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Xanomeline Enteric Capsule
Xanomeline Enteric Capsule is a muscarinic receptor agonist Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Alzheimer's disease. Also known as: BMS-986519, KarX-EC.
Xanomeline is a muscarinic receptor agonist that targets the M1 and M4 subtypes.
Xanomeline Enteric Capsule is a small molecule that acts as a muscarinic acetylcholine receptor M4 agonist. It is being studied in clinical trials for the treatment of Alzheimer Disease, Psychiatric Disorders, Agitation, and as a placebo-controlled intervention in a Phase 3 study for the treatment of agitation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Xanomeline Enteric Capsule |
|---|---|
| Also known as | BMS-986519, KarX-EC |
| Sponsor | Bristol-Myers Squibb |
| Drug class | muscarinic receptor agonist |
| Target | M1, M4 |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
By activating these subtypes, xanomeline aims to improve cognitive function and potentially treat conditions such as Alzheimer's disease. However, its exact mechanism of action and therapeutic effects are still being investigated in clinical trials.
Approved indications
- Alzheimer's disease
Common side effects
- Nausea
- Headache
- Dizziness
Key clinical trials
- 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 Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) (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-2) (PHASE3)
- A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants (PHASE1)
- Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xanomeline Enteric Capsule CI brief — competitive landscape report
- Xanomeline Enteric Capsule updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Xanomeline Enteric Capsule
What is Xanomeline Enteric Capsule?
How does Xanomeline Enteric Capsule work?
What is Xanomeline Enteric Capsule used for?
Who makes Xanomeline Enteric Capsule?
Is Xanomeline Enteric Capsule also known as anything else?
What drug class is Xanomeline Enteric Capsule in?
What development phase is Xanomeline Enteric Capsule in?
What are the side effects of Xanomeline Enteric Capsule?
What does Xanomeline Enteric Capsule target?
Related
- Drug class: All muscarinic receptor agonist drugs
- Target: All drugs targeting M1, M4
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Alzheimer's disease
- Also known as: BMS-986519, KarX-EC
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing