Drugs / Xanomeline
Xanomeline
also known as
KarX-EC · LY-246708 · LY-246708 FREE BASE · LY-246708 TARTRATE · Xanomelina · Xanomeline (+)-l-hydrogen tartrate · Xanomeline enteric capsules, BMS-986519 · Xanomeline tartaric acid · +2 more
Small molecule targets CHRM1, CHRM4 via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | COBENFY | — | 2024-09-26 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07228338 | Dec 2026 → Dec 2031 expected | amnestic disorder, epilepsy | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07204418 | Oct 2025 → Dec 2026 expected | — | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07063342 | Jun 2025 → Mar 2027 expected | — | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1 | NCT06853171 | Apr → Jul 2025 | psychiatric disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT06605950 | Oct 2024 → May 2025 | — | Karuna Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02831231 | Sep → Oct 2016 | schizophrenia | Karuna Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07624227 | Aug 2026 → Jun 2032 expected | substance-related disorder | University of Kentucky | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07423546 | Jul 2026 → Apr 2027 expected | schizoaffective disorder, schizophrenia 1 | New York State Psychiatric Institute | Recruiting | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT03697252 | Sep 2018 → Sep 2019 | schizophrenia | Karuna Therapeutics, Inc. | Completed | Met primary |
| Phase 320 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT07284745 | Sep 2026 → Jul 2029 expected | autism spectrum disorder | Bristol-Myers Squibb | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07686263 | Aug 2026 → Mar 2029 expected | schizophrenia | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07424404 | Apr 2026 → Mar 2030 expected | autism, schizophrenia | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06937229 | Dec 2025 → Jun 2029 expected | Alzheimer disease | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07140913 | Oct 2025 → Jun 2027 expected | bipolar I disorder, manic bipolar affective disorder | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT06929273 | Jul 2025 → Jun 2028 expected | bipolar I disorder | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07011745 | Jul 2025 → Nov 2028 expected | Alzheimer disease | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07011732 | Jul 2025 → Nov 2028 expected | Alzheimer disease | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT06951698 | Jun 2025 → Nov 2026 expected | bipolar I disorder | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT06126224 | Aug 2023 → Dec 2026 expected | psychotic disorder | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05980949 | Jul 2023 → Sep 2027 expected | psychotic disorder | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05919823 | May 2023 → Sep 2024 | schizophrenia | Karuna Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT05643170 | Nov 2022 → Mar 2023 | schizophrenia | Karuna Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05511363 | Aug 2022 → Oct 2026 expected | psychotic disorder | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05304767 | Mar 2022 → Mar 2026 overdue | schizophrenia | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05145413 | Nov 2021 → Mar 2025 | schizophrenia | Karuna Therapeutics, Inc. | Completed | Missed primary |
| Phase 3 | NCT04820309 | Jun 2021 → May 2024 | schizophrenia | Karuna Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04738123 | Apr 2021 → Nov 2022 | schizophrenia | Karuna Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04659174 | Feb 2021 → Oct 2023 | schizophrenia | Karuna Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04659161 | Dec 2020 → May 2022 | schizophrenia | Karuna Therapeutics, Inc. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07681076 | Sep → Nov 2026 expected | — | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT07221877 | Jan 2026 → Dec 2027 expected | schizophrenia | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 4 | NCT06924255 | Apr → Dec 2025 overdue | schizophrenia | Collaborative Neuroscience Research, LLC | Not yet recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT07118215 Background | Sep 2025 → Jun 2026 overdue | — | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07212062 Comparator | Dec 2025 → Apr 2028 expected | Alzheimer disease | Neurology Office of South Florida | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06923891 Comparator | Apr 2025 → Oct 2026 expected | schizophrenia | Vanguard Research Group | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-03-28 | Bristol-Myers Squibb | Results Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy™ (xanomeline and trospium chloride) bms.com ↗
Through 8 weeks, patients remained stable with mean Positive and Negative Syndrome Scale (PANSS) total scores remaining below baseline, and no new safety signals were observed, regardless of cross-titration duration. |
