Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Xanomeline and trospium chloride (KarXT), Xanomeline and trospium chloride
xanomeline · 10 trials · 2 indications
PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales: Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210. Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes. Baseline is defined as last non-missing assessment prior to the first dose of study drug.
PANSS Total Score is a clinician administered measure of schizophrenia symptom severity used widely in antipsychotic research. It includes 30 items across 3 subscales: * Positive Symptoms (7 items) assessing excesses or distortions such as hallucinations, delusions, or grandiosity * Negative Symptoms (7 items) assessing diminished function such as social withdrawal or reduced motivation and * General Psychopathology (16 items) capturing broader symptoms like anxiety, depression, guilt, or cognitive impairment Each item is scored from 1 (absent) to 7 (extreme), producing a PANSS Total Score ranging from 30 to 210, with higher scores indicating more severe symptoms. Baseline is defined as the last non missing PANSS Total Score before first dose. This endpoint evaluates change from Baseline to Week 6, with negative values indicating improvement.
TEAEs are defined as events with an onset date on or after the first dose of KarXT. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of participants with schizophrenia and is widely used in the study of antipsychotic therapy. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function such as hallucinations, delusions, grandiosity, and hostility, and the negative symptoms in schizophrenia are the diminution or loss of normal functions. PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. The PANSS Total Score is then the sum of the positive, negative, and general psychopathology symptom scores. Baseline is defined as the PANSS score at screening.
TEAEs are defined as events with an onset date on or after the first dose of KarXT. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
| Arm | Type | Description |
|---|---|---|
| KarXT | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Drug: KarXT | EXPERIMENTAL | - |
| Xanomeline plus placebo | ACTIVE_COMPARATOR | Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Placebo, TID |
| Xanomeline plus trospium | EXPERIMENTAL | Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Drug: Trospium chloride 20 mg BID, for a 40 mg total daily dose |
| Name | Type | Description |
|---|---|---|
| Xanomeline/Trospium Chloride | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
| Xanomeline and Trospium Chloride Capsules | DRUG | Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. |
| Placebo Capsules | DRUG | Placebo Capsules |
| xanomeline tartrate | DRUG | xanomeline tartrate, 75 mg capsule, TID |
| Trospium chloride | DRUG | trospium chloride, over encapsulated 20 mg tablet, BID |
Inclusion Criteria * Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at scre...
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.
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.
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.
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.
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.
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.