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Can a new schizophrenia drug stay safe over the long haul?

NCT ID NCT07783373

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study tracks the long-term safety of Cobenfy (xanomeline-trospium chloride) in 3,000 adults with schizophrenia receiving routine care in the U.S. Researchers will monitor for side effects like urinary retention, liver problems, and heart rhythm changes, comparing Cobenfy users to those on other oral antipsychotics. The goal is to see if this newer medication remains safe when used in everyday clinical practice over an extended period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
xanomeline-trospium chloride (Cobenfy), an oral medication for schizophrenia
What this could lead to
If the safety profile holds up, it could support Cobenfy as a long-term treatment option for schizophrenia, offering an alternative to current antipsychotics.
What could go wrong
This is an observational study, not a controlled trial, so it can't prove cause and effect. Side effects like urinary retention or liver issues may still emerge, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years at the index date. * Either: 1. ≥1 inpatient/emergency room claim with a primary diagnosis of schizophrenia; or 2. ≥2 office visit claims with a diagnosis of schizophrenia; or 3. ≥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. * Secondary objectives: eligible participants may be selected more than once for inclusion in the study. The treatment episode closest to the start of the study period that is eligible for inclusion will be selected as the first treatment episode for each individual. If an individual switches treatment group during the follow-up period, then this will result in another treatment episode for that individual. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Local Institution - 0001

    Suwanee, Georgia, 30024, United States

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