Clinical Trials

Numerous clinical trials evaluate oxybutynin from Phase 1 through Phase 4, focusing primarily on urological conditions such as overactive bladder and urge incontinence, as well as non-urological indications including hyperhidrosis and vasomotor symptoms. Sponsored by academic institutions and pharmaceutical companies, these studies encompass active, recruiting, completed, terminated, and withdrawn statuses. Key evaluations assess drug efficacy for urological disorders and the management of treatment-emergent side effects such as xerostomia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07679282 NOT_YET_RECRUITING
Obstructive Sleep Apnea (OSA)
Sairam Parthasarathy
 2026-09-01 PHASE4
NCT07030803 RECRUITING
Overactive Bladder (OAB); Transcutaneous Neurostimulation; Posterior Tibial Nerve Stimulation
Centre Hospitalier Universitaire, Amiens
 2025-11-05
NCT06106529 RECRUITING
Breast Cancer; Hot Flash Due to Medication
Reinier de Graaf Groep
 2024-10-03 PHASE3
NCT06966778 RECRUITING
Localized Prostate Cancer; Postoperative Urinary Incontinence
National Taiwan University Hospital
 2025-09-15
NCT07114640 NOT_YET_RECRUITING
Urinary Bladder, Overactive
Far Eastern Memorial Hospital
 2025-08-07 PHASE3
NCT04526353 RECRUITING
Male Urogenital Diseases
University Hospital, Bordeaux
 2020-09-10 PHASE2
NCT07027020 RECRUITING
Spina Bifida
Central Hospital, Nancy, France
 2026-01-15 PHASE3
NCT07577661 NOT_YET_RECRUITING
Obstructive Sleep Apnea; Sleep-disordered Breathing
Brigham and Women's Hospital
 2026-06-01 PHASE1; PHASE2
NCT03952299 RECRUITING
Overactive Bladder Syndrome; Neuropathic Bladder
University of California, Davis
 2021-09-01 PHASE3
NCT05933603 ACTIVE_NOT_RECRUITING
Obstructive Sleep Apnea; Down Syndrome
University of Arizona
 2023-09-29 PHASE2
NCT06737016 RECRUITING
Posterior Urethral Valve
Mansoura University
 2024-11-01 PHASE3
NCT07259148 ACTIVE_NOT_RECRUITING
Urgency Urinary Incontinence
Emilio José Dávila Álvarez
 2025-11-22
NCT07668232 COMPLETED
Posterior Urethral Valve
South Valley University
 2025-01-01
NCT06295562 COMPLETED
Obstructive Sleep Apnea of Adult
China Medical University Hospital
 2024-11-05 PHASE4
NCT05100017 ACTIVE_NOT_RECRUITING
Kidney Calculi; Kidney Diseases; Nephrolithiasis; Urolithiasis; Ureteral Diseases; Ureteral Calculi
Northwestern University
 2021-09-30
NCT05944965 COMPLETED
OSA
Brigham and Women's Hospital
 2023-12-01 PHASE1; PHASE2
NCT06181591 UNKNOWN
Overactive Bladder
Seoul National University Hospital
 2024-04-01 PHASE2
NCT05550246 UNKNOWN
Obstructive Sleep Apnea
Brigham and Women's Hospital
 2022-05-05 PHASE1; PHASE2
NCT05102396 UNKNOWN
Hyperhidrosis; Oxybutynin; Sweat Gland Diseases; Skin Diseases; Autonomic Agents; Cholinergic Antagonists; Parasympatholytics
Samantha Rodrigues Camargo Neves de Moura
 2022-09-26 PHASE2
NCT04600336 COMPLETED
Prostate Carcinoma
Alliance for Clinical Trials in Oncology
 2021-10-28 PHASE2
NCT06162065 UNKNOWN
Urinary Bladder, Overactive
Universidad de Valparaiso
 2023-11-01 PHASE1
NCT05637671 UNKNOWN
Vasomotor Symptoms
Cairo University
 2022-02-10 PHASE3
NCT03919955 COMPLETED
Sleep Apnea
Brigham and Women's Hospital
 2019-09-03 PHASE2
NCT01192568 COMPLETED
Overactive Detrusor; Neurogenic Bladder
AbbVie
 2011-05-17 PHASE4
NCT04115878 COMPLETED
