drug
as of 2026-07-01Xanomeline-trospium (Cobenfy)
Xanomeline and trospium chloride (KarXT)KarXT (xanomeline and trospium)Xanomeline and Trospium Chloride CapsulesKarXTxanomeline tartrateTrospium chloridexanomeline and trospium chloride (X/T) therapyXanomeline and Trospium Chloride
UNII 1E6682427ERxCUI 2694828FDA_ApplNo NDA216158SPL_set_id 8f0e73bf-6025-44f6-ab64-0983322de0dfFDA_sponsor BRISTOL-MYERSOrangeBook_Appl A091289, A091513, A091573, A091575, A091635, A091688, A201291, A204945
at a glance
small molecule · Cholinergic Muscarinic Agonist [EPC]
US-approved (2024) as Cobenfy
Orange Book protection to 2039
25 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Cholinergic Muscarinic Agonist [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of xanomeline in the treatment of schizophrenia is unclear; however, its efficacy is thought to be due to its agonist activity at M1 and M4 muscarinic acetylcholine receptors in the central nervous system. Trospium chloride is a muscarinic antagonist. Trospium chloride antagonizes the muscarinic receptors primarily in the peripheral tissues.
RxCUI
2694828
Combination
trospium / xanomeline
Indications
Labeled
Schizophrenia
Investigational (via trials)
Patents & exclusivity
Orange Book
patent 125583172039-10-29
patent 11471413 · U-35132039-09-27
patent 11452692 · U-35132039-09-27
patent 10933020 · U-35132039-09-27
patent 11890378 · U-35132039-09-27
patent 109258322039-09-27
patent 10369143 · U-35132030-07-21
patent 10265311 · U-35132030-07-21
patent 102386432030-07-21
patent 10695339 · U-35132030-07-21
patent 10369144 · U-35132030-07-21
exclusivity NCE2029-09-26
Adverse-event signal
FAERS spontaneous · within-drug share
Gi24.4%
top term: NAUSEA
Anticholinergic14.8%
top term: CONSTIPATION
Sedation3.4%
top term: SOMNOLENCE
Eps Akathisia2.4%
top term: TREMOR
Qt Cardiac1.3%
top term: TACHYCARDIA
Mortality0.6%
top term: DEATH
Weight Metabolic0.4%
top term: WEIGHT INCREASED
Spontaneous reports — a signal of reporting share, not incidence.
Regulatory history
Drugs@FDA submissions
Type 1 - New Molecular EntityNDA216158 s1STANDARD
2024-09-26Trials
25
A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively
NCT07424404Phase 3Recruiting
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
NCT07288567Phase 3Recruiting
Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
NCT07101094—Recruiting
A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
NCT07084831Phase 3Not Yet Recruiting
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
NCT06882785Phase 3Recruiting
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
NCT07379827—Recruiting
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
NCT06947941Phase 3Recruiting
A Study to Evaluate the Effect of KarXT on Urological Safety
NCT07221877Phase 4Recruiting
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
NCT07061288Phase 1Recruiting
A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia
NCT07423546Phase 1, Phase 2Not Yet Recruiting
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
NCT06585787Phase 3Recruiting
An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients
NCT06923891Phase 4Not Yet Recruiting
Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users
NCT07571148—Active Not Recruiting
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05304767Phase 3Recruiting
An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia
NCT06924255Phase 4Not Yet Recruiting
A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05145413Phase 3Completed
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
NCT06572449Phase 3Completed
A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia
NCT05919823Phase 3Completed
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
NCT04820309Phase 3Completed
An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
NCT04659174Phase 3Completed
An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia
NCT05643170Phase 3Terminated
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)
NCT04738123Phase 3Completed
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
NCT04659161Phase 3Completed
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
NCT03697252Phase 2Completed
KOLs & investigators
5
Publications & congress
30
Long-term efficacy, safety, and tolerability of xanomeline and trospium chloride in schizophrenia: A 52-week, open-label trial (EMERGENT-5).
Schizophrenia research · 2026 · high-value
Efficacy and safety of the muscarinic receptor agonist KarXT (Xanomeline-Trospium) in schizophrenia: a systematic review, meta-analysis and Bayesian sensitivity analysis.
