Drugs / Oxybutynin
last change Sep 2026 re-read 8 days ago

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 · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed overactive bladder 1 milestone
Filed US (FDA) Ditropan XL overactive bladder —

“IMPAX's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Ditropan XL (Oxybutynin Chloride) Tablets, 15 mg.” amneal.com ↗

Approved Indication not stated 4 milestones
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

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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 · 1 missed
Phase 1 NCT00926926 Jun → Jul 2009 — Watson Pharmaceuticals Completed No outcome recorded
Phase 1 NCT00752141 Sep → Oct 2008 — Watson Pharmaceuticals Completed Missed primary
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 Sep 2026 → Sep 2028 expected obstructive sleep apnea syndrome Brigham and Women's Hospital 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 · 3 met primary
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 Met primary
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 Met primary
Phase 2 NCT04449133 Jul → Oct 2020 obstructive sleep apnea syndrome Istituto Auxologico Italiano Completed Met primary
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 · 1 missed
Phase 2/3 NCT04394143 Oct 2020 → Jul 2021 obstructive sleep apnea syndrome Raphael Heinzer Completed Missed primary
Phase 314 trials · 2 met primary
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 Met primary
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 Met primary
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 · 1 met primary · 1 missed
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 Missed primary
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 Stop: Enrollment
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
Comparator or background therapy40 trials
Phase 0 NCT07016451 Background Apr 2024 → Sep 2025 radiation cystitis Ramathibodi Hospital Completed No outcome recorded
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 1/2 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

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2013-01-25 Merck Sharp & Dohme LLC Regulatory FDA Approves OXYTROL® FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women merck.com ↗
2012-11-09 Merck Sharp & Dohme LLC Regulatory Merck to Continue Work with FDA for OXYTROL® as an Over-the-Counter Treatment for Overactive Bladder in Women merck.com ↗
Today, Merck (NYSE: MRK), known as MSD outside the United States and Canada, confirmed that the U.S. Food and Drug Administration’s (FDA) Nonprescription Drug Advisory Committee proposed that the FDA consider labeling modifications as part of their review of OXYTROL (oxybutynin transdermal system) as an over-the-counter (OTC) treatment for overactive bladder (OAB) in women.
2007-05-09 Impax Laboratories, LLC Regulatory IMPAX Receives Final FDA Approval for Generic Ditropan(R) XL 5 mg and 10 mg amneal.com ↗
IMPAX Laboratories, Inc. (OTC: IPXL) ("IMPAX" or "the Company") today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Ditropan(R) XL, (Oxybutynin Chloride) 5 mg and 10 mg Extended-release Tablets.
2006-11-10 Impax Laboratories, LLC Regulatory IMPAX Receives Final FDA Approval and First-to-File Status for Generic Version of Ditropan(R) XL 15 mg amneal.com ↗
The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product.
2005-02-02 Impax Laboratories, LLC Regulatory IMPAX Receives Tentative FDA Approval for Generic Version of Ditropan XL; First Approval in 2005 amneal.com ↗
IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan(R) XL (Oxybutynin Chloride) 5, 10 and 15 mg Extended Release Tablets.

All press releases naming this drug 11 releases

DateIssuerRelease

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 ↗

Show 83 more sources

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 ↗

Show 7 more sources

Known as Oxybutynin Cl “Drug: Oxybutynin Cl” NCT00800462 ↗
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 Hydrochloride” NCT07027020 ↗
Known as oxybutynin IR “oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days” NCT01178827 ↗