Otsuka’s Simtriyo has received FDA approval as a once-daily extended-release capsule for treating ADHD in adults and children aged six and older weighing at least 20 kg.
The drug, known generically as centanafadine, is the first and only approved norepinephrine, dopamine, and serotonin reuptake inhibitor, introducing a distinct treatment mechanism to the ADHD market.
By blocking the reuptake of three key neurotransmitters simultaneously, Simtriyo increases their availability in brain pathways linked to attention and behavioral regulation.
ADHD is a chronic neurodevelopmental disorder affecting approximately 7 million children in the United States and an estimated 15.5 million adults, according to the Centers for Disease Control and Prevention.
The approval was supported by results from four pivotal Phase 3 clinical trials evaluating Simtriyo across adult, adolescent, and pediatric patient groups.
In those trials, Simtriyo demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo across multiple validated rating scales.
Adult studies showed that both dose groups improved their scores on the Adult ADHD Investigator Symptom Rating Scale over six weeks, sustaining that benefit throughout the treatment period.
Pediatric and adolescent trials found that high-dose centanafadine significantly improved ADHD Rating Scale-5 scores versus placebo, including a notable early response observed as soon as week one.
The FDA placed a boxed warning on Simtriyo flagging a risk of suicidal ideation and behaviors, as well as risks of abuse, misuse, and addiction associated with the medication.
Common side effects in younger patients included headache, nausea, rash, decreased appetite, and abdominal pain, while adults additionally reported insomnia, dry mouth, and diarrhea.
Controlled substance scheduling remains pending for Simtriyo, and Otsuka has said it expects the drug to become available to patients later in the year following classification by the U.S. Drug Enforcement Agency.
Analysts at Jefferies described the FDA approval as an “important de-risking event,” noting that the decision “marks the arrival of Otsuka’s next major CNS launch.”
Otsuka has previously forecast peak sales of more than 100 billion yen, equivalent to roughly $615 million, for Simtriyo, underlining the commercial ambitions attached to the new therapy.
Beyond the core ADHD indication, Otsuka is also evaluating centanafadine for patients with comorbid anxiety, following the recent completion of a Phase 3b study in that population.
Full findings from that anxiety study are expected to be presented at a future scientific forum, potentially broadening the clinical case for Simtriyo across related conditions.