Drugs / Trospium
Trospium
also known as
Trospium Chloride · Chlorure de trospium · Cloruro de trospio · Flotros · IP-631 · Regurin · Regurin xl · Relaspium · +12 more
Small molecule targets CHRM2, CHRM3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed schizophrenia 1 milestone | |||||
| Filed | US (FDA) | — | schizophrenia | — | “In November 2023, Karuna announced that the FDA has accepted its NDA for xanomeline-trospium for the treatment of schizophrenia in adults.” zailaboratory.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | SANCTURA | — | 2004-05-28 | fda.gov ↗ |
Trials 43
| 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 17 trials | ||||||
| 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 | NCT03168828 | Apr 2017 → Jul 2018 | overactive bladder | Taris Biomedical LLC | Completed | No outcome recorded |
| Phase 1 | NCT03109379 | Apr 2017 → Sep 2019 | overactive bladder | Taris Biomedical LLC | Completed | No outcome recorded |
| Phase 1 | NCT02831231 | Sep → Oct 2016 | schizophrenia | Karuna Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00986401 | Oct → Nov 2009 | — | Allergan | Completed | No outcome recorded |
| Phase 1/23 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 1/2 | NCT00465959 | Apr → Jun 2007 | chronic obstructive pulmonary disease | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT03697252 | Sep 2018 → Sep 2019 | schizophrenia | Karuna Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT00801684 | Feb → Apr 2009 | chronic obstructive pulmonary disease | Alkermes, Inc. | Completed | Met primary |
| Phase 319 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 | 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 49 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 |
| Phase 4 | NCT04227184 | Feb 2020 → Feb 2025 | overactive bladder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT04090190 | Oct 2019 → May 2021 | overactive bladder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01178827 | Aug 2010 → Mar 2011 | overactive bladder | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01089751 | Mar 2010 → Jun 2012 | overactive bladder | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00932022 | Jul 2009 → Dec 2011 | obesity disorder, overactive bladder | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00863551 | Apr → Aug 2009 | overactive bladder | Allergan | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03104101 | Nov 2014 → Nov 2015 | overactive bladder | Alexandria University | Completed | No outcome recorded |
| — | NCT01499069 | Feb 2010 → Nov 2015 | overactive bladder | Samsung Medical Center | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 0 | NCT05880862 Comparator | Sep 2023 → Dec 2025 | overactive bladder | The University of Texas Medical Branch, Galveston | Completed | No outcome recorded |
| Phase 1 | NCT07204418 Background | Oct 2025 → Dec 2026 expected | — | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07118215 Background | Sep 2025 → Jun 2026 overdue | — | Karuna Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT03011463 Comparator | Nov 2016 → Mar 2017 | — | Dr. R. Pfleger Chemische Fabrik GmbH | Completed | 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 3 | NCT05658874 Background | Dec 2022 → Dec 2024 | interstitial cystitis, levator syndrome | Jocelyn Fitzgerald | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01166438 Comparator | Mar 2010 → May 2012 | overactive bladder | NICHD Pelvic Floor Disorders Network | Completed | Missed primary |
| Phase 4 | NCT06923891 Comparator | Apr 2025 → Oct 2026 expected | schizophrenia | Vanguard Research Group | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06346522 Comparator | Apr → Sep 2024 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT01922115 Comparator | Jun 2013 → Jun 2015 | cognitive disorder, overactive bladder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT00800462 Comparator | Mar 2008 → Jun 2012 | overactive bladder, spinal cord injury | Toronto Rehabilitation Institute | Completed | No outcome recorded |
| Phase 4 | NCT00547378 Comparator | Oct 2007 → Aug 2016 | overactive bladder | MedtronicNeuro | Completed | No outcome recorded |
| — | NCT03709992 Comparator | Dec 2020 → Aug 2024 | ureteral obstruction, ureterolithiasis | Mansoura University | Suspended | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| 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. |
| 2024-09-27 | PureTech | Regulatory PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults puretechhealth.com ↗ |
| 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. |
| 2023-11-29 | PureTech | Regulatory PureTech Founded Entity Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia puretechhealth.com ↗
PureTech Founded Entity Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia |
| 2023-11-17 | PureTech | Results PureTech Founded Entity Karuna Therapeutics Announces Positive Results from Phase 1b Ambulatory Blood Pressure Monitoring Trial of KarXT in Schizophrenia puretechhealth.com ↗
