23 recruiting, 11 completed, 2 not yet recruiting. 25 Phase 3, 7 Phase 1, 3 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 25 | Recruiting 18, Completed 5, Not yet recruiting 2 |
| Phase 1 | 7 | Completed 4, Recruiting 3 |
| Phase 4 | 3 | Recruiting 2, Completed 1 |
| Phase 2 | 1 | Completed 1 |
Follow KarXT: new trials by email Literature Review of KarXT trials Research Report on KarXT
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 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 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 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 | 2026-11-06 |
| 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 |
| A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN) KarXT, KarXT Matching Placebo - Schizophrenia | Phase 3 | Recruiting | Bristol-Myers Squibb | 166 | 2026-01-29 | 2026-10-06 |
| 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 |
| 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 | 2026-11-03 |
| 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 |
| A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT KarXT - Schizophrenia | Phase 1 | Recruiting | Bristol-Myers Squibb | 131 | 2025-09-03 | 2026-09-02 |
| A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) KarXT, KarX-EC, Placebo - Alzheimer's Disease | Phase 3 | Recruiting | Bristol-Myers Squibb | 586 | 2025-07-21 | 2026-10-08 |
| 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 | 2026-11-03 |
| A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease KarXT, KarX-EC, Placebo - Alzheimer's Disease | Phase 3 | Recruiting | Bristol-Myers Squibb | 586 | 2025-07-14 | 2026-10-27 |
| 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 | 2026-11-06 |
| A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Trospium Chloride - Healthy Volunteers | Phase 1 | Recruiting | Bristol-Myers Squibb | 236 | 2025-06-27 | 2026-08-17 |
Showing 20 of 36. Sign in to see all of them.
Schizophrenia (12) · Alzheimer Disease (7) · Mania (4) · Dementia (3) · Psychotic Disorders (3) · Autism Spectrum Disorder (2) · Cognitive Dysfunction (2) · Mental Disorders (2) · Psychomotor Agitation (2) · Autistic Disorder (1) · Bipolar Disorder (1) · Disease (1) · Nausea (1) · Vomiting (1)
Bristol-Myers Squibb (18) · Karuna Therapeutics, Inc., a Bristol Myers Squibb company (18)
United States (33) · Japan (13) · Poland (13) · Romania (13) · Spain (12) · Argentina (11) · France (11) · India (11) · Italy (10) · Bulgaria (9) · China (9) · Hungary (9) · Puerto Rico (9) · Ukraine (9) · Canada (8)
Inder Kaul, MD (2) · Stephen Brannan, MD (1)
PMID 40047530, PMID 40212458, PMID 40215379, PMID 33626254, PMID 34700212, PMID 35552528, PMID 36414626, PMID 38104575, PMID 40145363
2025 (11), 2023 (2)