KarX-EC
Sponsors
Bristol-Myers Squibb Services Unlimited Company, Karuna Therapeutics, Bristol-Myers Squibb
Conditions
AgitationAgitation Associated with
Alzheimer’s DiseaseAgitation Associated with Alzheimer’s DiseaseAlzheimer DiseaseAlzheimer's DiseaseHealthy VolunteersIrritability Associated With Autism Spectrum DisorderMild to moderate Alzheimer’s Disease
Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants
CompletedNCT06605950
Start: 2024-10-01End: 2025-05-31Updated: 2025-07-04
Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
CompletedNCT06853171
Start: 2025-04-29End: 2025-07-22Updated: 2025-08-06
Phase 3
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
RecruitingNCT06937229
Start: 2025-12-02End: 2029-07-20Target: 650Updated: 2026-09-16
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
RecruitingNCT06947941
Start: 2026-03-25End: 2028-03-20Target: 325Updated: 2026-06-30
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
RecruitingNCT06976203
Start: 2025-07-21End: 2029-02-23Target: 586Updated: 2026-09-17
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
RecruitingNCT06976216
Start: 2025-07-14End: 2029-02-23Target: 586Updated: 2026-08-20
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-1)
RecruitingCTIS2025-520613-31-00
Start: 2025-10-31Target: 101Updated: 2025-11-14
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 2)
RecruitingCTIS2025-520747-32-00
Start: 2025-10-29Target: 292Updated: 2026-01-26
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated with Mild to Moderate Alzheimer’s Disease (MINDSET 1)
RecruitingCTIS2025-520746-30-00
Start: 2025-11-18Target: 225Updated: 2025-11-05
CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)
Not yet recruitingCTIS2024-519994-20-00
Target: 191Updated: 2025-11-27
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate
the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with
Alzheimer’s Disease (ADAGIO-2)
RecruitingCTIS2025-520612-34-00
Start: 2025-11-28Target: 90Updated: 2025-10-26
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
Not yet recruitingNCT07284745
Start: 2026-09-11End: 2029-08-06Target: 176Updated: 2026-08-24
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
Not yet recruitingNCT07285798
Start: 2026-09-11End: 2029-08-06Target: 176Updated: 2026-08-24
A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 years of age) with Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 years of age) with Irritability Associated with Autism Spectrum Disorder
Not yet recruitingCTIS2025-524062-16-00
Target: 40Updated: 2026-05-29