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

NCT ID NCT06951698

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

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 4 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.

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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

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
Hotei Hospital
RECRUITING

Kōnan, Aichi-ken, 4838248, Japan
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 - 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 - 0114
NOT_YET_RECRUITING

Budapest, 1135, Hungary
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
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
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