New drug KarXT aims to safely control bipolar mania over the long haul

NCT ID NCT06929273

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This phase 3 study is testing the long-term safety of KarXT, a new drug for managing mania in people with bipolar I disorder. About 450 participants, including those who completed earlier studies and new volunteers, will take KarXT along with standard mood stabilizers like lithium or valproate. Researchers will monitor side effects over time to see if KarXT is safe for extended 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 could show that KarXT is a safe long-term option for managing mania in bipolar I disorder, potentially offering a new treatment choice.
What could go wrong: This is an open-label extension study, so there is no placebo group for comparison. It focuses on safety, not how well the drug works. Side effects are still being tracked.

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 450 people

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

Started

Jul 2025

Expected to finish

Jun 2028

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 who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): a. Participants must have completed treatment period of parent study. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania. 2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline. 3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline. 4. Participants does not require hospitalization for acute mania. Exclusion Criteria: * All participants: 1\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS. * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): 1\. Discontinuation from any KarXT parent studies. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year). 2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. 3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test. 4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 5. Participants must not have 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 disorder type I with mania

How to take part

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

The places running it

168 sites in 20 countries. The list below names each one and where it is.
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 ↗
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
Aalborg Universitetshospital Psykiatrien
RECRUITING

Gistrup, 9260, Denmark
Adams Clinical Dallas
RECRUITING

DeSoto, Texas, 75115, United States
Advanced Research Center Inc.
RECRUITING

Anaheim, California, 92805, United States
Advanced Research Institute of Miami
RECRUITING

Miami, Florida, 33135, United States
Arch Clinical Trials
RECRUITING

St Louis, Missouri, 63141, United States
Asha Hospital - Hyderabad
RECRUITING

Hyderabad, Telangana, 500034, India
Atlanta Center for Medical Research
RECRUITING

Atlanta, Georgia, 30331, United States
Azienda Ospedaliero Universitaria Pisana
RECRUITING

Pisa, Tuscany, 56126, Italy
Azienda Ospedaliero Universitaria Senese
RECRUITING

Siena, Tuscany, 53100, Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING

Ancona, 60126, Italy
Barzilai Medical Center
RECRUITING

Ashkelon, 78306, Israel
Be'er Sheva Mental Health Center
RECRUITING

Beersheba, Southern District, 8461144, Israel
Behavioral Clinical Research
RECRUITING

Hollywood, Florida, 33021, United States
CBH Health
RECRUITING

Gaithersburg, Maryland, 20877, United States
Catalina Research Institute, LLC
RECRUITING

Montclair, California, 91763, United States
CenExel iResearch, LLC
RECRUITING

Decatur, Georgia, 30030, United States
CenExel iResearch, LLC
RECRUITING

Savannah, Georgia, 31405, United States
Center for Mental Health Prof. Dr. Ivan Temkov
RECRUITING

Burgas, 8001, Bulgaria
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
RECRUITING

Bucharest, 060222, Romania
Centrum Medyczne HCP
RECRUITING

Poznan, Greater Poland Voivodeship, 61-485, Poland
Chethana Center for Neuropsychiatry
RECRUITING

Kozhikode, Kerala, 673009, India
Clinica Inventiva
RECRUITING

Tuszyn, 95-080, Poland
Clinical Innovations, Inc. dba CITrials
RECRUITING

Bellflower, California, 90706, United States
Clinical Innovations, Inc. dba CITrials
RECRUITING

Riverside, California, 92506, United States
Collaborative Neuroscience Research, LLC
RECRUITING

Garden Grove, California, 92845-2506, United States
Collaborative Neuroscience Research, LLC
RECRUITING

Torrance, California, 90504, United States
Community Clinical Research
RECRUITING

Austin, Texas, 78754, United States
Dayanand Medical College and Hospital
RECRUITING

Ludhiana, Punjab, 141001, India
Elevate Clinical Research-Houston
RECRUITING

Houston, Texas, 77058, United States
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING

Milan, Lombardy, 20122, Italy
Glostrup Hospital
RECRUITING

Glostrup Municipality, 2600, Denmark
Goryokai Medical Corporation - Goryokai Hospital
RECRUITING

