A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Latest Information Update: 12 Feb 2026
At a glance
- Drugs Trospium chloride/xanomeline (Primary) ; Xanomeline (Primary)
- Indications Autism spectrum disorder; Irritability
- Focus Registrational; Therapeutic Use
- Sponsors Bristol-Myers Squibb
Most Recent Events
- 26 Jan 2026 Planned End Date changed from 5 Jul 2026 to 5 Jul 2029.
- 26 Jan 2026 Planned primary completion date changed from 5 Jul 2026 to 5 Jul 2029.
- 23 Dec 2025 New trial record