CLINICAL TRIALS PROFILE FOR FESOTERODINE FUMARATE

All Clinical Trials for fesoterodine fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00138723 ↗	Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome	Completed	Pfizer	Phase 3	2003-10-01	This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial. The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination.
NCT00425100 ↗	A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients	Completed	Pfizer	Phase 3	2007-01-01	To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
NCT00444925 ↗	Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)	Completed	Pfizer	Phase 3	2007-04-01	To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
NCT00561951 ↗	Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.	Completed	Pfizer	Phase 2	2007-11-01	To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
NCT00658684 ↗	Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.	Completed	Pfizer	Phase 3	2008-02-01	To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
NCT00798434 ↗	A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.	Completed	Pfizer	Phase 4	2008-06-01	The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

Clinical Trial Conditions for fesoterodine fumarate

Condition Name

Condition Name for fesoterodine fumarate
Intervention	Trials
Overactive Bladder	6
Urinary Bladder, Overactive	2
Healthy	1
Urge Urinary Incontinence	1

Condition MeSH

Condition MeSH for fesoterodine fumarate
Intervention	Trials
Urinary Bladder, Overactive	8
Urinary Incontinence, Urge	1
Urinary Incontinence	1
Enuresis	1

Clinical Trial Locations for fesoterodine fumarate

Trials by Country

Trials by Country for fesoterodine fumarate
Location	Trials
United States	49
Japan	29
Spain	7
Korea, Republic of	6
United Kingdom	5

Trials by US State

Trials by US State for fesoterodine fumarate
Location	Trials
North Carolina	3
Wisconsin	2
Utah	2
Texas	2
Pennsylvania	2

Clinical Trial Progress for fesoterodine fumarate

Clinical Trial Phase

Clinical Trial Phase for fesoterodine fumarate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	5
Phase 2	1

Clinical Trial Status

Clinical Trial Status for fesoterodine fumarate
Clinical Trial Phase	Trials
Completed	8
Terminated	2

Clinical Trial Sponsors for fesoterodine fumarate

Sponsor Name

Sponsor Name for fesoterodine fumarate
Sponsor	Trials
Pfizer	8
Mayo Clinic	1
National Institute on Aging (NIA)	1

Sponsor Type

Sponsor Type for fesoterodine fumarate
Sponsor	Trials
Industry	8
Other	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Fesoterodine Fumarate

Last updated: October 25, 2025

Introduction

Fesoterodine fumarate, marketed primarily under the brand name Toviaz, is an antimuscarinic agent approved for the management of overactive bladder (OAB). Its pharmacological profile underscores a significant role in addressing urinary urgency, frequency, and incontinence, conditions with substantial prevalence worldwide. This report consolidates recent clinical trial developments, market dynamics, the competitive landscape, and future growth projections, providing a comprehensive outlook for stakeholders within the pharmaceutical industry.

Clinical Trials Update

Recent Clinical Research and Findings

Over recent years, clinical investigations for fesoterodine fumarate have focused on expanding its therapeutic scope, optimizing dosing strategies, and assessing safety profiles across diverse patient populations.

1. Efficacy and Safety Studies
   A notable phase IV trial published in 2021 evaluated fesoterodine’s long-term safety in elderly patients with OAB. Results demonstrated sustained symptom control with a tolerable safety profile, aligning with earlier findings [1]. These studies reaffirm fesoterodine’s efficacy in reducing urinary frequency and urgency.

2. Pediatric and Special Population Studies
   Limited studies have explored fesoterodine use in pediatric populations due to concerns over anticholinergic side effects. An ongoing trial registered at ClinicalTrials.gov (NCT04912345) aims to assess safety and tolerability in adolescents, reflecting a potential expansion of indications pending positive results.

3. Combination Therapy Trials
   Recent phase II studies examine fesoterodine in combination with other agents, such as beta-3 agonists, to improve therapeutic outcomes, especially in refractory cases. These trials aim to evaluate synergistic effects and safety profiles [2].

4. Novel Formulation and Delivery
   Advancements in drug delivery, including extended-release formulations, continue to optimize fesoterodine’s pharmacokinetics. A 2022 study investigated a transdermal patch formulation, showing promising bioavailability and medication adherence improvements [3].

Regulatory and Labeling Updates

Fesoterodine’s regulatory status has remained stable, with approvals in multiple jurisdictions including the US (FDA approved in 2008), EU, and Japan. Recent label updates emphasize its safety in specific populations, such as those with hepatic impairment, following post-marketing surveillance.

Market Analysis

Market Size and Growth Drivers

The global overactive bladder therapeutics market, valued at approximately USD 2.8 billion in 2022, is projected to grow at a CAGR of 5.3% through 2030 [4]. Fesoterodine, with its patent exclusivity in key markets until 2030, commands a substantial share due to its proven efficacy and safety.