Sapporo, Hokkaido, 002-8029, Japan
Hassman Research Institute Marlton Site
RECRUITING

Marlton, New Jersey, 08053, United States
Health Synergy Clinical Research
RECRUITING

West Palm Beach, Florida, 33407, United States
Hino Hospital - Yokohama
RECRUITING

Yokohama, Kanagawa, 234-0051, Japan
Hospital Clínic de Barcelona
RECRUITING

Barcelona, Catalunya [Cataluña], 08036, Spain
Hotei Hospital
RECRUITING

Kōnan, Aichi-ken, 4838248, Japan
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
RECRUITING

Genova, 16132, Italy
Inland Psychiatric Medical Group - Chino
RECRUITING

Chino, California, 91710, United States
Innovative Clinical Research, Inc.
RECRUITING

Miami Lakes, Florida, 33016, United States
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
RECRUITING

Bucharest, 011241, Romania
Instytut Psychiatrii i Neurologii
RECRUITING

Warsaw, Masovian Voivodeship, 02-957, Poland
Juntendo University Hospital
RECRUITING

Bunkyo-ku, Tokyo, 113-8431, Japan
Kansai Medical University Medical Center
RECRUITING

Moriguchi, Osaka, 570-8507, Japan
Kfar Shaul Mental Health Center
RECRUITING

Jerusalem, 9546105, Israel
Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-272, Poland
Klinika za psihijatriju "Vrapče"
RECRUITING

Zagreb, 10090, Croatia
Klinika za psihijatriju "Vrapče"
RECRUITING

Zagreb, 10090, Croatia
Klinika za psihijatriju "Vrapče"
RECRUITING

Zagreb, 10090, Croatia
Kochi Health Sciences Center
RECRUITING

Kochi, 781-8555, Japan
Kuramitsu Hospital
RECRUITING

Fukuoka, 819-0037, Japan
LCC Medical Research Institute
RECRUITING

Miami, Florida, 33126, United States
Local Institution - 0007
WITHDRAWN

Sakai-shi, Osaka, 590-0018, Japan
Local Institution - 0016
WITHDRAWN

Iruma, Saitama, 350-0495, Japan
Local Institution - 0018
WITHDRAWN

Zagreb, City of Zagreb, 10090, Croatia
Local Institution - 0026
NOT_YET_RECRUITING

Hialeah Gardens, Florida, 33016, United States
Local Institution - 0031
NOT_YET_RECRUITING

Chicago, Illinois, 60640, United States
Local Institution - 0036
WITHDRAWN

Irving, Texas, 75062, United States
Local Institution - 0044
NOT_YET_RECRUITING

Cerritos, California, 90703, United States
Local Institution - 0045
NOT_YET_RECRUITING

St. Petersburg, Florida, 33713, United States
Local Institution - 0046
WITHDRAWN

Houston, Texas, 77021, United States
Local Institution - 0058
WITHDRAWN

Marlton, New Jersey, 08053, United States
Local Institution - 0063
WITHDRAWN

Kitakyushu, Fukuoka, 803-0831, Japan
Local Institution - 0080
NOT_YET_RECRUITING

Hyderabad, Telangana, 500082, India
Local Institution - 0084
NOT_YET_RECRUITING

Petah Tikva, Central District, 4910002, Israel
Local Institution - 0097
NOT_YET_RECRUITING

Iași, 700282, Romania
Local Institution - 0111
NOT_YET_RECRUITING

Vadodara, Gujarat, 390021, India
Local Institution - 0112
WITHDRAWN

Uppsala, Uppsala Län [se-03], 751 85, Sweden
Local Institution - 0115
COMPLETED

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0116
WITHDRAWN

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden
Local Institution - 0117
NOT_YET_RECRUITING

Vranov nad Topľou, Presov, 093 01, Slovakia
Local Institution - 0119
NOT_YET_RECRUITING

Košice, Košice Region, 040 01, Slovakia
Local Institution - 0120
NOT_YET_RECRUITING

Glendale, Arizona, 85304, United States
Local Institution - 0121
NOT_YET_RECRUITING

