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FDA Approves Centanafadine for ADHD in Adults, Children Aged ≥ 6 Years
The first-in-class NDSRI showed significant symptom improvement as early as week 1 across 4 phase 3 trials but carries boxed warnings for suicidality and abuse potential.
First-in-Class NDSRI Cleared for Pediatric and Adult ADHD
The US Food and Drug Administration (FDA) has approved centanafadine (SIMTRIYO), a once-daily extended-release capsule, for the treatment of ADHD in adults and pediatric patients aged ≥ 6 years weighing ≥ 20 kg, Ostuka Pharmaceutical announced on July 24, 2026.¹
Centanafadine is the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), a mechanism distinct from existing stimulant and nonstimulant ADHD therapies.¹ The drug increases availability of norepinephrine, dopamine, and serotonin in pathways tied to attention and behavioral regulation.¹ It is expected to become commercially available later in 2026 pending scheduling by the US Drug Enforcement Administration.¹
“Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning,” said Lenard A. Adler, MD, director of the adult ADHD program at NYU Langone Health, in a statement. “The approval of SIMTRIYO introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients.”
Phase 3 Data Showed Early, Sustained Symptom Improvement
The approval rests on 4 randomized, double-blind, placebo-controlled phase 3 trials spanning children, adolescents, and adults.¹ In 2 adult trials, centanafadine produced statistically significant improvements in Adult ADHD Investigator Symptom Rating Scale scores versus placebo.1,2
In the pediatric and adolescent trials, the high-dose group showed statistically significant improvement in ADHD Rating Scale-5 total scores compared with placebo (P =.0008 and P =.0006), with benefit emerging by week 1 and sustained through 6 weeks.3 A completed phase 3b study in adults with ADHD and comorbid anxiety additionally found significant symptom improvement over placebo, with full results slated for presentation at a future scientific meeting.¹
Centanafadine Safety Profile Includes Boxed Warnings
Centanafadine carries boxed warnings for suicidal ideation and behaviors in patients aged 6 to 12 years, who showed greater rates than those on placebo, and for abuse, misuse, and addiction, given its status as a CNS stimulant.¹ Clinicians are advised to assess abuse risk before prescribing and to monitor patients for emergent suicidality throughout treatment.¹
The most common adverse reactions were rash and decreased appetite in children aged 6 to 12 years; rash, decreased appetite, nausea, headache, and abdominal pain in adolescents aged 13 – 17 years; and decreased appetite, nausea, headache, insomnia, dry mouth, and diarrhea in adults.¹ The drug is contraindicated with monoamine oxidase inhibitor use within 14 days and in patients with pheochromocytoma.¹
Clinicians Highlight Need for Additional ADHD Options
ADHD affects an estimated 7 million children and 15.5 million adults in the US, according to the Centers for Disease Control and Prevention.¹ Adler noted that psychiatric disease can impact school, work, and relationships.
“Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient,” Adler continued.
References
Otsuka Receives FDA Approval for First-In-Class SIMTRIYO (Centanafadine) For the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older. Otsuka Pharmaceutical. Published on July 24, 2026. Accessed July 27, 2026. https://www.otsuka-us.com/otsuka-shares-fda-review-update-for-centanafadine
Otsuka Announces Positive Phase 3b Results for Centanafadine in Adults with ADHD and Comorbid Anxiety. Ostuka Pharmaceutical. Published June 25, 2026. Accessed July 27, 2026. https://www.otsuka-us.com/news/otsuka-announces-positive-phase-3b-results-centanafadine-adults-adhd-and-comorbid-anxiety
Centanafadine Shows Promise in Phase 3 Trials for Adolescent ADHD. HCPLive. Published October 30, 2023. Accessed July 27, 2026. https://www.hcplive.com/view/centanafadine-shows-promise-phase-3-trials-adolescent-adhd
