Delving into the Latest Updates on Oxybutynin Chloride with Synapse

Overview

Basic Info

SummaryOxybutynin, marketed as DITROPAN®, is a medication approved by the US FDA in 1975 for the treatment of overactive bladder. Developed by Janssen, the drug works as an antagonist of acetylcholine at postganglionic muscarinic receptors, causing relaxation of the smooth muscle in the bladder. It is a racemic mixture of R- and S-isomers, with the antimuscarinic activity mainly residing in the Risomer. Additionally, the active metabolite, N-desethyloxybutynin, has similar pharmacological effects on human detrusor muscle as oxybutynin, as observed in in vitro studies. Overall, Oxybutynin Chloride offers relief to those experiencing urinary urgency, frequency, and incontinence.

Drug Type

Small molecule drug

Synonyms

Aroxybutynin, oxybutynin, Oxybutynin (USAN/INN)

+ [42]

Target

mAChRs

Action

antagonists

Mechanism

mAChRs antagonists(Muscarinic acetylcholine receptor antagonists)

Therapeutic Areas

Skin and Musculoskeletal DiseasesUrogenital DiseasesNervous System Diseases+ [1]

Active Indication

HyperhidrosisHyperhidrosis Palmaris Et PlantarisUrinary Incontinence, Urge+ [5]

Inactive Indication

Lower Urinary Tract SymptomsSpinal DysraphismUrinary Incontinence, Stress

Originator Organization

Johnson & Johnson

Active Organization

Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

Hisamitsu Pharmaceutical Co., Inc.Teva Pharmaceuticals Europe BV

+ [6]

Inactive Organization

Ortho-McNeil Pharmaceutical LLC

McNeil Consumer & Specialty Pharmaceuticals, Inc.

ALZA Corp.

+ [3]

License Organization

Daewoong Pharmaceutical Co., Ltd.

Actavis, Inc.

Antares Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (16 Jul 1975),

Urinary Bladder, Overactive

Regulation-

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Structure/Sequence

Molecular FormulaC22H32ClNO3

InChIKeySWIJYDAEGSIQPZ-UHFFFAOYSA-N

CAS Registry1508-65-2

This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.

Start Date15 Feb 2026

Sponsor / Collaborator

Trigone Pharma Ltd.

NCT06966778

/ Not yet recruitingNot ApplicableIIT

A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy

The goal of this double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.
The main questions it aims to answer are:
[Does oxybutynin chloride improve continence recovery after RARP compared to a placebo?] [What are the predictors of continence recovery?]
Researchers will compare the treatment group (oxybutynin chloride 10 mg/day) with the control group (placebo) to assess differences in continence outcomes.
Participants will:
[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.] [Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.] [Record any adverse events or concomitant medication use.]
Safety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.

Start Date23 Sep 2025

Sponsor / Collaborator

National Taiwan University Hospital

[+1]

NCT07027020

/ Not yet recruitingPhase 3IIT

Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction: A Randomized, Prospective Controlled Multi-center Trial