| 2025-12-23 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Approval of COBENFY (xanomeline and trospium chloride) in China, a First-in-Class Therapy for Schizophrenia zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for COBENFY® (xanomeline and trospium chloride) for the treatment of schizophrenia in adults. |
| 2025-04-22 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults with Schizophrenia bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. |
| 2025-01-17 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia zailaboratory.com ↗
China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. |
| 2024-10-31 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Reports Third Quarter Financial Results for 2024 bms.com ↗ |
| 2024-10-31 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Long-term Data from the EMERGENT Program Evaluating COBENFY™ (xanomeline and trospium chloride) in Adults with Schizophrenia at Psych Congress 2024 bms.com ↗
Long-term treatment with COBENFY was associated with continued improvements in symptoms of schizophrenia, demonstrating maintenance of effect |
| 2024-10-29 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Reports Positive Topline Data from Phase 3 Bridging Trial Evaluating KarXT for the Treatment of Schizophrenia in China zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced positive topline results from the company’s Phase 3 multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) in China. |
| 2024-09-26 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Bristol Myers Squibb’s COBENFY™ (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults. |
| 2024-05-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at the 2024 American Society of Clinical Psychopharmacology Annual Meeting bms.com ↗
Consistent with short-term studies, KarXT was not associated with clinically meaningful changes in movement disorder scale scores and a low incidence rate of extrapyramidal symptoms was reported over long-term trials in adults with schizophrenia |
| 2024-04-06 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia. |
| 2023-03-20 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Partner Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia zailaboratory.com ↗
Consistent with prior trials, KarXT demonstrated an early and sustained statistically significant reduction of symptoms from Week 2 (p<0.05) through the end of the trial as assessed by PANSS total score. |
| 2022-08-08 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Partner Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-2 Trial of KarXT in Schizophrenia zailaboratory.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Xanomeline | “Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, followed by IV cocaine self-administration and...” NCT07624227 ↗34“multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride” NCT06853171 ↗ “dual-burst release of Xanomeline with immediate-release Trospium Chloride” NCT06605950 ↗ “50 mg/20 mg orally BID of xanomeline and trospium chloride (COBENFY)” NCT07228338 ↗ “Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic” NCT07681076 ↗ “Xanomeline and Trospium Chloride Capsules” NCT05511363 ↗ “Xanomeline and Trospium Chloride Capsules” NCT07212062 ↗ “Xanomeline and Trospium Chloride Capsules” NCT05980949 ↗ “Xanomeline and Trospium Chloride Capsules” NCT06126224 ↗ “Xanomeline enteric capsules, BMS-986519” NCT06937229 ↗ “Xanomeline and trospium chloride” NCT06929273 ↗ |
| Known as | KarX-EC | “xanomeline enteric capsules (KarX-EC)” NCT06937229 ↗ |
| Known as | LY-246708 | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | LY-246708 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | LY-246708 TARTRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | Xanomelina | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | Xanomeline (+)-l-hydrogen tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | Xanomeline enteric capsules, BMS-986519 | “Xanomeline enteric capsules, BMS-986519” NCT06937229 ↗ |
| Known as | Xanomeline tartaric acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | XANOMELINE TARTRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Known as | Xanomeline tartrate component of cobenfy | ChEMBL registry synonym — accepted as the source's own label CHEMBL21536 ↗ |
| Action | Activate | “The muscarinic receptor agonist xanomeline improved cognition in phase 2 trials in Alzheimer's disease and schizophrenia.” PMID 36414626 ↗ Nov 20222“Muscarinic acetylcholine receptor M1 agonist” CHEMBL21536 ↗ “Muscarinic acetylcholine receptor M4 agonist” CHEMBL21536 ↗ |
| Modality | Small molecule | — CHEMBL21536 ↗ |
| Route | Oral | “Objective: To further characterize the efficacy of oral xanomeline and trospium chloride in the treatment of agitation associated with schizophrenia.” PMID 40215379 ↗ Mar 2025 |
| Target | CHRM1 | “Muscarinic acetylcholine receptor M1 agonist” CHEMBL21536 ↗ |
| Target | CHRM4 | “Muscarinic acetylcholine receptor M4 agonist” CHEMBL21536 ↗ |