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New schizophrenia drug KarXT under Real-World scrutiny

NCT ID NCT07379827

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tracks 1,500 adults with schizophrenia who start taking KarXT (xanomeline and trospium chloride) in routine clinical care across the U.S. Researchers will monitor how doctors adjust doses, side effects, weight changes, and relapses over time. The goal is to understand how well the drug works outside of controlled trials.

What this could mean

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

Active substance
Xanomeline and trospium chloride (KarXT)
What this could lead to
If successful, this study could provide real-world evidence on how well KarXT works for schizophrenia and its side effects, helping doctors make better treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors like patient selection or incomplete data. It does not test a new drug but rather monitors existing use.

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.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

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.

Who is studied

The study population will include adults diagnosed with schizophrenia who have switched or plan to switch from prior antipsychotic treatment to xanomeline and trospium chloride (KarXT)

Ages

18 years and older

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: * Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines. * Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up. * Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below: * Be within \<16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR * On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications. * Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period. Exclusion Criteria: * Prior use of KarXT that has been discontinued for any reason prior to Baseline. * Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period. * Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma. * In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are \< 16 weeks from initiation of KarXT. * Participants who are pregnant, planning to become pregnant, or breastfeeding.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    55 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amr Conventions Research - Illinois

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Banyan Behavioal Care Program - CSU

    RECRUITING

    Miami, Florida, 33134, United States

  • BioResearch Partner - Miami

    RECRUITING

    Miami, Florida, 33175, United States

  • Emory University.

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Envision Trials LLC

    RECRUITING

    Bonita Springs, Florida, 34134, United States

  • Galiz Research

    RECRUITING

    Hialeah, Florida, 33016-1814, United States

  • Inland Psychiatric Medical Group (IPMG)-Chino

    RECRUITING

    Chino, California, 91710, United States

  • Local Institution - 0003

    NOT_YET_RECRUITING

    Anaheim, California, 92805, United States

  • Local Institution - 0004

    NOT_YET_RECRUITING

    Monsey, New York, 10952, United States

  • Local Institution - 0007

    NOT_YET_RECRUITING

    Miami, Florida, 33155, United States

  • Local Institution - 0010

    NOT_YET_RECRUITING

    Houston, Texas, 77054, United States

  • Local Institution - 0012

    NOT_YET_RECRUITING

    La Palma, California, 90623, United States

  • Local Institution - 0013

    NOT_YET_RECRUITING

    McKinney, Texas, 75092, United States

  • Local Institution - 0014

    NOT_YET_RECRUITING

    Bloomfield Township, Michigan, 48302-1909, United States

  • Local Institution - 0016

    NOT_YET_RECRUITING

    Austin, Texas, 78754, United States

  • Local Institution - 0017

    NOT_YET_RECRUITING

    Irving, Texas, 75062-2757, United States

  • Local Institution - 0018

    NOT_YET_RECRUITING

    Stafford, Texas, 77477-3954, United States

  • Local Institution - 0020

    NOT_YET_RECRUITING

    White Plains, New York, 10601, United States

  • Local Institution - 0021

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76132, United States

  • Local Institution - 0022

    NOT_YET_RECRUITING

    Houston, Texas, 77054-2852, United States

  • Local Institution - 0026

    NOT_YET_RECRUITING

    Houston, Texas, 77008-1758, United States

  • Local Institution - 0028

    NOT_YET_RECRUITING

    Stanford, California, 94304, United States

  • Local Institution - 0030

    NOT_YET_RECRUITING

    Homestead, Florida, 33030, United States

  • Local Institution - 0031

    NOT_YET_RECRUITING

    Mason, Ohio, 45040-7846, United States

  • Local Institution - 0032

    NOT_YET_RECRUITING

    Miami, Florida, 33015, United States

  • Local Institution - 0033

    NOT_YET_RECRUITING

    Houston, Texas, 77007-9015, United States

  • Local Institution - 0034

    NOT_YET_RECRUITING

    Apple Valley, Minnesota, 55124, United States

  • Local Institution - 0036

    NOT_YET_RECRUITING

    Detroit, Michigan, 48203, United States

  • Local Institution - 0037

    NOT_YET_RECRUITING

    Buffalo, New York, 14215, United States

  • Local Institution - 0038

    NOT_YET_RECRUITING

    Rochester, New York, 14623, United States

  • Local Institution - 0040

    NOT_YET_RECRUITING

    Orlando, Florida, 32803, United States

  • Local Institution - 0041

    NOT_YET_RECRUITING

    Lincoln, Nebraska, 68526-9474, United States

  • Local Institution - 0043

    NOT_YET_RECRUITING

    Oceanside, California, 92056-4509, United States

  • Local Institution - 0044

    NOT_YET_RECRUITING

    Marietta, Georgia, 30060, United States

  • Local Institution - 0045

    NOT_YET_RECRUITING

    Petersburg, Virginia, 23805, United States

  • Local Institution - 0046

    NOT_YET_RECRUITING

    Crystal Lake, Illinois, 60523, United States

  • Local Institution - 0049

    NOT_YET_RECRUITING

    Austell, Georgia, 30106, United States

  • Local Institution - 0050

    NOT_YET_RECRUITING

    Dallas, Texas, 75390, United States

  • Local Institution - 0051

    NOT_YET_RECRUITING

    Cordova, Tennessee, 38018, United States

  • Local Institution - 0052

    NOT_YET_RECRUITING

    Tulsa, Oklahoma, 74135, United States

  • Local Institution - 0053

    NOT_YET_RECRUITING

    State College, Pennsylvania, 16801, United States

  • Local Institution - 0054

    NOT_YET_RECRUITING

    Duluth, Minnesota, 55811, United States

  • Local Institution - 0055

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89146, United States

  • Magnolia Clinical Research, LLC

    RECRUITING

    Cary, North Carolina, 27513, United States

  • Medical Research of Central Florida

    RECRUITING

    Orange City, Florida, 32763, United States

  • New Access Research & Medical Services Inc - Kendall

    RECRUITING

    Kendall, Florida, 33186, United States

  • PPD Virtual - PPD - US

    RECRUITING

    Wilmington, North Carolina, 28401-3331, United States

  • Pamoja Advanced Nursing Practice

    RECRUITING

    Anaheim, California, 92801, United States

  • Perceptive Pharma Research

    RECRUITING

    Richmond, Texas, 77407-3498, United States

  • Perelman School of Medicine at the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4238, United States

  • Pioneer Research Solutions, Inc.

    RECRUITING

    Houston, Texas, 77099, United States

  • Psychiatric Consultants, Pc

    RECRUITING

    Franklin, Tennessee, 37607, United States

  • SanRo Clinical Research Group

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • The Rivus Wellness & Research Institute

    RECRUITING

    Oklahoma City, Oklahoma, 73112-8729, United States

  • UT Health San Antonio - Behavioral Health and Wellness Center

    RECRUITING

    San Antonio, Texas, 78240, United States

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Other studies related to the condition(s) this trial covers.