KarXT for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests KarXT, a treatment for people with schizophrenia, to assess its effects on bladder function and overall urological safety. The goal is to understand how this medication works in the body and ensure its safety for long-term use. The trial seeks participants diagnosed with schizophrenia (confirmed by a mental health evaluation) who have no recent history of other mental disorders or substance abuse. Those managing schizophrenia and willing to stop other antipsychotic medications might be a good fit for this study. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment benefits more patients.
Will I have to stop taking my current medications?
Yes, you will need to stop taking all antipsychotic medications before the study begins.
What is the safety track record for KarXT?
Research has shown that KarXT, a combination of xanomeline and trospium chloride, is generally safe for people with schizophrenia. Studies have found it helps with both the negative and positive symptoms of the condition. Most side effects are mild, making it manageable for most people.
In one study, patients tolerated KarXT well, even during severe episodes of psychosis. Another study demonstrated its benefits for people with psychosis, not only in schizophrenia but also in dementia, which is encouraging for understanding its safety in different conditions.
A 52-week safety study on a similar drug, Cobenfy, highlighted some concerns. It found a risk of trouble urinating and advised caution for people with liver problems. However, proper medical advice can usually manage these risks.
Overall, while KarXT is effective, patients should be aware of possible side effects and discuss any concerns with their healthcare providers.12345Why are researchers enthusiastic about this study treatment?
KarXT is unique because it targets the muscarinic receptors in the brain, which is different from most schizophrenia treatments that primarily focus on dopamine receptors. This novel mechanism of action is exciting because it has the potential to reduce symptoms without the common side effects associated with traditional antipsychotics, such as weight gain and movement disorders. Researchers are particularly interested in KarXT because it offers hope for a more tolerable treatment option that could improve the quality of life for those living with schizophrenia.
What is the effectiveness track record for KarXT in treating schizophrenia?
Research has shown that KarXT, the treatment under study in this trial, effectively treats schizophrenia. It addresses both positive symptoms, such as hallucinations, and negative symptoms, such as lack of motivation. Long-term use has been linked to positive outcomes, making it a promising option for managing schizophrenia. Known for its tolerability, KarXT causes fewer side effects than some other treatments. Due to its proven effectiveness and safety, KarXT is considered a strong choice for individuals with schizophrenia.26789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for men and women aged 18 to 65 with schizophrenia, as diagnosed by a psychiatric evaluation. They must have certain scores on mental health scales (PANSS ≤ 80, CGI-S ≤ 4), a BMI between ≥18 and ≤40 kg/m2, be willing to stop current antipsychotics before starting the study, and able to follow the study rules. People at risk of suicide or with recent substance abuse issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KarXT to evaluate its effect on voiding dynamics and urological safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KarXT
Trial Overview
The trial is testing KarXT (a combination of Xanomeline/trospium chloride) specifically looking at how it affects bladder control and safety in people with schizophrenia.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
KarXT for schizophrenia–effectiveness and value
Schizophrenia is a serious mental illness that affects about 3.9 million people in the United States and 24 million people worldwide.
Long-term treatment with KarXT was associated ...
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis ...
Efficacy of KarXT on negative symptoms in acute ...
Data were pooled from the three pivotal trials of KarXT monotherapy in people with schizophrenia with an acute exacerbation of psychosis. All 3 studies used ...
4.
bmcpsychiatry.biomedcentral.com
bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06696-5Does KarXT (xanomeline-trospium) represent a novel ...
Suicide in schizophrenia: an educational overview. Med (Kaunas). 2019;55. Sultzer DL. Psychosis and antipsychotic medications in Alzheimer's ...
Efficacy and Safety of Xanomeline-Trospium Chloride in ...
Conclusions and Relevance Xanomeline-trospium was efficacious and well tolerated in people with schizophrenia experiencing acute psychosis.
Cobenfy™ (xanomeline and trospium chloride) Safety Data
See 52-week safety data for COBENFY in adults with schizophrenia · Risk of Urinary Retention: · Risk of Use in Patients with Hepatic Impairment: · Risk of Use in ...
Safety and tolerability of KarXT (xanomeline–trospium) in a ...
Despite evidence of antipsychotic efficacy in patients with psychosis associated with dementia as well as schizophrenia, the earlier clinical ...
Efficacy and Safety of the Muscarinic Receptor Agonist ...
KarXT offers significant improvements in both negative and positive symptoms of schizophrenia with a manageable safety profile.
NCT03697252 | A Study to Assess Safety and Efficacy of ...
The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.
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