PRINCETON, N.J. and TOKYO, Japan, July 24, 2026
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved SIMTRIYO® (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20 kg. The approval makes SIMTRIYO the first and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for ADHD, introducing a new mechanism of action for patients and healthcare providers. By increasing the availability of norepinephrine, dopamine, and serotonin, the therapy targets key neurological pathways involved in attention and behavioral regulation. The FDA decision was supported by results from four pivotal Phase 3 clinical trials that demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms across adult and pediatric populations. SIMTRIYO is expected to become commercially available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA).
Phase 3 Trials Demonstrated Early and Significant Symptom Improvement
The FDA approval was based on data from four randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating centanafadine in adults, adolescents, and children with ADHD. In the two pivotal adult studies, both dose groups achieved significant improvements in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores compared with placebo, with symptom improvements observed as early as Week 1 and maintained throughout the six-week treatment period. Similarly, pediatric and adolescent studies showed that high-dose SIMTRIYO significantly improved ADHD Rating Scale-5 (ADHD-RS-5) scores versus placebo, with benefits also appearing during the first week of treatment. Otsuka also reported positive results from a recently completed Phase 3b study involving adults with ADHD and coexisting anxiety, further expanding the evidence supporting the therapy. These additional findings are expected to be presented at an upcoming scientific meeting.
Novel NDSRI Mechanism Expands ADHD Treatment Options
SIMTRIYO represents the first FDA-approved NDSRI for ADHD, offering a distinct therapeutic option beyond existing stimulant and non-stimulant medications. ADHD is a chronic neurodevelopmental disorder affecting approximately 22.5 million children, adolescents, and adults in the United States, often impairing attention, impulse control, academic achievement, workplace performance, and social relationships. According to Otsuka, the approval provides physicians with an additional treatment option tailored to the individualized nature of ADHD management. Across the Phase 3 development program, SIMTRIYO demonstrated a well-characterized safety profile, with the most common adverse events including decreased appetite, headache, nausea, rash, insomnia, dry mouth, abdominal pain, and diarrhea, varying by patient age group. The prescribing information also includes boxed warnings regarding suicidal ideation in pediatric patients and the potential for abuse, misuse, and addiction, highlighting the importance of careful patient monitoring during treatment.
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FDA Approval Marks a New Milestone in ADHD Treatment
The approval of SIMTRIYO® represents a significant advancement in ADHD treatment by introducing the first FDA-approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for both adults and eligible pediatric patients. With positive Phase 3 clinical results, early symptom improvement, and a once-daily extended-release formulation, SIMTRIYO expands treatment options for healthcare professionals managing this highly individualized disorder. As Otsuka prepares for the product’s commercial launch following DEA scheduling, the company continues to strengthen its neuroscience portfolio while advancing innovative therapies designed to improve long-term outcomes and quality of life for patients living with ADHD.
Source: Otsuka press release
