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Xanomeline/Trospium Chloride

Phase 3

Alzheimer Disease | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Aug 26, 2026

Target and mechanism

ModalitySmall molecule

Also known as Xanomeline and trospium chloride (KarXT), Xanomeline and trospium chloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment426

FDA Designations

No designations recorded

Clinical trial landscape

Xanomeline/Trospium Chloride · 6 trials · 5 indications

Phase 3 3Phase 1 3
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 LamotrigineMania
RECRUITING424 Analytics
NCT07011745A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's DiseaseAlzheimer's Disease
RECRUITING426 Analytics
NCT07011732A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)Alzheimer Disease
RECRUITING426 Analytics
PHASE3RECRUITING
A 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 Lamotrigine
Mania
NCT07140913424
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PHASE3RECRUITING
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Alzheimer's Disease
NCT07011745426
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PHASE3RECRUITING
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
NCT07011732426
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Study Endpoints

Primary Endpoints

Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
At Week 5
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14
At Week 14
Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))
Up to Day 17
Maximum observed concentration (Cmax)
Up to Day 23
Time of maximum observed concentration (Tmax)
Up to Day 23
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Day 23
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 23
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Up to Day 23
Concentration at the end of a dosing interval (Ctau)
Up to Day 23
Apparent total body clearance (CLT/F)
Up to Day 23
Effective elimination half-life during dosing interval (T-HALF(eff))
Up to Day 23
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Up to 30 days after final dose of study intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to Day 14
Maximum observed plasma concentration (Cmax)
Up to day 54
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to day 54
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to day 54

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 -
KarXT + KarX-ECEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
KarXTEXPERIMENTAL -
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3aEXPERIMENTAL -
Part 3bEXPERIMENTAL -
Part 4aEXPERIMENTAL -
Part 4bEXPERIMENTAL -
Part AEXPERIMENTAL -
Part BEXPERIMENTAL -
Part CEXPERIMENTAL -
Part DEXPERIMENTAL -
Part EEXPERIMENTAL -
Part FEXPERIMENTAL -

Interventions

NameTypeDescription
Xanomeline/Trospium ChlorideDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
Xanomeline/Trospium Chloride CapsuleDRUGSpecified dose on specified days
Xanomeline Enteric CapsuleDRUGSpecified dose on specified days
Xanomeline/ Trospium ChlorideDRUGSpecified dose on specified days
Trospium ChlorideDRUGSpecified dose on specified days
Xanomeline MRDRUGSpecified dose on specified days
XanomelineDRUGSpecified dose on specified days
LithiumDRUGSpecified dose on specified days
Valproic AcidDRUGSpecified dose on specified days
LamotrigineDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites104

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 StatesArgentinaBulgariaChinaDenmarkFranceIndiaIsraelItalyJapanPolandRomaniaUkraineChileCzechiaGermanyHungaryPuerto RicoSouth KoreaUnited KingdomBrazilCanadaCroatiaGreeceMexicoPortugalSpainTaiwan
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Competitive Landscape -Alzheimer's Disease 66 trials (matched to "Alzheimer Disease")

Top 20 of 24 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC
Eli Lilly and CompanyLLY12PHASE3Donanemab, Dexamethasone
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Merck & Co., Inc.MRK1PHASE2MK-2214
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, Inc.IGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Denali Therapeutics Inc.DNLI1PHASE1DNL628
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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Recent Changes (Last 90 Days)

LOWAug 26, 2026NCT07011745lastUpdatePostDate: changed
LOWAug 26, 2026NCT07011745lastUpdatePostDate: changed
MEDIUMAug 17, 2026NCT07063342Enrollment: 72 → 236
MEDIUMAug 17, 2026NCT07063342Enrollment: 72 → 236
LOWAug 11, 2026NCT07011732lastUpdatePostDate: changed
LOWAug 11, 2026NCT07011732lastUpdatePostDate: changed
LOWJul 29, 2026NCT07011745Enrollment: 352 → 426
LOWJul 29, 2026NCT07011745Enrollment: 352 → 426
LOWJul 13, 2026NCT07011732lastUpdatePostDate: changed
LOWJul 13, 2026NCT07011732lastUpdatePostDate: changed
MEDIUMJul 9, 2026NCT07063342primaryCompletionDate: changed
MEDIUMJul 9, 2026NCT07063342primaryCompletionDate: changed
LOWJun 30, 2026NCT07011732Enrollment: 352 → 426
LOWJun 30, 2026NCT07011732Enrollment: 352 → 426
LOWJun 30, 2026NCT07011732Enrollment: 352 → 426
LOWJun 25, 2026NCT07011745lastUpdatePostDate: changed
LOWJun 25, 2026NCT07011745lastUpdatePostDate: changed
LOWJun 25, 2026NCT07011745lastUpdatePostDate: changed
LOWJun 23, 2026NCT07140913lastUpdatePostDate: changed
LOWJun 23, 2026NCT07140913lastUpdatePostDate: changed

Frequently asked questions about Xanomeline/Trospium Chloride

What is Xanomeline and trospium chloride used for?

Xanomeline and trospium chloride, also known as KarXT, is an investigational small molecule being studied for schizophrenia, Alzheimer's disease, and mania associated with bipolar I disorder. It is also used in clinical trials involving healthy volunteers to evaluate drug interactions and formulations.

What does Xanomeline and trospium chloride target?

Xanomeline and trospium chloride is a combination of xanomeline, a muscarinic acetylcholine receptor agonist, and trospium chloride, a muscarinic receptor antagonist. The combination is designed to target muscarinic receptors in the brain while limiting peripheral side effects.

Who makes Xanomeline and trospium chloride?

Xanomeline and trospium chloride is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials across multiple indications including schizophrenia, Alzheimer's disease, and bipolar disorder.

What phase is Xanomeline and trospium chloride in?

Xanomeline and trospium chloride is in Phase 1 clinical development for healthy volunteer studies and Phase 3 clinical development for Alzheimer's disease and mania associated with bipolar I disorder. It is investigational and not yet approved by the FDA.

What clinical trials is Xanomeline and trospium chloride in?

Xanomeline and trospium chloride is being studied in several trials including NCT06729970, a Phase 1 drug interaction study in healthy volunteers; NCT07011732, a Phase 3 study for agitation in Alzheimer's disease; NCT07063342, a Phase 1 formulation study; and NCT07140913, a Phase 3 study for mania in bipolar I disorder.

Is Xanomeline and trospium chloride the same as KarXT?

Yes, Xanomeline and trospium chloride is also known as KarXT, as well as xanomeline/trospium and xanomeline/trospium chloride. These names refer to the same investigational drug combination being developed by Bristol-Myers Squibb.