oxybutynin

Trade name: ditropan

Small moleculeapproved

Approved

Jul 16, 1975

Oxybutynin is an antispasmodic, anticholinergic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin relaxes bladder smooth muscle. Oxybutynin exhibits only one-fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. Antimuscarinic activity resides predominantly in the R-isomer. Oxybutynin exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects). By inhibiting particularily the M1 and M2 receptors of the bladder, detrusor activity is markedly decreased. — NCATS

Clinical trial activity

91 trials · 102 clinical orgs · 44 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 1, 1995 (NCT00304499)

Timeline

1970s

Jul 16, 1975
Johnson and Johnson — Earliest FDA Approval
Jul 16, 1975
Johnson and Johnson — NDA Secondary Org
Jul 16, 1975
Johnson and Johnson — NDA Organization
Nov 29, 1979
Johnson and Johnson — Marketing Organization

1980s

Nov 14, 1988
Teva — Marketing Organization

1990s

Jan 1, 1995
Earliest Phase 3 Sponsor(trial)
Mar 29, 1996
Lannett Company, Inc. — Marketing Organization
Jul 31, 1996
Upsher-Smith Laboratories — Marketing Organization
Feb 12, 1997
Wockhardt — Marketing Organization
Feb 12, 1997
Xttrium Laboratories — Marketing Organization
Oct 15, 1997
Apotex — Marketing Organization
Oct 31, 1997
Vintage — Marketing Organization
Dec 18, 1998
Pharmaceutical Associates — Marketing Organization
Jan 29, 1999
Chartwell Pharmaceuticals — Marketing Organization
Jan 29, 1999
Mikart — Marketing Organization
Jan 29, 1999
ANDA Repository — Marketing Organization

2000s

Jan 1, 2002
Mylan — Earliest Phase 1 Sponsor(trial)
Feb 26, 2003
Allergan — NDA Secondary Org
Feb 26, 2003
Allergan — Marketing Organization
Feb 26, 2003
GlaxoSmithKline — NDA Secondary Org
Jan 1, 2004
Johnson and Johnson — Earliest Phase 2 Sponsor(trial)
Nov 9, 2006
Impax Laboratories — Marketing Organization
Nov 9, 2006
Mylan — Marketing Organization
Jan 27, 2009
AbbVie — Marketing Organization
Jan 27, 2009
AbbVie — NDA Secondary Org
Feb 4, 2009
Osmotica Pharmaceutical — Marketing Organization

2010s

Mar 4, 2014
Barr Laboratories — Marketing Organization
Nov 23, 2015
Amneal Pharmaceuticals — Marketing Organization
Feb 29, 2016
Accord Research — Marketing Organization
May 27, 2016
Unique Pharmaceuticals Ltd, India — Marketing Organization
Jun 26, 2017
Zydus Discovery DMCC — Marketing Organization
Oct 23, 2017
Novitium Pharma — Marketing Organization
Dec 21, 2017
Appco Pharma — Marketing Organization
Dec 21, 2017
Arise Pharmaceuticals — Marketing Organization
Dec 21, 2017
Rising Pharmaceuticals — Marketing Organization
Dec 22, 2017
Abhai LLC — Marketing Organization
May 31, 2018
Par Pharmaceuticals — Marketing Organization
Sep 6, 2018
Tulex Pharmaceuticals — Marketing Organization
Feb 6, 2019
Invatech — Marketing Organization
Feb 6, 2019
Athem — Marketing Organization
Feb 6, 2019
Eywa Pharma — Marketing Organization
Feb 28, 2019
Ajanta Pharma Ltd — Marketing Organization
May 10, 2019
Emcure — Marketing Organization
May 10, 2019
Avet Lifesciences — Marketing Organization
Oct 30, 2019
Novast Labs — Marketing Organization
Dec 17, 2019
Bionpharma Inc — Marketing Organization

2020s

Apr 6, 2020
Leading Pharma Llc — Marketing Organization
Oct 27, 2020
Rubicon Research — Marketing Organization
Dec 17, 2020
Strides Pharma Science — Marketing Organization
Jul 14, 2022
Beximco — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Muscarinic acetylcholine receptor M2ANTAGONIST
CHRM2 antagonist
Indicated for overactive bladder, M2 likely responsible
- Muscarinic acetylcholine receptor M2 (CHRM2) ↗
Muscarinic acetylcholine receptor M3ANTAGONIST
CHRM3 antagonist
Indicated for overactive bladder, M3 likely responsible
- Muscarinic acetylcholine receptor M3 (CHRM3) ↗

