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Drug

Fesoterodine fumarate

Approved · EMA
Late-stage development

Also known as Fesoterodine, Toviaz.

RxNorm797196
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Prevention of Fall in Older Adults With Overactive Bladdar

Clinical trial2023-05-06Results posted · ClinicalTrials.gov

Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly

Clinical trial2020-03-18Results posted · ClinicalTrials.gov

A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

Clinical trial2020-01-31Completed · ClinicalTrials.gov

Randomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease Population

Clinical trial2019-06-07Terminated · ClinicalTrials.gov

A Phase II, Open-Label Exploratory Study Investigating the Efficacy of Toviaz for Treatment of Adult Patients With Spinal Cord Injury With Neurogenic Detrusor Overactivity for Amelioration of Autonomic Dysreflexia(PIIR-AK-TOVIAZ-AD)

Clinical trial2019-01-31Completed · ClinicalTrials.gov

A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.

Clinical trial2018-12-05Results posted · ClinicalTrials.gov

A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

Clinical trial2018-12-04Results posted · ClinicalTrials.gov

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.

Clinical trial2018-12-04Results posted · ClinicalTrials.gov

Efficacy and Tolerability of Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children: a Comparative Study.

Clinical trial2018-08-01Completed · ClinicalTrials.gov

Efficacy and Tolerability of Fesoterodine for Overactive Bladder Syndrome in Children: an Extension Study.

Clinical trial2018-08-01Completed · ClinicalTrials.gov

A Randomized Double-blinded Trial Comparing DEsmopressin to FEsoterodine in the Treatment of Severe Nocturia in Women Aged 65 and olDer: The DEFEND Trial

Clinical trial2016-02-01Terminated · ClinicalTrials.gov

Approval: Toviaz (EMA)

Regulatory2007-04-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Fesoterodine fumarate
Aliases & brands
FesoterodineToviaz
RxNorm CUI
797196
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-04-20
Latest approval
2007-04-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-04-20Approval
Approval: Toviaz (EMA)

Indication: Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

39 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
39
registered trials across all phases
LATEST COMPLETION 2020
25
Late-stage (III+)
34
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 39
Phase 19Phase 25Phase 2 / 31Phase 39Phase 413Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease Population

TerminatedPH IVSir Mortimer B. Davis - Jewish General Hospitaln=52019

Prevention of Fall in Older Adults With Overactive Bladdar

CompletedPH IVUniversity of Pennsylvanian=742017

A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Laparoscopic Prostatectomy )

CompletedPH IVAbramson Cancer Center at Penn Medicinen=32013

Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate

TerminatedPH IVMayo Clinicn=42013

A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

CompletedPH IVKey trialPfizern=2,0122012

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

CompletedPH IIUniversity of Albertan=472020

A Phase II, Open-Label Exploratory Study Investigating the Efficacy of Toviaz for Treatment of Adult Patients With Spinal Cord Injury With Neurogenic Detrusor Overactivity for Amelioration of Autonomic Dysreflexia(PIIR-AK-TOVIAZ-AD)

CompletedPH IIUniversity of British Columbian=152019

Efficacy and Tolerability of Fesoterodine for Overactive Bladder Syndrome in Children: an Extension Study.

CompletedPH IIIStéphane Bolducn=262018

Efficacy and Tolerability of Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children: a Comparative Study.

CompletedPH IIIStéphane Bolducn=622018

Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly

CompletedPH IIIUniversity of North Carolina, Chapel Hilln=612017

Prevention of Fall in Older Adults With Overactive Bladdar

CompletedPH IVUniversity of Pennsylvanian=742017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.