Otsuka Pharmaceutical has announced that US regulators approved Simtriyo (centanafadine extended-release capsules), a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older weighing at least 20 kg.

The approval is supported by four Phase III trials involving 906 adults and 909 children or adolescents, with statistically significant symptom improvement on validated rating scales by week 6 and onset observed as early as week 1. High-dose once-daily regimens met endpoints in both the 6 to 12 and 13 to 17 age cohorts, whilst lower doses did not reach significance, informing the labelling and posology.

Centanafadine's triple monoamine reuptake profile differentiates it from stimulants and selective noradrenergic agents such as atomoxetine, offering a non-stimulant option with once- or twice-daily flexibility. For Otsuka, the asset complements its neuropsychiatry franchise and provides a paediatric-to-adult lifecycle product with potential extension into adjunctive or comorbid indications.