FDA Approves Otsuka's Simtriyo, the First Triple-Reuptake Inhibitor for ADHD in Adults and Children

Overview

The Food and Drug Administration has approved Simtriyo (centanafadine), a once-daily extended-release capsule from Otsuka, for treating attention-deficit hyperactivity disorder in adults and pediatric patients aged 6 years and older who weigh at least 20 kilograms, according to Otsuka’s announcement carried by Yahoo Finance. Simtriyo is the first approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) on the U.S. market, a new drug class also described as a triple reuptake inhibitor, according to both Yahoo Finance and BioSpace.

What We Know

The drug works by blocking the reuptake of norepinephrine, dopamine, and serotonin, increasing their availability in brain pathways tied to attention and behavioral regulation, according to Yahoo Finance. The approval rests on four pivotal Phase 3 clinical trials spanning adult, adolescent, and pediatric populations. Two trials in adults measured against the Adult ADHD Investigator Symptom Rating Scale, and two trials in children and adolescents measured against the ADHD Rating Scale-5, with Simtriyo showing statistically significant and clinically meaningful symptom improvement over placebo as early as week 1, sustained through six weeks of treatment, according to both Yahoo Finance and BioSpace.

The most common adverse events were decreased appetite, nausea, rash, headache, and abdominal pain in children and adolescents, and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults, per Yahoo Finance. The label carries a boxed warning covering two risks: higher rates of suicidal ideation and behavior observed in Simtriyo-treated patients aged 6 to 12 compared with those on placebo, and a potential for abuse, misuse, and addiction, according to both Yahoo Finance and BioSpace.

John Kraus, executive vice president and chief medical officer at Otsuka, said “the approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,” according to Yahoo Finance. Lenard A. Adler, director of the adult ADHD program at NYU Langone Health, said “having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient,” per Yahoo Finance. ADHD affects an estimated 7 million children and 15.5 million adults in the United States, or roughly 22.5 million people combined, according to CDC figures cited in Otsuka’s announcement.

Simtriyo will not reach pharmacy shelves immediately. As a central nervous system stimulant, it still requires controlled-substance scheduling from the Drug Enforcement Administration before Otsuka can launch it, which the company expects to happen in time for the drug to become available “later this year,” according to both Yahoo Finance and BioSpace. Wall Street reacted favorably: Jefferies analysts called the approval “an important de-risking event” that “marks the arrival of Otsuka’s next major CNS launch,” noting the company has previously forecast peak sales of more than ¥100 billion, or roughly $615 million, for the drug, according to BioSpace. The firm described “the ADHD market” as “large and under-penetrated,” adding that Simtriyo is “well positioned to address patients seeking alternatives to traditional stimulant therapies,” and argued that even a stricter-than-hoped DEA schedule could still leave the drug positioned between conventional stimulants and non-stimulants in a way that could prove commercially advantageous, per BioSpace.

What We Don’t Know

Neither source reviewed specifies which DEA schedule Simtriyo is likely to receive or when that review will conclude beyond Otsuka’s general expectation of availability later in 2026. The exact calendar date the FDA signed off on the approval was not stated consistently across coverage and is not asserted here beyond “late July 2026.” Pricing has not been disclosed, and the specific clinical trial identifiers and enrollment numbers behind the four Phase 3 studies were not detailed in the sources reviewed.