KarXT Matching Placebo
Sponsors
Karuna Therapeutics Inc., Bristol-Myers Squibb Services Unlimited Company, Bristol-Myers Squibb
Conditions
Agitation Associated with
Alzheimer’s DiseaseAgitation Associated with Alzheimer’s DiseaseBP-I mania or mania with mixed featuresMild to moderate Alzheimer’s DiseaseSchizophrenia
Phase 3
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia
CompletedCTIS2024-510770-25-00
Start: 2023-03-22End: 2025-02-24Target: 65Updated: 2025-03-19
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
RecruitingCTIS2024-520165-32-00
Start: 2025-11-04Target: 77Updated: 2025-08-26
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
RecruitingCTIS2024-520195-94-00
Start: 2025-09-25Target: 89Updated: 2025-09-08
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 1)
RecruitingCTIS2025-520746-30-00
Start: 2025-11-18Target: 225Updated: 2025-11-05
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 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 to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
RecruitingNCT07288567
Start: 2026-01-29End: 2029-12-18Target: 166Updated: 2026-09-04
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals with Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Not yet recruitingCTIS2025-521845-26-00
Target: 185Updated: 2026-01-21
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)
Not yet recruitingCTIS2025-523711-11-00
Target: 28Updated: 2026-04-20