Long-Term Real-World Safety of Cobenfy in Adults With Schizophrenia

NCT07783373 | Active Not Recruiting FDA Drug

• 1 other identifier: CN012-0062
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the long-term real-world safety of xanomeline-trospium chloride in adults with schizophrenia receiving routine clinical care in the United States.

Conditions

Schizophrenia

Keywords

Schizophrenia; Xanomeline-trospium chloride

Outcome Measures

Primary Outcomes (1)

• Number of participants with incident urinary retention

  Up to 3-years

Secondary Outcomes (5)

• Number of participants with incident biliary disorders

  Up to 3-years

• Number of participants with incident sinus tachycardia

  Up to 3-years

• Number of participants with incident syncope resulting from orthostatic hypotension

  Up to 3-years

• Number of participants with incident hypertension

  Up to 3-years

• Number of participants with incident liver injury

  Up to 3-years

Study Arms (2)

Xanomeline-trospium chloride

Participants who initiate xanomeline-trospium chloride treatment

Drug: xanomeline-trospium chloride

Comparator Oral Antipsychotics

Participants who initiate first-generation or second-generation oral antipsychotics

Drug: Oral antipsychotics

Interventions

xanomeline-trospium chloride DRUG

As per product label

Xanomeline-trospium chloride

Oral antipsychotics DRUG

As per product label

Comparator Oral Antipsychotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adults in the United States with schizophrenia who initiate xanomeline-trospium chloride or comparator oral antipsychotics between 27 September 2024 and 26 September 2027.

You may qualify if:

• Age ≥18 years at the index date.
• Either:
• ≥1 inpatient/emergency room claim with a primary diagnosis of schizophrenia; or
• ≥2 office visit claims with a diagnosis of schizophrenia; or
• ≥2 qualifying claims with a diagnosis of schizophrenia plus qualifying psychiatric Current Procedural Terminology (CPT) services.
• ≥1 prescription dispensation claim for xanomeline-trospium chloride or a comparator oral antipsychotic during the study period.
• Continuous medical and pharmacy coverage during the 183 days before and including the index date.
• No prescription claims for xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period.
• Primary objective: earliest eligible treatment episode included once per participant.

You may not qualify if:

• Prior exposure to xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period.
• Age \<18 years.
• Primary outcome: urinary retention during the baseline period or on the index date.
• Secondary outcome: occurrence of sinus tachycardia, syncope resulting from orthostatic hypotension, hypertension, or liver injury during the baseline period or on the index date.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Suwanee, Georgia, 30024, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Schizophrenia

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): April 26, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)