Oxytrol

(Oxybutynin)

ApprovedSmall molecule

Oxytrol is a small molecule that works as a Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]

Oxytrol is one of 358 small molecule programs targeting Enuresis. It is currently in Approved.

Indications

Total Trials

Active Trials

357

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

EnuresisActive, not recruiting

Neurogenic BladderApproved

HyperhidrosisApproved

Cognitive ImpairmentActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

PolyuriaActive, not recruiting

DroolingApproved

Urinary IncontinenceActive, not recruiting

Breast CancerApproved

Diffuse Large B-Cell LymphomaActive, not recruiting

EnuresisPhase 3

Active, not recruiting

Neurogenic BladderApproved

Approved

HyperhidrosisApproved

Approved

Cognitive ImpairmentPhase 2

Active, not recruiting

Obstructive Sleep ApneaPhase 2

Active, not recruiting

PolyuriaApproved

Active, not recruiting

DroolingApproved

Approved

Urinary IncontinencePhase 3

Active, not recruiting

Breast CancerApproved

Approved

Diffuse Large B-Cell LymphomaPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Oxytrol

WWim Janssens

Approved

41 2

Gemzar

GGynecologic Oncology Group

Preclinical

22 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Zolymbus

AbbVie

Preclinical

1 5

Acupan

YYonsei University

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 9

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 10

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Posterior Urethral Valve

NCT06737016

Phase 3Recruiting

Post-Surgical

NCT03952299

Q1 2029

Phase 3Recruiting

Hot Flashes

NCT06106529

Clinical

Trials by Indication[1]

Overactive Bladder9 trials

Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

Completed·WWatson Pharmaceuticals·Phase 4·NCT00224016·57 enrolled

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

Completed· Astellas logo

Astellas··NCT03602508·5,589 enrolled

Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder

Completed·WWatson Pharmaceuticals·Phase 4·NCT00224146·2,878 enrolled

Show 6 more trials

A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition

Completed·WWatson Pharmaceuticals·Phase 4·NCT00224029·24 enrolled

Urinary Biomarkers in Overactive Bladder in Children

Unknown status·—·N/A·NCT02704013·50 enrolled

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Completed· Astellas logo

Astellas··NCT03572231·805 enrolled

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

Completed· Astellas logo

Astellas·Phase 4·NCT00431041·132 enrolled

A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Completed·WWatson Pharmaceuticals·Phase 3·NCT00350636·789 enrolled

Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Unknown status·—·Phase 4·NCT01423838·500 enrolled

Hyperhidrosis6 trials

Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Withdrawn·CCristália Produtos Químicos Farmacêuticos Ltda.·Phase 3·NCT02099695

Use of Oxybutynin to Treat Axillary Hyperhidrosis

Completed·GGrupo de Cirurgia Vascular·N/A·NCT01118429·100 enrolled

Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis

Completed·HHospital Israelita Albert Einstein··NCT01956591·1,100 enrolled

Show 3 more trials

Treatment of Hyperhidrosis With Oxybutynin

Completed·UUniversity Hospital, Brest·Phase 3·NCT01855256·62 enrolled

Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

Completed·UUniversity of Sao Paulo·Phase 4·NCT01310712·50 enrolled

The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.

Completed·TTel-Aviv Sourasky Medical Center·N/A·NCT02973659·61 enrolled

Neurogenic bladder2 trials

Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

Completed· AbbVie logo

AbbVie·Phase 4·NCT01192568·52 enrolled

Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT01716624·20 enrolled

Urinary incontinence2 trials

A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

Completed·FFemmePharma Global Healthcare, Inc.·Phase 2·NCT00749632·45 enrolled

Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence

Completed·AAlza Corporation, DE, USA·Phase 3·NCT00304499·176 enrolled

Hot flashes2 trials

A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

Active, not recruiting· Astellas logo

Astellas··NCT06049797·999 enrolled

REDucing Hot FLASHes in Women Using Endocrine Therapy.

