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Could this pill ease Autism's core challenges?

NCT ID NCT06333964

Completed Symptom relief Sponsor: Astrogen, Inc. Source: ClinicalTrials.gov ↗

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

Summary

This phase 3 trial tested an experimental drug called AST-001 in 169 children with autism spectrum disorder. The goal was to see if it improves core symptoms like social communication and repetitive behaviors better than a placebo. The study is already completed, and results will show whether this drug might become a new treatment option.

What this could mean

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

Active substance
AST-001 (an experimental drug taken twice daily by mouth)
What this could lead to
If it works, this could lead to a first approved medicine that eases core autism symptoms like social and communication challenges.
What could go wrong
This is an early-stage trial with only 169 children, so results may not apply to everyone. The drug may not prove better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

AUTISM SPECTRUM DISORDER

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Chungnam National University Hospital

    Daejeon, South Korea

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do, South Korea

  • Hanyang University Seoul Hospital

    Seoul, South Korea

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, South Korea

  • Koera University Guro Hospital

    Seoul, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, South Korea

  • Samsung Changwon Medical Center

    Changwon, Gyeongsangnam-do, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan, Chungcheongnam-do, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, South Korea

More trials for these conditions

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