Simtriyo (centanafadine) has been approved by the FDA for ADHD in adults and children aged 6 and up who weigh at least 20 kg, marking it as the first-in-class NDSRI—norepinephrine-dopamine-serotonin reuptake inhibitor.

The drug works by blocking reuptake of three neurotransmitters, aligning with a stimulant-like approach to ADHD treatment.

The approval covers a broad ADHD population and may offer a new option for patients who also have anxiety comorbidity.

DEA scheduling is a next step, with a commercial release expected later in 2026 after scheduling.

Simtriyo will be a once-daily extended-release capsule, designed to become available later this year following scheduling.

Phase 3 trials showed efficacy in adults and in pediatric/adolescent groups, with improvements seen as early as week 1 in youth and by week 6 in adults, across high-dose cohorts.

Common adverse events vary by age but include headache, decreased appetite, nausea, rash, insomnia, abdominal pain, dry mouth, and gastrointestinal symptoms; overall safety was characterized as well-studied across the program.

The prescribing information carries boxed warnings for suicidality in children aged 6–12 and for risk of abuse, misuse, and addiction due to stimulant properties.

Indirect comparisons suggest centanafadine may have similar efficacy to some stimulants with potentially better tolerability and a lower abuse potential, though direct head-to-head data are limited.

Otsuka frames centanafadine as a novel mechanism that broadens ADHD treatment options and supports individualized care, with ongoing Phase 3b work in adults with comorbid anxiety.

Label expansion toward patients with comorbid anxiety is under consideration, underscoring the drug’s relevance for broader ADHD management.

Full Phase 3 results and payer formulary decisions will unfold over the coming months as independent analyses and presentations at scientific meetings advance.