Back to discover
Drug

Oxybutynin

Approved · EMA
Emerging researchLate-stage development
Also known as 4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester, 4-Diethylamino-2-butinyl alpha-cyclohexylmandelat, 4-Diethylamino-2-butynyl alpha-phenylcyclohexaneglycolate, Anturol+7 more

4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester, 4-Diethylamino-2-butinyl alpha-cyclohexylmandelat, 4-Diethylamino-2-butynyl alpha-phenylcyclohexaneglycolate, Anturol, Ditropan, Gelnique, Oxibutinina, Oxytrol, Oxybutynine, Oxybutynin Chloride, Oxybutyninum.

RxNorm32675ChEMBLCHEMBL1231UNIIK9P6MC7092
1
Research papers
4
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

Oxybutynin for Post-surgical Bladder Pain and Urgency

Clinical trial2026-01-29Results expected Q4 2026 · ClinicalTrials.gov

Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure

Clinical trial2025-06-30Primary completion · ClinicalTrials.gov

A 8 Weeks, Randomized, Open Label, Parallel Group, Active Control Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB)

Clinical trial2025-04-01Primary completion · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy

Clinical trial2025-03-30Results posted · ClinicalTrials.gov

A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.

Clinical trial2025-02-04Results expected Q1 2029 · ClinicalTrials.gov

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

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients

Clinical trial2024-09-04Results posted · ClinicalTrials.gov

Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial

Clinical trial2024-06-30Primary completion · ClinicalTrials.gov

Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity.

Research2009-08-15The Journal of urology

Approval: Kentera (previously Oxybutynin Nicobrand) (EMA)

Regulatory2004-06-15EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Oxybutynin
Aliases & brands
4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester4-Diethylamino-2-butinyl alpha-cyclohexylmandelat4-Diethylamino-2-butynyl alpha-phenylcyclohexaneglycolateAnturolDitropanGelniqueOxibutininaOxytrolOxybutynineOxybutynin ChlorideOxybutyninum
RxNorm CUI
32675
ChEMBL ID
CHEMBL1231
UNII
K9P6MC7092
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-06-15
Latest approval
2004-06-15
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2004-06-15Approval
Approval: Kentera (previously Oxybutynin Nicobrand) (EMA)

Indication: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

38 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
38
registered trials across all phases
LATEST COMPLETION 2024
4
Active studies
3
Recruiting
27
Late-stage (III+)
27
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 38
Early Phase 11Phase 1 / 21Phase 29Phase 313Phase 47Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients

CompletedPH IVAbbVien=522023

Efficacy of Oxybutynin in Paediatric Cystitis

CompletedPH IVUniversity of Calgaryn=812014

Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence

CompletedPH IVJewish General Hospitaln=662013

Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial

Unknown statusPH IVAdana Numune Training and Research Hospitaln=5002012

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

CompletedPH IVUniversity of Sao Paulon=502011

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy

CompletedPH IIAlliance for Clinical Trials in Oncologyn=882024

A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients

CompletedPH IVAbbVien=522023

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

CompletedPH IIBrigham and Women's Hospitaln=1172023

A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in The Management of Children With Overactive Bladder

CompletedN/ADr. Lutfi Kirdar Kartal Training and Research Hospitaln=902020

A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)

CompletedPH IIIPfizern=1812020

A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

CompletedPH IIUniversity of Albertan=472020

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • The Journal of urology1
Leading researchers
  • Cartwright PC1
  • Coplen DE1
  • Finan E1
  • Hoel G1
  • Kogan BA1
  • Volinn W1
Leading institutions
free-text, unnormalised
  • University of Utah and Department of Pediatric Urology1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.