Obstructive Sleep Apnea; Down Syndrome
University of Arizona
 2020-10-21 PHASE2
NCT04909255 UNKNOWN
Sjogren's Syndrome; Overactive Bladder Syndrome
China Medical University Hospital
 2021-03-23 PHASE4
NCT05637671 Recruiting
Vasomotor Symptoms
Cairo University
 2022-02-10 Phase 3
NCT03187795 UNKNOWN
Spinal Cord Injuries; Urinary Bladder, Neurogenic
Kessler Foundation
 2019-04-03 PHASE2
NCT04090190 COMPLETED
Urinary Incontinence; Urgency Urinary
Brigham and Women's Hospital
 2019-10-30 PHASE4
NCT04580394 COMPLETED
Obstructive Sleep Apnea
Apnimed
 2020-10-27 PHASE2
NCT04526353 Unknown status
Male Urogenital Diseases
University Hospital Bordeaux
 2020-09-10 Phase 2
NCT02240459 COMPLETED
Overactive Bladder; Mild Cognitive Impairment
University of Alberta
 2016-08 PHASE2
NCT03205605 COMPLETED
Heat Effect
University of Maryland, Baltimore
 2018-01-02 EARLY_PHASE1
NCT01557244 COMPLETED
Urinary Bladder, Neurogenic
Pfizer
 2012-07-02 PHASE3
NCT02522936 WITHDRAWN
Overactive Bladder; Xerostomia; Compliance
University of Southern California
 2018-08-01 PHASE4
NCT07081906 COMPLETED
Overactive Bladder (OAB); Drug Delivery Systems; Anticholinergic Side Effects; Children and Adolescents, Boys and Girls
Dr. Lutfi Kirdar Kartal Training and Research Hospital
 2019-02-15
NCT02522936 Withdrawn
Overactive Bladder|Xerostomia|Compliance
University of Southern California
 2018-08-01 Phase 4
NCT01050114 UNKNOWN
Overactive Bladder
Christopher Patrick Smith
 2013-08 PHASE3
NCT02961790 COMPLETED
Breast Carcinoma; Ductal Breast Carcinoma In Situ; Hot Flashes; Lobular Breast Carcinoma In Situ; No Evidence of Disease
Academic and Community Cancer Research United
 2016-12-09 PHASE3
NCT02327936 COMPLETED
Overactive Bladder
Stéphane Bolduc
 2014-12 PHASE3
NCT02704013 UNKNOWN
Overactive Bladder
Children's Hospital Zagreb
 2016-04
NCT02908529 COMPLETED
Obstructive Sleep Apnea (OSA)
Brigham and Women's Hospital
 2016-09 PHASE1; PHASE2
NCT03050827 COMPLETED
Diabetic; Neuropathic, Polyneuropathy (Manifestation)
Eastern Virginia Medical School
 2014-05-01 PHASE3
NCT01824420 COMPLETED
Overactive Bladder
Buddhist Tzu Chi General Hospital
 2013-03 PHASE4
NCT02483793 WITHDRAWN
Disorder of Urinary Stent
Phoenix Children's Hospital
 2015-07
NCT02176642 TERMINATED
Urinary Urge Incontinence
Duke University
 2014-08 PHASE4
NCT02973659 COMPLETED
Hyperhidrosis
Tel-Aviv Sourasky Medical Center
 2015-05
NCT02633371 COMPLETED
Hyperhidrosis
University of Colorado, Denver
 2016-02
NCT02099695 WITHDRAWN
Hyperhidrosis
Cristália Produtos Químicos Farmacêuticos Ltda.
 2015-12 PHASE3
NCT02099695 Withdrawn
Hyperhidrosis
Cristália Produtos Químicos Farmacêuticos Ltda.|Hospital Israelita Albert Einstein|University of Sao Paulo
 2015-12 Phase 3
NCT02070042 TERMINATED
Overactive Bladder
TriHealth Inc.
 2014-02
NCT02538302 COMPLETED
Nocturnal Enuresis
Hormozgan University of Medical Sciences
 2013-07 PHASE3
NCT00892450 COMPLETED
Parkinson's Disease; Overactive Bladder
US Department of Veterans Affairs
 2009-05
NCT03877289 COMPLETED
Cystitis
University of Calgary
 2008-10 PHASE4
NCT01855256 COMPLETED
Hyperhidrosis
University Hospital, Brest
 2013-06 PHASE3
NCT01423838 UNKNOWN
Overactive Bladder
Adana Numune Training and Research Hospital
 2011-09 PHASE4
NCT01370811 COMPLETED
Sialorrhoea
Orient Pharma Co., Ltd.