KarXT demonstrated a mean change from baseline to week 8 in 24-hour ambulatory systolic blood pressure of -0.59 mmHg. |
| 2023-09-28 | PureTech | Regulatory KarXT, invented at PureTech, submitted for FDA Approval in Schizophrenia puretechhealth.com ↗ |
| 2023-03-20 | PureTech | Results PureTech Founded Entity Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia puretechhealth.com ↗ |
| 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 | PureTech | Results PureTech Founded Entity Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-2 Trial of KarXT in Schizophrenia puretechhealth.com ↗ |
| 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 ↗ |
| 2021-06-23 | PureTech | Results PureTech Founded Entity Karuna Therapeutics Announces Results from Phase 1b Trial Evaluating the Safety and Tolerability of KarXT in Healthy Elderly Volunteers puretechhealth.com ↗
Results suggest that KarXT can be administered to elderly volunteers at doses which achieve xanomeline blood levels similar to those reported in the Phase 2 EMERGENT-1 trial in adults with schizophrenia while maintaining a favorable tolerability profile |
| 2021-02-25 | PureTech | Results PureTech Founded Entity Karuna Therapeutics Announces New England Journal of Medicine Publication of Data from EMERGENT-1 Phase 2 Trial Evaluating KarXT in Schizophrenia puretechhealth.com ↗
KarXT demonstrated statistically significant and clinically meaningful improvements in primary and key secondary efficacy measures compared with placebo |
| 2013-05-29 | Perrigo Company | Regulatory Perrigo Announces FDA Final Approval For Generic Equivalent To Sanctura XR® perrigo.com ↗
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval for the generic version of Sanctura XR®. |
| 2007-09-26 | Alkermes, Inc. | Results Alkermes and Indevus Announce Positive Results from Phase 2a Clinical Study of ALKS 27 for the Treatment of COPD alkermes.com ↗
In the study, single doses of ALKS 27 demonstrated a rapid onset of action and produced a significant improvement in lung function (p less than .0001) over 24 hours compared to placebo. |
All press releases naming this drug 23 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trospium | “Participants receive Cobenfy maintenance (100 mg xanomeline + 20 mg trospium twice daily) during the inpatient protocol, followed by IV cocaine self-administration and...” NCT07624227 ↗20“Trospium is a peripherally restricted muscarinic receptor antagonist that reduces peripheral cholinergic effects of xanomeline.” PMID 33626254 ↗ Feb 2021 “Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)” NCT05658874 ↗ “Xanomeline and Trospium Chloride Capsules” NCT07212062 ↗ “Trospium 20mg” NCT00547378 ↗ “* Trospium” NCT07016451 ↗ |
| Known as | Chlorure de trospium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Cloruro de trospio | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Flotros | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | IP-631 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Regurin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Regurin xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Relaspium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Sanctura | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Sanctura XR | “Trospium Chloride (Sanctura XR®)” NCT00986401 ↗ |
| Known as | Spasmex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Spasmo-lyt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Spasmoplex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | TrCl | “Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.” NCT00801684 ↗ |
| Known as | TrIP | “trospium chloride inhalation powder (TrIP)” NCT00465959 ↗ |
| Known as | Trospium cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Trospium Chloride | “This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin...” NCT00800462 ↗41“Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.” NCT00801684 ↗ “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 ↗ “one tablet Trospium Chloride 20 mg once daily Plus TPTNS” NCT03104101 ↗ “Xanomeline and Trospium Chloride Capsules” NCT04820309 ↗ “Xanomeline and Trospium Chloride Capsules” NCT04738123 ↗ “Xanomeline and Trospium Chloride Capsules” NCT05980949 ↗ “Xanomeline and Trospium Chloride Capsules” NCT06126224 ↗ |
| Known as | Trospium chloride component of cobenfy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Trospium Cl | “Drug: Trospium Cl” NCT00800462 ↗ |
| Known as | Trospium ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Known as | Uraplex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176 ↗ |
| Action | Inhibit | “two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide)” NCT00800462 ↗2“Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1888176 ↗ “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1888176 ↗ |
| Modality | Small molecule | — CHEMBL1888176 ↗ |
| Route | Inhaled | “Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP)” NCT00465959 ↗ |
| Target | CHRM2 | “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1888176 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1888176 ↗ |