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New hope for bipolar mania? phase 3 trial of KarXT begins

NCT ID NCT06951698

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 5 times

Summary

This Phase 3 study tests whether KarXT, a combination of two drugs, can safely reduce manic symptoms in people with Bipolar-I disorder. About 274 participants hospitalized for mania will receive either KarXT or a placebo. The main goal is to see if KarXT improves scores on a standard mania rating scale over time.

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 chloride)
What this could lead to
If successful, KarXT could offer a new treatment option for managing manic episodes in Bipolar-I disorder, potentially with fewer side effects than current therapies.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The drug may not prove more effective than placebo, and side effects could emerge. It is not a cure and will require ongoing management.

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 274 people

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

Started

Jun 2025

Expected to finish

Nov 2026

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 Bipolar-I disorder established by a comprehensive psychiatric evaluation. * Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks). * Participants must require hospitalization for the acute exacerbation or relapse of mania. * Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug. * Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline. * Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline. Exclusion Criteria: * Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. * Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year). * Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test. * Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS). * Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. * Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder Mania

As listed by the trial registrant

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

Bipolar-I disorder with mania or mania with mixed features

How to take part

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

  1. The places running it

    68 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

  • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD

    RECRUITING

    Pleven, 5800, Bulgaria

  • Advanced Research Center Inc.

    RECRUITING

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami

    RECRUITING

    Homestead, Florida, 33033, United States

  • CITrials

    RECRUITING

    Bellflower, California, 90706, United States

  • Catalina Research Institute, LLC

    RECRUITING

    Montclair, California, 91763, United States

  • CenExel iResearch, LLC

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Center for Mental Health Prof. Dr. Ivan Temkov

    RECRUITING

    Burgas, 8001, Bulgaria

  • Centrum Medyczne HCP

    RECRUITING

    Poznan, Greater Poland Voivodeship, 61-485, Poland

  • Clinica Inventiva

    RECRUITING

    Tuszyn, 95-080, Poland

  • Clinica del Prado

    RECRUITING

    Las Heras, Mendoza Province, 5539, Argentina

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Long Beach, California, 90806, United States

  • Connecticut Mental Health Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Goryokai Medical Corporation - Goryokai Hospital

    RECRUITING

    Sapporo, Hokkaido, 002-8029, Japan

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Hospital Italiano de Buenos Aires

    RECRUITING

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Innovative Clinical Research, Inc.

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Instytut Psychiatrii i Neurologii

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-957, Poland

  • Kansai Medical University Medical Center

    RECRUITING

    Moriguchi, Osaka, 570-8507, Japan

  • Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-272, Poland

  • Kuramitsu Hospital

    RECRUITING

    Fukuoka, 819-0037, Japan

  • Local Institution - 0014

    NOT_YET_RECRUITING

    Cerritos, California, 90703, United States

  • Local Institution - 0015

    NOT_YET_RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Local Institution - 0029

    WITHDRAWN

    Irving, Texas, 75062, United States

  • Local Institution - 0058

    ACTIVE_NOT_RECRUITING

    Bentonville, Arkansas, 72712, United States

  • Local Institution - 0081

    WITHDRAWN

    Iruma, Saitama, 350-0495, Japan

  • Local Institution - 0082

    ACTIVE_NOT_RECRUITING

    Kōnan, Aichi-ken, 4838248, Japan

  • Local Institution - 0084

    WITHDRAWN

    Osaka, 590-0018, Japan

  • Local Institution - 0100

    WITHDRAWN

    Kitakyushu, Fukuoka, 803-0831, Japan

  • Local Institution - 0102

    NOT_YET_RECRUITING

    Sosnowiec, Silesian Voivodeship, 41-200, Poland

  • Local Institution - 0109

    NOT_YET_RECRUITING

    Mendoza, 5502, Argentina

  • Local Institution - 0111

    NOT_YET_RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Local Institution - 0126

    NOT_YET_RECRUITING

    Kropyvnytskyi, 25491, Ukraine

  • Local Institution - 0129

    NOT_YET_RECRUITING

    Kyiv, 04080, Ukraine

  • Local Institution - 0130

    NOT_YET_RECRUITING

    Dnipro, 49115, Ukraine

  • Local Institution - 0131

    NOT_YET_RECRUITING

    Smila, Cherkasy Oblast, 20708, Ukraine

  • Local Institution - 0132

    NOT_YET_RECRUITING

    Poltava, 36013, Ukraine

  • Local Institution - 0133

    NOT_YET_RECRUITING

    Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine

  • Local Institution - 0137

    NOT_YET_RECRUITING

    Ternopil, 46027, Ukraine

  • Local Institution - 0138

    NOT_YET_RECRUITING

    Kazanlak, Stara Zagora, 6100, Bulgaria

  • Local Institution - 0139

    NOT_YET_RECRUITING

    Haskovo, 6300, Bulgaria

  • Local Institution - 0140

    NOT_YET_RECRUITING

    Santiago del Estero, G4200DND, Argentina

  • Local Institution - 0141

    NOT_YET_RECRUITING

    Austin, Texas, 78754, United States

  • M2M Med

    RECRUITING

    Rybnik, Silesian Voivodeship, 44-200, Poland

  • MHAT "Dr. Ival Seliminski"

    RECRUITING

    Sliven, 8800, Bulgaria

  • Mental Health Center - Vratsa

    RECRUITING

    Vratsa, 3000, Bulgaria

  • Miyazaki Prefectural Miyazaki Hospital

    RECRUITING

    Miyazaki, 880-8510, Japan

  • NRC Research Institute

    RECRUITING

    Los Angeles, California, 90015, United States

  • Narimasu Kosei Hospital

    RECRUITING

    tabashi City, Tokyo, 175-0091, Japan

  • National Center of Neurology and Psychiatry

    RECRUITING

    Kodaira, Tokyo, 187-8551, Japan

  • National Kohnodai Medical Center.

    RECRUITING

    Ichikawa, Chiba, 272-8516, Japan

  • Neuro-Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • North Shore Hospital

    RECRUITING

    Auckland, 0622, New Zealand

  • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet

    RECRUITING

    Budapest, 1135, Hungary

  • Obihiro Kosei Hospital

    RECRUITING

    Obihiro, Hokkaido, 080-0024, Japan

  • Okehazama Hospital

    RECRUITING

    Toyoake, Aichi-ken, 470-1168, Japan

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, 545-8586, Japan

  • Petz Aladar Egyetemi Oktato Korhaz

    RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Pillar Clinical Research - Richardson

    RECRUITING

    Richardson, Texas, 75080, United States

  • Pillar Clinical Research -Chicago

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Rainbow and Sea Hospital

    RECRUITING

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

  • Ramsay Clinic New Farm

    RECRUITING

    Brisbane, Queensland, 4005, Australia

  • Ramsay Clinic Northside

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Research Centers of America ( Hollywood )

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10314, United States

  • Saitama Konan Hospital

    RECRUITING

    Kumagaya, Saitama, 360-0114, Japan

  • Sanatorio Morra S.A.

    RECRUITING

    Córdoba, 5000, Argentina

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1083, Hungary

  • Showa Medical University Karasuyama Hospital

    RECRUITING

    Tokyo, 157-8577, Japan

  • South Florida Research Phase I-IV

    RECRUITING

    Miami, Florida, 33166, United States

  • State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar

    RECRUITING

    Novi Iskar, 1282, Bulgaria

  • Synexus Clinical Research US, Inc.

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, 641-8510, Japan

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Yamagata Sakuracho Hospital

    RECRUITING

    Yamagata, 990-0045, Japan