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fesoterodine

Trade name: toviaz

Small moleculeapproved

Approved

Oct 31, 2008

Fesoterodine (trade name Toviaz) is a prodrug of 5-hydroxymethyl tolterodine, which is also the active metabolite of tolterodine. Fesoterodine and its active metabolites are nonsubtype selective, competitive antagonists of human muscarinic receptors, but 5-hydroxymethyl tolterodine has greater potency than the parent compound. A prodrug approach was necessary for systemic bioavailability of 5-hydroxymethyl tolterodine after oral administration. Fesoterodine was originated by Schwarz Pharma (later a subsidiary of UCB) and is being developed by Pfizer for the treatment of overactive bladder and urinary urge incontinence. The agent is launched in several countries for the treatment of overactive bladder, including the US, Japan, Canada, Europe and Asia. — NCATS

Clinical trial activity

60 trials · 35 clinical orgs · 19 marketing orgs

Phase 1
15
Phase 2
23
Phase 3
16
Phase 4
15

Earliest trial started Jun 1, 2003 (NCT00220389)

Timeline

1990s

  1. Jun 1, 1998

    Schwarz Pharma — IND Organization

  2. Jun 1, 1998

    Schwarz Pharma — IND Organization

2000s

  1. Jan 1, 2003

    Pfizer — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Pfizer — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Pfizer — Earliest Phase 1 Sponsor(trial)

  4. Oct 31, 2008

    Pfizer — Earliest FDA Approval

  5. Oct 31, 2008

    Pfizer — NDA Organization

2010s

  1. Feb 27, 2015

    Sun Pharmaceuticals — Marketing Organization

  2. Apr 28, 2015

    Alembic — Marketing Organization

  3. Apr 28, 2015

    Amerigen Pharmaceuticals — Marketing Organization

  4. Apr 29, 2015

    Actavis — Marketing Organization

  5. Apr 29, 2015

    Lupin — Marketing Organization

  6. Apr 30, 2015

    Amneal Pharmaceuticals — Marketing Organization

  7. May 1, 2015

    Sandoz — Marketing Organization

  8. May 1, 2015

    Novartis — Marketing Organization

  9. Dec 10, 2015

    Alkem Labs Ltd — Marketing Organization

  10. Dec 29, 2015

    Dr. Reddy's Laboratories — Marketing Organization

  11. May 27, 2016

    Accord Research — Marketing Organization

  12. Feb 17, 2017

    Aurobindo Pharma — Marketing Organization

  13. Oct 3, 2017

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Jan 4, 2023

    Ani Pharmaceuticals — Marketing Organization

  2. Jan 4, 2023

    AbbVie — Marketing Organization

  3. Jan 5, 2023

    Chartwell Pharmaceuticals — Marketing Organization

  4. Jan 9, 2024

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 31, 2008

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Mol. weight
411.59 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • fes
  • fes
  • feso
  • feso
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine
  • fesoterodine fumarate
  • fesoterodine fumarate
  • fesoterodine fumarate
  • fesoterodine fumarate
  • fesoterodine fumarate
  • fesoterodine fumarate
  • fesoterodine fumarate
  • spm-8272
  • spm-8272
  • spm-907
  • spm-907
  • toviaz
  • toviaz
  • toviaz
  • toviaz
  • toviaz
  • toviaz

