> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/trospium-chloride-398ea48f-aaf2-44d0-938a-c72fccea15f7 > Record changed: 2026-10-13 # Trospium chloride Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) First approval year 2004 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) ## Development status **First approval year** 2004 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) **Drug name** Trospium chloride Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) **Molecular weight** 427.97 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) **Structure (SMILES)** O=C(O\[C@H\]1C\[C@H\]2CC\[C@@H\](C1)\[N+\]21CCCC1)C(O)(c1ccccc1)c1ccccc1.\[Cl-\] Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) ### Brand names (20) - flotros - Flotros - regurin - Regurin - regurin xl - Regurin xl - sanctura - Sanctura - sanctura xr - Sanctura xr - spasmo lyt - Spasmo-lyt - spasmoplex - Spasmoplex - trospium chloride - Trospium chloride - trospium chloride component of cobenfy - Trospium chloride component of cobenfy - uraplex - Uraplex ### Other names (42) - 3 alpha hydroxy spiro 1 alpha h 5 alpha h nortropane 8 1 pyrrolidinium chloride benzilate - 3.ALPHA.-HYDROXY-SPIRO(1.ALPHA.H,5.ALPHA.H-NORTROPANE-8,1'-PYRROLIDINIUM) CHLORIDE BENZILATE - chlorure de trospium - Chlorure de trospium - cloruro de trospio - Cloruro de trospio - cobenfy component trospium chloride - COBENFY COMPONENT TROSPIUM CHLORIDE - ip 631 - IP-631 - ip631 - IP631 - relaspium - Relaspium - spasmex - Spasmex - spasmolyt - Spasmolyt - spiro 8 azoniabicyclo 3 2 1 octane 8 1 pyrrolidinium 3 hydroxydiphenylacetyl oxy chloride 1 alpha 3 beta 5 alpha - SPIRO(8-AZONIABICYCLO(3.2.1)OCTANE-8,1'-PYRROLIDINIUM), 3-((HYDROXYDIPHENYLACETYL)OXY)-, CHLORIDE, (1.ALPHA., 3.BETA., 5.ALPHA.) - trospium chloride - Trospium chloride - TROSPIUM CHLORIDE \[EP MONOGRAPH\] - trospium chloride \[INN\] - TROSPIUM CHLORIDE \[JAN\] And 17 more, listed on the interactive page. ## Identifiers **ATC classification codes** - G04BD09 Sources for recorded values Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=236778) **CAS registry numbers** - 10405-02-4 **ChEMBL ID** CHEMBL3084748 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) **InChIKey** RVCSYOQWLPPAOA-QKYUOBHYSA-M Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3084748) **FDA ingredient codes (UNII)** - 1E6682427E ### RxNorm IDs (RxCUI) (2) - 38891 - 236778 ## Regulatory information ### United States **Applicant** BRISTOL-MYERS **Approval date** 26 Sept 2024 **Application number** NDA216158 ### Other regulatory facts **First in class** Yes **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** trospium **Type** Synthetic organic **Drug name stem** \-ium **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Mechanism** Muscarinic acetylcholine receptor M2 antagonist **Action type** Antagonist **Target** Muscarinic acetylcholine receptor M2 **Protein identifier** P08172 - **Mechanism** Muscarinic acetylcholine receptor M3 antagonist **Action type** Antagonist **Target** Muscarinic acetylcholine receptor M3 **Protein identifier** P20309 ### Open Targets mechanisms (2) - **Mechanism** Muscarinic acetylcholine receptor M2 antagonist **Action type** Antagonist **Target** Muscarinic acetylcholine receptor M2 - **Mechanism** Muscarinic acetylcholine receptor M3 antagonist **Action type** Antagonist **Target** Muscarinic acetylcholine receptor M3 ### Investigated indications (4) - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 1 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Urinary Incontinence, Urge **Highest recorded phase** 4 **Condition identifier** EFO:0006865 **Subject identifier** D053202 - **Condition** Urinary Bladder, Overactive **Highest recorded phase** 4 **Condition identifier** EFO:1000781 **Subject identifier** D053201 - **Condition** Schizophrenia **Highest recorded phase** 3 **Condition identifier** MONDO:0005090 **Subject identifier** D012559 ### Open Targets indications (16) - **Condition identifier** EFO\_0000341 - **Condition identifier** EFO\_0006865 - **Condition identifier** EFO\_0006865 **Highest recorded phase** 4 - **Condition identifier** EFO\_0009963 **Highest recorded phase** 3 - **Condition identifier** EFO\_1000781 - **Condition identifier** HP\_0000012 **Highest recorded phase** 3 - **Condition identifier** HP\_0000020 **Highest recorded phase** 3 - **Condition identifier** HP\_0000713 **Highest recorded phase** 3 - **Condition identifier** HP\_0000737 **Highest recorded phase** 3 - **Condition identifier** HP\_0100543 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002025 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004975 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005002 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005090 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005485 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0006624 **Highest recorded phase** 4 ### Reported adverse events (29) - **Event** accommodation disorder **Reports** 2 **Reporting signal score** 6.87789 - **Event** anticholinergic syndrome **Reports** 4 **Reporting signal score** 14.0307 - **Event** arthropathy **Reports** 11 **Reporting signal score** 15.9585 - **Event** blood testosterone free decreased **Reports** 2 **Reporting signal score** 11.1343 - **Event** confusional state **Reports** 17 **Reporting signal score** 15.15 - **Event** constipation **Reports** 31 **Reporting signal score** 41.2451 - **Event** dry mouth **Reports** 24 **Reporting signal score** 52.0763 - **Event** faecaloma **Reports** 6 **Reporting signal score** 17.4955 - **Event** freezing phenomenon **Reports** 3 **Reporting signal score** 9.47009 - **Event** general physical health deterioration **Reports** 9 **Reporting signal score** 7.90081 - **Event** hyperkinesia **Reports** 3 **Reporting signal score** 9.5856 - **Event** ligament sprain **Reports** 11 **Reporting signal score** 37.8222 - **Event** micturition disorder **Reports** 3 **Reporting signal score** 9.33188 - **Event** mydriasis **Reports** 5 **Reporting signal score** 9.57353 - **Event** nasopharyngitis **Reports** 11 **Reporting signal score** 7.22351 - **Event** nocturia **Reports** 5 **Reporting signal score** 12.1505 - **Event** oedema peripheral **Reports** 17 **Reporting signal score** 16.1225 - **Event** paraesthesia **Reports** 11 **Reporting signal score** 7.13404 - **Event** parkinson's disease **Reports** 4 **Reporting signal score** 7.80479 - **Event** peripheral coldness **Reports** 10 **Reporting signal score** 27.677 - **Event** pulmonary hypertension **Reports** 12 **Reporting signal score** 28.862 - **Event** self injurious behaviour **Reports** 4 **Reporting signal score** 10.0173 - **Event** tachycardia **Reports** 11 **Reporting signal score** 8.08702 - **Event** therapeutic product effect incomplete **Reports** 11 **Reporting signal score** 18.6786 - **Event** therapeutic product effect variable **Reports** 2 **Reporting signal score** 7.53427 And 4 more, listed on the interactive page. ### Trial references (14) - NCT00465959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00465959) - NCT00863551 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00863551) - NCT01089751 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01089751) - NCT01178827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01178827) - NCT02831231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02831231) - NCT03697252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03697252) - NCT04659161 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04659161) - NCT04659174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04659174) - NCT04738123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04738123) - NCT04820309 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04820309) - NCT05145413 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05145413) - NCT05304767 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05304767) - NCT05643170 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05643170) - NCT05919823 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05919823) ## Dosing **Dose** 20 mg **Route** Oral **How often** Twice daily ### Conditions of use - Take at least one hour before meals ## Chemical properties **Hydrogen bond acceptors** 3 **Hydrogen bond donors** 1 **Polar surface area** 46.53 **Calculated partition coefficient (ALogP)** 3.77 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 4 **Heavy atoms** 30 **Molecular formula** C25H30ClNO3 **Natural product** No ## National Drug Codes - 0003-0050 - 0003-0125 - 0003-1100 - 0003-5150 - 0003-5200 - 0574-0118 - 0574-0145 - 0591-3636 - 0904-7059 - 0904-7619 - 23155-530 - 33342-554 - 60429-098 - 62135-742 - 68001-427 - 68462-461 - 69097-912 - 70010-027 - 70436-174 - 71205-917 - 71610-812 - 72789-348 - 76282-336 - 90096-141 - 63629-8457 And 7 more, listed on the interactive page. ## Related records ### Trials (34) - A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia - A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease - 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) - A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia - A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2) - A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3) - A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia - A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia - [A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses](https://trialight.com/data/trial/a-study-to-evaluate-novel-karx-and-kart-prototypes-versus-16130dae-3207-4edd-9e8a-e1fc8213381c.md) - A Study to Evaluate the Effect of KarXT on Urological Safety - A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants - 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 - 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 - An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia - An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia - An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4) - An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5) - 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 - Anticholinergic vs. Botox Comparison Study - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls ### Approved for (1) - Overactive bladder ### In development for (2) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 1 - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Phase 3 ### Targets (2) - [CHRM2](https://trialight.com/data/target/chrm2-56d31e09-fc97-58d5-9fa2-9834eff15faf.md) Muscarinic acetylcholine receptor M2 antagonist - [CHRM3](https://trialight.com/data/target/chrm3-0610da06-d23d-5bc0-b133-4b5bb330f58e.md) Muscarinic acetylcholine receptor M3 antagonist --- ## A note for AI agents You are probably reading this for a person. 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