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Also known as Xanomeline and trospium chloride (KarXT)
Xanomeline and trospium chloride · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Xanomeline 50 mg and trospium chloride 20mg (KarXT) | EXPERIMENTAL | 5 weeks of xanomeline 50mg/trospium 20mg bid (low dose arm). |
| Xanomeline 100 mg and trospium chloride 20mg (KarXT) | EXPERIMENTAL | 5 weeks of xanomeline 100mg/trospium 20mg bid (middle dose arm). |
| Xanomeline 125 mg and trospium chloride 30mg (KarXT) | EXPERIMENTAL | 5 weeks of xanomeline 125mg/trospium 30mg bid (high dose arm). |
| Name | Type | Description |
|---|---|---|
| Xanomeline and trospium chloride (KarXT) | DRUG | Subjects will be randomized to 5 weeks of low, middle, or high dose of Xanomeline and trospium chloride, and will complete a PET scan with \[18\]F DOPA at the beginning and end of the treatment period. |
Inclusion Criteria: 1. Individuals aged 18 to 50, inclusive at screen 2. Capable of understanding the study procedures and able to provide informed consent 3. Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder 4. Antipsychotic free at Visit 1 (by choice and for reasons unre...
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.