Data updated: May 26, 2026
OXYBUTYNIN
Urology
Approved 2014-03-04
1
Indication
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-03-04
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
OXYBUTYNIN Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2014 to 2016
Jan 2016 SUPPL
Label · Labeling
What OXYBUTYNIN Treats
1 FDA approvalsOriginally approved for its first indication in 2014 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2014)Letter
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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| NCT02099695 | CRT069 | Ph 3 | withdrawn | Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis |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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
OXYBUTYNIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.