{"id":"xanomeline","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"5-hydroxytryptamine receptor 1D","category":"target"},{"label":"HTR1D","category":"gene"},{"label":"CHRM3","category":"gene"},{"label":"HTR2B","category":"gene"},{"label":"Active","category":"status"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Agonists","category":"pharmacology"},{"label":"Muscarinic Agonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympathomimetics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Nausea","drugRate":"19%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"18%","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"17%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Hypertension","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Abdominal Pain","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Tachycardia","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Gastroesophageal Reflux Disease","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Dry Mouth","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Somnolence","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Vision Blurred","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Salivary Hypersecretion","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Orthostatic Hypotension","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Extrapyramidal Symptoms (non-akathisia)","drugRate":"2%","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Liver Enzyme Elevations (ALT/AST ≥3x ULN)","drugRate":"2.8%","severity":"serious"},{"effect":"Study Discontinuation due to Adverse Reactions","drugRate":"6%","severity":"serious"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":["xanomeline","LY246708","xanomeline tartrate","LY-246708","cobenfy"],"offLabel":[],"synonyms":["xanomeline","LY246708","xanomeline tartrate","LY-246708"],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"target":"5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 1A","targets":[{"gene":"HTR1D","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1D","protein":"5-hydroxytryptamine receptor 1D"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"HTR2C","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2C","protein":"5-hydroxytryptamine receptor 2C"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"HTR1B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1B","protein":"5-hydroxytryptamine receptor 1B"},{"gene":"HTR1A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1A","protein":"5-hydroxytryptamine receptor 1A"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"}],"modality":"Small Molecule","explanation":"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.","oneSentence":"Xanomeline works by binding to the 5-hydroxytryptamine receptor 1D, which is involved in various physiological processes.","technicalDetail":"Xanomeline acts as a selective agonist at the 5-hydroxytryptamine receptor 1D, modulating downstream signaling pathways involved in mood regulation and other physiological processes."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3652","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=XANOMELINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=XANOMELINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T16:10:08.499175","biosimilars":[],"competitors":[{"drugName":"amifostine","drugSlug":"amifostine","fdaApproval":"1995-12-08","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"amiodarone","drugSlug":"amiodarone","fdaApproval":"1985-12-24","patentExpiry":"Mar 13, 2029","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amisulpride","drugSlug":"amisulpride","fdaApproval":"2020-02-26","patentExpiry":"Mar 10, 2031","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amitriptyline","drugSlug":"amitriptyline","fdaApproval":"1961-04-07","genericCount":33,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"amoxapine","drugSlug":"amoxapine","fdaApproval":"1980-09-22","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"apomorphine","drugSlug":"apomorphine","fdaApproval":"2004-04-20","patentExpiry":"Jun 11, 2030","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"aripiprazole","drugSlug":"aripiprazole","fdaApproval":"2002-11-15","patentExpiry":"Sep 24, 2033","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"aripiprazole lauroxil","drugSlug":"aripiprazole-lauroxil","fdaApproval":"2015-10-05","patentExpiry":"Sep 8, 2035","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"armodafinil","drugSlug":"armodafinil","fdaApproval":"2007-06-05","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"asenapine","drugSlug":"asenapine","fdaApproval":"2009-08-13","patentExpiry":"Sep 22, 2033","patentStatus":"Patent protected","relationship":"same-target"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"xanomeline","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"amifostine","brandName":"amifostine","genericName":"amifostine","approvalYear":"1995","relationship":"same-target"},{"drugId":"amiodarone","brandName":"amiodarone","genericName":"amiodarone","approvalYear":"1985","relationship":"same-target"},{"drugId":"amisulpride","brandName":"amisulpride","genericName":"amisulpride","approvalYear":"2020","relationship":"same-target"},{"drugId":"amitriptyline","brandName":"amitriptyline","genericName":"amitriptyline","approvalYear":"1961","relationship":"same-target"},{"drugId":"amoxapine","brandName":"amoxapine","genericName":"amoxapine","approvalYear":"1980","relationship":"same-target"},{"drugId":"apomorphine","brandName":"apomorphine","genericName":"apomorphine","approvalYear":"2004","relationship":"same-target"},{"drugId":"aripiprazole","brandName":"aripiprazole","genericName":"aripiprazole","approvalYear":"2002","relationship":"same-target"},{"drugId":"aripiprazole-lauroxil","brandName":"aripiprazole