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Xanomeline/Trospium Chloride

Phase 3

Mania | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: May 27, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment424
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07140913A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or LamotriginePHASE3 RECRUITING 424 — — Oct 8, 2025Jun 28, 2027May 27, 2026105 United States, Argentina +11
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Study Endpoints
Primary Endpoints
Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
At Week 5
Secondary Endpoints
Change from baseline in Clinical Global Impressions Bipolar (CGI-BP) at Week 5
At Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 50% decrease from baseline in Young Mania Rating Scale (YMRS) score
At Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 1 change from baseline in CGI-BP
At Week 5
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KarXT + Lithium, Valproate, or LamotrigineEXPERIMENTAL -
Placebo + Lithium, Valproate, or LamotriginePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Xanomeline/Trospium ChlorideDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites105

Inclusion Criteria: * Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2. * Individual is experiencing an acute exacer...

Countries:United StatesArgentinaBulgariaChinaDenmarkFranceIndiaIsraelItalyJapanPolandRomaniaUkraine
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07140913lastUpdatePostDate: changed
LOWMay 28, 2026NCT07140913lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07140913primaryCompletionDate: changed
LOWMay 24, 2026NCT07140913studyFirstPostDate: changed