North Las Vegas, Nevada, 89030, United States
Local Institution - 0122
WITHDRAWN

North Las Vegas, Nevada, 89030, United States
Local Institution - 0124
WITHDRAWN

Charlotte, North Carolina, 28211, United States
Local Institution - 0126
NOT_YET_RECRUITING

Mendoza, 5502, Argentina
Local Institution - 0128
NOT_YET_RECRUITING

ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0132
NOT_YET_RECRUITING

Belagavi, Karnataka, 590010, India
Local Institution - 0136
WITHDRAWN

Santa Ana, California, 92705, United States
Local Institution - 0141
NOT_YET_RECRUITING

Poltava, 36013, Ukraine
Local Institution - 0143
NOT_YET_RECRUITING

Hlevakha, Kyivska Oblast, 08631, Ukraine
Local Institution - 0144
NOT_YET_RECRUITING

Odesa, 65006, Ukraine
Local Institution - 0145
NOT_YET_RECRUITING

Odesa, Odesa Oblast, 67513, Ukraine
Local Institution - 0146
NOT_YET_RECRUITING

Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine
Local Institution - 0147
NOT_YET_RECRUITING

Lviv, Lviv Oblast, 79021, Ukraine
Local Institution - 0148
NOT_YET_RECRUITING

Vinnytsia, Vinnytsia Oblast, 21037, Ukraine
Local Institution - 0149
NOT_YET_RECRUITING

Dnipro, 49115, Ukraine
Local Institution - 0150
NOT_YET_RECRUITING

Kyiv, 04080, Ukraine
Local Institution - 0151
NOT_YET_RECRUITING

Kropyvnytskyi, 25491, Ukraine
Local Institution - 0152
NOT_YET_RECRUITING

Smila, Cherkasy Oblast, 20708, Ukraine
Local Institution - 0158
NOT_YET_RECRUITING

Madurai, Tamil Nadu, 625020, India
Local Institution - 0160
NOT_YET_RECRUITING

Kolkata, West Bengal, 700025, India
Local Institution - 0166
WITHDRAWN

Iizuka, Fukuoka, 820-8505, Japan
Local Institution - 0168
NOT_YET_RECRUITING

Jerusalem, 91120, Israel
Local Institution - 0170
NOT_YET_RECRUITING

Nice, Alpes-Maritimes, 06000, France
Local Institution - 0171
NOT_YET_RECRUITING

Clermont-Ferrand, 63000, France
Local Institution - 0172
NOT_YET_RECRUITING

Montpellier, 34295, France
Local Institution - 0174
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100096, China
Local Institution - 0175
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510370, China
Local Institution - 0177
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100088, China
Local Institution - 0179
NOT_YET_RECRUITING

Chengdu, Sichuan, 610036, China
Local Institution - 0180
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210029, China
Local Institution - 0181
NOT_YET_RECRUITING

Baoding, Hebei, 071000, China
Local Institution - 0182
NOT_YET_RECRUITING

Ningbo, Zhejiang, 315201, China
Local Institution - 0183
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300022, China
Local Institution - 0184
NOT_YET_RECRUITING

Changsha, Hunan, 410011, China
Local Institution - 0188
NOT_YET_RECRUITING

Kazanlak, Stara Zagora, 6100, Bulgaria
Local Institution - 0189
NOT_YET_RECRUITING

Ternopil, 46000, Ukraine
Local Institution - 0190
NOT_YET_RECRUITING

Mangalore, Karnataka, 574143, India
Local Institution - 0191
NOT_YET_RECRUITING

Haskovo, 6300, Bulgaria
Local Institution - 0197
NOT_YET_RECRUITING

Lincoln, Nebraska, 68526, United States
Local Institution - 0198
NOT_YET_RECRUITING

Wichita Falls, Texas, 76309, United States
Local Institution - 0199
NOT_YET_RECRUITING

Carrollton, Texas, 75010, United States
Local Institution - 0200
NOT_YET_RECRUITING

Northridge, California, 91325, United States
Local Institution - 0201
NOT_YET_RECRUITING

