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Label indication OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) FDA label
Oxybutynin · 1 trial · 2 indications
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Oxybutynin Gel 56 mg/day | EXPERIMENTAL | - |
| Oxybutynin Gel 84 mg/day | EXPERIMENTAL | - |
| Placebo Gel | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Oxybutynin | DRUG | Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo |
| Placebo | DRUG | Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo |
Inclusion Criteria: * Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months * Have a history of at least 1 - 2 urge episodes and 8 or more voids per day Exclusion Criteria: * Incontinence that is predominantly stress, insensate, o...
Oxybutynin is being developed for urge urinary incontinence and urinary frequency. Halozyme Therapeutics is studying a topically administered gel formulation in this indication. The Phase 3 trial enrolled adults 18 years and older of all sexes in the United States. Oxybutynin is a small molecule therapeutic candidate.
Oxybutynin targets the muscarinic acetylcholine receptors CHRM2 and CHRM3, acting as an antagonist. By blocking these receptors, it is designed to reduce bladder muscle contractions associated with urge urinary incontinence and urinary frequency. This mechanism underlies its development as a small molecule therapy for these urologic symptoms.
Halozyme Therapeutics, Inc., which trades under the ticker HALO, is developing Oxybutynin. The company is advancing a topically administered gel formulation of the small molecule for urge urinary incontinence and urinary frequency. The program has completed a Phase 3 clinical trial in the United States.
Oxybutynin is in Phase 3 development for urge urinary incontinence. The program's Phase 3 trial, NCT00909181, has been completed. Oxybutynin remains an investigational therapy and is not approved for this use based on the available development information. No active trials are currently listed for the program.
Oxybutynin has been studied in the Phase 3 trial NCT00909181, titled Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence. The trial was completed, enrolled 626 participants, and was randomized, double-blind, and placebo-controlled. It included adults 18 years and older of all sexes in the United States.