Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that FDA granted approval of Simtriyo (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder in adults and pediatric patients aged 6 years and older weighing at least 20kg.

Simtriyo is the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), introducing a new treatment approach for patients and healthcare professionals managing a condition the companies describe as complex and highly individualized.¹

By inhibiting the reuptake of norepinephrine, dopamine, and serotonin, Simtriyo increases the availability of these neurotransmitters in pathways involved in attention and behavioral regulation. Simtriyo, an NDSRI and central nervous system stimulant, is expected to be available later this year following scheduling by the U.S. Drug Enforcement Administration.

What supported the approval?

The approval is based on results from four pivotal Phase III clinical trials evaluating the efficacy and safety of Simtriyo across adult, adolescent, and pediatric patients.¹ Across those studies, Simtriyo demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in children and adolescents, along with the Adult ADHD Investigator Symptom Rating Scale (AISRS) in adults.¹ In both pediatric and adult studies, improvements in ADHD symptoms were observed as early as the first week.

In the two pivotal adult studies (NCT03605680 and NCT03605836), both centanafadine dose groups demonstrated statistically significant improvements in AISRS total scores compared with placebo, with improvements maintained throughout the six-week treatment period.^2,3 In the pivotal pediatric and adolescent studies (NCT05428033 and NCT05257265), high-dose centanafadine demonstrated statistically significant improvements in ADHD-RS-5 total scores compared with placebo, also as early as week 1.^4,5

Across the Phase III clinical development program, centanafadine was generally well-tolerated, with clinical and preclinical data demonstrating a well-studied and consistent safety profile.¹ The most common adverse reactions included rash and decreased appetite in children aged 6 to 12 years; decreased appetite, nausea, rash, headache, and abdominal pain in adolescents 13 to 17 years of age; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.^2,3,4,5

What does this mean for ADHD treatment?

"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, Otsuka. "ADHD is a complex and highly individualized disorder that can affect people throughout childhood, adolescence, and adulthood. Today's approval reflects our commitment to advancing innovative treatment options that address the diverse needs of patients and families managing ADHD. We are deeply grateful to the patients, caregivers, investigators, and clinical teams whose participation made this achievement possible."

Dr. Lenard A. Adler, director of the adult ADHD program at NYU Langone Health, pointed to the persistent burden many patients face even under existing treatment. "ADHD can significantly affect many aspects of daily life across school, work, and relationships," Adler said. "Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning. The approval of Simtriyo introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients. Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient."

Sources

1. 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 businesswire July 24, 2026 https://www.businesswire.com/news/home/20260724968244/en/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
2. A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/​Hyperactivity Disorder National Library of Medicine March 15, 2022, https://clinicaltrials.gov/study/NCT03605680
3. A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/​Hyperactivity Disorder National Library of Medicine October 18, 2021 https://clinicaltrials.gov/study/NCT03605836
4. Efficacy of Centanafadine for Executive Functioning and Learning Problems in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder National Library of Medicine April 9, 2026, https://pubmed.ncbi.nlm.nih.gov/41958186/
5. A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/​Hyperactivity Disorder National Library of Medicine September 27, 2024, https://clinicaltrials.gov/study/NCT05257265