20 recruiting, 5 completed. 25 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 25 | Recruiting 20, Completed 5 |
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 KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Recruiting | Bristol-Myers Squibb | 176 | 2026-10-06 | 2026-11-10 |
| 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 | Recruiting | Bristol-Myers Squibb | 176 | 2026-10-06 | 2026-11-10 |
| 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 | 2026-11-12 |
| 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 | 2026-11-12 |
| 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 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 the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2) KarXT, Placebo - Bipolar Disorder Type I With Mania or Mania With Mixed Features | Phase 3 | Recruiting | Bristol-Myers Squibb | 274 | 2025-06-13 | 2026-11-10 |
| A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder KarXT, Placebo - Bipolar-I Disorder With Mania or Mania With Mixed Features | Phase 3 | Recruiting | Bristol-Myers Squibb | 274 | 2025-06-11 | 2026-10-23 |
| A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia KarXT, Placebo - Schizophrenia | Phase 3 | Recruiting | Bristol-Myers Squibb | 250 | 2025-06-10 | 2026-11-02 |
| Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia KarXT - Schizophrenia | Phase 3 | Completed | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 173 | 2024-10-28 | 2026-06-22 |
| A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) KarXT, Placebo - Alzheimer Disease | Phase 3 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 406 | 2024-09-26 | 2026-10-27 |
| A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) KarXT, Placebo - Psychosis Associated With Alzheimer's Disease | Phase 3 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 500 | 2023-08-28 | 2026-10-16 |
| Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) KarXT - Psychosis Associated With Alzheimer's Disease | Phase 3 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 1000 | 2023-07-11 | 2026-11-12 |
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Schizophrenia (9) · Alzheimer Disease (7) · Mania (4) · Dementia (3) · Psychotic Disorders (3) · Autism Spectrum Disorder (2) · Cognitive Dysfunction (2) · Psychomotor Agitation (2) · Autistic Disorder (1) · Bipolar Disorder (1) · Disease (1) · Mental Disorders (1)
Bristol-Myers Squibb (14) · Karuna Therapeutics, Inc., a Bristol Myers Squibb company (11)
United States (23) · 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)
PMID 38104575, PMID 40047530, PMID 40212458, PMID 40215379
2025 (11), 2023 (2)