 2011-08 PHASE2
NCT00800462 COMPLETED
Spinal Cord Injury; Neurogenic Detrusor Overactivity
Toronto Rehabilitation Institute
 2008-03 PHASE4
NCT01716624 COMPLETED
Neurogenic Bladder
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2011-05 PHASE3
NCT04534491 COMPLETED
Overactive Bladder
Bayer
 2010-05-25 PHASE3
NCT01178827 COMPLETED
Overactive Bladder
Allergan
 2010-08 PHASE4
NCT01310712 COMPLETED
Hyperhidrosis
University of Sao Paulo
 2010-12 PHASE4
NCT00629642 COMPLETED
Multiple Sclerosis; Neurogenic Bladder; Spinal Cord Diseases
Astellas Pharma Inc
 2008-03-14 PHASE4
NCT01126424 COMPLETED
Cognition
Astellas Pharma Inc
 2010-04 PHASE4
NCT01796548 TERMINATED
Detrusor Function, Overactive
Janssen-Cilag Ltd.,Thailand
 2008-12 PHASE4
NCT01477736 COMPLETED
Spinal Cord Injury
Centro de Reabilitação e Readaptação Dr. Henrique Santillo
 2009-01
NCT00909181 COMPLETED
Urge Urinary Incontinence; Urinary Frequency
Antares Pharma Inc.
 2009-03 PHASE3
NCT01328015 COMPLETED
Hyperhidrosis
Federal University of São Paulo
 2010-03 PHASE2
NCT01187498 COMPLETED
Overactive Bladder
US Department of Veterans Affairs
 2005-01 PHASE3
NCT00926926 COMPLETED
Healthy
Watson Pharmaceuticals
 2009-06 PHASE1
NCT01118429 COMPLETED
Axillary Hyperhidrosis; Osmidrosis
Grupo de Cirurgia Vascular
 2007-01
NCT00223821 COMPLETED
Urinary Incontinence
US Department of Veterans Affairs
 2003-09
NCT00752141 COMPLETED
Healthy Volunteers
Watson Pharmaceuticals
 2008-09 PHASE1
NCT00749632 COMPLETED
Urinary Incontinence, Urge
FemmePharma Global Healthcare, Inc.
 2007-07 PHASE2
NCT00613327 COMPLETED
Urinary Bladder, Overactive
Janssen Korea, Ltd., Korea
 2007-09 PHASE4
NCT00431041 COMPLETED
Overactive Bladder
Astellas Pharma Inc
 2006-12 PHASE4
NCT00501267 COMPLETED
Overactive Bladder
GlaxoSmithKline
 2007-06 PHASE1
NCT00411437 COMPLETED
Memory; Cognition
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-12 PHASE4
NCT00350636 COMPLETED
Overactive Bladder
Watson Pharmaceuticals
 2006-06 PHASE3
NCT00224016 COMPLETED
Detrusor Hyperreflexia
Watson Pharmaceuticals
 2004-12 PHASE4
NCT00649272 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2006-01 PHASE1
NCT00224029 COMPLETED
Detrusor Hyperreflexia
Watson Pharmaceuticals
 2004-12 PHASE4
NCT00816972 COMPLETED
Post-nasal Drip; Seasonal Allergic Rhinitis; Rhinorrhea
Organon and Co
 2005-04 PHASE2
NCT00224146 COMPLETED
Overactive Bladder; Urinary Incontinence; Quality of Life
Watson Pharmaceuticals
 2004-05 PHASE4
NCT00990886 COMPLETED
Menopause; Hot Flashes
Ortho-McNeil Janssen Scientific Affairs, LLC
 2004-04 PHASE2
NCT00648843 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2002-12 PHASE1
NCT00650481 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2002-12 PHASE1
NCT00649259 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2002-10 PHASE1
NCT00649129 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2002-07 PHASE1
NCT00649727 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2002-07 PHASE1
NCT00293839 COMPLETED
Urinary Incontinence
Alza Corporation, DE, USA
 PHASE3
NCT00269750 COMPLETED
Urge Incontinence
Alza Corporation, DE, USA
 1996-07 PHASE3
NCT00304499 COMPLETED
Urinary Incontinence
Alza Corporation, DE, USA
 1995-12 PHASE3
NCT00338624 COMPLETED
Urination Disorders
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
 2004-05 PHASE3
NCT00269724 COMPLETED
Urinary Incontinence
Alza Corporation, DE, USA
 1997-03 PHASE3
NCT00170768 COMPLETED
Healthy Volunteers
Novartis
 2005-02 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the Oxybutynin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxybutynin acts as a competitive antagonist of the M1, M2, and M3 muscarinic acetylcholine receptor subtypes, blocking acetylcholine-mediated activation of G protein-coupled signaling pathways to reduce intracellular calcium mobilization in smooth muscle cells. This inhibition decreases detrusor muscle spasms and promotes bladder relaxation, providing therapeutic efficacy for clinical conditions such as overactive bladder, urinary urge incontinence, and detrusor hyperreflexia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.