Malformation of the lumbosacral region (spina bifida) affects the innervation of the bladder in children. The usual evolution leads to a neurological bladder with small capacity, poor compliancy and overactivity, exposing to incontinence and obstruction to the evacuation of urine. It is responsible for renal failure requiring dialysis and transplantation. Current therapeutics aim to evacuate urine and reduce intravesical pressure. It gradually combines 1) intermittent catheterization, 2) anticholinergics, 3) botulinum toxin (Botox®) injection into the detrusor (bladder muscle) by cystoscopy and 4) surgery (vesicostomy, Bricker, enterocystoplasty). Oxybutynin relaxes the detrusor, improves continence and reduces intravesical pressure. It is usually administered per os, but there are contraindications (glaucoma, myasthenia), side effects (constipation, dry mouth). It can be difficult to swallow for children, and drug resistance may develop. It can lead to ineffective treatment requiring therapeutic escalation. The next step, intradetrusor Botox® injection, is invasive (cystoscopy), has a limited duration of action (6 months) and must be performed under general anesthesia in children.
Surgical treatments are effective but irreversible and responsible for morbidity and mortality. A randomized study was performed demonstrating the efficacy of intravesical oxybutynin compared to oral administration in adult patients. This study found a significant increase in bladder capacity and a significant decrease in side effects in the intravesical oxybutynin group. Due to the relative difficulties of intravesical oxybutynin delivery (preparation, cost) and the more invasive nature, it is not used as an alternative to oral oxybutynin.
Our hypothesis is that this treatment may have a legitimate place in the treatment of neurogenic bladder in patients with failure of anticholinergic treatment before a therapeutic escalation requiring an invasive procedure (Botox®, enterocystoplasty) especially in children for whom repeated general anesthesia for Botox® injection may interfere with brain development. In this way, we aim to extend the time to therapeutic escalation in the pediatric population.
The main objective of the trial is to compare the efficacy on maximal bladder capacity of intravesical oxybutynin instillation versus placebo in the treatment of children with overactive neurogenic bladder (spina bifida), performing intermittent catheterization, for whom oral anticholinergic treatment is ineffective or poorly tolerated.

Start Date01 Sep 2025

Sponsor / Collaborator

FARCO-PHARMA GmbH

100 Clinical Results associated with Oxybutynin Chloride

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100 Translational Medicine associated with Oxybutynin Chloride

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100 Patents (Medical) associated with Oxybutynin Chloride

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1,792

Literatures (Medical) associated with Oxybutynin Chloride

31 Dec 2026·DRUG DELIVERY

Introducing personalized patient care in overactive bladder management using the MedRing OAB system for intravaginal oxybutynin administration

Article

Author: Juachon, M. J. ; Otten, A. ; Klaassen, E. S. ; Klarenbeek, N. B. ; Heerema-Snoep, O. ; Koopmans, I. ; Peltenburg, S. I.

Although numerous drugs have been developed for intravaginal administration, the implementation of personalized intravaginal treatment options is limited. The MedRing overactive bladder (OAB) system is a medical device for intravaginal oxybutynin administration via patient-controlled schedules. The primary aim was to assess the feasibility, tolerability, and safety of intravaginal oxybutynin administration via the MedRing OAB system. Second, the functioning of the MedRing OAB system, user satisfaction and quality of life (QoL) were assessed. Female OAB patients were included to receive the MedRing OAB system. Treatment was divided into three periods with increasing dosing flexibility: 2 mg at three fixed timepoints daily, 2 mg at three patient-defined timepoints daily, and flexible dosing up to 6 mg/day of 1 or 2 mg doses. Feasibility, tolerability, satisfaction, and QoL were assessed via questionnaires, safety via treatment-emergent adverse events (TEAEs), device deficiencies (DDs) and physical examination and functioning via pharmacokinetics and MedRing logs. Thirteen patients were enrolled, of whom three patients discontinued the study prematurely. Most patients reported low user burden, found the system practical and expressed positive opinions. The TEAEs were consistent with known oxybutynin effects and local TEAEs were comparable to other intravaginal devices. Most DDs were synchronization difficulties, which improved after a software update. After 10 minutes, oxybutynin levels were detected in 12 of the 13 patients. This study showed that the MedRing OAB system appears to be a feasible, tolerable and safe alternative intravaginal oxybutynin administration for 28 days in OAB patients, offering a potential alternative to existing treatment options and introducing personalized patient care.

01 Feb 2026·BJU INTERNATIONAL

Article

Author: Epstein, Jonathan ; Hatem, Zahi ; Buzzi, Marie ; Lemelle, Jean‐Louis ; Mazeaud, Charles ; Juge, Nadine ; Berte, Nicolas

Background:

Neurogenic bladder is defined as a dysfunction of the bladder resulting from damage to the central or peripheral nervous systems. Its treatment is based on a progressive therapeutic escalation, rapidly involving invasive therapeutic procedures such as repeated intradetrusor injections and surgery. Given the risk of repeated general anaesthesia in children, there is a need for non‐invasive treatment for young patients who do not respond to or have adverse effects from oral anticholinergic treatment. The ‘Place de l’OXybutynine Intravésicale chez le Patient Enfant Neurologique’ (POXIPEN) trial aims to assess the efficacy of intra‐vesical oxybutynin on bladder capacity in a sample of French children with neurogenic bladder.

