TheraRadar
Data updated: May 26, 2026

GELNIQUE 3% (oxybutynin)

Urology Approved 2011-12-07
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2011-12-07
Routes
TRANSDERMAL
Dosage Forms
GEL, METERED

Companies

AbbVie
Active Ingredient: OXYBUTYNIN

GELNIQUE 3% Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2011 to 2015
Jul 2015 SUPPL
Label · Labeling
FDA Letter Label
Jan 2013 SUPPL
Label · Labeling
FDA Letter Label
Dec 2011 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What GELNIQUE 3% Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
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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NCT02099695 CRT069 Ph 3 withdrawn Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis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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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

GELNIQUE 3% FDA Label Details

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Data Sources

FDA Approval: NDA202513 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.