Tolterodine

also known as Detrusitol · Tolterodine Tartrate · Tolterodine ER · Detrol · Detrol LA · Incont LA · Tolterodine (Detrol LA or equivalent generic) · Tolterodine Tartrate ER

Developed for: overactive bladder · benign prostatic hyperplasia · prostatitis · urinary bladder disorder · urinary tract obstruction · female stress incontinence · nocturnal enuresis · urethral syndrome
+1 more
· urinary system disorder
Investigated by: Viatris Inc. · Pfizer · Astellas Pharma Inc · Merck Sharp & Dohme LLC · Brigham and Women's Hospital · Far Eastern Memorial Hospital
+21 more
· Samsung Medical Center · Astellas Pharma Global Development, Inc. · Buddhist Tzu Chi General Hospital · Carelon Research · Chongqing Medical University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Fuling Central Hospital of Chongqing City · GlaxoSmithKline · Inje University · Insel Gruppe AG, University Hospital Bern · KYU-SUNG LEE · Mayo Clinic · Medical University of Silesia · National Science and Technology Council, Taiwan · National Taiwan University Hospital · Peking University People's Hospital · Rambam Health Care Campus · Siami, Paul F., M.D. · Uroplasty, Inc · Xuanwu Hospital, Beijing · elbion AG

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (2)	US (FDA)	DETROL LA	—	2004-04-14 – 2005-10-20	fda.gov ↗
Label expansion	US (FDA)	DETROL	—	2001-04-06	fda.gov ↗
Approved	US (FDA)	DETROL	—	1998-03-25	fda.gov ↗

Trials 41

today

US approved 1998

NCT05946902 · Ph 4 NCT03280316 · not/applicable NCT04090190 · Ph 4 NCT02599311 · Ph 3 NCT02294396 · Ph 4 NCT02138747 · Ph 4 NCT01964183 · Ph 4 NCT01661621 · Ph 4 NCT01500382 · Ph 1 NCT01521767 · Ph 1 NCT01314872 · Ph 2 NCT01302938 · Ph 4 NCT01282840 · not/applicable NCT01043666 · Ph 3 NCT01011036 · Ph 3 NCT00913315 · not/applicable NCT00939120 · Ph 4 NCT00922506 · Ph 4 NCT00836381 · Ph 4 NCT00768521 · Ph 1 NCT01503580 · not/applicable NCT00689104 · Ph 3 NCT00481728 · Ph 1 NCT00439192 · Ph 2 NCT01181505 · Ph 1 NCT00411437 · Ph 4 NCT00730535 · Ph 4 NCT00448175 · Ph 4 NCT00323635 · Ph 4 NCT00313924 · Ph 4 NCT00746681 · Ph 2 NCT00230789 · Ph 4 NCT00332137 · Ph 2 NCT00139724 · Ph 3 NCT00143481 · Ph 4 NCT00147654 · Ph 4 NCT00137397 · Ph 4 NCT00143377 · Ph 4 NCT00090584 · not/applicable NCT00645281 · Ph 4 NCT00802373 · Ph 3