lauroxil","genericName":"aripiprazole lauroxil","approvalYear":"2015","relationship":"same-target"},{"drugId":"armodafinil","brandName":"armodafinil","genericName":"armodafinil","approvalYear":"2007","relationship":"same-target"},{"drugId":"asenapine","brandName":"asenapine","genericName":"asenapine","approvalYear":"2009","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT05511363","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)","status":"RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2022-08-23","conditions":["Psychosis Associated With Alzheimer's Disease"],"enrollment":410,"completionDate":"2026-10-05"},{"nctId":"NCT07011732","phase":"PHASE3","title":"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)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-07-10","conditions":["Alzheimer Disease"],"enrollment":352,"completionDate":"2028-12-08"},{"nctId":"NCT06126224","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2023-08-28","conditions":["Psychosis Associated With Alzheimer's Disease"],"enrollment":500,"completionDate":"2026-12-09"},{"nctId":"NCT05980949","phase":"PHASE3","title":"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)","status":"RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2023-07-11","conditions":["Psychosis Associated With Alzheimer's Disease"],"enrollment":800,"completionDate":"2027-09-07"},{"nctId":"NCT06951711","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-06-13","conditions":["Bipolar Disorder Type I With Mania or Mania With Mixed Features"],"enrollment":274,"completionDate":"2026-11-02"},{"nctId":"NCT06951698","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-06-11","conditions":["Bipolar-I Disorder With Mania or Mania With Mixed Features"],"enrollment":274,"completionDate":"2026-11-01"},{"nctId":"NCT06929273","phase":"PHASE3","title":"A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-07-18","conditions":["Bipolar Disorder Type I With Mania"],"enrollment":450,"completionDate":"2028-06-13"},{"nctId":"NCT06937229","phase":"PHASE3","title":"A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-12-02","conditions":["Alzheimer Disease","Agitation"],"enrollment":600,"completionDate":"2029-07-20"},{"nctId":"NCT07101094","phase":"","title":"Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-09-22","conditions":["Schizophrenia"],"enrollment":300,"completionDate":"2029-05-14"},{"nctId":"NCT07221877","phase":"PHASE4","title":"A Study to Evaluate the Effect of KarXT on Urological Safety","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2026-01-20","conditions":["Schizophrenia"],"enrollment":60,"completionDate":"2027-12-30"},{"nctId":"NCT05304767","phase":"PHASE3","title":"An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia","status":"RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2022-03-07","conditions":["Schizophrenia"],"enrollment":280,"completionDate":"2026-03-19"},{"nctId":"NCT07379827","phase":"","title":"Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2026-02-26","conditions":["Schizophrenia"],"enrollment":1500,"completionDate":"2028-06-20"},{"nctId":"NCT07011745","phase":"PHASE3","title":"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)","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-07-16","conditions":["Alzheimer Disease"],"enrollment":352,"completionDate":"2028-11-13"},{"nctId":"NCT07084831","phase":"PHASE3","title":"A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia","status":"RECRUITING","sponsor":"European Group for Research In Schizophrenia","startDate":"2026-01-14","conditions":["Schizophrenia; Psychosis","Cognitive Impairment"],"enrollment":171,"completionDate":"2028-07-01"},{"nctId":"NCT07118215","phase":"PHASE1","title":"A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin","status":"RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2025-09-29","conditions":["Healthy Volunteers"],"enrollment":60,"completionDate":"2026-04-05"},{"nctId":"NCT06729970","phase":"PHASE1","title":"A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2024-12-26","conditions":["Healthy Volunteers"],"enrollment":133,"completionDate":"2026-01-23"},{"nctId":"NCT07140913","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-10-08","conditions":["Mania","Bipolar Disorder"],"enrollment":424,"completionDate":"2027-06-28"},{"nctId":"NCT07423546","phase":"PHASE1,PHASE2","title":"A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia","status":"NOT_YET_RECRUITING","sponsor":"New York State Psychiatric Institute","startDate":"2026-04-01","conditions":["SCHIZOPHRENIA 1 (Disorder)","Schizoaffecitve Disorder"],"enrollment":12,"completionDate":"2027-12-31"},{"nctId":"NCT07204418","phase":"PHASE1","title":"A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants","status":"RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2025-10-13","conditions":["Healthy Volunteers"],"enrollment":56,"completionDate":"2026-12-03"},{"nctId":"NCT07257120","phase":"PHASE4","title":"KarXT