Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could this pill ease Autism's core challenges?

NCT ID NCT06333964

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

169 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Those who meet the criteria of diagnostic and statistical manual of mental disorder (DSM)-5 during screening * During screening period, individuals who are diagnosed with ASD through ADI-R assessment * Subject with a CGI-S score of 4 or higher as a result of Clinical Global Impression(CGI) evaluation during baseline visit(visit 2) * Subject or/and legally authorized representative voluntarily agreed to participate in this clinical trial and provided their informed consent by signing the written consent form * In case of subjects who were receiving non-pharmacological therapy at the time of screening, the non-pharmacological therapy lasted at least 3 months prior to participation in screening and is expected to be sustainable during this clinical trial * Subject whose legally authorized representative is able to participate in the provision of reliable information about the subject's condition, execute all scheduled site visits, oversee IP administration, fully understand and speak Korean, and conduct survey evaluation regarding the subject Exclusion Criteria: * At the time of screening, subject has the medical history, concomitant condition, or surgical history * During the screening period, uncontrolled medical conditions, * During the screening period, display of severe self-harm or injury to others that requires medical treatment, determined by investigator * At the time of screening, weight over 60kg * Inappropriate to participate in the trial determined by investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Autism spectrum disorder are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

Other studies related to the condition(s) this trial covers.