Last reviewed · How we verify
XANOMELINE
Xanomeline works by binding to the 5-hydroxytryptamine receptor 1D, which is involved in various physiological processes.
Xanomeline is a small molecule modality targeting the 5-hydroxytryptamine receptor 1D. Its mechanism and commercial status are not well-documented, and it does not appear to be FDA-approved. As a result, there is limited information available on its approved indications, half-life, bioavailability, generic manufacturers, or off-patent status. Further research is needed to fully understand this compound. It is unclear if it is patented or available as a generic.
At a glance
| Generic name | XANOMELINE |
|---|---|
| Target | 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 1A |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Think of it like a key fitting into a lock. Xanomeline is the key that binds to the 5-hydroxytryptamine receptor 1D, which is like a lock on a cell. This binding can affect how the cell responds to signals, which can help treat certain conditions.
Approved indications
Common side effects
- Nausea
- Dyspepsia
- Constipation
- Vomiting
- Hypertension
- Abdominal Pain
- Diarrhea
- Tachycardia
- Dizziness
- Gastroesophageal Reflux Disease
- Dry Mouth
- Somnolence
Serious adverse events
- Liver Enzyme Elevations (ALT/AST ≥3x ULN)
- Study Discontinuation due to Adverse Reactions
Key clinical trials
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1) (PHASE3)
- 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) (PHASE3)
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) (PHASE3)
- Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (PHASE3)
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) (PHASE3)
- A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |