Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users

The Current Landscape of Cobenfy (KarXT): Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization

This study uses existing health records and insurance claims data to understand how adults in the United States are treated with KarXT, a medication for schizophrenia. It will describe who receives KarXT, how it is used in real-world practice, and how often healthcare services such as hospital visits are used. It will also explore information recorded by clinicians about schizophrenia symptoms

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: KarXT (xanomeline and trospium)

• Study Type: Observational
• Enrollment (Actual): 6876

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Veradigm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with schizophrenia in the United States with a prescription for KarXT identified in linked electronic health record and administrative claims data.

Description

Inclusion Criteria:

• Participants in the Veradigm EHR/claims-linked database with evidence of treatment with KarXT on or after September 24, 2024
• Earliest KarXT treatment date = index date
• Aged 18 years or older on index date

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults treated with KarXT; Adults aged ≥18 years in the United States with at least one prescription for KarXT on or after September 24, 2024 identified in linked electronic health record and claims data.	Drug: KarXT (xanomeline and trospium); As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of all-cause and schizophrenia-related healthcare encounters per participant	Number of inpatient admissions, emergency room visits, urgent care visits, and outpatient visits identified from claims and EHR data. Schizophrenia-related encounters are defined as those with a primary diagnosis of schizophrenia using ICD-10-CM codes.	Baseline and up to 6 months
Number of participants adherent to KarXT (proportion of days covered ≥80%)	Adherence measured using proportion of days covered (PDC), defined as total days of KarXT supply divided by total number of days in the follow-up period. Participants with PDC ≥80% are classified as adherent. Reported as number and percentage of participants meeting adherence criteria.	Baseline and up to 6 months
Time to discontinuation of KarXT	Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply.	Baseline and up to 6 months
KarXT initial dose (index dose)	Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack)	Baseline
Number of of participants with dose increases or decreases		Baseline and up to 6 months
Number of participants using concomitant antipsychotic and anticholinergic medications		Baseline and up to 6 months
Number of participants with comorbidities		Baseline and up to 6 months
Number of participants with gastrointestinal adverse events		Baseline and up to 6 months
Number of participants with documented schizophrenia symptoms	Presence of positive and negative schizophrenia symptoms identified using natural language processing (NLP) of unstructured clinical notes, including hallucinations, delusions, disorganized thought, amotivation, avolition, anhedonia, asociality, alogia, and blunted affect.	Baseline and up to 6 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Actual): March 25, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; KarXT; xanomeline; trospium
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; xanomeline; trospium chloride
• Other Study ID Numbers: CN012-0080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No