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New schizophrenia drug KarXT shows promise in safety trial

NCT ID NCT06572449

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested the safety of a new drug called KarXT in 173 adults with schizophrenia. Researchers slowly increased the dose to see how well participants tolerated it and whether food affected the drug. The main goal was to track side effects, with secondary measures looking at symptom changes.

What this could mean

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

Active substance
KarXT (a combination of xanomeline and trospium)
What this could lead to
If successful, this could provide a new treatment option for schizophrenia with a better understanding of how to manage side effects.
What could go wrong
This is an early-phase study focused on safety, not proof of effectiveness. Side effects like nausea, dizziness, and confusion are possible.

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

173 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2025

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: * 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 (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2. * Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline. * Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline. * Willing and able to discontinue all antipsychotic medications prior to baseline visit. Exclusion Criteria: * History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * Any primary DSM-5 disorder other than schizophrenia within 12 months before screening. * History of treatment resistance to schizophrenia medications. * History of allergy/hypersensitivity to KarXT. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

disease psychiatric disorder schizophrenia

As listed by the trial registrant

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

Schizophrenia

Contacts and locations

Locations

  • Local Institution - 0001

    Marlton, New Jersey, 08053-3449, United States

  • Local Institution - 0002

    Los Alamitos, California, 90720-3118, United States

  • Local Institution - 0003

    Decatur, Georgia, 30030, United States

  • Local Institution - 0004

    Riverside, California, 92506-3257, United States

  • Local Institution - 0005

    Atlanta, Georgia, 30331, United States

  • Local Institution - 0006

    Hollywood, Florida, 33024, United States

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