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Xanomeline and trospium chloride

Phase 1

SCHIZOPHRENIA 1 (Disorder) | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07423546A PET/MRI Study of Cobenfy on Dopamine Transmission in SchizophreniaPHASE1 NOT YET_RECRUITING 12Jul 1, 2026Dec 31, 2027Apr 13, 20261 United States
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Study Endpoints
Primary Endpoints
[18F]DOPA Kicer ([18F]DOPA relative uptake rate)
Pre/post 5 weeks of Xanomeline and trospium chloride (KarXT)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Xanomeline 50 mg and trospium chloride 20mg (KarXT)EXPERIMENTAL5 weeks of xanomeline 50mg/trospium 20mg bid (low dose arm).
Xanomeline 100 mg and trospium chloride 20mg (KarXT)EXPERIMENTAL5 weeks of xanomeline 100mg/trospium 20mg bid (middle dose arm).
Xanomeline 125 mg and trospium chloride 30mg (KarXT)EXPERIMENTAL5 weeks of xanomeline 125mg/trospium 30mg bid (high dose arm).
Interventions
NameTypeDescription
Xanomeline and trospium chloride (KarXT)DRUGSubjects will be randomized to 5 weeks of low, middle, or high dose of Xanomeline and trospium chloride, and will complete a PET scan with \[18\]F DOPA at the beginning and end of the treatment period.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Individuals aged 18 to 50, inclusive at screen 2. Capable of understanding the study procedures and able to provide informed consent 3. Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder 4. Antipsychotic free at Visit 1 (by choice and for reasons unre...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07423546studyFirstPostDate: changed