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New drug aims to keep schizophrenia in check

NCT ID NCT07686263

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether KarXT (a combination of xanomeline and trospium chloride) can prevent relapse in people with schizophrenia. Participants who have had a recent hospitalization for schizophrenia and still have symptoms will receive KarXT or a placebo. The study measures how long it takes for a relapse to occur and tracks side effects.

What this could mean

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

Active substance
Xanomeline/Trospium Chloride (KarXT)
What this could lead to
If successful, this could provide a new treatment option to help people with schizophrenia maintain stability and avoid relapse.
What could go wrong
This is an early-phase trial, and results may not confirm effectiveness. Side effects related to cholinergic activity 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

About 472 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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 * Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening. * Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. * Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1. * Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) * Participant must have a CGI-S score of ≥ 4 at screening and Day -1 * Participant must have a BMI ≥ 18 and ≤ 40 kg/m2. Exclusion Criteria * Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening * Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. * Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS). * Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. * Participant must not have a history of treatment resistance to schizophrenia medications * Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. * 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

    61 sites in 9 countries. 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

  • Local Institution - 0001

    Poznan, 60-744, Poland

  • Local Institution - 0002

    Córdoba, 5000, Argentina

  • Local Institution - 0014

    Klecany, 25067, Czechia

  • Local Institution - 0021

    Little Rock, Arkansas, 72211, United States

  • Local Institution - 0023

    St Louis, Missouri, 63141, United States

  • Local Institution - 0030

    Pico Rivera, California, 90660, United States

  • Local Institution - 0032

    Culver City, California, 90230, United States

  • Local Institution - 0037

    Garden Grove, California, 92845, United States

  • Local Institution - 0040

    Bellflower, California, 90706, United States

  • Local Institution - 0044

    West Palm Beach, Florida, 33407, United States

  • Local Institution - 0047

    Oklahoma City, Oklahoma, 73112, United States

  • Local Institution - 0049

    Austin, Texas, 78754, United States

  • Local Institution - 0054

    Miami Lakes, Florida, 33016, United States

  • Local Institution - 0055

    Iași, 700282, Romania

  • Local Institution - 0056

    Chicago, Illinois, 60641, United States

  • Local Institution - 0067

    Chicago, Illinois, 60640-5017, United States

  • Local Institution - 0068

    La Habra, California, 90631, United States

  • Local Institution - 0070

    Sandy Springs, Georgia, 30328, United States

  • Local Institution - 0075

    Miami, Florida, 33135, United States

  • Local Institution - 0101

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Local Institution - 0103

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0105

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0106

    Bucharest, 41914, Romania

  • Local Institution - 0107

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0109

    Bucharest, 41914, Romania

  • Local Institution - 0110

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0112

    Barcelona, Barcelona [Barcelona], 08003, Spain

  • Local Institution - 0120

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Local Institution - 0122

    Bialystok, Podlaskie Voivodeship, 15-272, Poland

  • Local Institution - 0123

    Warsaw, Masovian Voivodeship, 02-957, Poland

  • Local Institution - 0128

    Lemon Grove, California, 91945, United States

  • Local Institution - 0133

    Bentonville, Arkansas, 72712, United States

  • Local Institution - 0134

    Miami Springs, Florida, 33166, United States

  • Local Institution - 0135

    Buffalo, New York, 14215, United States

  • Local Institution - 0139

    Little Rock, Arkansas, 72204, United States

  • Local Institution - 0143

    Buenos Aires, C1199ABB, Argentina

  • Local Institution - 0144

    Santiago del Estero, 4200, Argentina

  • Local Institution - 0145

    Hollywood, Florida, 33024, United States

  • Local Institution - 0149

    Hollywood, Florida, 33021, United States

  • Local Institution - 0151

    Orange, California, 92868, United States

  • Local Institution - 0153

    Rogers, Arkansas, 72758, United States

  • Local Institution - 0154

    Bentonville, Arkansas, 72712, United States

  • Local Institution - 0157

    Glostrup, Region Sjælland, 2600, Denmark

  • Local Institution - 0158

    Aalborg, 9000, Denmark

  • Local Institution - 0159

    Aarhus, Central Jutland, 8200, Denmark

  • Local Institution - 0162

    Brno, 625 00, Czechia

  • Local Institution - 0166

    Atlanta, Georgia, 30331, United States

  • Local Institution - 0167

    Valladolid, 47012, Spain

  • Local Institution - 0174

    Bucharest, 011241, Romania

  • Local Institution - 0175

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Local Institution - 0177

    Oxford, Oxfordshire, OX3 7JX, United Kingdom

  • Local Institution - 0181

    Zamora, 49021, Spain

  • Local Institution - 0182

    Hovedvejen 19, Frederiksberg, 2000, Denmark

  • Local Institution - 0183

    Cincinnati, Ohio, 45219, United States

  • Local Institution - 0185

    Redlands, California, 92373, United States

  • Local Institution - 0186

    Riverside, California, 92506, United States

  • Local Institution - 0187

    Montclair, California, 91763, United States

  • Local Institution - 0188

    Chino, California, 91710, United States

  • Local Institution - 0189

    Savannah, Georgia, 31405, United States

  • Local Institution - 0190

    Anaheim, California, 92805, United States

  • Local Institution - 0191

    Novi Iskar, 1282, Bulgaria

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