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 · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed overactive bladder 1 milestone | |||||
| Filed | US (FDA) | — | overactive bladder | 2013-07-03 | “filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of TOVIAZ® with the U.S. Food & Drug Administration” amneal.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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| Phase 0 | NCT00713921 | Sep 2009 → Jan 2014 | urinary bladder disorder | Saint Thomas Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 17 trials · 2 missed | ||||||
| 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 | Missed primary |
| 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 | Missed primary |
| Phase 26 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 2 | NCT00220389 | Jun 2003 → Jun 2007 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 315 trials · 4 met primary · 2 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT01557244 | Jul 2012 → Nov 2019 | urinary bladder disorder | Pfizer | Completed | Met primary |
| Phase 3 | NCT00658684 | Feb 2008 → Aug 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00611026 | Feb 2008 → Oct 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00546637 | Nov 2007 → Feb 2009 | overactive bladder | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00536484 | Aug 2007 → Mar 2008 | overactive bladder | Pfizer | Completed | Met primary |
| Phase 3 | NCT00444925 | Apr 2007 → Jul 2008 | overactive bladder | Pfizer | Completed | Met primary |
| Phase 3 | NCT00425100 | Jan → Oct 2007 | overactive bladder | Pfizer | Completed | Met primary |
| 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 · 4 met primary | ||||||
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 4 | NCT01302067 | May 2011 → Nov 2012 | overactive bladder | Pfizer | Completed | Met primary |
| 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 | Met primary |
| Phase 4 | NCT00911937 | Aug 2009 → Sep 2011 | overactive bladder | Pfizer | Completed | Met primary |
| 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 · 1 missed | ||||||
| — | NCT01367886 | Aug 2010 → Sep 2011 | overactive bladder | Washington University School of Medicine | Completed | Missed primary |
| — | NCT01499069 | Feb 2010 → Nov 2015 | overactive bladder | Samsung Medical Center | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01566760 Comparator | May → Jul 2012 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 2/3 | NCT02262936 Comparator | Jul 2015 → Feb 2016 | nocturnal enuresis | Mount Sinai Hospital, Canada | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01605617 Comparator | Jun 2012 → Mar 2013 | overactive bladder | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-01-06 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Fesoterodine Fumarate Extended-Release Tablets lupin.com ↗
Mumbai, Baltimore, January 06, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, to market a generic equivalent of Toviaz® Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. |
| 2023-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory 6th January, 2023, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended -Release Tablets, 4 mg and 8 mg. |
| 2022-02-01 | Alembic Pharmaceuticals Ltd. | Regulatory 2nd February, 2022, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2013-07-03 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to Generic TOVIAZ® 4 mg and 8 mg amneal.com ↗
Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-01-06 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Fesoterodine Fumarate Extended-Release Tablets lupin.com ↗ |
| 2023-01-01 | Alembic Pharmaceuticals Ltd. | 6th January, 2023, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2022-02-01 | Alembic Pharmaceuticals Ltd. | 2nd February, 2022, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2013-07-03 | Impax Laboratories, LLC | Impax Laboratories Confirms Patent Challenge Relating to Generic TOVIAZ® 4 mg and 8 mg amneal.com ↗ |
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” NCT00832650 ↗ “Drug: fesoterodine fumarate” NCT00444925 ↗ |
| 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 ↗ |