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Xanomeline/trospium

Phase 3

Schizophrenia; Psychosis | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: May 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment171
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07084831A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With SchizophreniaPHASE3 NOT YET_RECRUITING 171Jan 1, 2027Jul 1, 2029May 13, 202616 Austria, Belgium +8
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Study Endpoints
Primary Endpoints
Change in cognitive performance after 24 weeks of treatment, relative to baseline.
24 weeks

The within-participant change in the Brief Assessment of Cognition in Schizophrenia composite cognitive score from baseline to follow-up after 24 weeks. Higher score means better cognition. There is no max score, as the tests have different scoring methods (number correct, reaction time).

Secondary Endpoints
Change in negative symptoms after 24 weeks of treatment, relative to baseline.
24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Xanomeline/trospiumEXPERIMENTALXanomeline/trospium that is provided to all participants
Interventions
NameTypeDescription
Xanomeline/trospiumDRUGParticipants will receive oral xanomeline/trospium during the trial (target dose 125/30 BID).
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria: 1. Be between 18 and 55 years of age. 2. Be willing and able to provide informed consent, after the nature of the study has been fully explained. This includes being able to understand the locally approved informed consent (and information letter) in the local language. 3. Have ...

Countries:AustriaBelgiumCzechiaDenmarkGermanyHungaryIsraelItalyNetherlandsSpain
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07084831studyFirstPostDate: changed