199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 15 trials · 1 met primary
Phase 1	NCT01500382	Feb 2012 → Jan 2013	overactive bladder	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT01521767	Oct → Nov 2011	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 1	NCT00768521	Sep 2008 → Jan 2009	overactive bladder	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 1	NCT00481728	Jun 2007 → Dec 2008	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 1	NCT01181505	Jan 2007 → Jun 2008	—	Inje University	Completed	No outcome recorded
Phase 24 trials · 1 met primary
Phase 2	NCT01314872	Mar 2011 → Oct 2012	overactive bladder	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 2	NCT00439192	Feb → Aug 2007	overactive bladder	elbion AG	Terminated	No outcome recorded
Phase 2	NCT00746681	Dec 2005 → Nov 2006	overactive bladder	Pfizer	Completed	No outcome recorded
Phase 2	NCT00332137	Sep 2005 → Aug 2007	—	Mayo Clinic	Completed	No outcome recorded
Phase 36 trials · 1 met primary
Phase 3	NCT02599311	Aug 2015 → Oct 2019	pelvic organ prolapse	Peking University People's Hospital	Unknown	No outcome recorded
Phase 3	NCT01043666	Dec 2009 → Sep 2011	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 3	NCT01011036	Dec 2009 → Apr 2010	—	Insel Gruppe AG, University Hospital Bern	Completed	No outcome recorded
Phase 3	NCT00689104	Apr 2008 → Mar 2009	overactive bladder	Astellas Pharma Inc	Completed	Met primary
Phase 3	NCT00139724	May 2005 → Oct 2006	—	Viatris Inc.	Completed	No outcome recorded
Phase 3	NCT00802373	Jul 2003 → Oct 2004	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 421 trials · 1 missed
Phase 4	NCT05946902	Sep 2023 → Jul 2024	overactive bladder	Far Eastern Memorial Hospital	Unknown	No outcome recorded
Phase 4	NCT04090190	Oct 2019 → May 2021	overactive bladder	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 4	NCT02294396	Oct 2014 → Sep 2016	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT02138747	Jul 2014 → Oct 2015	overactive bladder	Astellas Pharma Global Development, Inc.	Completed	No outcome recorded
Phase 4	NCT01964183	Jun → Aug 2013	—	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT01661621	Aug 2012 → Aug 2013	urinary tract obstruction	Buddhist Tzu Chi General Hospital	Completed	No outcome recorded
Phase 4	NCT01302938	Mar 2011 → Aug 2012	overactive bladder	Viatris Inc.	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00939120	Jul 2009 → Sep 2014	benign prostatic hyperplasia	Siami, Paul F., M.D.	Completed	No outcome recorded
Phase 4	NCT00922506	May 2009 → May 2014	benign prostatic hyperplasia, overactive bladder	Samsung Medical Center	Completed	No outcome recorded
Phase 4	NCT00836381	Feb 2009 → Jan 2012	overactive bladder	Samsung Medical Center	Completed	No outcome recorded
Phase 4	NCT00411437	Dec 2006 → Jun 2007	—	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00730535	Aug 2006 → Jul 2009	overactive bladder	KYU-SUNG LEE	Completed	No outcome recorded
Phase 4	NCT00448175	Jun 2006 → Oct 2008	overactive bladder	Uroplasty, Inc	Completed	No outcome recorded
Phase 4	NCT00323635	Apr 2006 → Jan 2010	overactive bladder	Brigham and Women's Hospital	Terminated	No outcome recorded
Phase 4	NCT00313924	Feb → Mar 2006	overactive bladder	Rambam Health Care Campus	Unknown	No outcome recorded
Phase 4	NCT00230789	Oct 2005 → Dec 2006	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00143481	Mar 2005 → Jun 2006	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00147654	Nov 2004 → May 2006	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00137397	Nov 2004 → Aug 2006	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00143377	Sep 2004 → Oct 2005	overactive bladder	Viatris Inc.	Completed	Missed primary
Phase 4	NCT00645281	Mar 2004 → Jan 2005	overactive bladder	Viatris Inc.	Completed	No outcome recorded

