FDA approves Simtriyo for ADHD

The U.S. Food and Drug Administration approved Otsuka’s Simtriyo, or centanafadine, on July 24 for attention-deficit/hyperactivity disorder in adults and pediatric patients age 6 and older who weigh at least 20 kilograms. Otsuka described the drug as the first approved norepinephrine, dopamine and serotonin reuptake inhibitor for ADHD, giving the market a new mechanism in a category long dominated by stimulants and older non-stimulants. The FDA-approved label also classifies Simtriyo as a central nervous system stimulant, a detail that places it inside the agency’s standard stimulant warning framework. ### Who can get the drug under the FDA label? The approved indication covers adults and children 6 years and older who weigh at least 20 kilograms, according to Otsuka and the FDA-approved prescribing information. The label says use is not recommended in children younger than 6 or in pediatric patients under 20 kilograms, citing lack of data in the lower-weight group and a higher incidence of weight loss in younger children. (otsuka-us.com) The drug is formulated as a once-daily extended-release capsule, Otsuka said in its approval announcement. That places it alongside other long-acting ADHD therapies aimed at all-day symptom control in outpatient care. ### What is different about Simtriyo? Simtriyo’s distinguishing feature is its triple reuptake profile. Otsuka said the medicine inhibits reuptake of norepinephrine, dopamine and serotonin, and the prescribing information uses the same three-neurotransmitter description. (otsuka-us.com) That makes it the first FDA-approved ADHD medicine built around that combination, according to the company and the approved label. Patient Care Online, in an August roundup of July FDA actions, listed centanafadine among notable behavioral-health decisions and described the approval as covering patients across age groups. The FDA’s 2026 novel drug approvals page also lists Simtriyo among the year’s new drug approvals. ### What evidence supported the approval? Drugs.com, citing the approval announcement, said the decision was based on four pivotal Phase 3 trials that showed statistically significant and clinically meaningful improvement in ADHD symptoms compared with placebo. (otsuka-us.com) Otsuka’s release announcing the approval did not detail all trial results in the excerpt available through search, but it tied the approval to the company’s clinical development program for centanafadine. (patientcareonline.com) The FDA approval letter shows the agency acted on a new drug application received on November 24, 2025. That letter confirms the approval applies to Simtriyo extended-release capsules submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. ### What should prescribers watch in the label? The FDA-approved prescribing information says the most common adverse reactions, at a threshold of at least 5%, are decreased appetite, insomnia and irritability. (drugs.com) The label also carries stimulant-related warnings, including abuse and misuse risk, and says clinicians should follow the product’s screening and monitoring recommendations. (accessdata.fda.gov) The same prescribing information says use is not recommended in certain pediatric subgroups because of weight-loss concerns and missing data. That makes baseline assessment and follow-up weight monitoring part of routine use in children who meet the approved age and weight thresholds. ### Where does this leave Otsuka now? Otsuka Pharmaceutical Development & Commercialization and Otsuka Pharmaceutical Co. announced the approval jointly from Princeton, New Jersey, and Tokyo on July 24. (accessdata.fda.gov) The company’s next step is launch under the new FDA-approved label, with physicians, pharmacists and payers relying on the prescribing information to determine patient selection, dosing and monitoring. (otsuka-us.com)