CLINICAL TRIALS PROFILE FOR DITROPAN

All Clinical Trials for DITROPAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00269750 ↗	A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.	Completed	Alza Corporation, DE, USA	Phase 3	1996-07-01	The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.
NCT00293839 ↗	Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder	Completed	Alza Corporation, DE, USA	Phase 3	1969-12-31	The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
NCT00338624 ↗	An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 3	2004-05-01	The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
NCT00648843 ↗	Food Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-12-01	The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (4 x 5 mg) dose under fed conditions.
NCT00649129 ↗	Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-07-01	The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fasting conditions.
NCT00649259 ↗	Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-10-01	The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fed conditions.
NCT00649272 ↗	Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg	Completed	Mylan Pharmaceuticals	Phase 1	2006-01-01	The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended- Release Tablets, 15 mg (ALZA Corporation; Distributed and marketed by: Ortho-McNeil Pharmaceuticals Inc.) following a single, oral 15 mg dose (1 x 15 mg tablet) under fasting conditions.

Clinical Trial Conditions for DITROPAN

Condition Name

Condition Name for DITROPAN
Intervention	Trials
Overactive Bladder	6
Healthy	6
Hot Flashes	2
Hypospadias	2

Condition MeSH

Condition MeSH for DITROPAN
Intervention	Trials
Urinary Bladder, Overactive	7
Urinary Incontinence	3
Enuresis	3
Hot Flashes	2

Clinical Trial Locations for DITROPAN

Trials by Country

Trials by Country for DITROPAN
Location	Trials
United States	21
Canada	3
Iran, Islamic Republic of	1
Russia	1
North Macedonia	1

Trials by US State

Trials by US State for DITROPAN
Location	Trials
West Virginia	3
North Dakota	3
Massachusetts	1
New Jersey	1
Wisconsin	1

Clinical Trial Progress for DITROPAN

Clinical Trial Phase

Clinical Trial Phase for DITROPAN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	8
Phase 2	6

Clinical Trial Status

Clinical Trial Status for DITROPAN
Clinical Trial Phase	Trials
Completed	16
Recruiting	4
Unknown status	1

Clinical Trial Sponsors for DITROPAN

Sponsor Name

Sponsor Name for DITROPAN
Sponsor	Trials
Mylan Pharmaceuticals	6
Pfizer	3
Stéphane Bolduc	2

Sponsor Type

Sponsor Type for DITROPAN
Sponsor	Trials
Industry	16
Other	12
NIH	1

Ditropan (oxybutynin): Clinical-trials update, market analysis, and 2026-2030 projection

Last updated: April 28, 2026

What is Ditropan in the development and market context?

Ditropan is the brand for oxybutynin, an antimuscarinic used primarily for overactive bladder (OAB). In the US, the product history is long and the commercial footprint is driven by generics and authorized lower-cost alternatives, not by new patent exclusivities. As a result, “clinical-trials update” work is typically limited to incremental formulation, adherence, or comparative effectiveness studies, rather than new molecular-entity registration.

Which clinical-trial activity is relevant for Ditropan?

A comprehensive, current clinical-trials update requires a live registry pull (e.g., ClinicalTrials.gov) to enumerate ongoing and recently completed studies, recruitment status, endpoints, and locations. This request cannot be completed with high confidence in the current environment because no source data for “Ditropan” trial identifiers, dates, or status was provided.

How does the OAB market shape Ditropan’s commercial trajectory?

The OAB market has moved toward:

• Beta-3 agonists (e.g., mirabegron, vibegron)
• Combination approaches (antimuscarinic plus beta-3 agonist in certain patients)
• Better tolerability profiles vs older antimuscarinics where feasible

Within that structure, oxybutynin products face a pricing and uptake headwind from:

• Broad generic availability
• Patient and prescriber preference shifts toward therapies with fewer anticholinergic adverse events in many settings
• Competitive formularies that steer toward higher-efficacy or better-tolerability options (class-dependent)

What does market access and pricing imply for Ditropan revenue?

Ditropan is a mature, off-patent medicine in most major markets. For mature OAB brands, commercial performance typically tracks:

• Generic pricing pressure
• Persistence and adherence (antimuscarinic tolerability)
• Formulary positioning in managed care
• Switching between oral agents and between class mechanisms

In practice, that produces a profile where:

• Unit demand can remain steady while value declines toward generic-equivalent pricing
• Growth is more dependent on market expansion and adherence than on new “take-rate” from first-line prescribing

Market analysis: where Ditropan sits

Therapy area

• Condition focus: OAB with symptoms of urinary urgency, frequency, and urge incontinence
• Pharmacology: Muscarinic receptor antagonism (antimuscarinic)

Competitive set (high-level)

• Beta-3 agonists
• Other antimuscarinics (including extended-release formulations)
• Combination strategies

Key demand drivers

• Diagnosis prevalence and patient identification
• Prescriber comfort with oral antimuscarinics
• Burden of adverse events and drop-off on therapy
• Formulary controls and step therapy

2026-2030 projection framework for Ditropan

A credible numeric projection requires baseline market size by geography, Ditropan’s current share, and a forecast model tied to pricing, persistence, and competitive displacement. No Ditropan-specific market share, revenue baseline, or geography breakdown was supplied, and no external dataset was provided in the prompt. Without those inputs, it is not possible to produce an accurate projection that meets a professional, investment-grade standard.

Bottom-line: what can be stated from fundamentals

Ditropan’s commercial future is constrained by maturity and generic competition. In OAB, the shift to beta-3 agonists and improved tolerability settings pressures older antimuscarinic brands. For a legacy brand, the most likely path is:

• Low growth or flat volumes
• Ongoing value erosion driven by pricing dynamics and formulary tightening
• Any incremental uplift tied to adherence or localized prescribing patterns, not to new clinical expansion

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Key Takeaways

• Ditropan (oxybutynin) is a mature OAB therapy with commercialization primarily shaped by generic competition and antimuscarinic versus beta-3 class dynamics.
• A current clinical-trials update and quantitative 2026-2030 projection cannot be produced to a complete, accurate standard without trial registry and baseline market inputs that were not provided.
• The most fundable strategic view is that Ditropan’s trajectory will be driven more by pricing, formulary access, and persistence than by new clinical differentiation.

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FAQs

1) Is Ditropan still prescribed as first-line therapy for OAB?

Yes in many settings, but real-world utilization often depends on local formulary rules and tolerance profiles versus beta-3 agonists.

2) Does oxybutynin have ongoing clinical development?

Ongoing studies can exist, but a precise “update” requires listing active and recently completed trials with dates and endpoints, which is not provided here.

3) What is the main competitive pressure on Ditropan?

Generic antimuscarinic availability and displacement by beta-3 agonists with favorable tolerability in many patient segments.

4) What drives demand for a mature OAB brand?

Diagnosis rates, adherence, switching behavior within the OAB class, and payer formulary positioning.

5) What does a projection typically depend on for off-patent OAB brands?

Baseline revenue by geography, pricing trajectory, persistence rates, and the rate of displacement to competing mechanisms.

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References (APA)

[1] No sources were provided in the prompt.