Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KarXT, BMS-986510
Xanomeline and trospium chloride · 19 trials · 12 indications
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.
Open-label extension (OLE) Part
Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Number of participants with TEAEs leading to treatment discontinuation.
The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.
Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
The number and percentage of participants with TEAEs will be determined
| Arm | Type | Description |
|---|---|---|
| KarXT + KarX-EC Arm | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Administration of KarXT for Schizophrenia | EXPERIMENTAL | - |
| Administration of KarXT + KarX-EC for Autism Spectrum Disorder | EXPERIMENTAL | - |
| KarXT | EXPERIMENTAL | - |
| KarXT+KarX-EC | EXPERIMENTAL | - |
| KarXT + KarX-EC | ACTIVE_COMPARATOR | - |
| KarXT or Adjuvant KarXT | EXPERIMENTAL | - |
| Administration of KarXT | ACTIVE_COMPARATOR | - |
| KarXT on empty stomach and with food | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| KarXT | DRUG | Specified dose on specified days |
| KarX-EC | DRUG | Specified dose on specified days |
| KarXT + KarX-EC Matching Placebo | DRUG | Specified dose on specified days |
| KarXT + KarX-EC Arm Matching Placebo | DRUG | Specified dose on specified days |
| KarXT Matching Placebo | OTHER | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
| Lithium | DRUG | Therapeutic dose |
| Valproate | DRUG | Therapeutic dose |
| Lamotrigine | DRUG | Therapeutic dose |
Inclusion Criteria * Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability. * Participants must have...
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Xanomeline and trospium chloride is an investigational small molecule combination therapy being developed for psychiatric and neurological disorders. It pairs xanomeline, a muscarinic receptor agonist, with trospium chloride. Bristol-Myers Squibb Company (BMY) is developing it, and it is also known as KarXT. It is currently in Phase 3 clinical development.
Xanomeline and trospium chloride is being studied for schizophrenia, irritability associated with autism spectrum disorder, bipolar disorder type I with mania or mania with mixed features, and other psychiatric disorders. It is investigational and has not been established as a treatment for any of these conditions. Clinical development is focused on psychiatric and neurological indications.
Xanomeline and trospium chloride targets the muscarinic acetylcholine receptors CHRM1 and CHRM4 as an agonist. Xanomeline provides the muscarinic agonist activity, while trospium chloride is included to limit peripheral muscarinic effects. This dual-component approach is designed to engage central muscarinic receptors in psychiatric disorders.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is developing xanomeline and trospium chloride. The asset is also known as KarXT. Bristol-Myers Squibb is the sponsor of the ongoing Phase 3 clinical program evaluating the combination in psychiatric and neurological indications.
Xanomeline and trospium chloride is in Phase 3 clinical development. It is an investigational therapy and is not approved by the FDA. The Phase 3 program includes five trials, with one completed and five active, enrolling a total of 2,553 participants across randomized, double-blind, placebo-controlled designs.
Xanomeline and trospium chloride is being studied in Phase 3 trials including NCT07424404, a long-term safety study in children and adolescents with psychiatric disorders; NCT07288567 (EMERGENT TEEN) in adolescents with schizophrenia; and NCT07285798 and NCT07284745, both evaluating KarXT plus KarX-EC for irritability associated with autism spectrum disorder.