Approval history

approvedJul 16, 1975

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CC)CC#CCOC(=O)C(O)(c1ccccc1)C1CCCCC1

Mol. weight: 357.49 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral, Topical
Availability: Over the Counter

Oral

Yes

Parenteral

Topical

Yes

Sources

Also known as

4-diethylamino-2-butinyl alpha-cyclohexylmandelat
4-diethylamino-2-butinyl alpha-cyclohexylmandelat
4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate
4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate
4-diethylamino-2-butynyl alpha-phenylcyclohexaneglycolate
4-diethylamino-2-butynyl alpha-phenylcyclohexaneglycolate
4-(diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester
4-(diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester
5058
anturol
anturol
apo-oxybutynin
benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester
benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester
contimin
contimin 2.5
contimin 5
cyclohexaneglycolic acid, alpha-phenyl-, 4-(diethylamino)-2-butynyl ester
cyclohexaneglycolic acid, alpha-phenyl-, 4-(diethylamino)-2-butynyl ester
cystonorm
cystrin
cystrin
cystrin
ditropan
ditropan
ditropan
ditropan
ditropan
ditropan
ditropan xl
ditropan xl
dresplan
dridase
driptane
gelnique
gelnique
gelnique
gelnique
gen-oxybutynin
kentera
kentera
kentera
lyrinel xl
lyrinel xl
mj-4309-1
mj-4309-1
novo-oxybutynin
nu-oxybutyn
oxibutinina
oxibutinina
oxyb abz
oxybugamma
oxybutin holsten
oxybuton
oxybutynin
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oxybutynin azu
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oxymedin
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oxytrol for women
pms-oxybutynin
pollakisu
promictuline
renamel
ryol
spasmex oxybutynin
spasyt
tavor
urimin
zatur

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07280468	Phase 4	Feb 1, 2026	Patient-Centered Outcomes Research Institute, University of Arizona
NCT07259148	N/A	Nov 22, 2025	Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"
NCT07030803	N/A	Nov 5, 2025	Rouen Normandy University, University of Picardie Jules Verne
NCT07027020	Phase 3	Sep 30, 2025	Government of France, University of Lorraine
NCT06966778	N/A	Sep 23, 2025	National Taiwan University, Synmosa Biopharma Corp.
NCT06295562	Phase 4	Oct 14, 2024	China Medical University
NCT06181591	Phase 2	Jan 15, 2024	Il-Yang Pharm. Co., Ltd., Seoul National University
NCT06106529	Phase 3	Jan 8, 2024	Reinier de Graaf Groep
NCT06162065	Phase 1	Nov 1, 2023	Universidad de Valparaiso
NCT05550246	Phase 1/Phase 2 (Phase 2)	Oct 31, 2023	Harvard University
NCT05944965	Phase 1/Phase 2 (Phase 2)	Oct 22, 2023	Harvard University
NCT05933603	Phase 2	Aug 1, 2023	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Arizona
NCT05102396	Phase 2	Oct 31, 2021	Science Valley Research Institute
NCT05100017	N/A	Sep 30, 2021	Northwestern University
NCT04600336	Phase 2	Jul 30, 2021	Mayo Clinic, National Cancer Institute (NCI)
NCT04909255	Phase 4	Mar 23, 2021	China Medical University
NCT04526353	Phase 2	Sep 10, 2020	CHU La Timone, Hôpital universitaire Robert-Debré, University of Bordeaux, University of Caen-Normandie, University of Limoges, University of Paris, University of Rennes, University of Toulouse
NCT04394143	Phase 2/Phase 3 (Phase 3)	Jun 1, 2020	Apnimed, Inc., University of Lausanne
NCT04115878	Phase 2	Nov 30, 2019	National Heart, Lung, and Blood Institute (NHLBI), University of Arizona
NCT04090190	N/A	Sep 30, 2019	Harvard University, Silesian University of Medicine