The international journal of neuropsychopharmacology · 2026 · high-value
Comparative efficacy and tolerability of antidopaminergic and muscarinic antipsychotics for acute schizophrenia: a network meta-analysis of randomised controlled trials indexed in international English and Chinese databases.
Lancet (London, England) · 2026 · high-value
Long-Term Safety and Efficacy of Xanomeline and Trospium Chloride in Schizophrenia: A 52-Week Open-Label Extension Trial.
The American journal of psychiatry · 2026 · high-value
Efficacy of xanomeline and xanomeline trospium in the treatment of cognitive impairment: A systematic review of preclinical and clinical trials.
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2026 · high-value
Impact of selected second and third generation antipsychotics on cognitive dysfunction in schizophrenia-spectrum disorders. Systematic review and network meta-analysis.
International clinical psychopharmacology · 2026 · high-value
Efficacy and safety of xanomeline-trospium chloride in schizophrenia: A systematic review and meta-analysis.
Journal of psychiatric research · 2025 · high-value
Novel pharmaceutical treatment approaches for schizophrenia: a systematic literature review.
European journal of clinical pharmacology · 2025 · high-value
Xanomeline and Trospium Chloride for the Treatment of Agitation Associated With Schizophrenia: PANSS-Excited Component Results From 3 Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials.
The Journal of clinical psychiatry · 2025 · high-value
Xanomeline-Trospium for Adults with Schizophrenia Experiencing Acute Psychosis: A Systematic Review and Meta-analysis of Safety and Tolerability Outcomes.
Pharmacopsychiatry · 2025 · high-value
Does KarXT (xanomeline-trospium) represent a novel approach to schizophrenia management? A GRADE-assessed systematic review and meta-analysis of randomized controlled clinical trials.
BMC psychiatry · 2025 · high-value
Is muscarinic receptor agonist effective and tolerant for schizophrenia?
BMC psychiatry · 2025 · high-value
Efficacy, tolerability, and safety of xanomeline-trospium chloride for schizophrenia: A systematic review and meta-analysis.
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2025 · high-value
The Impact of Xanomeline and Trospium Chloride on Cognitive Impairment in Acute Schizophrenia: Replication in Pooled Data From Two Phase 3 Trials.
The American journal of psychiatry · 2025 · high-value
Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From the 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials.
The Journal of clinical psychiatry · 2025 · high-value
Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments.
Pharmacopsychiatry · 2024 · high-value
Facts & assertions
27 sourced
Anda Generic Count
12
Available Strengths
trospium chloride 20 MG / xanomeline 50 MG Oral Capsule, trospium chloride 30 MG / xanomeline 125 MG Oral Capsule, trospium chloride 20 MG / xanomeline 100 MG Oral Capsule
Dose Forms
Oral Capsule
Dosing Frequency
twice daily
Faers Share Anticholinergic
0.148
Faers Share Eps Akathisia
0.024
Faers Share Gi
0.244
Faers Share Mortality
0.006
Faers Share Qt Cardiac
0.013
Faers Share Sedation
0.034
Faers Share Weight Metabolic
0.004
Fda Pharm Class Epc
Cholinergic Muscarinic Agonist [EPC]
Fda Pharm Class Moa
Cholinergic Muscarinic Agonists [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]
Has Generic Competition
yes
Is Combination Product
trospium / xanomeline
Label Expansions ApprovedXanomeline-trospium (Cobenfy): 0 approved efficacy label-expansion supplements since launch on NDA216158. Higher count = more aggressive addressable-market broadening (competitive-threat velocity signal).
0
Latest Exclusivity Expiry
2029-09-26
Latest Patent Expiry
2039-10-29
Latest Protection Date
2039-10-29
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of xanomeline in the treatment of schizophrenia is unclear; however, its efficacy is thought to be due to its agonist activity at M1 and M4 muscarinic acetylcholine receptors in the central nervous system. Trospium chloride is a muscarinic antagonist.
Originator Company
Bristol-Myers
Precise Ingredient
xanomeline tartrate
Rxcui
2694828
Safety Eps Akathisia
present in label
Safety Sedation Somnolence
present in label
Us Approved
yes
Us Original Approval Date
2024-09-26
relationships
The graph out of here
developer
trial
indication
KOL
Stephen Brannan, MD
personKOL score 39
Inder Kaul, MD
personKOL score 30
Joshua T Kantrowitz, MD
personKOL score 16
Lukasz Biernat, PhD
personKOL score —