# FDA approval of Simtriyo for ADHD treatment

> Live situation record from CLSTR: https://clstr.news/situations/fda-approval-of-simtriyo-for-adhd-treatment
> Updated: 2026-08-08T00:35:36.000Z. Sources: 2. Developments: 2.

The U.S. Food and Drug Administration has approved Otsuka Pharmaceutical’s Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older weighing at least 20 kg.

Simtriyo is an extended-release, once-daily triple reuptake inhibitor affecting norepinephrine, dopamine, and serotonin transporters, though it demonstrates significantly higher potency at the norepinephrine transporter. While clinical trials showed statistically significant symptom reduction, data indicates its effect size may be lower than traditional amphetamines.

The medication is expected to be regulated as a controlled substance and is anticipated to be available commercially in late 2026 following scheduling by the U.S. Drug Enforcement Administration.

## Timeline

### 2026-08-08: FDA approves Simtriyo for adult and pediatric ADHD treatment

The FDA has approved Simtriyo (centanafadine) for ADHD in adults and children. The once-daily medication acts on three neurotransmitters but primarily targets norepinephrine.

2 sources. https://clstr.news/cluster/fda-approves-simtriyo-for-adult-and-pediatric-adhd-treatment

### 2026-07-27: US FDA Approves Otsuka's Simtriyo for ADHD

FDA approved Otsuka’s Simtriyo, a first‑in‑class norepinephrine‑dopamine‑serotonin reuptake inhibitor, for ADHD in adults and children 6+, citing Phase III trials showing early symptom improvement and a toler‑​

2 sources. https://clstr.news/cluster/fda-grants-approval-to-otsukas-simtriyo-for-adhd

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Cite as: FDA approval of Simtriyo for ADHD treatment. CLSTR, https://clstr.news/situations/fda-approval-of-simtriyo-for-adhd-treatment