Xanomeline/Trospium Chloride

DRUG5 trials

Sponsors

Karuna Therapeutics, Bristol-Myers Squibb, Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Conditions

Bipolar DisorderHealthy VolunteersManiaSchizophrenia

Phase 1

A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants

CompletedNCT06729970

Karuna TherapeuticsHealthy Volunteers

Start: 2024-12-26End: 2026-01-23Updated: 2026-02-24

Phase 3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

RecruitingNCT07140913

Bristol-Myers SquibbBipolar Disorder, Mania

Start: 2025-10-08End: 2027-06-28Target: 424Updated: 2026-06-23

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

RecruitingNCT07686263

Karuna Therapeutics, Inc., a Bristol Myers Squibb companySchizophrenia

Start: 2026-08-20End: 2029-03-03Target: 472Updated: 2026-09-14

Phase 4

A Study to Evaluate the Effect of KarXT on Urological Safety

RecruitingNCT07221877

Bristol-Myers SquibbSchizophrenia

Start: 2026-01-20End: 2027-12-30Target: 60Updated: 2026-06-03

KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

CompletedNCT07257120

Karuna Therapeutics, Inc., a Bristol Myers Squibb companyHealthy Volunteers

Start: 2026-01-09End: 2026-06-08Updated: 2026-06-23