New schizophrenia drug KarXT shows promise in Long-Term safety trial

NCT ID NCT04820309

Disease control Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 study tested the long-term safety and effectiveness of KarXT, a combination of two drugs (xanomeline and trospium), in 566 adults with schizophrenia. Participants took KarXT twice daily for up to 52 weeks. The main goal was to see how safe and tolerable the drug is over time, with a secondary focus on how well it controls symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: KarXT (xanomeline and trospium chloride capsules)
What this could lead to: If successful, KarXT could offer a new long-term treatment option for schizophrenia that helps control symptoms with a manageable safety profile.
What could go wrong: This is an open-label study without a placebo group, so results may be biased. Side effects are possible, and long-term effectiveness is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

566 people

The number who actually took part.

Started

Jun 2021

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is aged 18 to 65 years at screening. 2. Subject is capable of providing informed consent. 1. A signed informed consent form (ICF) must be provided before any study assessments are performed. 2. Subject must be fluent in (oral and written) the language of the ICGF to consent. 3. Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2. 4. Subject has not required psychiatric hospitalization, acute crisis intervention, or other increase in level of care due to symptom exacerbation within 8 weeks of screening and is psychiatrically stable in the opinion of the investigator. 5. PANSS total score ≤ 80 at screening and Baseline Visit B (Day 0). 6. Clinical Global Impression - Severity (CGI-S) score of ≤ 4 at screening and Baseline Visit B (Day 0). 7. At the time of screening, or at any time within the 30 days prior to screening, the subject must have received an oral antipsychotic medication daily at a dose and frequency consistent with the drug label. 8. In the opinion of the investigator, it is clinically appropriate for the subject to discontinue current antipsychotic therapy and initiate experimental treatment with KarXT. 9. Subject is willing and able, in the opinion of the investigator, to discontinue all antipsychotic medications prior to baseline visit. 10. Subject has an identified reliable informant willing to be able to address some questions related to certain study visits, if needed. An informant may not be necessary if the subject has been the patient of the investigator for ≥1 year. 11. At Day 0, subject will have been off lithium therapy for at least 2 weeks and must have discontinued all oral antipsychotic medications. 12. Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for paliperidone palmitate) before Day 0. 13. Body mass index must be ≥ 18 and ≤ 40 kg/m2. 14. Subject resides in a stable living situation and is anticipated to remain in a stable living situation for the duration of study enrollment, in the opinion of the investigator. 15. Women of childbearing potential or men with sexual partners of childbearing potential must be willing and able to use at least 1 highly effective method of contraception during the study and for at least 30 days after the last dose of KarXT. Sperm donation is not allowed for 30 days after the final dose of KarXT. Exclusion Criteria: 1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening). 2. Subject has a history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline. 3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results 4. Subject has human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma 6. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months 7. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS). 8. Clinically significant abnormal finding from the physical examination, medical history, ECG, or clinical laboratory results at screening. 9. Subjects cannot currently (within 5 half-lives before Day 0) be receiving monoamine oxidase inhibitors, anticonvulsants, tricyclic antidepressants, centrally active anticholinergics, or any other psychoactive medications other than daily antipsychotic maintenance therapy. As-needed anxiolytics and/or sleep aids are permitted. Selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors taken at stable dose may be permitted. 10. Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the past 12 months or having received clozapine within the past 3 years 11. Pregnant, lactating, or less than 3 months postpartum. 12. If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements. 13. Subjects has tested positive for coronavirus disease 2019 (COVID-19) within 2 weeks of screening. 14. Subject has extreme concerns relating to global pandemics, such as COVID-19, that preclude study participation. 15. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. 16. Subject has prior exposure to KarXT. 17. Risk of violent or destructive behavior. 18. Current involuntary hospitalization or incarceration.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

ATP Clinical Research Inc

Costa Mesa, California, 92626, United States
ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States
Advanced Research Center, Inc.

