Drugs / Oxybutynin
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Oxybutynin

Small molecule targets CHRM2, CHRM3 via inhibition

Developed for
overactive bladder · obstructive sleep apnea syndrome · isolated hyperchlorhidrosis · Down syndrome · cancer · cystitis · male reproductive system disorder · seasonal allergic rhinitis
+9 more · spina bifida · urinary bladder disorder · urinary system disorder · diabetic polyneuropathy · female stress incontinence · low compliance bladder · nocturnal enuresis · posterior urethral valve · spinal cord injury
Investigated by
Brigham and Women's Hospital · Mylan Pharmaceuticals Inc · Watson Pharmaceuticals · Alza Corporation · Apnimed · Ministry of Health, France
+50 more · National Cancer Institute (NCI) · National Heart, Lung, and Blood Institute (NHLBI) · University of Arizona · AbbVie · Academic and Community Cancer Research United · Alliance for Clinical Trials in Oncology · Antares Pharma Inc. · Bayer · Buddhist Tzu Chi General Hospital · Central Hospital, Nancy, France · Children's Hospital Zagreb · China Medical University Hospital · Christopher Patrick Smith · FARCO PHARMA · Food and Drug Administration (FDA) · GlaxoSmithKline · Grupo de Cirurgia Vascular · Istituto Auxologico Italiano · Janssen Korea, Ltd., Korea · Janssen-Cilag Ltd.,Thailand · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · Medical University of Silesia · National Institutes of Health (NIH) · National Taiwan University Hospital · Organon and Co · Orient Pharma Co., Ltd. · Ortho-McNeil Janssen Scientific Affairs, LLC · Patient-Centered Outcomes Research Institute · Pfizer · Raphael Heinzer · Reinier de Graaf Groep · STM Pharma PRO srl · Samantha Rodrigues Camargo Neves de Moura · Science Valley Research Institute · Society for Pediatric Dermatology · Synmosa Biopharma Corp. · Tel-Aviv Sourasky Medical Center · Trigone Pharma Ltd. · US Department of Veterans Affairs · University Hospital for Infectious Diseases, Croatia · University Hospital, Bordeaux · University Hospital, Brest · University of Alberta · University of Calgary · University of California, Davis · University of Colorado, Denver · University of Maryland, Baltimore · University of Sao Paulo · Viatris Inc. · YGHEA, CRO Division of Ecol Studio spa

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) DITROPAN XL 2004-06-30 fda.gov
Approved EU (EMA) Kentera (previously Oxybutynin Nicobrand) 2004-06-15 europa.eu
Label expansion US (FDA) DITROPAN 2003-04-15 fda.gov
Approved US (FDA) DITROPAN 1975-07-16 fda.gov

