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New schizophrenia drug KarXT under scrutiny for bladder safety

NCT ID NCT07221877

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study is testing how the drug KarXT affects bladder function and overall safety in 60 adults with schizophrenia over 12 months. Participants will stop their current antipsychotics and take KarXT to see if it causes any urinary problems. The goal is to ensure the drug is safe for long-term use.

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)
What this could lead to
If successful, this study could show that KarXT is safe for the bladder and urinary system, supporting its use as a long-term treatment for schizophrenia.
What could go wrong
This is a small, open-label safety study with no placebo group, so results may not prove effectiveness. Side effects related to bladder function or other issues could still arise.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

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

Started

Jan 2026

Expected to finish

Dec 2027

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.

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 * Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2). * Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2. * Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements. Exclusion Criteria * Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results. * Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study. * Other protocol-defined Inclusion/Exclusion criteria apply

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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

    13 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

  • ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Adams Clinical Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • CenExel CNS - Garden Grove

    RECRUITING

    Garden Grove, California, 92845, United States

  • Clinical Innovations, Inc. dba CITrials

    RECRUITING

    Bellflower, California, 90706, United States

  • Hassman Research Institute Marlton Site

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • IMA Clinical Research Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • InSite Clinical Research

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Innovative Clinical Research

    RECRUITING

    Lauderhill, Florida, 33319, United States

  • Local Institution - 0001

    NOT_YET_RECRUITING

    Austin, Texas, 78754, United States

  • Pillar Clinical Research -Chicago

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Pillar Clinical Research- Little Rock

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Uptown Research Institute

    RECRUITING

    Chicago, Illinois, 60640, United States

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