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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 ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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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