Cerritos, California, 90703, United States
Local Institution - 0202
NOT_YET_RECRUITING

West Chester, Ohio, 45069, United States
Local Institution - 0203
NOT_YET_RECRUITING

Colorado Springs, Colorado, 80910, United States
Local Institution - 0204
NOT_YET_RECRUITING

Scottsdale, Arizona, 85260, United States
Local Institution - 0205
NOT_YET_RECRUITING

Tucson, Arizona, 85704, 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

Orange, California, 92868, United States
Nacka Local Hospital
RECRUITING

Nacka, Stockholms Län [se-01], 131 45, Sweden
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
Ness Ziona Mental Health Center
RECRUITING

Ness Ziona, Central District, 7410001, Israel
Neuro-Behavioral Clinical Research
RECRUITING

North Canton, Ohio, 44720, United States
Nil Ratan Sircar Medical College and Hospital
RECRUITING

Kolkata, West Bengal, 700014, India
Nippon Medical School Hospital
RECRUITING

Bunkyo-ku, Tokyo, 1138603, Japan
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
Omega Clinical Trials - La Habra
RECRUITING

La Habra, California, 90631, United States
Osaka Metropolitan University Hospital
RECRUITING

Osaka, 545-8586, Japan
Osi Bilbao-Basurto
RECRUITING

Bilbao, Basque Country, 48013, Spain
Petz Aladar Egyetemi Oktato Korhaz
RECRUITING

Győr, Győr-Moson-Sopron, 9024, Hungary
Pillar Clinical Research - Richardson
RECRUITING

Bentonville, Arkansas, 72712, United States
Pillar Clinical Research - Richardson
RECRUITING

Richardson, Texas, 75080, United States
Pillar Clinical Research -Chicago
RECRUITING

Chicago, Illinois, 60641, United States
Pillar Clinical Research- Little Rock
RECRUITING

Little Rock, Arkansas, 72204, United States
Precise Research Centers
RECRUITING

Flowood, Mississippi, 39232, United States
Prime Clinical Research - Mansfield
RECRUITING

Mansfield, Texas, 76063, United States
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Proscience Research Group
RECRUITING

Culver City, California, 90230, United States
Psihijatrijska bolnica "Sveti Ivan"
RECRUITING

Zagreb, 10090, Croatia
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
Shalvata Mental Health Center
RECRUITING

Hod HaSharon, Central District, 4534708, Israel
Sheba Medical Center
RECRUITING

Ramat Gan, Central District, 5265601, Israel
Showa Medical University Karasuyama Hospital
RECRUITING

Tokyo, 157-8577, Japan
South Florida Research Phase I-IV
RECRUITING

Miami Springs, Florida, 33166, United States
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
RECRUITING

Bucharest, 0, Romania
Spitalul de Psihiatrie și Neurologie Brașov
RECRUITING

Sanpetru /Brasov, 507190, Romania
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
RECRUITING

Novi Iskar, 1282, Bulgaria
Synexus Clinical Research US, Inc.
RECRUITING

Atlanta, Georgia, 30328, United States
University of Cincinnati Medical Center
RECRUITING

Cincinnati, Ohio, 45219, United States
Univerzitna Nemocnica L. Pasteura Kosice
RECRUITING

Košice, Košice Region, 040 01, Slovakia
Uniwersyteckie Centrum Kliniczne
RECRUITING

Gdansk, Pomeranian Voivodeship, 80-214, Poland
Velocity Clinical Research, Hallandale Beach
RECRUITING

Hallandale, Florida, 33009, United States
Wakayama Medical University Hospital
RECRUITING

Wakayama, 641-8510, Japan
Woodland International Research Group
RECRUITING

Little Rock, Arkansas, 72211, United States
Woodland Research Northwest
RECRUITING

Rogers, Arkansas, 72758, United States
Xi An Mental Health Center
RECRUITING

Xi'an, Shaanxi, 710061, China
Yale New Haven Hospital-Smilow Cancer Center
RECRUITING

New Haven, Connecticut, 06510, United States
Yamagata Sakuracho Hospital
RECRUITING

Yamagata, 990-0045, Japan