KarXT for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of the new drug KarXT for individuals with schizophrenia. The focus is on determining the appropriate doses and understanding the drug's behavior in the body when administered as an injection. It is suitable for those who have lived with schizophrenia for a while and are willing to discontinue other antipsychotic medications. Participants should not have any recent mental health diagnoses or substance abuse issues. The goal is to determine if KarXT can reliably manage schizophrenia symptoms. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
Yes, you will need to stop taking all antipsychotic medications before the study begins.
Is there any evidence suggesting that KarXT is likely to be safe for humans?
Research has shown that KarXT, a combination of two medications, is generally well-tolerated by people with schizophrenia. Studies have found that it improves both the negative and positive symptoms of the condition while keeping safety concerns manageable. In earlier research, patients experienced improvements without major side effects. This suggests that KarXT might be safe for people, but monitoring for any side effects remains important. As always, joining a clinical trial should involve consulting healthcare professionals to fully understand the possible risks and benefits.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about KarXT for schizophrenia because it offers a novel approach to treatment through its mechanism of action. Unlike standard treatments like antipsychotics, which primarily target dopamine receptors, KarXT focuses on muscarinic receptors in the brain. This unique targeting could potentially reduce common side effects like weight gain and movement disorders associated with current medications. Additionally, KarXT combines xanomeline and trospium, which may enhance its effectiveness and safety profile, providing new hope for patients seeking alternatives to traditional therapies.
What evidence suggests that KarXT might be an effective treatment for Schizophrenia?
Research has shown that KarXT, the treatment under study in this trial, is a promising option for schizophrenia. Studies have found that this new drug can help reduce symptoms during severe episodes of psychosis. KarXT is particularly effective in treating negative symptoms, which are usually hard to manage. This treatment combines two ingredients, xanomeline and trospium, and targets specific parts of the brain linked to schizophrenia. Long-term research suggests that KarXT is well tolerated, making it a potentially safe option for patients.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 individuals with schizophrenia. Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for schizophrenia and be stable enough to participate in a clinical study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular injection of KarXT to evaluate dose levels, safety, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KarXT
Trial Overview
The study is testing KarXT, an intramuscular injection, to determine the appropriate dose levels and assess its safety profile as well as how the drug behaves inside the body (pharmacokinetics) of 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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