Drugs / Fesoterodine
Fesoterodine
also known as
fesoterodine fumarate · SPM 907 · Toviaz · Fesoterodina · Fesoterodine ER · Fesoterodine SR3 · Fesoterodine SR4 · SPM 8272
Other / unclassified targets CHRM2, CHRM3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TOVIAZ | — | 2021-06-17 | fda.gov ↗ |
| Approved | US (FDA) | TOVIAZ | — | 2008-10-31 | fda.gov ↗ |
| Approved | EU (EMA) | Toviaz | — | 2007-04-20 | europa.eu ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00713921 | Sep 2009 → Jan 2014 | urinary bladder disorder | Saint Thomas Health | Withdrawn | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT02160158 | Jul → Dec 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01925456 | May 2011 → Dec 2013 | overactive bladder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 1 | NCT01286454 | Dec 2010 → Mar 2011 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01161472 | Jul → Sep 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00914667 | Jul → Aug 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00911235 | May → Jul 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00832650 | Apr → Dec 2009 | — | Pfizer | Terminated | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT02240459 | Aug 2016 → Jan 2020 | cognitive impairment with or without cerebellar ataxia, overactive bladder | University of Alberta | Completed | No outcome recorded |
| Phase 2 | NCT02676154 | Feb 2016 → Jan 2019 | autonomic dysreflexia | University of British Columbia | Completed | No outcome recorded |
| Phase 2 | NCT00857896 | Mar 2009 → Dec 2010 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01042236 | Jan 2009 → Jul 2010 | female stress incontinence | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00561951 | Nov 2007 → Jan 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00220389 | Jun 2003 → Jun 2007 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT02614482 | Oct 2015 → Jun 2018 | overactive bladder | Stéphane Bolduc | Completed | No outcome recorded |
| Phase 3 | NCT02501928 | Jun 2015 → Apr 2020 | urinary bladder disorder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02327936 | Dec 2014 → Mar 2018 | overactive bladder | Stéphane Bolduc | Completed | No outcome recorded |
| Phase 3 | NCT01786967 | Sep 2012 → Dec 2017 | urinary bladder disorder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 3 | NCT01557244 | Jul 2012 → Nov 2019 | urinary bladder disorder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00611026 | Feb 2008 → Oct 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00658684 | Feb 2008 → Aug 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00546637 | Nov 2007 → Feb 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00536484 | Aug 2007 → Mar 2008 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00444925 | Apr 2007 → Jul 2008 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00425100 | Jan → Oct 2007 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00220402 | Jul 2004 → Jul 2007 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00220376 | Apr 2004 → Jul 2007 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00220363 | Jan 2004 → Feb 2005 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00138723 | Oct 2003 → Feb 2005 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT04090190 | Oct 2019 → May 2021 | overactive bladder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02385500 | Sep 2016 → Jun 2019 | Parkinson disease, overactive bladder | Sir Mortimer B. Davis - Jewish General Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT03946124 | Jul 2015 → Jul 2017 | overactive bladder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01661166 | Jan 2012 → Apr 2013 | prostate adenocarcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01302054 | May 2011 → May 2012 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT01302067 | May 2011 → Nov 2012 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT01054222 | May 2010 → Jan 2012 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00605319 | Jan 2010 → Jan 2013 | urinary tract obstruction | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT00928070 | Sep 2009 → Sep 2011 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00911937 | Aug 2009 → Sep 2011 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00806494 | Feb 2009 → Jan 2010 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00862745 | Jan 2009 → May 2010 | overactive bladder | University of California, San Francisco | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01367886 | Aug 2010 → Sep 2011 | overactive bladder | Washington University School of Medicine | 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 9 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 11 trial | ||||||
| Phase 1 | NCT01566760 Comparator | May → Jul 2012 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02262936 Comparator | Jul 2015 → Feb 2016 | nocturnal enuresis | Mount Sinai Hospital, Canada | Terminated | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT01605617 Comparator | Jun 2012 → Mar 2013 | overactive bladder | Mayo Clinic | Terminated | No outcome recorded |
| Phase 4 | NCT01613170 Background | Apr 2012 → Apr 2018 | overactive bladder | The Cleveland Clinic | Unknown | No outcome recorded |
| Phase 4 | NCT01578304 Comparator | Dec 2010 → Oct 2011 | overactive bladder | LG Life Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00798434 Comparator | Jun 2008 → Sep 2010 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03662893 Comparator | Jan 2015 → Dec 2017 | overactive bladder | Ankara Training and Research Hospital | Completed | No outcome recorded |
| — | NCT01595152 Comparator | May 2012 → May 2013 | overactive bladder | Rambam Health Care Campus | Unknown | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fesoterodine | “The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.” NCT00220389 ↗47“This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.” NCT00220402 ↗ “Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)” NCT03662893 ↗ “Fesoterodine is a medication used to treat overactive bladder.” PMID 35881009 ↗ Jul 2022 “* Fesoterodine β3-Adrenergic Agonists” NCT07016451 ↗ “fesoterodine (SPM 907) 4mg” NCT00220363 ↗ |
| Known as | Fesoterodina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201764 ↗ |
| Known as | Fesoterodine ER | “Commercial Fesoterodine ER 4 mg (single dose)” NCT02160158 ↗ |
| Known as | fesoterodine fumarate | “one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose” NCT01566760 ↗4“Drug: fesoterodine fumarate” NCT00561951 ↗ “Drug: fesoterodine fumarate” NCT00444925 ↗ “Drug: fesoterodine fumarate” NCT00832650 ↗ |
| Known as | Fesoterodine SR3 | “Fesoterodine SR3 4 mg (single dose)” NCT02160158 ↗ |
| Known as | Fesoterodine SR4 | “Fesoterodine SR4 4 mg (single dose)” NCT02160158 ↗ |
| Known as | SPM 8272 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201764 ↗ |
| Known as | SPM 907 | “The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.” NCT00220389 ↗3“This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.” NCT00220402 ↗ “fesoterodine (SPM 907) 4mg” NCT00220363 ↗ |
| Known as | Toviaz | “At the end of the 12 week blinded trial, participants will be offered open-label fesoterodine (Toviaz™), for 9 months beginning at 4 mg with participant directed dose adjustment.” NCT00862745 ↗3“Toviaz (fesoterodine) is approved to treat the condition that is discussed in this summary.” PMID 35881009 ↗ Jul 2022 |
| Action | Inhibit | “Fesoterodine is an antimuscarinic for the treatment of overactive bladder” PMID 20723260 ↗ Aug 20102“Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1201764 ↗ “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1201764 ↗ |
| Modality | Other / unclassified | “Fesoterodine, an antimuscarinic drug, has been successfully employed as a first-line treatment for detrusor overactivity in individuals without an underlying neurological disorder.” PMID 30467135 ↗ Nov 2018 |
| Route | Oral | “Tablets” NCT00444925 ↗ |
| Target | CHRM2 | “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1201764 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1201764 ↗ |