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05659797Early Phase 1 (Phase 1)Jan 31, 2023University of Pennsylvania
NCT04452838Phase 1Jun 26, 2020Pfizer
NCT04125277N/ANov 30, 2019Borstkanker Onderzoek Groep, Dutch Cancer Society, University of Groningen
NCT04478357Phase 1Nov 12, 2019Pfizer
NCT04090190N/ASep 30, 2019Harvard University, Silesian University of Medicine
NCT03703492Phase 2Nov 12, 2018National Cancer Institute (NCI), University of Wisconsin
NCT02240459Phase 2Aug 1, 2016Pfizer, University of Alberta
NCT02676154Phase 2Feb 1, 2016International Collaboration On Repair Discoveries (ICORD), Pfizer, University of British Columbia, Vancouver Coastal Health
NCT02614482Phase 3Oct 1, 2015Laval University, Pfizer
NCT03946124Phase 4Jul 25, 2015Pfizer, University of Pennsylvania
NCT02262936Phase 2/Phase 3 (Phase 3)Jul 1, 2015Icahn School of Medicine at Mount Sinai, The Physicians' Services Incorporated Foundation, University of Toronto
NCT02501928Phase 3Jun 5, 2015Pfizer
NCT02409316Phase 2May 1, 2015University of Pennsylvania
NCT02385500Phase 4Mar 1, 2015McGill University
NCT03662893N/AJan 1, 2015Government of Turkey, University of Ankara
NCT02327936Phase 3Dec 1, 2014Laval University, Pfizer
NCT02160158Phase 1Jul 1, 2014Pfizer
NCT01786967Phase 3Sep 1, 2012National Institute on Aging (NIA), University of North Carolina at Chapel Hill
NCT01557244Phase 3Jul 2, 2012Pfizer
NCT01605617Phase 4Jun 1, 2012Mayo Clinic
Showing 20 of 60 trials
Page 1 / 3

Organizations

Research & Development (35)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit453642003
University of PennsylvaniaAcademic/Hospital5532011
Hoosier Cancer Research NetworkAcademic/Hospital4022003
Laval UniversityAcademic/Hospital2212014
Sungkyunkwan UniversityAcademic/Hospital2122010
Belinson Medical centerAcademic/Hospital1012012
Borstkanker Onderzoek GroepAcademic/Hospital1012019
Cornell UniversityAcademic/Hospital1112010
Dutch Cancer SocietyAcademic/Hospital1012019
Government of TurkeyGovernment1012015
Harvard UniversityAcademic/Hospital1112019
Hebrew UniversityAcademic/Hospital1012012
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012015
International Collaboration On Repair Discoveries (ICORD)Academic/Hospital1012016
Kyorin PharmaFor profit1012010
LGFor profit1112010
Mayo ClinicAcademic/Hospital1112012
McGill UniversityAcademic/Hospital1112015
National Cancer Institute (NCI)Government1012018
National Institute on Aging (NIA)Government1012012
35 organizations
Page 1 / 2

Marketing (24)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJan 4, 2023
Accord ResearchFor profitMKTGMay 27, 2016
Accord ResearchFor profitSYNJan 4, 2023
ActavisFor profitMKTGApr 29, 2015
AlembicFor profitMKTGApr 28, 2015
AlembicFor profitSYNJan 4, 2023
Alkem Labs LtdFor profitMKTGDec 10, 2015
Amerigen PharmaceuticalsFor profitMKTGApr 28, 2015
Amneal PharmaceuticalsFor profitMKTGApr 30, 2015
Amneal PharmaceuticalsFor profitSYNJan 4, 2023
Ani PharmaceuticalsFor profitMKTGJan 4, 2023
Aurobindo PharmaFor profitMKTGFeb 17, 2017
Aurobindo PharmaFor profitSYNFeb 17, 2017
Chartwell PharmaceuticalsFor profitMKTGJan 5, 2023
Dr. Reddy's LaboratoriesFor profitSYNAug 13, 2019
Dr. Reddy's LaboratoriesFor profitMKTGDec 29, 2015
Hetero Labs LtdFor profitMKTGJan 9, 2024
LupinFor profitMKTGApr 29, 2015
NovartisFor profitMKTGMay 1, 2015
PfizerFor profitNDAOct 31, 2008
SandozFor profitMKTGMay 1, 2015
Schwarz PharmaFor profitINDJun 1, 1998
Sun PharmaceuticalsFor profitMKTGFeb 27, 2015
Zydus Discovery DMCCFor profitMKTGOct 3, 2017