrated statistically significant and clinically relevant improvements compared to placebo, with a mean reduction of 18.5 compared with 12.6, respectively, with statistically significant improvements seen as soon as week one.
Statistically significant improvements versus placebo were also observed in the key secondary efficacy endpoint of change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score, with a reduction of 12.5 points in the treatment group compared to a 10.6-point reduction in the placebo cohort.
Dr John Kraus, executive vice president and CMO of Otsuka, said: “Adults with ADHD and comorbid anxiety represent a substantial and particularly challenging population to treat. These results provide additional insight into centanafadine’s clinical profile and expand the evidence base supporting its potential in adults with ADHD across diverse patient presentations.”
The most frequently observed adverse events (AEs) were nausea, decreased appetite, diarrhoea, insomnia, dry mouth and vomiting, with the safety and tolerability profile remaining consistent with the known safety profile of the candidate.
Full results will be presented at an upcoming scientific meeting. Centanafadine is currently under regulatory review in the US for the treatment of ADHD in children, adolescents, and adults. The drug has been granted Priority Review by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of 24 July 2026.
There are a range of reuptake inhibitors in the pharma pipeline for ADHD treatment. In March 2025, Axsome announced its ADHD therapy, Sunosi (solriamfetol), met its primary endpoint in a Phase III trial, providing a statistically significant 45% drop in ADHD symptoms. Sunosi is a dopamine and norepinephrine reuptake inhibitor (DNRI).
A drug with a recent approval extension in the US, though not the UK, was Supernus Pharmaceuticals’ Qelbree (viloxazine extended-release capsules). The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults.
ADHD treatments have been in the political crosshairs in the US. The disorder, along with autism, has been singled out by the Trump administration for an “over-utilisation of medication”.
Analysis by GlobalData estimates that across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, Japan), the ADHD market is looking to decline from $11.9bn in 2022, down to $10.9bn in 2032.
GlobalData is the parent company of Clinical Trials Arena.
