17 recruiting, 15 completed, 6 not yet recruiting, 1 terminated. 21 Phase 3, 8 Phase 1, 5 Phase 4, 2 Phase 2.
Follow xanomeline: new trials by email Literature Review of xanomeline trials Research Report on xanomeline
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 | Not yet recruiting | European Group for Research In Schizophrenia | 171 | 2027-01-01 | 2026-05-13 |
| 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 | 2026-09-28 |
| 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 Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) KarXT, KarX-EC - Alzheimer Disease, Agitation | Phase 3 | Recruiting | Bristol-Myers Squibb | 650 | 2025-12-02 | 2026-10-16 |
| 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 | 2026-09-14 |
| 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 |
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Schizophrenia (20) · Alzheimer Disease (4) · Mania (4) · Psychotic Disorders (4) · Autism Spectrum Disorder (2) · Psychomotor Agitation (2) · Autistic Disorder (1) · Bipolar Disorder (1) · Cognitive Dysfunction (1) · Dementia (1) · Mental Disorders (1) · Nausea (1) · Vomiting (1)
Karuna Therapeutics, Inc., a Bristol Myers Squibb company (18) · Bristol-Myers Squibb (16) · Collaborative Neuroscience Research, LLC (1) · European Group for Research In Schizophrenia (1) · New York State Psychiatric Institute (1) · Vanguard Research Group (1) · Zai Lab (Shanghai) Co., Ltd. (1)
United States (35) · Japan (10) · Poland (9) · Romania (9) · Bulgaria (8) · India (8) · Spain (8) · Ukraine (8) · Argentina (7) · Hungary (7) · China (6) · France (6) · Israel (6) · Italy (6) · United Kingdom (6)
Inder Kaul, MD (3) · Joshua T Kantrowitz, MD (1) · Lukasz Biernat, PhD (1) · Ragy Girgis, MD (1) · Stephen Brannan, MD (1)
PMID 40047530, PMID 40212458, PMID 40215379, PMID 33626254, PMID 34700212, PMID 35552528, PMID 36414626, PMID 38104575, PMID 38691387, PMID 40145363, PMID 42531291
2025 (9)