FDA approves Simtriyo for ADHD in adults and children aged 6 years and older

The once-daily treatment introduces the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, with US availability dependent on DEA scheduling.

The FDA has approved Otsuka’s Simtriyo (centanafadine) extended-release capsules for attention-deficit/hyperactivity disorder in adults and paediatric patients aged 6 years and older who weigh at least 20 kg. The approval expands ADHD treatment options across childhood, adolescence and adulthood, although the central nervous system stimulant carries boxed warnings and will not become commercially available until controlled-substance scheduling is completed.

Field	Content
Alert Type	Drug Approval
Drug Name	Simtriyo (centanafadine)
Indication	Treatment of attention-deficit/hyperactivity disorder in adults and paediatric patients aged 6 years and older weighing at least 20 kg
Therapy Area(s)	Psychiatry; paediatrics; neurodevelopmental disorders
Geography	US (FDA)
What Happened	Otsuka announced on 24 July 2026 that the FDA had approved Simtriyo, a once-daily extended-release capsule, for ADHD in adults and paediatric patients aged 6 years and older weighing at least 20 kg. The approval was supported by four randomised, double-blind, placebo-controlled Phase 3 studies conducted in children, adolescents and adults.
Why It Matters	Simtriyo is the first approved treatment described as inhibiting the reuptake of norepinephrine, dopamine and serotonin, providing an additional pharmacological option for patients across multiple age groups. The higher doses evaluated in the pivotal paediatric and adolescent studies produced statistically significant improvements in ADHD symptom scores compared with placebo.
Supporting Context	Simtriyo is classified as a central nervous system stimulant. Its prescribing information includes boxed warnings concerning suicidal ideation and behaviours in paediatric patients and the potential for abuse, misuse and addiction; it is not recommended for children younger than 6 years or those weighing under 20 kg.
Key Takeaway	The approval adds a once-daily treatment with a distinct triple-reuptake mechanism to the US ADHD market for eligible children, adolescents and adults.
What to Watch	DEA controlled-substance scheduling, commercial availability later in 2026 and the presentation of findings from Otsuka’s Phase 3b study in adults with ADHD and comorbid anxiety.
Primary Source	Otsuka’s official FDA approval announcement
Relevant Date	24 July 2026 — FDA approval announcement date

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