Anaheim, California, 92805, United States
Alliance for Wellness

Long Beach, California, 90807, United States
Alliance for Wellness dba Alliance for Research

Long Beach, California, 90807, United States
Altea Research Institute

Las Vegas, Nevada, 89102, United States
Arch Clinical Trials

St Louis, Missouri, 63118, United States
Ascension Via Christi Research

Wichita, Kansas, 67214, United States
Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States
Behavioral Clinical Research, Inc.

Glendale, California, 91206, United States
BioBehavioral Research of Austin

Austin, Texas, 78759, United States
BioBehavioral Research of Austin P.C.

Austin, Texas, 78759, United States
CBH Health, LLC

Gaithersburg, Maryland, 20877, United States
CITrials

Riverside, California, 92506, United States
CITrials

Santa Ana, California, 92705, United States
CNRI-Los Angeles, LLC

Pico Rivera, California, 90660, United States
Cedar Clinical Research

Draper, Utah, 84020, United States
Central Miami Medical Institute

Miami, Florida, 33125, United States
Cincy Science

West Chester, Ohio, 45069, United States
Clinical Innovations, Inc

Bellflower, California, 90706, United States
Clinical Trials of America

Hickory, North Carolina, 28601, United States
Collaborative Neuroscience Research

Torrance, California, 90502, United States
Community Clinical Research

Austin, Texas, 78754, United States
Core Clinical Research

Richmond, Texas, 77407, United States
Excell Research Inc

Oceanside, California, 92056, United States
Finger Lakes Clinical Research

Rochester, New York, 14618, United States
Global Medical Institutes LLC Scranton Medical Institute

Moosic, Pennsylvania, 18507, United States
Hassman Research Institute

Berlin, New Jersey, 08009, United States
Hassman Research Institute

Marlton, New Jersey, 08053, United States
Health Synergy Clinical Research

Okeechobee, Florida, 34972, United States
Homestead Research Institute, Inc.

Homestead, Florida, 33030, United States
INSPIRA Clinical Research

San Juan, PR, 918, Puerto Rico
InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States
Innovative Clinical Research

