Otsuka Receives FDA Approval for SIMTRIYO® (Centanafadine)
First-in-Class Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD)
July 24, 2026
Introduction to ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder characterized primarily by persistent patterns of inattention, hyperactivity, and impulsivity. These symptoms can significantly interfere with academic performance, occupational functioning, social relationships, and overall daily life.
Although ADHD is most often diagnosed in childhood, symptoms frequently continue into adolescence and adulthood. In the United States, ADHD affects approximately 7 million children and an estimated 15.5 million adults, totaling around 22.5 million people. Because ADHD is highly individualized, treatment needs vary widely among patients, and having multiple therapeutic options is essential.
FDA Approval Announcement
On 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 ADHD in adults and pediatric patients aged 6 years and older who weigh at least 20 kg.
Key Highlights
- First-in-class mechanism: SIMTRIYO is the first and only approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). By inhibiting the reuptake of these three neurotransmitters, it increases their availability in brain pathways involved in attention and behavioral regulation.
- CNS stimulant: Classified as a central nervous system stimulant.
- Availability: Expected to become commercially available later in 2026 following scheduling by the U.S. Drug Enforcement Administration (DEA).
- Clinical evidence: Supported by four pivotal Phase 3 randomized, double-blind, placebo-controlled trials in adults, adolescents, and children. Statistically significant and clinically meaningful improvements in ADHD symptoms were observed (measured by AISRS in adults and ADHD-RS-5 in pediatric patients), with benefits appearing as early as Week 1.
Safety Profile
Across the Phase 3 clinical program, SIMTRIYO was generally well-tolerated.
Most common adverse reactions:
- Children (6–12 years): Rash and decreased appetite
- Adolescents (13–17 years): Decreased appetite, nausea, rash, headache, and abdominal pain
- Adults: Headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea
Important Safety Information – Boxed Warnings
- Suicidal Ideation and Behaviors: Higher rates observed in SIMTRIYO-treated pediatric patients (especially ages 6–12). Close monitoring is required.
- Abuse, Misuse, and Addiction: As a CNS stimulant, SIMTRIYO has potential for abuse and misuse, which can lead to substance use disorder, overdose, or death. Risk assessment and ongoing monitoring are essential.
Other important risks include cardiac effects, increased blood pressure and heart rate, psychiatric adverse reactions, long-term growth suppression in children, peripheral vasculopathy (including Raynaud’s phenomenon), serotonin syndrome, and worsening of tics or Tourette’s syndrome.
Limitations of Use: Not recommended for pediatric patients younger than 6 years of age or those weighing less than 20 kg due to higher risk of weight loss and lack of data.
Expert Perspectives
“The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,” said John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Otsuka.
Dr. Lenard A. Adler, Director of the Adult ADHD Program at NYU Langone Health, noted: “Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient.”
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