FDA Approves First Triple Reuptake Inhibitor for ADHD in Adults and Children
The FDA approved centanafadine, sold as Simtriyo, in July 2026 as the first norepinephrine, dopamine, and serotonin reuptake inhibitor cleared for ADHD. The once-daily capsule is approved for patients aged 6 and older weighing at least 44 pounds. Four phase III clinical trials supported the approval.
The U.S. Food and Drug Administration approved centanafadine, marketed as Simtriyo, in July 2026 for the treatment of attention-deficit/hyperactivity disorder in patients aged 6 and older who weigh at least 44 pounds (20 kg).
Developed by Otsuka, centanafadine is the first norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) approved for ADHD. It works as a central nervous system stimulant by increasing the availability of all three neurotransmitters in pathways linked to attention and behavioral regulation.
Four phase III clinical trials involving children, adolescents, and adults supported the approval. The trials showed statistically significant improvements in ADHD symptoms compared to placebo, with some patients seeing results within the first week of treatment.
The drug's label includes a boxed warning about the potential for abuse, misuse, addiction, and the risk of suicidal thoughts in pediatric patients. Common side effects include decreased appetite, nausea, headache, rash, and insomnia. The medication is not approved for patients taking monoamine oxidase inhibitors or those with a history of pheochromocytoma.
The 2026 ADHD treatment landscape also saw three new ultra-long-acting stimulant formulations approved, designed to provide symptom control for 16 or more hours and eliminate the afternoon crash associated with shorter-acting medications. Two new non-stimulant medications targeting histamine H3 and orexin receptors were also cleared, offering options for patients who experience cardiovascular side effects from traditional stimulants.
