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Health & Medicine

A new kind of ADHD medicine is approved in the US, the first to act on three brain chemicals at once

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US regulators have approved centanafadine, the first ADHD drug of its class. In four trials it beat a placebo on symptom scores at six weeks, and its label is candid about the risks that come with it.

Official data Checked 3 August 2026
Key numbers
16.3 points
Fall in ADHD symptom score in children aged 6 to 12, at six weeks
from an average starting score of 43, against 10.8 points on a placebo
18.5 points
Fall in symptom score in adolescents aged 13 to 17
from an average starting score of about 37, against 14.2 points on a placebo
1st
Drug of its class approved for ADHD
no medicine blocking all three of these chemicals had been licensed for the condition before

On 24 July 2026 the US Food and Drug Administration approved an ADHD medicine that reaches the brain by a route no other ADHD medicine uses. Centanafadine, sold as Simtriyo, works on three neurotransmitters, the chemical messengers nerve cells use to signal to one another: norepinephrine, dopamine and serotonin. It blocks their reuptake, the step in which the cell that released a messenger draws it back inside, so more of each stays available in the circuits involved in attention and behaviour. It is the first drug of that class licensed for the condition, and the twenty-ninth novel medicine the agency has approved this year.

How we know

The approval rests on four randomised, placebo-controlled trials that together enrolled more than 1,800 people aged 6 to 55, and the results are set out in the prescribing label the FDA published with it. In children aged 6 to 12, the approved dose lowered scores on an 18-item ADHD rating scale by 16.3 points over six weeks, from an average starting score of 43, against 10.8 points for a placebo. In adolescents aged 13 to 17 the fall was 18.5 points against 14.2. In two adult trials the drug beat placebo by between 2.7 and 4.4 points on a comparable scale. The lower dose is not part of the approval: in both the child and the adolescent trial it failed to separate from placebo.

Why it matters

About 7 million children and 15.5 million adults in the United States have ADHD, on the CDC figures the manufacturer cites, and no two of them respond to treatment the same way. That is why a new mechanism counts for more than the size of any single result: it is somewhere else for a doctor to go when the existing options do not suit a patient. The label is blunt about the trade. It calls centanafadine a norepinephrine-dopamine-serotonin reuptake inhibitor and a central nervous system stimulant, not an alternative to one, and it opens with a boxed warning, the alert the FDA prints inside a box at the top of a drug label, covering both the risk of abuse, misuse and addiction and higher rates of suicidal thoughts and behaviour among treated children aged 6 to 12 than among those given a placebo. Nobody can weigh any of that in a pharmacy yet. Otsuka says the capsules will go on sale later this year, once the Drug Enforcement Administration has set their controlled substance schedule, the category that decides how tightly a drug is controlled.

What is not solved yet

What the trials measured is a symptom score at six weeks, not a cure and not a long-term outcome: none of the four ran longer than that. Only the higher dose worked in children and adolescents, and the two adult trials tested an earlier formulation rather than the capsule that was approved. All four were run by the manufacturer. The label's most serious warnings, printed in a box at its head, cover abuse, misuse and addiction, and higher rates of suicidal thoughts and behaviour in treated children aged 6 to 12 than in those on a placebo. The approval is US only, and the drug is not on sale yet: the Drug Enforcement Administration has still to decide how tightly it will be controlled.

Common questions
How does centanafadine work?

Centanafadine blocks the reuptake of norepinephrine, dopamine and serotonin, the step that would normally draw those three messengers back into the nerve cell that released them, so more of each stays available in the circuits involved in attention and behaviour. No other approved ADHD medicine works on all three. The FDA label adds that exactly how this improves ADHD symptoms is still unclear.

Is it a stimulant?

The label says so. The FDA describes Simtriyo as a central nervous system stimulant as well as a triple reuptake inhibitor, and the label opens with a warning, printed in a box at its head, about the risk of abuse, misuse and addiction. How tightly the drug will be controlled is still to be decided by the Drug Enforcement Administration.

How well did it work in the trials?

In children aged 6 to 12 the approved dose cut scores on an 18-item ADHD rating scale by 16.3 points over six weeks, from an average starting score of 43, against 10.8 points for a placebo. In adolescents the fall was 18.5 points against 14.2. In two adult trials the drug beat placebo by between 2.7 and 4.4 points on a comparable scale.

Can people get it now?

Not yet. Otsuka says Simtriyo will go on sale later this year, once the Drug Enforcement Administration has finished deciding how tightly it should be controlled. The approval covers the United States only.

Sources
  1. US Food and Drug Administration, Novel Drug Approvals for 2026 (entry 29: Simtriyo, centanafadine, approved 7/24/2026) Primary
  2. US Food and Drug Administration, SIMTRIYO (centanafadine) extended-release capsules: full prescribing information, NDA 218145
  3. Otsuka Pharmaceutical, Otsuka Receives FDA Approval for First-in-Class SIMTRIYO (centanafadine) for the Treatment of ADHD
  4. Psychiatric Times, FDA Approves Centanafadine for ADHD in Children, Adolescents, and Adults