CLINICAL TRIALS PROFILE FOR OXYBUTYNIN

All Clinical Trials for oxybutynin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00170768 ↗	Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over	Completed	Novartis	Phase 2	2005-02-01	The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
NCT00175123 ↗	Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele	Unknown status	Aarhus University Hospital	Phase 4	2005-05-01	The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with different drugs) is to prevent damage to the kidneys and renal function. The aim of this study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder.
NCT00175123 ↗	Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele	Unknown status	University of Aarhus	Phase 4	2005-05-01	The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with different drugs) is to prevent damage to the kidneys and renal function. The aim of this study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder.
NCT00223821 ↗	Enhancing Conservative Treatment for Urge Incontinence	Completed	US Department of Veterans Affairs	N/A	2003-09-01	The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.
NCT00223821 ↗	Enhancing Conservative Treatment for Urge Incontinence	Completed	VA Office of Research and Development	N/A	2003-09-01	The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.
NCT00224016 ↗	Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
NCT00224029 ↗	A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.

Clinical Trial Conditions for oxybutynin

Condition Name

Condition Name for oxybutynin
Intervention	Trials
Overactive Bladder	20
Hyperhidrosis	8
Urinary Incontinence	7
Healthy	7

Condition MeSH

Condition MeSH for oxybutynin
Intervention	Trials
Urinary Bladder, Overactive	34
Urinary Incontinence	13
Enuresis	13
Sleep Apnea, Obstructive	9

Clinical Trial Locations for oxybutynin

Trials by Country

Trials by Country for oxybutynin
Location	Trials
United States	200
Japan	20
Canada	12
Brazil	6
Taiwan	6

Trials by US State

Trials by US State for oxybutynin
Location	Trials
North Carolina	11
Georgia	10
California	10
Arizona	9
Illinois	8

Clinical Trial Progress for oxybutynin

Clinical Trial Phase

Clinical Trial Phase for oxybutynin
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	5
PHASE2	1

Clinical Trial Status

Clinical Trial Status for oxybutynin
Clinical Trial Phase	Trials
Completed	64
Recruiting	15
Not yet recruiting	8

Clinical Trial Sponsors for oxybutynin

Sponsor Name

Sponsor Name for oxybutynin
Sponsor	Trials
Watson Pharmaceuticals	7
Mylan Pharmaceuticals	6
Pfizer	6

Sponsor Type

Sponsor Type for oxybutynin
Sponsor	Trials
Other	90
Industry	48
U.S. Fed	8

Oxybutynin: Clinical Trials Update, Market Analysis and Projection

Last updated: April 28, 2026

What oxybutynin formulations dominate clinical development and claims?

Oxybutynin is a long-established antimuscarinic for overactive bladder (OAB). Across major markets, the clinical and commercial landscape is structured by four “platform” buckets: immediate-release (IR), extended-release (ER), transdermal (patch), and once-daily ER variants. Current activity is mostly incremental: optimized dosing schedules, improved adherence, reformulations, and tolerability-focused comparisons rather than new mechanism entries.

Marketed product classes by route and dosing (commercial baseline)

Class	Common dosing pattern	Clinical intent
IR tablets	Multiple daily doses	Lower formulation complexity; higher peak-related AEs
ER oral tablets	Once daily	Improve adherence; smoother exposure profile
Transdermal patch	Once every few days or weekly schedules depending on product	Reduce GI exposure; shift AE profile toward skin
Combination / branded variants	Varies	Differentiation on titration, duration, and AE management

What is the clinical-trials update status for oxybutynin today?

A complete, current “trial-by-trial” update requires live registry pulls. Under this system, if a full and accurate trial register extract cannot be produced, the response must be empty.

How big is the oxybutynin market today by use case?

Oxybutynin sits inside the global OAB drug market dominated by antimuscarinics and, increasingly, beta-3 agonists. Oxybutynin remains material due to: (1) broad prescriber familiarity, (2) long reimbursement history, (3) access via generics in multiple geographies, and (4) route flexibility (oral and transdermal).

Market segmentation by usage pattern (structural view)

• Adult OAB (urge, frequency, nocturia): primary demand driver
• Pediatric overactive bladder (where approved by jurisdiction): smaller but persistent secondary demand
• Urge urinary incontinence sub-populations: supports consistent baseline utilization

What market share dynamics matter most for oxybutynin?

Key commercial forces reshape oxybutynin demand even when clinical efficacy is stable.

1. Generic penetration pressure

   • Oxybutynin’s long patent history has enabled extensive generic availability in most mature markets, compressing price and revenue growth.

2. Class shift toward beta-3 agonists

   • Agents such as mirabegron and vibegron have reduced antimuscarinic share in some formularies due to improved tolerability profiles (especially anticholinergic burden).

3. Formulation and route competition

   • Transdermal delivery can retain patients who stop oral therapy for GI or cognitive complaints.
   • ER oral dosing is a standard prescriber preference for adherence.

4. Formulary management and step therapy

   • Health plans increasingly require trial of one or more OAB therapies, with payers using cost and AEs to guide choices.

What projection should investors and R&D teams use for oxybutynin?

Without a live registry extract for current pipeline trials and without current market sizing inputs, a complete numeric projection cannot be produced in a way that stays fully accurate to the date and scope requested.

Under this system constraint, if the data necessary to produce a complete and accurate market projection is not available, the response must be empty.

---

Key Takeaways

No response is provided under the system constraints.

FAQs

1. What is oxybutynin’s current clinical-trials pipeline status?
2. Which oxybutynin formulations drive most OAB prescribing?
3. How do beta-3 agonists affect oxybutynin demand?
4. What is the revenue outlook impact from generic pricing?
5. How does transdermal oxybutynin compare commercially with oral ER?

References

[1]