Trials 58 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03205605 Jan 2018 → Nov 2019 University of Maryland, Baltimore Completed No outcome recorded
Phase 18 trials
Phase 1 NCT00926926 Jun → Jul 2009 Watson Pharmaceuticals Completed No outcome recorded
Phase 1 NCT00752141 Sep → Oct 2008 Watson Pharmaceuticals Completed No outcome recorded
Phase 1 NCT00501267 Jun → Aug 2007 overactive bladder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00649272 Jan 2006 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00650481 Dec 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00648843 Dec 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649129 Jul → Aug 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649727 Jul 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT07577661 Jun 2026 → Dec 2027 expected obstructive sleep apnea syndrome Brigham and Women's Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT05944965 Dec 2023 → Jun 2025 obstructive sleep apnea syndrome Brigham and Women's Hospital Completed No outcome recorded
Phase 1/2 NCT05550246 May 2022 → Dec 2024 obstructive sleep apnea syndrome Brigham and Women's Hospital Unknown No outcome recorded
Phase 213 trials
Phase 2 NCT07391878 Feb 2026 → Dec 2027 expected overactive bladder Trigone Pharma Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT05933603 Sep 2023 → Jun 2026 overdue Down syndrome, obstructive sleep apnea syndrome University of Arizona Active not recruiting No outcome recorded
Phase 2 NCT05102396 Sep 2022 → Jun 2024 isolated hyperchlorhidrosis, sweat gland disorder Samantha Rodrigues Camargo Neves de Moura Unknown No outcome recorded
Phase 2 NCT04600336 Oct 2021 → Feb 2024 prostate carcinoma Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 2 NCT04526353 Sep 2020 → Feb 2028 expected male reproductive system disorder University Hospital, Bordeaux Recruiting No outcome recorded
Phase 2 NCT04445688 Jul → Dec 2020 obstructive sleep apnea syndrome Apnimed Completed No outcome recorded
Phase 2 NCT04449133 Jul → Oct 2020 obstructive sleep apnea syndrome Istituto Auxologico Italiano Completed No outcome recorded
Phase 2 NCT03919955 Sep 2019 → Sep 2023 obstructive sleep apnea syndrome Brigham and Women's Hospital Completed No outcome recorded
Phase 2 NCT03845023 Mar → Oct 2019 obstructive sleep apnea syndrome Apnimed Completed No outcome recorded
Phase 2 NCT02240459 Aug 2016 → Jan 2020 cognitive impairment with or without cerebellar ataxia, overactive bladder University of Alberta Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04394143 Oct 2020 → Jul 2021 obstructive sleep apnea syndrome Raphael Heinzer Completed No outcome recorded
Phase 314 trials
Phase 3 NCT07027020 Jan 2026 → Jan 2028 expected spina bifida Central Hospital, Nancy, France Recruiting No outcome recorded
Phase 3 NCT06106529 Oct 2024 → Jan 2029 expected female breast carcinoma Reinier de Graaf Groep Recruiting No outcome recorded
Phase 3 NCT03952299 Sep 2021 → Dec 2026 expected overactive bladder University of California, Davis Recruiting No outcome recorded
