Drugs / Tolterodine
Tolterodine
also known as
Detrusitol · tolterodine tartrate · Tolterodine ER · Detrol LA · Blerone xl · Detrol · Detrusitol xl · Efflosomyl xl · +13 more
Small molecule targets CHRM2, CHRM3 via inhibition
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 44 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01500382 | Feb 2012 → Jan 2013 | overactive bladder | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| Phase 2 | NCT01314872 | Mar 2011 → Oct 2012 | overactive bladder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 423 trials | ||||||
| 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 | NCT01741454 | Nov 2012 → Mar 2018 | ureteral obstruction | University of Wisconsin, Madison | 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 |
| 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 | NCT00282932 | Jan 2006 → May 2007 | overactive bladder | Viatris Inc. | Completed | 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 | No outcome recorded |
| Phase 4 | NCT00645281 | Mar 2004 → Jan 2005 | overactive bladder | Viatris Inc. | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | 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 |
| — | NCT00780832 | May 2008 → Dec 2012 | overactive bladder | IWK Health Centre | Terminated | No outcome recorded |
| — | NCT00090584 | Aug 2004 → Dec 2005 | urinary bladder disorder | Carelon Research | Completed | No outcome recorded |
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| 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 1/21 trial | ||||||
| Phase 1/2 | NCT01291316 Comparator | Apr 2010 → Nov 2011 | neuropathy, painful | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT01729819 Background | Jan 2013 → Nov 2014 | overactive bladder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2/34 trials | ||||||
| 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 | No outcome recorded |
| Phase 315 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase 3 | NCT03575702 Comparator | Jul 2016 → Aug 2017 | overactive bladder | R-Pharm | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 48 trials | ||||||
| Phase 4 | NCT05362292 Comparator | Oct 2022 → May 2027 expected | overactive bladder | 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 | No outcome recorded |
| 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 |
| Phase not applicable4 trials | ||||||
| — | 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 1 release
| Date | Issuer | Release |
|---|---|---|
| 2014-01-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of Authorized Generic of Detrol® tevapharm.com ↗ |
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 90 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 202378“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 ↗ |
| Known as | Blerone xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| 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 ↗ |
| Known as | Detrusitol xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Efflosomyl xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Inconex xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Incont LA | “long acting tolterodine (Incont LA, Adwia, Egypt) 4 mg at bedtime” NCT02877901 ↗ |
| Known as | KABI 2234 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Mariosea xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Neditol xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | PNU-200583E | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Preblacon xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Santizor xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| Known as | Tolterodina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| 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 ↗3“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 l-tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1382 ↗ |
| 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 ↗ |
| Known as | Tolterodine Tartrate ER | “single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks” NCT03492281 ↗ |
| Known as | Urotol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03575702 ↗ |
| Action | Inhibit | “An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.” NCT00465894 ↗2“Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1382 ↗ “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1382 ↗ |
| Modality | Small molecule | — CHEMBL1382 ↗ |
| Route | Oral | “take either tolterodine or placebo tablets for 8 weeks” NCT00323635 ↗ |
| Target | CHRM2 | “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1382 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1382 ↗ |