Could a new pill tame Autism-Related irritability in kids?

NCT ID NCT07285798

Not yet recruiting Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This Phase 3 study tests whether a combination of two drugs, KarXT and KarX-EC, can safely reduce irritability in children and adolescents aged 5 to 17 with autism spectrum disorder. About 176 participants will receive either the drug combo or a placebo for 8 weeks. The main goal is to see if the treatment lowers scores on a standard irritability checklist.

What this could mean

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

Active substance

KarXT (xanomeline/trospium chloride) and KarX-EC (xanomeline enteric-coated)

What this could lead to

If successful, this could provide a new medication option to reduce irritability in children and teens with autism, potentially improving daily functioning and quality of life.

What could go wrong

This is an early-stage Phase 3 trial with only 176 participants, so results may not apply to everyone. The drug may cause side effects or prove no better than placebo.

Disclaimer Read more

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.

autism spectrum disorder

As listed by the trial registrant

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

IRRITABILITY ASSOCIATED WITH AUTISM SPECTRUM DISORDER

Contacts and locations

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Local Institution - 0003

Pittsburgh, Pennsylvania, 15213, United States

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Local Institution - 0009

Orem, Utah, 84097, United States

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Local Institution - 0013

Glendale, California, 91203, United States

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Local Institution - 0014

Chicago, Illinois, 60622, United States

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Local Institution - 0016

Columbia, Missouri, 65201, United States

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Everett, Washington, 98201, United States

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Local Institution - 0038

Staten Island, New York, 10312, United States

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Local Institution - 0046

Lincoln, Nebraska, 68526, United States

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Local Institution - 0051

Lexington, Massachusetts, 02421, United States

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Local Institution - 0052

Cincinnati, Ohio, 45229, United States

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Local Institution - 0062

Phoenix, Arizona, 85006, United States

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Local Institution - 0080

Orlando, Florida, 32803, United States

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Local Institution - 0084

Madrid, 28007, Spain

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Local Institution - 0085

Barcelona, Barcelona [Barcelona], 08035, Spain

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Local Institution - 0086

Madrid, 28031, Spain

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Local Institution - 0087

Barcelona, Catalunya [Cataluña], 08036, Spain

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Local Institution - 0088

Eysines, 33320, France

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Local Institution - 0089

Paris, 75019, France

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Local Institution - 0090

Hirakata, Osaka, 573-0022, Japan

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Local Institution - 0091

Ōta-ku, Tokyo, 146-0095, Japan

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Local Institution - 0093

Yokohama, Kanagawa, 213-8507, Japan

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Local Institution - 0094

Miyakonojō, Miyazaki, 885-0093, Japan

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Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192, Japan

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Local Institution - 0096

Kozhikode, Kerala, 673009, India

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Local Institution - 0097

Kolkata, West Bengal, 700020, India

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Local Institution - 0101

Sakri, Maharashtra, 441108, India

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Bron, 69678, France

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Gdansk, 80-546, Germany

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Katowice, 40-146, Poland

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Wroclaw, Lower Silesian Voivodeship, 54-234, Poland

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Gdansk, Pomeranian Voivodeship, 80-542, Poland

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Warsaw, Masovian Voivodeship, 02-957, Poland

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Poznan, Greater Poland Voivodeship, 60-744, Poland

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Kraśnik, Lublin Voivodeship, 23-210, Poland

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Szeged, 6720, Hungary

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Budapest, 1021, Hungary

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Siófok, 8600, Hungary

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Szczecin, West Pomeranian Voivodeship, 70-419, Poland

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Local Institution - 0114

Neptune City, New Jersey, 07753-4859, United States

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San Juan Capistrano, California, 92675, United States

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San Rafael, California, 94903, United States

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Los Angeles, California, 90095, United States

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Local Institution - 0118

Bucharest, Bucharest, 030167, Romania

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Sibiu, 550082, Romania

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Bucharest, Bucharest, 041914, Romania

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Iași, 700282, Romania

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Timișoara, 300329, Romania

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Cluj-Napoca, 0, Romania

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Bucharest, 031871, Romania

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Local Institution - 0125

Spring, Texas, 77381, United States

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Orange, California, 92868, United States

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Local Institution - 0127

Budapest, 1143, Hungary

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Local Institution - 0129

Szczecin, West Pomeranian Voivodeship, 70-419, Poland

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Local Institution - 0130

New Haven, Connecticut, 06519, United States

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