Phase not applicable5 trials · 1 missed
—	NCT03280316	Jan → Oct 2023	overactive bladder, vascular malformation	Xuanwu Hospital, Beijing	Unknown	No outcome recorded
—	NCT01282840	Jul 2010 → Nov 2018	—	Far Eastern Memorial Hospital	Completed	No outcome recorded
—	NCT00913315	Aug → Oct 2009	prostatitis	Chongqing Medical University	Unknown	No outcome recorded
—	NCT01503580	Aug 2008 → Jul 2010	—	National Taiwan University Hospital	Completed	No outcome recorded
—	NCT00090584	Aug 2004 → Dec 2005	urinary bladder disorder	Carelon Research	Completed	Missed primary
Comparator or background therapy43 trials
Phase 0	NCT07016451 Background	Apr 2024 → Sep 2025	radiation cystitis	Ramathibodi Hospital	Completed	No outcome recorded
Phase 1	NCT04500860 Comparator	Dec 2020 → Jul 2022	overactive bladder	Kasr El Aini Hospital	Completed	No outcome recorded
Phase 1	NCT01036035 Comparator	Sep 2009 → Mar 2010	—	TheraVida, Inc.	Completed	No outcome recorded
Phase 1	NCT00703703 Comparator	May → Oct 2008	—	Novartis	Completed	No outcome recorded
Phase 1	NCT00553657 Background	Aug 2007 → Jan 2008	overactive bladder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1/2	NCT01291316 Comparator	Apr 2010 → Nov 2011	neuropathy, painful	University Hospital, Geneva	Completed	No outcome recorded
Phase 2	NCT01729819 Background	Jan 2013 → Nov 2014	overactive bladder	Ferring Pharmaceuticals	Completed	Missed primary
Phase 2	NCT01356355 Comparator	Apr 2012 → Sep 2014	—	Dr .S.B.PATANKAR	Completed	No outcome recorded
Phase 2	NCT00876421 Comparator	Apr 2009 → Apr 2010	overactive bladder	Ono Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 2	NCT00564226 Comparator	Nov 2007 → Feb 2009	overactive bladder	Sanofi	Completed	No outcome recorded
Phase 2	NCT00174798 Comparator	May 2005 → May 2006	overactive bladder	Sanofi	Completed	No outcome recorded
Phase 2	NCT01604928 Comparator	Apr 2004 → Jan 2005	overactive bladder	Astellas Pharma Europe B.V.	Completed	Met primary
Phase 2/3	NCT02877901 Comparator	May 2016 → Nov 2017	nocturnal enuresis	Mansoura University	Completed	No outcome recorded
Phase 2/3	NCT01530243 Comparator	Jan → Aug 2012	urinary system disorder	Urmia University of Medical Sciences	Completed	No outcome recorded
Phase 2/3	NCT01175382 Comparator	Jul 2010 → Jul 2015	overactive bladder	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 2/3	NCT00648310 Comparator	Jan 2004 → Dec 2007	overactive bladder	University of Insubria	Completed	Missed primary
Phase 3	NCT07114640 Comparator	Aug 2025 → Dec 2028 expected	overactive bladder	Far Eastern Memorial Hospital	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	NCT03583372 Comparator	Jun 2018 → Jun 2019	overactive bladder	Urovant Sciences GmbH	Completed	No outcome recorded
Phase 3	NCT03492281 Comparator	Mar 2018 → Jan 2019	overactive bladder	Urovant Sciences GmbH	Completed	Met primary
Phase 3	NCT02485067 Comparator	Jan 2015 → Jul 2016	overactive bladder	SK Chemicals Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT01179828 Comparator	Jul 2010 → Apr 2015	—	Insel Gruppe AG, University Hospital Bern	Completed	No outcome recorded
Phase 3	NCT01512004 Comparator	Jan 2010	overactive bladder	Lee's Pharmaceutical Limited	Completed	No outcome recorded
Phase 3	NCT00966004 Comparator	Jul 2009 → Feb 2010	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 3	NCT00688688 Comparator	Apr 2008 → May 2010	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 3	NCT00611026 Comparator	Feb 2008 → Oct 2009	overactive bladder	Pfizer	Completed	No outcome recorded
Phase 3	NCT00444925 Comparator	Apr 2007 → Jul 2008	overactive bladder	Pfizer	Completed	Met primary
Phase 3	NCT00368706 Comparator	Sep 2006 → Mar 2008	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 3	NCT00646880 Comparator	Mar → Aug 2003	overactive bladder	Pfizer	Completed	No outcome recorded
Phase 3	NCT01004315 Comparator	—	overactive bladder	Kissei Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 4	NCT05362292 Comparator	Oct 2022 → May 2027 expected	overactive bladder	University of California, San Francisco	Recruiting	No outcome recorded
Phase 4	NCT07829029 Comparator	Oct 2022 → May 2027 expected	—	University of California, San Francisco	Recruiting	No outcome recorded
Phase 4	NCT04909255 Comparator	Mar 2021 → Aug 2022	Sjogren syndrome, overactive bladder	China Medical University Hospital	Unknown	No outcome recorded
Phase 4	NCT05250245 Comparator	Jun 2020 → Dec 2021	obstructive sleep apnea syndrome, overactive bladder	Yuzuncu Yil University	Completed	No outcome recorded
Phase 4	NCT02436889 Comparator	Feb 2016 → Dec 2017	overactive bladder	University of California, San Francisco	Completed	Missed primary
Phase 4	NCT01824420 Background	Mar 2013 → Feb 2017	overactive bladder	Buddhist Tzu Chi General Hospital	Completed	No outcome recorded
Phase 4	NCT00547378 Comparator	Oct 2007 → Aug 2016	overactive bladder	MedtronicNeuro	Completed	No outcome recorded
Phase 4	NCT00523068 Comparator	Sep 2007 → Jan 2010	female stress incontinence, overactive bladder	Imperial College London	Withdrawn	No outcome recorded
Phase 4	NCT00413790 Comparator	Nov 2006 → Sep 2007	—	Novartis	Completed	No outcome recorded
—	NCT02723279 Comparator	Apr → Oct 2016	urethral syndrome	Shanghai Institute of Acupuncture, Moxibustion and Meridian	Completed	No outcome recorded
—	NCT03662893 Comparator	Jan 2015 → Dec 2017	overactive bladder	Ankara Training and Research Hospital	Completed	No outcome recorded
—	NCT01829425 Comparator	Apr 2013 → Oct 2017	urinary bladder disorder	University of New Mexico	Completed	No outcome recorded
—	NCT00465894 Comparator	Apr 2007 → Jul 2010	overactive bladder	University of Alabama at Birmingham	Completed	No outcome recorded