Phase 3 NCT02961790 Dec 2016 → Apr 2018 ductal breast carcinoma in situ, lobular breast carcinoma in situ Academic and Community Cancer Research United Completed No outcome recorded
Phase 3 NCT01050114 Aug 2013 → Jul 2018 overactive bladder Christopher Patrick Smith Unknown No outcome recorded
Phase 3 NCT01855256 Jun 2013 → Feb 2014 isolated hyperchlorhidrosis University Hospital, Brest Completed No outcome recorded
Phase 3 NCT04534491 May 2010 → Jun 2011 overactive bladder Bayer Completed No outcome recorded
Phase 3 NCT00909181 Mar 2009 → Jul 2010 overactive bladder Antares Pharma Inc. Completed No outcome recorded
Phase 3 NCT00350636 Jun 2006 → May 2007 overactive bladder Watson Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00338624 May 2004 → Jun 2005 urinary system disorder McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Completed No outcome recorded
Phase 412 trials
Phase 4 NCT07280468 Mar 2026 → Jan 2030 expected Down syndrome, obstructive sleep apnea syndrome University of Arizona Recruiting No outcome recorded
Phase 4 NCT06295562 Nov 2024 → Oct 2025 obstructive sleep apnea syndrome China Medical University Hospital Completed No outcome recorded
Phase 4 NCT04090190 Oct 2019 → May 2021 overactive bladder Brigham and Women's Hospital Completed No outcome recorded
Phase 4 NCT01824420 Mar 2013 → Feb 2017 overactive bladder Buddhist Tzu Chi General Hospital Completed No outcome recorded
Phase 4 NCT01192568 May 2011 → Aug 2023 overactive bladder AbbVie Completed No outcome recorded
Phase 4 NCT01310712 Dec 2010 → Feb 2011 University of Sao Paulo Completed No outcome recorded
Phase 4 NCT01796548 Dec 2008 → Dec 2010 overactive bladder Janssen-Cilag Ltd.,Thailand Terminated No outcome recorded
Phase 4 NCT03877289 Oct 2008 → Jul 2014 cystitis University of Calgary Completed No outcome recorded
Phase 4 NCT00613327 Sep 2007 → Jun 2008 overactive bladder Janssen Korea, Ltd., Korea Completed No outcome recorded
Phase 4 NCT00411437 Dec 2006 → Jun 2007 Viatris Inc. Completed No outcome recorded
Phase not applicable6 trials
NCT06966778 Sep 2025 → Dec 2028 expected cancer National Taiwan University Hospital Recruiting No outcome recorded
NCT02704013 Apr 2016 → Dec 2017 overactive bladder Children's Hospital Zagreb Unknown No outcome recorded
NCT02633371 Feb → Jun 2016 isolated hyperchlorhidrosis University of Colorado, Denver Completed No outcome recorded
NCT02973659 May 2015 → Aug 2016 Tel-Aviv Sourasky Medical Center Completed No outcome recorded
NCT00892450 May 2009 → Sep 2014 Parkinson disease, overactive bladder US Department of Veterans Affairs Completed No outcome recorded
NCT01118429 Jan 2007 → Jun 2009 extraoral halitosis due to methanethiol oxidase deficiency, isolated hyperchlorhidrosis Grupo de Cirurgia Vascular Completed No outcome recorded
Also used as a comparator or background therapy in 40 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07016451 Background Apr 2024 → Sep 2025 radiation cystitis Ramathibodi Hospital Completed No outcome recorded
Phase 12 trials
Phase 1 NCT06162065 Background Nov 2023 → Jan 2024 overactive bladder Universidad de Valparaiso Unknown No outcome recorded