Showing 20 of 91 trials

Page 1 / 5

Organizations

Research & Development (102)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Watson Pharmaceuticals	For profit	7	7	3	2004
Mylan	For profit	6	6	1	2002
Harvard University	Academic/Hospital	5	5	2	2016
Alza	For profit	4	4	1	1995
Pfizer	For profit	4	2	3	2006
University of Arizona	Academic/Hospital	4	4	3	2015
University of Sao Paulo	Academic/Hospital	4	2	4	2007
Astellas	For profit	3	3	1	2006
Department of Veteran Affairs	Government	3	3	2	2003
Duramed Research	For profit	3	3	2	2004
Johnson and Johnson	For profit	3	3	2	2004
Kendle International Inc.	For profit	3	0	1	2002
PRACS	For profit	3	0	1	2002
Allergan	For profit	2	1	1	2010
China Medical University	Academic/Hospital	2	2	1	2021
Government of France	Government	2	0	1	2013
National Cancer Institute (NCI)	Government	2	1	2	2016
National Heart, Lung, and Blood Institute (NHLBI)	Government	2	0	1	2019
Academic and Community Cancer Research United	Academic/Hospital	1	1	1	2016
Adana Numune Training and Research Hospital	Academic/Hospital	1	1	1	2011

102 organizations

Page 1 / 6

Marketing (53)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Jan 29, 1999
AbbVie	For profit	MKTG	Jan 27, 2009
AbbVie	For profit	NDA2	Jan 27, 2009
Abhai LLC	For profit	MKTG	Dec 22, 2017
Accord Research	For profit	MKTG	Feb 29, 2016
Ajanta Pharma Ltd	For profit	MKTG	Feb 28, 2019
Allergan	For profit	NDA2	Feb 26, 2003
Allergan	For profit	MKTG	Feb 26, 2003
Amneal Pharmaceuticals	For profit	MKTG	Nov 23, 2015
Apotex	For profit	MKTG	Oct 15, 1997
Appco Pharma	For profit	MKTG	Dec 21, 2017
Appco Pharma	For profit	SYN	Dec 21, 2017
Arise Pharmaceuticals	For profit	MKTG	Dec 21, 2017
Athem	For profit	MKTG	Feb 6, 2019
Avet Lifesciences	For profit	MKTG	May 10, 2019
Barr Laboratories	For profit	MKTG	Mar 4, 2014
Beximco	For profit	MKTG	Jul 14, 2022
Bionpharma Inc	For profit	MKTG	Dec 17, 2019
Bionpharma Inc	For profit	SYN	Dec 17, 2019
Chartwell Pharmaceuticals	For profit	MKTG	Jan 29, 1999
Emcure	For profit	MKTG	May 10, 2019
Eywa Pharma	For profit	MKTG	Feb 6, 2019
GlaxoSmithKline	For profit	NDA2	Feb 26, 2003
Impax Laboratories	For profit	MKTG	Nov 9, 2006
Invatech	For profit	MKTG	Feb 6, 2019
Johnson and Johnson	For profit	NDA2	Jul 16, 1975
Johnson and Johnson	For profit	MKTG	Nov 29, 1979
Johnson and Johnson	For profit	NDA	Jul 16, 1975
Lannett Company, Inc.	For profit	MKTG	Mar 29, 1996
Leading Pharma Llc	For profit	MKTG	Apr 6, 2020
Leading Pharma Llc	For profit	SYN	Apr 6, 2020
Mikart	For profit	MKTG	Jan 29, 1999
Mylan	For profit	MKTG	Nov 9, 2006
Mylan	For profit	SYN	Nov 9, 2006
Novast Labs	For profit	MKTG	Oct 30, 2019
Novitium Pharma	For profit	MKTG	Oct 23, 2017
Osmotica Pharmaceutical	For profit	MKTG	Feb 4, 2009
Par Pharmaceuticals	For profit	MKTG	May 31, 2018
Pharmaceutical Associates	For profit	MKTG	Dec 18, 1998
Quantum Pharmaceutical	For profit	MKTG	—
Rising Pharmaceuticals	For profit	MKTG	Dec 21, 2017
Rubicon Research	For profit	MKTG	Oct 27, 2020
Strides Pharma Science	For profit	MKTG	Dec 17, 2020
Teva	For profit	MKTG	Nov 14, 1988
Tulex Pharmaceuticals	For profit	MKTG	Sep 6, 2018
Unique Pharmaceuticals Ltd, India	For profit	MKTG	May 27, 2016
Unique Pharmaceuticals Ltd, India	For profit	SYN	May 27, 2016
Upsher-Smith Laboratories	For profit	MKTG	Jul 31, 1996
Vintage	For profit	MKTG	Oct 31, 1997
Watson Pharmaceuticals	For profit	MKTG	—
Wockhardt	For profit	MKTG	Feb 12, 1997
Xttrium Laboratories	For profit	MKTG	Feb 12, 1997
Zydus Discovery DMCC	For profit	MKTG	Jun 26, 2017