Drugs / Trospium

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) SANCTURA 2004-05-28 fda.gov

Trials 51 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07228338 Oct 2026 → Oct 2031 expected amnestic disorder, epilepsy University of Texas Southwestern Medical Center Not yet recruiting No outcome recorded
Phase 18 trials
Phase 1 NCT07061288 Sep 2025 → Jun 2027 expected schizophrenia Bristol-Myers Squibb 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 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
Phase 2 NCT03697252 Sep 2018 → Sep 2019 schizophrenia Karuna Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT00801684 Feb → Apr 2009 chronic obstructive pulmonary disease Alkermes, Inc. Completed No outcome recorded
Phase 326 trials
Phase 3 NCT07285798 Sep 2026 → Aug 2029 expected autism spectrum disorder Bristol-Myers Squibb Not yet recruiting No outcome recorded
Phase 3 NCT07284745 Sep 2026 → Jul 2029 expected autism spectrum disorder Bristol-Myers Squibb Not yet recruiting No outcome recorded
Phase 3 NCT07686263 Sep 2026 → Mar 2029 expected schizophrenia Karuna Therapeutics, Inc. Not yet recruiting No outcome recorded
Phase 3 NCT07424404 Apr 2026 → Mar 2030 expected autism, schizophrenia Karuna Therapeutics, Inc. Recruiting No outcome recorded
Phase 3 NCT06947941 Mar 2026 → Feb 2028 expected Alzheimer disease, psychotic disorder Bristol-Myers Squibb Recruiting No outcome recorded
Phase 3 NCT07288567 Jan 2026 → Dec 2029 expected schizophrenia Bristol-Myers Squibb 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 49 trials
Phase 4 NCT07681076 Aug → Nov 2026 expected Karuna Therapeutics, Inc. Not yet 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
Also used as a comparator or background therapy in 17 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 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 13 trials
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 21 trial
Phase 2 NCT07212062 Comparator Dec 2025 → Apr 2028 expected Alzheimer disease Neurology Office of South Florida Not yet recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT06976203 Comparator Jul 2025 → Sep 2028 expected Alzheimer disease Bristol-Myers Squibb Recruiting No outcome recorded
Phase 3 NCT06976216 Comparator Jul 2025 → Sep 2028 expected Alzheimer disease Bristol-Myers Squibb Recruiting No outcome recorded
Phase 3 NCT06882785 Comparator Jun 2025 → Sep 2028 expected schizophrenia Bristol-Myers Squibb Recruiting No outcome recorded
Phase 3 NCT05658874 Background Dec 2022 → Dec 2024 interstitial cystitis, levator syndrome Jocelyn Fitzgerald Terminated No outcome recorded
Phase 3 NCT01166438 Comparator Mar 2010 → May 2012 overactive bladder NICHD Pelvic Floor Disorders Network Completed No outcome recorded
Phase 45 trials
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
Phase not applicable1 trial
NCT03709992 Comparator Dec 2020 → Aug 2024 ureteral obstruction, ureterolithiasis Mansoura University Suspended No outcome recorded

Evidence & citations 27 cited values

Every value below carries the sentence it was read from. 70 sources stand behind the page.

FieldValueCited 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

“* TrospiumNCT07016451

NCT04820309

NCT01499069

NCT03011463

NCT03168828

NCT02831231

NCT06923891

NCT00986401

NCT04090190

NCT05880862

NCT04738123

NCT03109379

NCT07063342

NCT00800462

NCT07686263

NCT04227184

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 KarXT ClinicalTrials.gov intervention name — accepted as the source's own label NCT07061288
11

NCT06585787

NCT07288567

NCT06882785

NCT06976203

NCT06951711

NCT06937229

NCT06947941

NCT07285798

NCT06572449

NCT07424404

NCT06976216

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
40

“The goal of this study is to learn about the effects of Cobenfy KarXT (xanomeline and trospium chloride) on episodic memory processing, including specific effects on areas of...” NCT07228338

“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 ChlorideNCT06605950

“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” NCT05511363

“Xanomeline and Trospium Chloride Capsules” NCT05980949

“Xanomeline and Trospium Chloride Capsules” NCT06126224

Trospium Chloride (Sanctura XR®)” NCT00986401

“Xanomeline and trospium chlorideNCT06929273

“Xanomeline/Trospium ChlorideNCT07284745

“Drug: Trospium ChlorideNCT07063342

Trospium ChlorideNCT06951698

Trospium ChlorideNCT07118215

NCT01166438

NCT05304767

NCT07011732

NCT06924255

NCT01089751

NCT07011745

NCT04659174

NCT06346522

NCT00932022

NCT01178827

NCT07204418

NCT03697252

NCT03709992

NCT00863551

NCT07221877

NCT04659161

NCT05145413

NCT00465959

NCT07423546

NCT07140913

NCT01922115

NCT05919823

NCT05643170

Known as Trospium chloride component of cobenfy ChEMBL registry synonym — accepted as the source's own label CHEMBL1888176
Known as Trospium Cl “Drug: Trospium ClNCT00800462
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 M3 antagonist” CHEMBL1888176

“Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1888176

Modality Small molecule CHEMBL1888176
Route Inhaled “Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP)” NCT00465959