Press releases naming this drug 2 releases

Date	Issuer	Release
2014-01-03	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of Authorized Generic of Detrol® tevapharm.com ↗
2011-06-03	Impax Laboratories, LLC	Impax Laboratories Confirms Patent Suit Relating to Generic Detrol(R) Immediate-Release 1 mg and 2 mg Tablets amneal.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 86 sources stand behind the page.

Field	Value	Cited text
Known as	Tolterodine	“Nine anticholinergic drugs were included in these studies: darifenacin; fesoterodine; imidafenacin; oxybutynin; propantheline; propiverine; solifenacin; tolterodine and trospium.” PMID 37160401 ↗ May 2023 79 “Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)” NCT03662893 ↗ “Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg” NCT00547378 ↗ “Combination of Tolterodine 2mg and Pilocarpine 9mg” NCT02485067 ↗ “Tolterodine (Detrol LA or equivalent generic)” NCT01829425 ↗ “Tolterodine (Detrusitol) 4mg QD” NCT01824420 ↗ “Tolterodine (Detrusitol)” NCT02485067 ↗ “* Tolterodine” NCT07016451 ↗ “Tolterodine” NCT03280316 ↗ NCT02599311 ↗ NCT01302938 ↗ Show 69 more sources
Known as	Detrol	“Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)” NCT05658874 ↗
Known as	Detrol LA	“The aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder...” PMID 26945271 ↗ Jul 2016
Known as	Detrusitol	“The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive...” NCT00143377 ↗ 5 “Tolterodine (Detrusitol) 4mg QD” NCT01824420 ↗ “Tolterodine (Detrusitol)” NCT02485067 ↗ NCT02485067 ↗ NCT01661621 ↗ NCT00313924 ↗
Known as	Incont LA	“long acting tolterodine (Incont LA, Adwia, Egypt) 4 mg at bedtime” NCT02877901 ↗
Known as	Tolterodine (Detrol LA or equivalent generic)	“Tolterodine (Detrol LA or equivalent generic)” NCT01829425 ↗
Known as	Tolterodine ER	“1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily” NCT00939120 ↗ 2 “Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial.” PMID 24792229 ↗ May 2014 “Participants received one tolterodine ER 4 mg capsule, taken orally once a day.” NCT01314872 ↗
Known as	Tolterodine Tartrate	“This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to...” NCT01512004 ↗ 4 “The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive...” NCT00143377 ↗ “Tolterodine tartrate (GSK， UK) 4mg per day is taken orally for six weeks” NCT02723279 ↗ “Drug: tolterodine tartrate” NCT00444925 ↗ NCT02436889 ↗
Known as	Tolterodine Tartrate ER	“single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks” NCT03492281 ↗
Action	Inhibit	“An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.” NCT00465894 ↗
Route	Oral	“take either tolterodine or placebo tablets for 8 weeks” NCT00323635 ↗