30 completed, 16 recruiting, 5 not yet recruiting, 1 suspended. 21 Phase 3, 12 Phase 4, 10 Phase 1, 2 Not applicable, 2 Phase 2.
Follow trospium chloride: new trials by email Literature Review of trospium chloride trials Research Report on trospium chloride
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia Xanomeline/trospium - Schizophrenia; Psychosis, Cognitive Impairment | Phase 3 | Withdrawn | European Group for Research In Schizophrenia | 2027-01-01 | 2026-10-30 | |
| A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Not yet recruiting | Bristol-Myers Squibb | 176 | 2026-10-02 | 2026-09-28 |
| A Prospective, Observational, Single-Arm, Multicenter Real-World Study Evaluating the Treatment Pattern, Safety and Effectiveness of Xanomeline and Trospium Chloride Capsules (KarXT) in the Treatment of Chinese Adult Participants With Schizophrenia Xanomeline and trospium chloride (KarXT) - Schizophrenia Disorder | Not yet recruiting | Zai Lab (Shanghai) Co., Ltd. | 250 | 2026-09-20 | 2026-09-03 | |
| A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Not yet recruiting | Bristol-Myers Squibb | 176 | 2026-09-11 | 2026-08-24 |
| Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers KarXT, Trimethobenzamide, Ondansetron - Healthy Volunteers | Phase 4 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 180 | 2026-09-03 | 2026-10-15 |
| Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia Xanomeline/Trospium Chloride, Placebo - Schizophrenia | Phase 3 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 472 | 2026-08-20 | 2026-10-30 |
| A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia Xanomeline and trospium chloride (KarXT) - SCHIZOPHRENIA 1 (Disorder), Schizoaffecitve Disorder | Phase 1 / Phase 2 | Recruiting | New York State Psychiatric Institute | 12 | 2026-07-01 | 2026-07-14 |
| A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents KarXT, KarX-EC - Schizophrenia, Autism-Related Irritability | Phase 3 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 400 | 2026-04-07 | 2026-10-15 |
| A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5) KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo - Alzheimer Disease, Psychosis | Phase 3 | Recruiting | Bristol-Myers Squibb | 325 | 2026-03-25 | 2026-06-30 |
| Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) Xanomeline and trospium chloride (KarXT) - Schizophrenia | Recruiting | Bristol-Myers Squibb | 1500 | 2026-02-26 | 2026-08-19 | |
| A Study to Evaluate the Effect of KarXT on Urological Safety Xanomeline/trospium chloride - Schizophrenia | Phase 4 | Recruiting | Bristol-Myers Squibb | 60 | 2026-01-20 | 2026-10-19 |
| Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users KarXT (xanomeline and trospium) - Schizophrenia | Completed | Bristol-Myers Squibb | 6876 | 2026-01-16 | 2026-10-01 | |
| KarXT Concentrations in the Breast Milk and Plasma of Lactating Females Xanomeline/trospium chloride - Healthy Volunteers | Phase 4 | Completed | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 10 | 2026-01-09 | 2026-06-23 |
| A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants Xanomeline/ Trospium Chloride - Healthy Volunteers | Phase 1 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 56 | 2025-10-13 | 2026-10-13 |
| 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 Xanomeline/Trospium Chloride, Placebo - Mania, Bipolar Disorder | Phase 3 | Recruiting | Bristol-Myers Squibb | 424 | 2025-10-08 | 2026-06-23 |
| A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin KarXT, Midazolam, Fexofenadine - Healthy Volunteers | Phase 1 | Completed | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 62 | 2025-09-29 | 2026-07-22 |
| Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU) xanomeline and trospium chloride (X/T) therapy - Schizophrenia | Recruiting | Bristol-Myers Squibb | 300 | 2025-09-22 | 2026-09-30 | |
| A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) KarXT, Lithium, Valproate - Bipolar Disorder Type I With Mania | Phase 3 | Recruiting | Bristol-Myers Squibb | 450 | 2025-07-18 | 2026-10-26 |
| A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo - Alzheimer's Disease | Phase 3 | Recruiting | Bristol-Myers Squibb | 426 | 2025-07-16 | 2026-10-08 |
| A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo - Alzheimer Disease | Phase 3 | Recruiting | Bristol-Myers Squibb | 426 | 2025-07-10 | 2026-10-15 |
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Schizophrenia (20) · Urinary Bladder, Overactive (11) · Mania (4) · Psychotic Disorders (4) · Alzheimer Disease (3) · Urinary Incontinence (3) · Autism Spectrum Disorder (2) · Autistic Disorder (1) · Bipolar Disorder (1) · Cognitive Dysfunction (1) · Dementia (1) · Mental Disorders (1) · Nausea (1) · Obesity (1) · Psychomotor Agitation (1)
Karuna Therapeutics, Inc., a Bristol Myers Squibb company (18) · Bristol-Myers Squibb (15) · Allergan (5) · Astellas Pharma Singapore Pte. Ltd. (2) · Astellas Scientific & Medical Affairs, Inc. (1) · Becky Clarkson (1) · Brigham and Women's Hospital (1) · Collaborative Neuroscience Research, LLC (1) · Dr. R. Pfleger Chemische Fabrik GmbH (1) · European Group for Research In Schizophrenia (1) · Mansoura University (1) · NICHD Pelvic Floor Disorders Network (1) · New York State Psychiatric Institute (1) · Samsung Medical Center (1) · The University of Texas Medical Branch, Galveston (1)
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Inder Kaul, MD (3) · Abdullatif AL-Terki, MD (1) · Anthony Visco, MD (1) · Becky Clarkson, PhD (1) · Elizabeth Geller, MD (1) · Joshua T Kantrowitz, MD (1) · Kyu-Sung Lee, Ph.D (1) · Lukasz Biernat, PhD (1) · Ragy Girgis, MD (1) · Stephen Brannan, MD (1)
PMID 40047530, PMID 40212458, PMID 40215379, PMID 22008247, PMID 23036134, PMID 26516810, PMID 27564385, PMID 28067745, PMID 29777865, PMID 31222714, PMID 33620895, PMID 33626254, PMID 34700212, PMID 35552528, PMID 36414626, PMID 37148497, PMID 37160401, PMID 38104575, PMID 38178267, PMID 38430402, PMID 38651909, PMID 38691387, PMID 40145363, PMID 42531291
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