Recent Updates
Recently added Catalysts

Xanomeline/trospium

Phase 3

Schizophrenia; Psychosis | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: May 13, 2026

Target and mechanism

ModalitySmall molecule

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment171

FDA Designations

No designations recorded

Clinical trial landscape

Xanomeline/trospium · 1 trial · 2 indications

Phase 3 1
NCT07084831A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With SchizophreniaSchizophrenia; Psychosis
NOT YET_RECRUITING171 Analytics
PHASE3NOT YET_RECRUITING
A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
Schizophrenia; PsychosisUnlock trial analytics

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
Unlock Study Endpoints

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).
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about Xanomeline/trospium

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.