OXYTROL (oxybutynin)
Oxytrol is a medication used for men who experience symptoms associated with an overactive bladder. It helps patients with urge urinary incontinence, as well as frequent or urgent needs to urinate. This treatment is prescribed to help manage involuntary bladder contractions and improve overall urinary control.
How OXYTROL Works
This drug works by blocking acetylcholine at muscarinic receptors, which leads to the relaxation of the bladder's smooth muscle. By relaxing these muscles, the medication increases the bladder's maximum capacity and delays the onset of involuntary contractions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2003-02-26
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
OXYTROL Approval History
What OXYTROL Treats
2 indicationsOXYTROL is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urge Urinary Incontinence
OXYTROL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OXYTROL
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03919955 results posted | 2019P000666 R01HL146697 | Ph 2 | completed | A Novel Pharmacological Therapy for Obstructive Sleep Apnea |
| NCT01855256 H²O | RB 12.035 H²O | Ph 3 | completed | Treatment of Hyperhidrosis With Oxybutynin |
| NCT06106529 REDFLASH | REDFLASH2023-004 | Ph 3 | recruiting | REDucing Hot FLASHes in Women Using Endocrine Therapy. |
| NCT06737016 | Tamsulosin & PUV | Ph 3 | recruiting | Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve. |
| NCT01192568 results posted | OG09002 | Ph 4 | completed | Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder |
| NCT03877289 | OxyRCT1 | Ph 4 | completed | Efficacy of Oxybutynin in Paediatric Cystitis |
| NCT01557244 results posted | A0221047 2010-022475-55 | Ph 3 | completed | A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition |
| NCT02240459 | FES-COG 1808 | Ph 2 | completed | A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment |
| NCT02099695 | CRT069 | Ph 3 | withdrawn | Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis |
| NCT02538302 | 92.121.505 | Ph 3 | completed | Minirin Versus Oxybutynin for Nocturnal Enuresis in Children |
| NCT00909181 results posted | 20070060 | Ph 3 | completed | Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence |
| NCT01716624 | R-11-140 17787 | Ph 3 | completed | Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder |
| NCT01126424 SENIOR results posted | 905-EC-008 2008-005966-29 | Ph 4 | completed | A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability |
| NCT01310712 | University of Sao Paulo | Ph 4 | completed | Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXYTROL FDA Label Details
Indications & Usage
FDA Label (PDF)OXYTROL is indicated for the treatment of Overactive Bladder; Urge Urinary Incontinence.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment