ADHD drug trial for preschoolers pulled before it started

NCT ID NCT07169162

Terminated Symptom relief Sponsor: Aytu BioPharma, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to test whether ADZENYS XR-ODT, a once-daily amphetamine tablet that dissolves in the mouth, could help manage ADHD symptoms in children aged 4 to less than 6 years. The trial was planned as a randomized, double-blind, placebo-controlled study, but it was withdrawn before enrolling any participants. As a result, no data or conclusions are available.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

ADZENYS XR-ODT (amphetamine, an extended-release tablet that dissolves in the mouth)

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATTENTION-DEFICIT / HYPERACTIVITY DISORDER

Contacts and locations

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Locations

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States