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ClinicalTrials.gov public records Last synced Sep 30, 2026, 5:49 PM EDT

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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Xanomeline/ Trospium Chloride Clear all
Recruiting Phase 3 Interventional

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)

NCT05980949
View directory record Official record
Conditions
Psychosis Associated With Alzheimer's Disease
Interventions
KarXT
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
55 Years to 90 Years
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
147
States / cities
Homewood, Alabama • Chandler, Arizona • Gilbert, Arizona + 92 more
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants

NCT06605950
View directory record Official record
Conditions
Healthy Volunteers
Interventions
KarXT, KarX-EC, Placebo, Omeprazole
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
19 Years to 90 Years
Enrollment
78 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Anaheim, California
Source: ClinicalTrials.gov public record
Updated Jul 4, 2025 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 3 Interventional

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

NCT06126224
View directory record Official record
Conditions
Psychosis Associated With Alzheimer's Disease
Interventions
KarXT, Placebo
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
55 Years to 90 Years
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
70
States / cities
Chandler, Arizona • Phoenix, Arizona • Anaheim, California + 43 more
Source: ClinicalTrials.gov public record
Updated Sep 4, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 3 Interventional Results available

An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)

NCT04659174
View directory record Official record
Conditions
Schizophrenia
Interventions
Xanomeline and Trospium Chloride Capsules
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 65 Years
Enrollment
152 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
34
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Anaheim, California + 27 more
Source: ClinicalTrials.gov public record
Updated Oct 28, 2024 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 3 Interventional

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

NCT07140913
View directory record Official record
Conditions
Mania, Bipolar Disorder
Interventions
Xanomeline/Trospium Chloride, Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
424 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
20
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Bellflower, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

NCT07204418
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Xanomeline/ Trospium Chloride
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 65 Years
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
3
States / cities
Anaheim, California • Lenexa, Kansas • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 19, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 4 Interventional

A Study to Evaluate the Effect of KarXT on Urological Safety

NCT07221877
View directory record Official record
Conditions
Schizophrenia
Interventions
Xanomeline/trospium chloride
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
13
States / cities
Little Rock, Arkansas • Bellflower, California • Garden Grove, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 2 Interventional Results available

A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia

NCT03697252
View directory record Official record
Conditions
Schizophrenia
Interventions
Xanomeline and Trospium Chloride Capsules, Placebo Capsules
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 60 Years
Enrollment
182 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
12
States / cities
Little Rock, Arkansas • Lemon Grove, California • Long Beach, California + 9 more
Source: ClinicalTrials.gov public record
Updated Oct 26, 2020 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 3 Interventional

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

NCT07011745
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
55 Years to 90 Years
Enrollment
426 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
42
States / cities
Chandler, Arizona • Garden Grove, California • Long Beach, California + 35 more
Source: ClinicalTrials.gov public record
Updated Sep 16, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Not yet recruiting Early Phase 1 Interventional

Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation

NCT07721272
View directory record Official record
Conditions
Epilepsy, Essential Tremor, Seizures, Memory Consolidation, Memory Disorders, Memory Replay, Memory Encoding, Cognitive Control, Motor Abilities
Interventions
Cobenfy KarXT pill (50/20 mg), Placebo
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 70 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jul 23, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting No phase listed Observational

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

NCT07379827
View directory record Official record
Conditions
Schizophrenia
Interventions
Xanomeline and trospium chloride (KarXT)
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years and older
Enrollment
1,500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
55
States / cities
Bryant, Arkansas • Anaheim, California • Chino, California + 44 more
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 3 Interventional

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

NCT06929273
View directory record Official record
Conditions
Bipolar Disorder Type I With Mania
Interventions
KarXT, Lithium, Valproate, Lamotrigine
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 65 Years
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
61
States / cities
Glendale, Arizona • Scottsdale, Arizona • Tucson, Arizona + 49 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Not yet recruiting Phase 4 Interventional

An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients

NCT06923891
View directory record Official record
Conditions
Schizophrenia
Interventions
Xanomeline/Trospium
Drug
Lead sponsor
Vanguard Research Group
Other
Eligibility
18 Years to 40 Years
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Richmond, Texas
Source: ClinicalTrials.gov public record
Updated Apr 11, 2025 · Synced Sep 30, 2026, 5:49 PM EDT
Not yet recruiting Phase 3 Interventional

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

NCT07285798
View directory record Official record
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
5 Years to 17 Years
Enrollment
176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
23
States / cities
Phoenix, Arizona • Glendale, California • Los Angeles, California + 19 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Not yet recruiting Phase 3 Interventional

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

NCT07284745
View directory record Official record
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
5 Years to 17 Years
Enrollment
176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
29
States / cities
Dothan, Alabama • Phoenix, Arizona • Anaheim, California + 25 more
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 3 Interventional Results available

A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)

NCT04738123
View directory record Official record
Conditions
Schizophrenia, Schizophrenia; Psychosis
Interventions
Xanomeline and Trospium Chloride Capsules, Placebo
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 65 Years
Enrollment
256 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
20
States / cities
Bentonville, Arkansas • Little Rock, Arkansas • Anaheim, California + 15 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2024 · Synced Sep 30, 2026, 5:49 PM EDT
Not yet recruiting Phase 4 Interventional

An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia

NCT06924255
View directory record Official record
Conditions
Schizophrenia Disorders
Interventions
Xanomeline and Trospium Chloride
Drug
Lead sponsor
Collaborative Neuroscience Research, LLC
Network
Eligibility
18 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
7
States / cities
Bellflower, California • Garden Grove, California • Riverside, California + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 11, 2025 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

NCT07257120
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Xanomeline/trospium chloride
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
1
States / cities
Las Vegas, Nevada
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 1Phase 2 Interventional

A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

NCT07423546
View directory record Official record
Conditions
SCHIZOPHRENIA 1 (Disorder), Schizoaffecitve Disorder
Interventions
Xanomeline and trospium chloride (KarXT)
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 50 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 1Phase 2 Interventional

The Impact of Cobenfy Maintenance on Cocaine's Effects

NCT07624227
View directory record Official record
Conditions
Cocaine Use Disorder (CUD)
Interventions
Cobenfy, Placebo
Drug
Lead sponsor
Joshua A. Lile, Ph.D.
Other
Eligibility
18 Years to 60 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2032
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers

NCT07681076
View directory record Official record
Conditions
Healthy Volunteers
Interventions
KarXT, Trimethobenzamide, Ondansetron, Meclizine
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 65 Years
Enrollment
225 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
4
States / cities
Los Alamitos, California • Hollywood, Florida • Atlanta, Georgia + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 18, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Recruiting Phase 3 Interventional

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

NCT06947941
View directory record Official record
Conditions
Alzheimer Disease, Psychosis
Interventions
KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
55 Years to 90 Years
Enrollment
325 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
6
States / cities
Gilbert, Arizona • Chino, California • Naples, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 3 Interventional Results available

A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

NCT05145413
View directory record Official record
Conditions
Schizophrenia
Interventions
Xanomeline and Trospium Chloride Capsules, Placebo
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 65 Years
Enrollment
396 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
79
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Anaheim, California + 61 more
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Sep 30, 2026, 5:49 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

NCT02831231
View directory record Official record
Conditions
Schizophrenia
Interventions
xanomeline tartrate, Trospium chloride
Drug
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Industry
Eligibility
18 Years to 60 Years
Enrollment
70 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 19, 2017 · Synced Sep 30, 2026, 5:49 PM EDT