FDA Gives Green Light to Simtriyo: A Groundbreaking Triple-Action ADHD Medication

In a groundbreaking move for mental health treatment, the U.S. Food and Drug Administration has given the green light to Simtriyo (centanafadine), a novel medication for attention-deficit/hyperactivity disorder (ADHD) that operates unlike any predecessor.

Formulated by Otsuka Pharmaceutical, Simtriyo stands as the inaugural norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) approved for ADHD. Unlike traditional ADHD medications that target one or two neurotransmitters, Simtriyo simultaneously blocks the reuptake of all three, enhancing attention, impulse control, and executive function in a unique manner.

The once-daily extended-release capsule has now received approval for both adults and children aged 6 years and older who weigh at least 44 pounds (20 kg). This approval was supported by results from four Phase 3 clinical trials, which demonstrated statistically significant improvements in ADHD symptoms across all age groups. In adult trials involving over 800 participants, the drug showed significant symptom reduction and was deemed well tolerated, with common side effects including decreased appetite and headaches.

“The approval of Simtriyo introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients,” stated Dr. Lenard A. Adler, director of the adult ADHD program at NYU Langone Health, and a co-investigator on the trials.

The drug still needs to pass a DEA scheduling review before it becomes commercially available, which is anticipated to happen later in 2026.

Source: Healthline – FDA Approves New CNS Drug Simtriyo for Adults and Children (July 29, 2026)