Simtriyo Approved for Attention-Deficit/Hyperactivity Disorder (ADHD)
On July 24, 2026, the US Food and Drug Administration (FDA) approved Otsuka Pharmaceutical’s Simtriyo® (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older weighing at least 20kg (44 pounds). Simtriyo is the first FDA-approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for ADHD. The triple reuptake inhibition mechanism targets three neurotransmitter systems involved in attention, impulse control, and behavioral regulation, providing a novel pharmacologic approach to treatment. The recommended dose is weight-based in children aged six to 12 years, 280mg once daily in adolescents, and 210mg once daily in adults, with titration to 280mg once daily based on clinical response and tolerability. It carries a boxed warning for suicidal ideation and behaviors in pediatric patients and for abuse, misuse, and addiction. Other notable warnings include cardiovascular, psychiatric, growth-related, and peripheral vascular risks. Commercial availability is expected later in 2026 following Drug Enforcement Administration (DEA) scheduling, which remains pending as regulators evaluate the potential abuse associated with Simtriyo’s central nervous system stimulant activity. Cost is not yet known. The prescribing information is here.
At a Glance
- Brand Drug: Simtriyo® (centanafadine)
- Manufacturer: Otsuka Pharmaceuticals
- Date Approved: July 24, 2026
- Indication: For the treatment of ADHD in adults and pediatric patients six years of age and older weighing at least 20kg
- Dosage Forms Available: 140mg, 210mg, and 280mg extended-release capsules
- Launch Date: Expected to be available following scheduling by the US Drug Enforcement Administration (DEA) later this year.
- Estimated Annual Cost: Not yet announced.
- FDA Designation: Priority Review.
- ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. It is one of the most common neurodevelopmental disorders of childhood and has no known cure. Symptoms often persist into adulthood, and patients may face an increased risk of associated conditions, including anxiety and depression.
- ADHD affects approximately seven million children and adolescents and an estimated 15.5 million adults in the United States.
- Approval was supported by four pivotal phase III trials in adults, adolescents, and children with ADHD. Simtriyo demonstrated statistically significant and clinically meaningful improvements in symptom scores compared with placebo. Symptom improvement was observed as early as week one and was maintained through week six across all age groups.
- The most common adverse events in trials included decreased appetite, nausea, rash, headache and abdominal pain in pediatric patients and headache, decreased appetite, nausea, dry mouth and diarrhea in adults.
- Simtriyo enters a competitive ADHD market that includes stimulant therapies and non-stimulant options such as Strattera® (atomoxetine – Eli Lilly/generics), Qelbree® (viloxazine ER – Supernus), Intuniv® (guanfacine ER – Takeda/generics), Kapvay® (clonidine ER – generics), and Onyda™ XR (clonidine ER oral suspension – Tris Pharma).
- The final DEA scheduling designation remains uncertain because Simtriyo modulates dopamine, a neurotransmitter associated with the abuse liability of stimulant therapies. However, its reuptake inhibition mechanism and available abuse-potential data have led some experts to anticipate a less restrictive classification than Schedule II stimulants. The final DEA scheduling designation remains pending.
- Simtriyo is also under investigation for major depressive disorder in phase II clinical trials.