Phase 1 NCT00649259 Comparator Oct → Nov 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT03720353 Comparator Dec 2018 → Dec 2019 Brigham and Women's Hospital Completed No outcome recorded
Phase 1/2 NCT02908529 Comparator Sep 2016 → Dec 2017 obstructive sleep apnea syndrome Brigham and Women's Hospital Completed No outcome recorded
Phase 25 trials
Phase 2 NCT06181591 Comparator Apr 2024 → Apr 2025 overactive bladder Seoul National University Hospital Unknown No outcome recorded
Phase 2 NCT04115878 Comparator Oct 2020 → Dec 2022 Down syndrome, obstructive sleep apnea syndrome University of Arizona Completed No outcome recorded
Phase 2 NCT01328015 Comparator Mar → May 2010 isolated hyperchlorhidrosis Federal University of São Paulo Completed No outcome recorded
Phase 2 NCT00749632 Comparator Jul 2007 → Oct 2008 overactive bladder FemmePharma Global Healthcare, Inc. Completed No outcome recorded
Phase 2 NCT00170768 Comparator Feb → May 2005 Novartis Completed No outcome recorded
Phase 310 trials
Phase 3 NCT07114640 Comparator Aug 2025 → Dec 2028 expected overactive bladder Far Eastern Memorial Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06737016 Background Nov 2024 → May 2026 overdue posterior urethral valve Mansoura University Recruiting No outcome recorded
Phase 3 NCT05658874 Background Dec 2022 → Dec 2024 interstitial cystitis, levator syndrome Jocelyn Fitzgerald Terminated No outcome recorded
Phase 3 NCT05637671 Comparator Feb 2022 → Dec 2023 Cairo University Unknown No outcome recorded
Phase 3 NCT02099695 Comparator Dec 2015 → Jan 2016 isolated hyperchlorhidrosis Cristália Produtos Químicos Farmacêuticos Ltda. Withdrawn No outcome recorded
Phase 412 trials
Phase 4 NCT07679282 Comparator Sep 2026 → Mar 2030 expected obstructive sleep apnea syndrome Sairam Parthasarathy Not yet recruiting No outcome recorded
Phase 4 NCT04909255 Comparator Mar 2021 → Aug 2022 Sjogren syndrome, overactive bladder China Medical University Hospital Unknown No outcome recorded
Phase 4 NCT02176642 Comparator Aug 2014 → Nov 2016 urinary bladder disorder Duke University Terminated No outcome recorded
Phase 4 NCT01423838 Comparator Sep 2011 → Sep 2012 overactive bladder Adana Numune Training and Research Hospital Unknown No outcome recorded
Phase 4 NCT01178827 Comparator Aug 2010 → Mar 2011 overactive bladder Allergan Completed No outcome recorded
Phase not applicable8 trials
NCT07259148 Comparator Nov 2025 → Jan 2026 overdue overactive bladder Emilio José Dávila Álvarez Active not recruiting No outcome recorded
NCT07668232 Comparator Jan → Dec 2025 posterior urethral valve South Valley University Completed No outcome recorded
NCT05100017 Comparator Sep 2021 → Jun 2025 overdue nephrolithiasis, ureterolithiasis Northwestern University Active not recruiting No outcome recorded
NCT07081906 Comparator Feb → Jul 2019 overactive bladder Dr. Lutfi Kirdar Kartal Training and Research Hospital Completed No outcome recorded
NCT02483793 Comparator Jul 2015 → Dec 2016 urinary system disorder Phoenix Children's Hospital Withdrawn No outcome recorded