Recruiting·RReinier de Graaf Groep·Phase 3·NCT06106529·260 enrolled

19 more indications

Sleep Apnea2 trials

Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy

Unknown status·—·Phase 1/2·NCT05550246·22 enrolled

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

Completed·BBrigham and Women's Hospital·Phase 2·NCT03919955·117 enrolled

Prospective1 trial

Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population

Withdrawn·PPhoenix Children's Hospital·N/A·NCT02483793

Absorption1 trial

Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT03205605·13 enrolled

Acute Lymphoblastic Leukemia1 trial

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Completed·AAntares Pharma Inc.·Phase 3·NCT00909181·626 enrolled

Posterior Urethral Valve1 trial

Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.

Recruiting·MMansoura University·Phase 3·NCT06737016·50 enrolled

Cystitis1 trial

Efficacy of Oxybutynin in Paediatric Cystitis

Completed·UUniversity of Calgary·Phase 4·NCT03877289·81 enrolled

Medication1 trial

A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability

Completed· Astellas logo

Astellas·Phase 4·NCT01126424·26 enrolled

Enuresis1 trial

Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Completed·HHormozgan University of Medical Sciences·Phase 3·NCT02538302·66 enrolled

Cognitive impairment1 trial

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

Completed·UUniversity of Alberta·Phase 2·NCT02240459·47 enrolled

Neurogenic Detrusor Overactivity1 trial

A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity

Completed·CCentro de Reabilitação e Readaptação Dr. Henrique Santillo·N/A·NCT01477736·68 enrolled

Post-surgical1 trial

Oxybutynin for Post-surgical Bladder Pain and Urgency

Recruiting·UUniversity of California, Davis·Phase 3·NCT03952299·100 enrolled

Treatment1 trial

Topical Oxybutynin for Treatment of Hyperidrosis: Local or Systemic Effect?

Recruiting·SSamantha Rodrigues Camargo Neves de Moura·Phase 2·NCT05102396·17 enrolled

Seasonal Allergic Rhinitis1 trial

Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

Completed·OOrganon and Co·Phase 2·NCT00816972·540 enrolled

Liver1 trial

Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.

Completed· Bayer logo

Bayer·Phase 3·NCT04534491·855 enrolled

Pediatric1 trial

Transdermal Versus Oral Oxybutynin in Pediatric OAB

Completed·—·N/A·NCT07081906·90 enrolled

Combination Therapy1 trial

Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.

Terminated·—·Phase 4·NCT02176642·55 enrolled

Children1 trial

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

Completed· Pfizer logo

Pfizer·Phase 3·NCT01557244·181 enrolled

Aged1 trial

Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Completed· Novartis logo

Novartis·Phase 2·NCT00170768·150 enrolled

Diffuse Large B-Cell Lymphoma1 trial

TRANSCEND FL: Liso-cel in Follicular Lymphoma

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT05100017·118 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DITROPAN

NDA NDA018211

Jan 1, 1982

DITROPAN

NDA NDA017577

Dec 16, 1998

DITROPAN XL

NDA NDA020897

Feb 26, 2003

OXYTROL

NDA NDA021351

Jan 27, 2009

GELNIQUE

NDA NDA022204

Dec 7, 2011

GELNIQUE 3%

NDA NDA202513

Jan 25, 2013

OXYTROL FOR WOMEN

NDA NDA202211

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Oxybutynin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oxybutynin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oxybutynin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202211). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Oxytrol. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[5]

Patent Cliff

Nov 6, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10449173Nov 6, 2029

9259388Nov 6, 2029

8920392Mar 26, 2031

Oxytrol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2029

Trials by Indication[1]

Overactive Bladder9 trials

Hyperhidrosis6 trials

Neurogenic bladder2 trials

Urinary incontinence2 trials

Hot flashes2 trials

Sleep Apnea2 trials

Prospective1 trial

Absorption1 trial

Acute Lymphoblastic Leukemia1 trial

Posterior Urethral Valve1 trial

Cystitis1 trial

Medication1 trial

Enuresis1 trial

Cognitive impairment1 trial

Neurogenic Detrusor Overactivity1 trial

Post-surgical1 trial

Treatment1 trial

Seasonal Allergic Rhinitis1 trial

Liver1 trial

Pediatric1 trial

Combination Therapy1 trial

Children1 trial

Aged1 trial

Diffuse Large B-Cell Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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