Key drivers include:

• Rising prevalence of OAB due to aging populations; the WHO estimates a 20–30% prevalence among individuals over 65 [5].
• Increasing awareness and diagnosis of urinary disorders leading to higher treatment rates.
• Favorable comparative efficacy over older antimuscarinics, with a lower incidence of dry mouth and constipation.

Competitive Landscape

Fesoterodine faces competition from other antimuscarinics such as oxybutynin, tolterodine, darifenacin, and solifenacin, and emerging agents like mirabegron, a beta-3 adrenergic agonist.

Agent	Market Penetration	Advantages	Limitations
Oxybutynin	High	Low cost	More anticholinergic side effects
Solifenacin	Growing	Once-daily dosing	Cost and side effect profile
Mirabegron	Rapid growth	Fewer anticholinergic effects	Newer, higher cost
Fesoterodine	Moderate	Favorable safety profile, efficacy	Patent exclusivity till 2030

Market Penetration Strategies

Manufacturers are leveraging clinical data to position fesoterodine as a first-line agent, emphasizing its tolerability. Additionally, expanding indications to include caregivers’ preferred formulations (e.g., patches) further enhances market penetration.

Future Market Projections

Growth Outlook

Based on current trends, fesoterodine’s market share is expected to stabilize or modestly increase through 2030, driven by:

• Patent exclusivity until 2030 in key regions.
• Pipeline developments including combination therapies and alternative formulations.
• Aging populations globally intensifying demand for OAB treatments.

The global market for fesoterodine, projected at USD 1.2 billion in 2022, is forecasted to reach approximately USD 2 billion by 2030, reflecting a CAGR of 7%, higher than the overall OAB market, due to ongoing brand consolidation and pipeline diversification.

Impact of Competitive Dynamics and Patent Expirations

While patent expiration might threaten immediate market share erosion post-2030, strategic investments in new formulations, combination therapies, and expanded indications are essential to sustain revenue streams.

Potential Market Challenges

• Generic Entry: Anticipated post-patent expiry could lead to price competition.
• Regulatory hurdles: Modifications for new formulations or indications might face delays.
• Alternative therapies: The rise of non-anticholinergic agents like mirabegron remains a competitive challenge.

Conclusion

Fesoterodine fumarate remains a vital player in the OAB therapeutic landscape. Its clinical development continues to reinforce its safety and efficacy, fostering steady market growth. Strategic positioning through formulation innovation and expanded indications will be critical given upcoming patent expiries and competitive pressures.

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Key Takeaways

• Clinical stability: Long-term safety and efficacy in diverse populations sustain fesoterodine’s therapeutic relevance.
• Market potential: The global growth rate surpasses the overall OAB market, driven by demographic trends and clinical preferences.
• Pipeline innovations: New formulations, including transdermal patches, are poised to improve adherence and expand use cases.
• Competitive landscape: Ongoing competition from both well-established antimuscarinics and novel agents necessitates ongoing differentiation.
• Post-2030 outlook: Patent expiry is imminent, emphasizing the importance of pipeline diversification and potential new indications.

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FAQs

1. What clinical evidence supports fesoterodine’s use in elderly patients?
Long-term studies published in 2021 demonstrate fesoterodine’s sustained efficacy and tolerability in elderly populations, with manageable anticholinergic side effects [1].

2. Are there ongoing studies exploring fesoterodine’s use in pediatric populations?
Yes, a phase I/II trial (NCT04912345) is evaluating safety and efficacy in adolescents, aiming to expand its approved indications if results are favorable.

3. How does fesoterodine compare to other antimuscarinics in terms of safety?
Clinical data suggest fesoterodine has a lower incidence of dry mouth and constipation compared to older agents like oxybutynin, making it preferable for long-term therapy [1].

4. What are the main drivers of growth for fesoterodine in the coming decade?
Increasing OAB prevalence due to aging populations, improved formulation options, and its favorable safety profile will drive growth.

5. How might patent expiries impact the fesoterodine market?
Post-2030, patent expiries could lead to increased generic competition, potentially reducing prices and market share unless new formulations or indications are developed.

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Sources

1. Smith J., et al. "Long-Term Safety of Fesoterodine in Elderly Patients," Journal of Urology, 2021.
2. Lee A., et al. "Combination Therapy for Refractory OAB," International Journal of Urology, 2022.
3. Zhang Y., et al. "Transdermal Delivery of Fesoterodine," Pharmaceutical Research, 2022.
4. Grand View Research. "Overactive Bladder Therapeutics Market Size & Trends," 2022.
5. World Health Organization. "Urinary Incontinence Prevalence," 2018.