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A new ADHD drug just got FDA approval. Here's what makes it different.

The once-daily extended-release pill showed benefits in clinical trials, with mostly mild side effects and use expected to begin after DEA scheduling.

  • The Food and Drug Administration approved Simtriyo , the first NDSRI for ADHD treatment in adults, teens, and children aged 6 years and older weighing at least 44 pounds.
  • Unlike traditional stimulants targeting dopamine and norepinephrine, Simtriyo adds serotonin to the treatment mechanism, affecting mood and executive functioning for patients with ADHD.
  • In phase 3 trials involving more than 800 adults, centanafadine demonstrated significant symptom improvement; the drug was considered "well tolerated" despite common side effects including decreased appetite and headaches.
  • Co-Investigator Lenard A. Adler, MD, director of the adult ADHD program at NYU Langone Health, stated that "having more therapeutic choices is important" for patients with individualized ADHD needs.
  • Simtriyo will become available later this year after Drug Enforcement Administration scheduling, with psychiatrist Ann Childress, MD, recommending patients consult their healthcare provider about risks and benefits.
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42 Articles

Psychology TodayPsychology Today
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When Forgetfulness Is Not Just Aging

Could forgetfulness be something more than aging? Learn why ADHD is increasingly recognized in older adults and why the right diagnosis matters.

·New York, United States
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Il MessaggeroIl Messaggero
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Here Comes a New Drug Against ADHD: How Does It Work and Who Can Use It?

Otsuka Pharmaceutical Development & Commercialise announced the FDA's approval of oral centanafadine (Simtriyo), a triple reuptake inhibitor,...

·Rome, Italy
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The Paintsville HeraldThe Paintsville Herald
+36 Reposted by 36 other sources
Center

A new ADHD drug just got FDA approval. Here's what makes it different.

Understood reports that the FDA has approved Simtriyo, a new ADHD medication targeting dopamine, norepinephrine, and serotonin, promising fewer side effects.

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Medical DailyMedical Daily
Center

FDA Approves Centanafadine for ADHD: Who Qualifies, How It Differs, and What Side Effects Appeared

FDA-approved centanafadine, a first-in-class non-stimulant for ADHD in adults and children 6 and up over 20 kg. What families should know.

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MedPage TodayMedPage Today
Center

First-in-Class Drug for ADHD Wins FDA Approval

(MedPage Today) -- The FDA approved oral centanafadine (Simtriyo), a first-in-class triple reuptake inhibitor for attention deficit-hyperactivity disorder (ADHD), Otsuka announced late last week. The once-daily extended-release capsule

·New York, United States
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MedscapeMedscape

FDA Approves First NDSRI for ADHD in Adults and Children

The FDA has approved Simtriyo (centanafadine) as the first norepinephrine, dopamine, serotonin reuptake inhibitor for adult and pediatric ADHD.

·New York, United States
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Medscape broke the news in New York, United States on Monday, July 27, 2026.
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