Miami Lakes, Florida, 33016, United States
Local Institution - 011-201

Rogers, Arkansas, 72758, United States
Local Institution - 011-202

Glendale, California, 91206-4282, United States
Local Institution - 011-203

Miami, Florida, 33122-1335, United States
Local Institution - 011-204

Chicago, Illinois, 60640-5017, United States
Local Institution - 011-205

Shreveport, Louisiana, 71101, United States
Local Institution - 011-206

Culver City, California, 90230, United States
Local Institution - 011-207

West Chester, Pennsylvania, 19380, United States
Local Institution - 011-209

Bellevue, Washington, 98007-4879, United States
Local Institution - 011-210

New York, New York, 10128, United States
Local Institution - 011-211

Gaithersburg, Maryland, 20877, United States
Local Institution - 011-215

Miami, Florida, 33125, United States
Local Institution - 011-216

Okeechobee, Florida, 34972, United States
Local Institution - 011-218

Dayton, Ohio, 45417, United States
Local Institution - 011-219

Pembroke Pines, Florida, 33024, United States
Local Institution - 011-220

Miami, Florida, 33165, United States
Local Institution - 011-221

West Chester, Ohio, 45069, United States
Local Institution - 011-222

Bellflower, California, 90706, United States
Local Institution - 011-223

Wichita, Kansas, 67214-2878, United States
Local Institution - 011-224

Hallandale, Florida, 33009, United States
Local Institution - 011-226

Flowood, Mississippi, 39170, United States
Local Institution - 011-227

Saint Charles, Missouri, 63304, United States
Local Institution - 011-229

Oceanside, California, 92056, United States
Local Institution - 011-230

Berlin, New Jersey, 08009, United States
Local Institution - 011-231

Homestead, Florida, 33030, United States
Local Institution - 011-232

Ann Arbor, Michigan, 48105-3205, United States
Local Institution - 011-233

Riverside, California, 92506, United States
Local Institution - 011-234

Miami Lakes, Florida, 33016, United States
Local Institution - 011-235

Decatur, Georgia, 30030-2549, United States
Local Institution - 011-236

DeSoto, Texas, 75115, United States
Local Institution - 011-237

Atlanta, Georgia, 30331, United States
Local Institution - 011-238

Little Rock, Arkansas, 72211-3702, United States
Local Institution - 011-239

Las Vegas, Nevada, 89102, United States
Local Institution - 011-240

Anaheim, California, 92805-5854, United States
Local Institution - 011-241

St Louis, Missouri, 63141, United States
Local Institution - 011-242

Orange, California, 92868, United States
Local Institution - 011-243

Austin, Texas, 78754, United States
Local Institution - 011-244

Pico Rivera, California, 90660, United States
Local Institution - 011-246

Sherman Oaks, California, 91403-1747, United States
Local Institution - 011-248

North Canton, Ohio, 44720, United States
Local Institution - 011-249

Marlton, New Jersey, 08053, United States
Local Institution - 011-250

Rochester, New York, 14618, United States
Local Institution - 011-251

Santa Rosa, California, 95401-4691, United States
Local Institution - 011-252

Torrance, California, 90504, United States
Local Institution - 011-253

Garden Grove, California, 92845, United States
Local Institution - 011-256

New York, New York, 10036, United States
Local Institution - 011-257

Cerritos, California, 90703, United States
Local Institution - 011-258

Fort Worth, Texas, 76104, United States
Local Institution - 011-259

Atlanta, Georgia, 30328, United States
Local Institution - 011-260

Everett, Washington, 98201, United States
Local Institution - 011-261

Hollywood, Florida, 33024, United States
Local Institution - 011-262

West Palm Beach, Florida, 33407, United States
Local Institution - 011-263

Bellflower, California, 90706, United States
Louisiana Clinical Research

Shreveport, Louisiana, 71101, United States
Manhattan Behavioral Medicine, PLLC

New York, New York, 10036, United States
Michigan Clinical Research Institute PC

Ann Arbor, Michigan, 48105, United States
Midwest Clinical Research Center

Dayton, Ohio, 45417, United States
Midwest Research Group - St. Charles Psychiatric Associates

Saint Charles, Missouri, 63304, United States
NRC Research Institute

Orange, California, 92868, United States
Neuro-Behavioral Clinical Research, Inc

North Canton, Ohio, 44720, United States
Neuroscience Research Institute

West Palm Beach, Florida, 33407, United States
North County Clinical Research (NCCR)

Oceanside, California, 92054, United States
Northwest Clinical Research Center

Bellevue, Washington, 98007, United States
Omega Clinical Trials

La Habra, California, 90631-3842, United States
Omega Clinical Trials

La Habra, California, 90631, United States
Phoenix Medical Research

Miami, Florida, 33165, United States
Pines Care Research Center

Pembroke Pines, Florida, 33024, United States
Precise Research Centers

Flowood, Mississippi, 39170, United States
Premier Clinical Research Institute

Miami, Florida, 33122, United States
ProScience Research Group

Culver City, California, 90230, United States
Psychiatric Consultants

Franklin, Tennessee, 37067, United States
Research Centers of America at Fort Lauderdale Behavioral Health Center

Oakland Park, Florida, 33334, United States
SP Research PLLC

Oklahoma City, Oklahoma, 73112, United States
Schuster Medical Research Institute

Sherman Oaks, California, 91403, United States
Siyan Clinical Research

Santa Rosa, California, 95401, United States
St. Charles Psychiatric Associates/Midwest Research Group

Saint Charles, Missouri, 63304, United States
Suburban Research Associates

Media, Pennsylvania, 19063, United States
Synexus Clinical Research US, Inc.

Atlanta, Georgia, 30328, United States
The Medical Research Network, LLC

New York, New York, 10128, United States
Uptown Research Institute

Chicago, Illinois, 60640, United States
Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States
Woodland International Research Group

Little Rock, Arkansas, 72211, United States
Woodland Research Northwest

Rogers, Arkansas, 72758, United States
healthTx

Richmond, Texas, 77407, United States

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