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.

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.

IRRITABILITY ASSOCIATED WITH AUTISM SPECTRUM DISORDER

Contacts and locations

Locations

Local Institution - 0003

Pittsburgh, Pennsylvania, 15213, United States
Local Institution - 0009

Orem, Utah, 84097, United States
Local Institution - 0013

Glendale, California, 91203, United States
Local Institution - 0014

Chicago, Illinois, 60622, United States
Local Institution - 0016

Columbia, Missouri, 65201, United States
Local Institution - 0019

Everett, Washington, 98201, United States
Local Institution - 0038

Staten Island, New York, 10312, United States
Local Institution - 0046

Lincoln, Nebraska, 68526, United States
Local Institution - 0051

Lexington, Massachusetts, 02421, United States
Local Institution - 0052

Cincinnati, Ohio, 45229, United States
Local Institution - 0062

Phoenix, Arizona, 85006, United States
Local Institution - 0080

Orlando, Florida, 32803, United States
Local Institution - 0084

Madrid, 28007, Spain
Local Institution - 0085

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0086

Madrid, 28031, Spain
Local Institution - 0087

Barcelona, Catalunya [Cataluña], 08036, Spain
Local Institution - 0088

Eysines, 33320, France
Local Institution - 0089

Paris, 75019, France
Local Institution - 0090

Hirakata, Osaka, 573-0022, Japan
Local Institution - 0091

Ōta-ku, Tokyo, 146-0095, Japan
Local Institution - 0093

Yokohama, Kanagawa, 213-8507, Japan
Local Institution - 0094

Miyakonojō, Miyazaki, 885-0093, Japan
Local Institution - 0095

Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192, Japan
Local Institution - 0096

Kozhikode, Kerala, 673009, India
Local Institution - 0097

Kolkata, West Bengal, 700020, India
Local Institution - 0101

Sakri, Maharashtra, 441108, India
Local Institution - 0102

Bron, 69678, France
Local Institution - 0103

Gdansk, 80-546, Germany
Local Institution - 0104

Katowice, 40-146, Poland
Local Institution - 0105

Wroclaw, Lower Silesian Voivodeship, 54-234, Poland
Local Institution - 0106

Gdansk, Pomeranian Voivodeship, 80-542, Poland
Local Institution - 0107

Warsaw, Masovian Voivodeship, 02-957, Poland
Local Institution - 0108

Poznan, Greater Poland Voivodeship, 60-744, Poland
Local Institution - 0109

Kraśnik, Lublin Voivodeship, 23-210, Poland
Local Institution - 0110

Szeged, 6720, Hungary
Local Institution - 0111

Budapest, 1021, Hungary
Local Institution - 0112

Siófok, 8600, Hungary
Local Institution - 0113

Szczecin, West Pomeranian Voivodeship, 70-419, Poland
Local Institution - 0114

Neptune City, New Jersey, 07753-4859, United States
Local Institution - 0115

San Juan Capistrano, California, 92675, United States
Local Institution - 0116

San Rafael, California, 94903, United States
Local Institution - 0117

Los Angeles, California, 90095, United States
Local Institution - 0118

Bucharest, Bucharest, 030167, Romania
Local Institution - 0119

Sibiu, 550082, Romania
Local Institution - 0120

Bucharest, Bucharest, 041914, Romania
Local Institution - 0121

Iași, 700282, Romania
Local Institution - 0122

Timișoara, 300329, Romania
Local Institution - 0123

Cluj-Napoca, 0, Romania
Local Institution - 0124

Bucharest, 031871, Romania
Local Institution - 0125

Spring, Texas, 77381, United States
Local Institution - 0126

Orange, California, 92868, United States
Local Institution - 0127

Budapest, 1143, Hungary
Local Institution - 0129

Szczecin, West Pomeranian Voivodeship, 70-419, Poland
Local Institution - 0130

New Haven, Connecticut, 06519, United States

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