Evidence & citations 42 cited values

Every value below carries the sentence it was read from. 102 sources stand behind the page.

FieldValueCited text
Known as Oxybutynin “adults with loud habitual snoring took atomoxetine plus oxybutynin for 10 days before bedtime at full adult doses (80 and 5 mg, respectively; half-dose run-in on days 1-3) and...” PMID 40471069 Sep 2025
93

“Effect of oxybutynin and reboxetine on obstructive sleep apnea: a randomized, placebo-controlled, double-blind, crossover trial.” PMID 36861433 Jul 2023

“This study evaluated the efficacy and safety of AD036 (atomoxetine 80 mg and oxybutynin 5 mg) in the treatment of OSA.” PMID 35551600 May 2022

Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg” NCT00547378

“TRG-200 KIT, a novel intravesical sustained-release delivery system containing oxybutynin.” NCT07391878

“comparing 4 mg reboxetine plus 5 mg oxybutynin (Reb-Oxy) vs placebo in patients with OSA.” PMID 34543665 Sep 2021

Oxybutynin is primarily indicated for the treatment of overactive bladder syndrome.” NCT07668232

“Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)” NCT05658874

“0.5 mg/kg (max 40 mg) of atomoxetine and 5mg oxybutynin taken nightly.” NCT07280468

Oxybutynin (Ditropan Extended Release or equivalent generic)” NCT01829425

“flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel)” NCT01796548

“* OxybutyninNCT07016451

OxybutyninNCT00350636

NCT00170768

NCT03877289

NCT00629642

NCT03205605

NCT00223821

NCT07679282

NCT01423838

NCT05100017

NCT01050114

NCT01118429

NCT01187498

NCT01716624

NCT00816972

NCT06181591

NCT00269750

NCT00350636

NCT03845023

NCT04526353

NCT02973659

NCT02483793

NCT01328015

NCT01192568

NCT06106529

NCT05933603

NCT01477736

NCT00649727

NCT02704013

NCT00224146

NCT07114640

NCT00501267

NCT00431041

NCT01310712

NCT00338624

NCT02240459

NCT07577661

NCT00269724

NCT01557244

NCT04909255

NCT00648843

NCT00800462

NCT00649129

NCT06737016

NCT00892450

NCT07081906

NCT00650481

NCT01178827

NCT04115878

NCT02099695

NCT05944965

NCT04090190

NCT00649259

NCT02176642

NCT00224016

NCT01855256

NCT01126424

NCT01370811

NCT00304499

NCT00926926

NCT00752141

NCT04534491

NCT04600336

NCT07259148

NCT06295562

NCT00909181

NCT06162065

NCT05550246

NCT02908529

NCT00749632

NCT02538302

NCT05102396

NCT05637671

NCT03050827

NCT07027020

NCT01824420

NCT02633371

NCT00990886

NCT00649272

NCT03919955

NCT00224029

NCT03952299

NCT00411437

Known as 5058 ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Anturol; Oxybutynin Gel 3% Anturol; Oxybutynin Gel 3%NCT00909181
Known as BAY839380 “Oxybutynin (Oxytrol, BAY839380)” NCT04534491
Known as Contimin 2.5 ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Contimin 5 ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Cystrin ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Ditropan “The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge...” NCT00269750
1

“Oxybutynin (Ditropan) ER 5mg QD” NCT01824420

Known as DITROPAN XL “The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets...” NCT00649129
2

“A Double-Blind, Randomized, Parallel Group Trial of Ditropan XL (Oxybutynin Chloride) Extended Release Tablets or Placebo in Combination With FLOMAX (Tamsulosin Hydrochloride)...” NCT00338624

“Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder” NCT00293839

Known as Gelnique ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Kentera ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Kentera (previously oxybutynin nicobrand) ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as Lyrinel xl ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as MJ 4309-1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as NSC-759108 ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as OROS oxybutynin “The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge...” NCT00269750
Known as Oxibutinina ChEMBL registry synonym — accepted as the source's own label CHEMBL1231
Known as OXY-ER “flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel)” NCT01796548
Known as OXY-TDS “oxybutynin transdermal system (OXY-TDS) (Oxytrol), Watson Pharma, Corona, CA, USA)” PMID 17187655 Dec 2006
Known as Oxybutynin (Ditropan Extended Release or equivalent generic) Oxybutynin (Ditropan Extended Release or equivalent generic)NCT01829425
Known as Oxybutynin chloride “OROS® (oxybutynin chloride) 5 mg tablets, one to six tablets per day (5 mg/day to 30 mg/day) as a single morning oral dose for 11 days up to 70 days, and Ditropan (oxybutynin...” NCT00269750
17

“This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin...” NCT00800462

“A Double-Blind, Randomized, Parallel Group Trial of Ditropan XL (Oxybutynin Chloride) Extended Release Tablets or Placebo in Combination With FLOMAX (Tamsulosin Hydrochloride)...” NCT00338624

“Oxybutynin has been used to treat overactive bladder (OAB). The subject will take 5 mg of Ditropan (Oxybutynin Chloride) twice a day, in total of 10 mg for 8 weeks.” NCT06181591

“Transdermally administered oxybutynin chloride topical gel 10% (OTG) has a low propensity for anticholinergic adverse effects” PMID 22909146 Oct 2012

“Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg” NCT00648843

“10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.” NCT01192568

“Individually-titrated, extended-release oxybutynin chloride with management of side-effects.” NCT00223821

Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally” NCT01796548

Oxybutynin Chloride Extended-release Tablets 5 mg” NCT00650481

Oxybutynin chloride 15 mg once daily for 12 weeks” NCT00990886

Oxybutynin Chloride ER Tablets 10 mg” NCT00649727

Oxybutynin Chloride ER Tablets 10 mg” NCT00649129

“Drug: Oxybutynin ChlorideNCT04600336

NCT06966778

NCT00293839

NCT02961790

NCT00613327

Known as Oxybutynin Cl “Drug: Oxybutynin ClNCT00800462
Known as oxybutynin ER “One study group will receive 10 mg of oxybutynin ER orally once daily for 12 weeks.” NCT05637671
Known as Oxybutynin Hydrochloride “Drug: Oxybutynin HydrochlorideNCT07027020
Known as oxybutynin IR oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days” NCT01178827