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New hope for schizophrenia: KarXT enters Late-Stage trial

NCT ID NCT06882785

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 28, 2026 · Updated 5 times

Summary

This phase 3 study tests whether KarXT, a new drug, can safely reduce schizophrenia symptoms in 250 Japanese adults experiencing acute psychosis. Participants first receive either KarXT or a placebo for 5 weeks, then all may receive KarXT for a year. The goal is to see if KarXT improves symptoms like hallucinations and disorganized thinking.

What this could mean

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

Active substance
KarXT (also known as BMS-986510)
What this could lead to
If successful, KarXT could offer a new treatment option for schizophrenia, helping to control symptoms like hallucinations and delusions.
What could go wrong
This is a phase 3 trial, but it is still early to know if KarXT works better than existing treatments. Side effects are possible, and results may not apply to all patients.

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 250 people

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

Started

Jun 2025

Expected to finish

Aug 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 * Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI). * Participants must have a PANSS total score between 80 and 120, inclusive. * Participants must have a CGI-S score of ≥ 4. Exclusion Criteria * Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening. * Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia. * Participants must not have any history or presence of clinically significant medical conditions. * 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

    50 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

  • Asuka Hospital

    RECRUITING

    Machida, Tokyo, 1940005, Japan

  • Dokkyo Medical University Hospital

    RECRUITING

    Shimotsuga, Tochigi, 321-0293, Japan

  • Fujimidai Hospital

    RECRUITING

    Hiratsuka, Kanagawa, 259-1205, Japan

  • Fujita Health University

    RECRUITING

    Toyoake, Aichi-ken, 470-1192, Japan

  • Goryokai Medical Corporation - Goryokai Hospital

    RECRUITING

    Sapporo, Hokkaido, 002-8029, Japan

  • Hino Hospital - Yokohama

    RECRUITING

    Yokohama, Kanagawa, 234-0051, Japan

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaido, 0608648, Japan

  • Holy Cross Hospital - Toki

    RECRUITING

    Toki, Gifu, 509-5142, Japan

  • Hotei Hospital

    RECRUITING

    Kōnan, Aichi-ken, 4838248, Japan

  • Inuo Hospital

    RECRUITING

    Tosu, Saga-ken, 841-0081, Japan

  • Kansai Medical University Medical Center

    RECRUITING

    Moriguchi, Osaka, 570-8507, Japan

  • Kitasato University Hospital

    RECRUITING

    Sagamihara, Kanagawa, 252-0375, Japan

  • Kuramitsu Hospital

    RECRUITING

    Fukuoka, 819-0037, Japan

  • Kure Medical Center

    RECRUITING

    Kure, Hiroshima, 737-0023, Japan

  • Local Institution - 0012

    WITHDRAWN

    Hachiōji, Tokyo, 192-0153, Japan

  • Local Institution - 0014

    WITHDRAWN

    Komoro, Nagano, 384-8540, Japan

  • Local Institution - 0018

    NOT_YET_RECRUITING

    Okinawa, 904-0012, Japan

  • Local Institution - 0019

    WITHDRAWN

    Yatsushiro, Kumamoto, 866-0043, Japan

  • Local Institution - 0025

    NOT_YET_RECRUITING

    Hadano-shi, Kanagawa, 257-0003, Japan

  • Local Institution - 0031

    NOT_YET_RECRUITING

    Osaka, 590-0018, Japan

  • Local Institution - 0032

    WITHDRAWN

    Iizuka, Fukuoka, 820-0014, Japan

  • Local Institution - 0033

    WITHDRAWN

    Tottori, 689-0203, Japan

  • Local Institution - 0037

    NOT_YET_RECRUITING

    Kitakyushu, Fukuoka, 803-0831, Japan

  • Local Institution - 0050

    WITHDRAWN

    Matsumoto, Nagano, 390-0847, Japan

  • Local Institution - 0054

    NOT_YET_RECRUITING

    Shimotsuke, Tochigi, 329-0498, Japan

  • Local Institution - 0056

    NOT_YET_RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • Miyakonojo Shinsei Hospital

    RECRUITING

    Miyakonojō, Miyazaki, 885-0093, Japan

  • Miyazaki Prefectural Miyazaki Hospital

    RECRUITING

    Miyazaki, 880-8510, Japan

  • Nagaokai Medical Corporation - Neyagawa Sanatorium

    RECRUITING

    Neyagawa, Osaka, 572-0854, Japan

  • Narimasu Kosei Hospital

    RECRUITING

    tabashi City, Tokyo, 175-0091, Japan

  • National Center of Neurology and Psychiatry

    RECRUITING

    Kodaira, Tokyo, 187-8551, Japan

  • National Hospital Organization Maizuru Medical Center

    RECRUITING

    Maizuru, Kyoto, 625-8502, Japan

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    RECRUITING

    MIdori-ku, Chiba-shi, Chiba, 266-0007, Japan

  • National Kohnodai Medical Center.

    RECRUITING

    Ichikawa, Chiba, 272-8516, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, 700-8558, Japan

  • Okehazama Hospital

    RECRUITING

    Toyoake, Aichi-ken, 470-1168, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Takatsuki, Osaka, 569-8686, Japan

  • Osaka Psychiatric Medical Center

    RECRUITING

    Hirakata, Osaka, 573-0022, Japan

  • Rainbow and Sea Hospital

    RECRUITING

    Karatsu-shi, Saga-ken, 847-0031, Japan

  • Saitama Konan Hospital

    RECRUITING

    Kumagaya, Saitama, 360-0114, Japan

  • Saitama Neuropsychitric Institute

    RECRUITING

    Saitama, 338-8577, Japan

  • Shin-Abuyama Hospital

    RECRUITING

    Takatsuki, Osaka, 569-1041, Japan

  • Shiranui Hospital

    RECRUITING

    Omuta, Fukuoka, 836-0004, Japan

  • Takeda General Hospital - Aizuwakamatsu

    RECRUITING

    Aizu-Wakamatsu, Fukushima, 965-0876, Japan

  • Tochigi Prefectural Okamotodai Hospital

    RECRUITING

    Utsunomiya, Tochigi, 3291104, Japan

  • Toho University Omori Medical Center

    RECRUITING

    Ōta-ku, Tokyo, 143-8541, Japan

  • Tokushima University Hospital

    RECRUITING

    Tokushima, 770-8503, Japan

  • Tokyo Metropolitan Matsuzawa Hospital

    RECRUITING

    Setagaya City, Tokyo, 1560057, Japan

  • Tsurumi Nishii Hospital

    RECRUITING

    Yokohama, Kanagawa, 230-0074, Japan

  • University Hospital,Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, 602-8566, Japan

  • University of the Ryukyus Hospital

    RECRUITING

    Ginowan, Okinawa, 901-2725, Japan

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, 641-8510, Japan

  • Yamagata Sakuracho Hospital

    RECRUITING

    Yamagata, 990-0045, Japan

  • Yamaguchi University Hospital

    RECRUITING

    Ube, Yamaguchi, 755-8505, Japan

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, Kanagawa, 232-0024, Japan

  • Yuge Hospital

    RECRUITING

    Kumamoto, Kumamoto, 861-8002, Japan

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