trospium

Trade name: sanctura

Small moleculeapproved

Approved

May 28, 2004

Trospium is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Receptor assays showed that trospium has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses. Trospium antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder. Trospium is marketed under the brand name Sancturain the US, Tropez OD in India,Trosec in Canada, Regurin and Flotros in the United Kingdom and Spasmex in Germany, Russia, Turkey, Argentina, Chile and Israel. — NCATS

Clinical trial activity

37 trials · 29 clinical orgs · 18 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Apr 1, 2007 (NCT00465959)

Timeline

2000s

May 28, 2004
Indevus Pharmaceuticals — Earliest FDA Approval
May 28, 2004
Allergan — NDA Secondary Org
May 28, 2004
Indevus Pharmaceuticals — NDA Organization
May 28, 2004
GlaxoSmithKline — NDA Secondary Org
Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
Jan 1, 2009
Earliest Phase 2 Sponsor(trial)

2010s

Jan 1, 2010
Earliest Phase 3 Sponsor(trial)
Aug 13, 2010
Glenmark Pharmaceuticals — Marketing Organization
Nov 17, 2010
Paddock Laboratories — Marketing Organization
Nov 17, 2010
Padagis Us — Marketing Organization
Dec 6, 2011
Apotex — Marketing Organization
Oct 12, 2012
Actavis — Marketing Organization
Apr 29, 2015
Upsher-Smith Laboratories — Marketing Organization
Aug 23, 2016
Invagen Pharms — Marketing Organization
Aug 23, 2016
Cipla — Marketing Organization
Aug 30, 2016
Heritage Pharma — Marketing Organization
Aug 30, 2016
Emcure — Marketing Organization

2020s

Apr 23, 2020
Granules India — Marketing Organization
Apr 30, 2021
Amta — Marketing Organization
Feb 16, 2022
ZAMEER PHARMS — Marketing Organization
Feb 16, 2022
Chartwell Pharmaceuticals — Marketing Organization
Jun 18, 2024
Macleods Pharmaceuticals, Ltd — Marketing Organization

Mechanism of action

Muscarinic acetylcholine receptor M2ANTAGONIST
CHRM2 antagonist
Indicated for overactive bladder, M2 likely responsible
- Muscarinic acetylcholine receptor M2 (CHRM2) ↗
Muscarinic acetylcholine receptor M3ANTAGONIST
CHRM3 antagonist
Indicated for overactive bladder, M3 likely responsible
- Muscarinic acetylcholine receptor M3 (CHRM3) ↗

Combination products

cobenfy
with xanomeline
Also known as karx-ec, xanomeline and trospium chloride

Approval history

approvedMay 28, 2004

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O[C@H]1C[C@H]2CC[C@@H](C1)[N+]21CCCC1)C(O)(c1ccccc1)c1ccccc1

Mol. weight: 392.52 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

First in class

Sources

Also known as

azoniaspiro(3 alpha-benziloyloxynortropane-8,1'- pyrrolidine) chloride
azoniaspiro compound xvii
ceris
flotros
flotros
ip631
ip631
regurin
regurin
regurin xl
relaspium
sanctura
sanctura
sanctura
sanctura
spasmex
spasmolyt
spasmo-lyt
spasmo-lyt
spasmo-lyt
spasmo-rhoival tc
spasmo-urgenin
spasmo-urgenin tc
trosec
trosec
trospi
trospium
trospium
trospium
trospium
trospium
trospium
trospium
trospium
trospium
trospium chloride
trospium chloride
trospium chloride
trospium chloride
trospium chloride
trospium chloride
uraplex
uraplex
uraplex
uraton

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07284745	Phase 3	Feb 27, 2026	Bristol-Myers Squibb
NCT07285798	Phase 3	Feb 27, 2026	Bristol-Myers Squibb
NCT07228338	Early Phase 1 (Phase 1)	Jan 31, 2026	The University of Texas, Dallas
NCT06937229	Phase 3	Dec 1, 2025	Bristol-Myers Squibb
NCT06947941	Phase 3	Jul 31, 2025	Bristol-Myers Squibb
NCT06976203	Phase 3	Jul 21, 2025	Bristol-Myers Squibb
NCT06976216	Phase 3	Jul 14, 2025	Bristol-Myers Squibb
NCT06853171	Phase 1	Apr 29, 2025	Bristol-Myers Squibb
NCT06605950	Phase 1	Oct 1, 2024	Bristol-Myers Squibb, Karuna Pharmaceuticals
NCT06346522	Phase 4	Feb 24, 2024	Ain Shams University
NCT05880862	Early Phase 1 (Phase 1)	Sep 28, 2023	National Institute on Aging (NIA), University of Texas, Galveston
NCT05919823	Phase 3	May 29, 2023	Karuna Pharmaceuticals, Zai Lab Pty. Ltd.
NCT05643170	Phase 3	Nov 8, 2022	Karuna Pharmaceuticals
NCT05304767	Phase 3	Mar 7, 2022	Karuna Pharmaceuticals
NCT05145413	Phase 3	Nov 12, 2021	Karuna Pharmaceuticals
NCT04820309	Phase 3	Jun 2, 2021	Karuna Pharmaceuticals
NCT04738123	Phase 3	Apr 6, 2021	Karuna Pharmaceuticals
NCT04659174	Phase 3	Jan 31, 2021	Karuna Pharmaceuticals
NCT04659161	Phase 3	Dec 16, 2020	Karuna Pharmaceuticals
NCT04227184	Phase 4	Jan 22, 2020	National Institute on Aging (NIA), University of Pittsburgh

Showing 20 of 37 trials

Page 1 / 2

Organizations

Research & Development (29)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Karuna Pharmaceuticals	For profit	11	11	3	2016
Bristol-Myers Squibb	For profit	8	7	2	2024
Allergan	For profit	5	5	2	2009
Alkermes	For profit	2	1	1	2007
National Institute on Aging (NIA)	Government	2	0	2	2020
Ain Shams University	Academic/Hospital	1	1	1	2024
Alexandria University	Academic/Hospital	1	1	1	2014
American Urogynecologic Society	Academic/Hospital	1	0	1	2013
Amiri Hospital - Kuwait	Academic/Hospital	1	0	1	2018
Dr. R. Pfleger Chemische Fabrik GmbH	For profit	1	1	1	2016
Duke University	Academic/Hospital	1	0	1	2010
Endo Pharmaceuticals	For profit	1	1	1	2007
Harvard University	Academic/Hospital	1	1	1	2019
Mansoura University	Academic/Hospital	1	1	1	2018
Medpace, Inc.	For profit	1	0	1	2016
National Institute of Child Health and Human Development (NICHD)	Government	1	1	1	2010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	1	0	1	2010
National Institutes of Health (NIH)	Government	1	0	1	2010
Ontario Neurotrauma Foundation	Academic/Hospital	1	0	1	2008
RTI International	Academic/Hospital	1	0	1	2010

29 organizations