Concentrations in the Breast Milk and Plasma of Lactating Females","status":"RECRUITING","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2026-01-09","conditions":["Healthy Volunteers"],"enrollment":8,"completionDate":"2027-11-30"},{"nctId":"NCT07284745","phase":"PHASE3","title":"A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism","status":"NOT_YET_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2026-02-27","conditions":["Irritability Associated With Autism Spectrum Disorder"],"enrollment":176,"completionDate":"2029-07-05"},{"nctId":"NCT07285798","phase":"PHASE3","title":"A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder","status":"NOT_YET_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2026-02-27","conditions":["Irritability Associated With Autism Spectrum Disorder"],"enrollment":176,"completionDate":"2029-08-04"},{"nctId":"NCT07063342","phase":"PHASE1","title":"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","status":"RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-06-27","conditions":["Healthy Volunteers"],"enrollment":72,"completionDate":"2026-08-15"},{"nctId":"NCT05919823","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2023-05-29","conditions":["Schizophrenia"],"enrollment":202,"completionDate":"2024-12-09"},{"nctId":"NCT07212062","phase":"PHASE2","title":"The Purpose of This Study is to Evaluate the Safety and Tolerability of X/T+X-EC in Participants With Alzheimer's Disease Who Are Currently Treated With Lecanemab.","status":"NOT_YET_RECRUITING","sponsor":"Neurology Office of South Florida","startDate":"2025-12-01","conditions":["Alzheimers Disease"],"enrollment":60,"completionDate":"2028-12-30"},{"nctId":"NCT04820309","phase":"PHASE3","title":"An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2021-06-02","conditions":["Schizophrenia"],"enrollment":566,"completionDate":"2024-05-24"},{"nctId":"NCT06853171","phase":"PHASE1","title":"Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2025-04-29","conditions":["Psychiatric Disorders"],"enrollment":24,"completionDate":"2025-07-22"},{"nctId":"NCT06605950","phase":"PHASE1","title":"A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2024-10-01","conditions":["Healthy Volunteers"],"enrollment":78,"completionDate":"2025-05-31"},{"nctId":"NCT06947941","phase":"PHASE3","title":"A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)","status":"NOT_YET_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-07-31","conditions":["Alzheimer Disease","Psychosis"],"enrollment":1046,"completionDate":"2027-10-25"},{"nctId":"NCT06923891","phase":"PHASE4","title":"An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients","status":"NOT_YET_RECRUITING","sponsor":"Vanguard Research Group","startDate":"2025-04-16","conditions":["Schizophrenia"],"enrollment":172,"completionDate":"2026-11-30"},{"nctId":"NCT06924255","phase":"PHASE4","title":"An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia","status":"NOT_YET_RECRUITING","sponsor":"Collaborative Neuroscience Research, LLC","startDate":"2025-04","conditions":["Schizophrenia Disorders"],"enrollment":100,"completionDate":"2025-12"},{"nctId":"NCT05145413","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2021-11-12","conditions":["Schizophrenia"],"enrollment":396,"completionDate":"2025-03-19"},{"nctId":"NCT04738123","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2021-04-06","conditions":["Schizophrenia","Schizophrenia; Psychosis"],"enrollment":256,"completionDate":"2022-12-07"},{"nctId":"NCT04659174","phase":"PHASE3","title":"An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2021-02-01","conditions":["Schizophrenia"],"enrollment":152,"completionDate":"2023-10-03"},{"nctId":"NCT05643170","phase":"PHASE3","title":"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","status":"TERMINATED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2022-11-08","conditions":["Schizophrenia"],"enrollment":4,"completionDate":"2023-03-08"},{"nctId":"NCT04659161","phase":"PHASE3","title":"A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2020-12-16","conditions":["Schizophrenia","Schizophrenia; Psychosis"],"enrollment":252,"completionDate":"2022-05-24"},{"nctId":"NCT03697252","phase":"PHASE2","title":"A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2018-09-18","conditions":["Schizophrenia"],"enrollment":182,"completionDate":"2019-09-04"},{"nctId":"NCT02831231","phase":"PHASE1","title":"Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium","status":"COMPLETED","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","startDate":"2016-09-07","conditions":["Schizophrenia"],"enrollment":70,"completionDate":"2016-10-28"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"UNII":"9ORI6L73CJ","CHEBI":"CHEBI:10056","INN_ID":"7125","UMLSCUI":"C0246836","ChEMBL_ID":"CHEMBL21536","KEGG_DRUG":"D06330","DRUGBANK_ID":"DB15357","PDB_CHEM_ID":"XNO","PUBCHEM_CID":"60809","IUPHAR_LIGAND_ID":"57","SECONDARY_CAS_RN":"152854-19-8","MESH_SUPPLEMENTAL_RECORD_UI":"C075257"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":312,"therapeuticAreas":["Other"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","brandName":"XANOMELINE","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"2024","aiSummary":"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.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":9,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}