FDA Approves Centanafadine for ADHD

The FDA approved centanafadine (Simtriyo, Otsuka) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older who weigh at least 20kg, according to Otsuka Pharmaceutical. Centanafadine will be available as a once-daily extended-release capsule in 140mg, 210mg, and 280mg strengths.

Centanafadine is the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI). The central nervous system (CNS) stimulant inhibits the reuptake of the 3 neurotransmitters, increasing their availability in pathways involved in attention and behavioral regulation.

Adult approval was supported by 4 randomized, double-blind, placebo-controlled phase 3 trials involving children, adolescents, and adults with ADHD. In 2 adult trials (NCT03605680 and NCT03605836), both centanafadine dose groups produced statistically significant improvements from baseline in Adult ADHD Investigator Symptom Rating Scale total scores compared with placebo. Improvements were observed by week 1 and maintained throughout the 6-week treatment period. In the pediatric and adolescent trials (NCT05428033 and NCT05257265), high-dose centanafadine produced statistically significant improvements in ADHD Rating Scale-5 total scores compared with placebo, with improvement observed by week 1. 

The most common adverse reactions were rash and decreased appetite among children aged 6 to 12 years; decreased appetite, nausea, rash, headache, and abdominal pain among adolescents aged 13 to 17 years; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea among adults.

Simtriyo is expected to become available later in 2026 after scheduling by the DEA

Source: Otsuka Pharmaceutical Co., Ltd. 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. News release. Otsuka Pharmaceutical Co., Ltd.; July 27, 2026. Accessed July 29, 2026.