Study Design:

The POXIPEN is a multicentre, randomised, double‐blind, placebo‐controlled trial.

Endpoints:

The primary outcome is change in maximal bladder capacity after treatment. Secondary outcomes include changes in voiding, urodynamic and ultrasound parameters. We will also assess changes on quality of life and usability of the product.

Patients and Methods:

We aim to randomly assign 60 children with neurogenic bladder secondary to spina bifida and deemed non‐responders to first‐line treatment with oral anticholinergics, to receive intravesical oxybutynin (IVO) or placebo for 4 weeks. Recruitment will start in September 2025. It will be the first prospective study to evaluate the efficacy of IVO in children, with a high level of evidence provided by its design. If IVO proves effective, it could lengthen the delay in therapeutic escalation to invasive procedures, thereby reducing the risk of complications associated with general anaesthesia in children with neurogenic bladder.

Trial registration:

This trial is registered with the European Union (EU) Clinical Trials Information System (CTIS) under EU CT Number: 2022–501 902–36‐00 (approved 09.01.2025) and ClinicalTrials.gov under identifier NCT07027020 (registered 18.06.2025).

01 Feb 2026·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Biologic therapy plus oral oxybutynin chloride in hidradenitis suppurativa: A potentially valid therapy to moderate acute flares

Article

Author: Lucarini, Guendalina ; Candelora, Matteo ; Molinelli, Elisa ; Dragonetti, Maria L ; Gambini, Daisy ; Belleggia, Sara ; Richiardi, Irene ; De Simoni, Edoardo ; Offidani, Annamaria ; Simonetti, Oriana

56

News (Medical) associated with Oxybutynin Chloride

10 Feb 2026

·www.drugs.com

Oxybutynin Beats Placebo for Reducing ADT-Linked Hot Flashes in Prostate Cancer

TUESDAY, Feb. 10, 2026 -- For men with prostate cancer experiencing androgen deprivation therapy-associated hot flashes , oxybutynin is superior to placebo in improving symptoms, according to a study published online Jan. 26 in the Journal of Clinical Oncology . Bradley J. Stish, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues examined whether oxybutynin could improve hot flash symptoms in a study involving patients with prostate cancer receiving a stable regimen of androgen deprivation therapy with at least 28 hot flashes per week. Participants were randomly assigned to receive oxybutynin 2.5 mg twice daily, oxybutynin 5 mg twice daily, or matching placebo for six weeks; 81 participants were eligible for a final analysis, reporting an average of 10.1 hot flashes per day. The researchers found that patients in the placebo arm, 2.5-mg oxybutynin arm, and 5-mg oxybutynin arm had reductions in hot flashes/day of 2.15, 4.77, and 6.89, respectively, on average. The daily hot flash scores were reduced by an average of 4.85, 9.94, and 13.95 points, respectively, for placebo, 2.5 mg oxybutynin, and 5 mg oxybutynin. There were no treatment-related grade 3+ adverse events reported. The Hot Flash-Related Daily Interference Scale scores improved by 14.2 and 20.7 points in the 2.5-mg and 5-mg oxybutynin arms, respectively, and by 3.1 points in the placebo arm. "Oxybutynin demonstrated clear and clinically meaningful improvements in both hot flash frequency and quality of life for men undergoing hormone therapy for prostate cancer," Stish said in a statement. "These results provide strong support for its use as an effective management option for this challenging and often overlooked side effect of prostate cancer treatment." Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text (subscription or payment may be required)

Clinical Result

04 Feb 2026

·www.drugs.com

Oxybutynin Can Reduce Hot Flashes Among Prostate Cancer Patients

WEDNESDAY, Feb. 4, 2026 — A pill used to treat an overactive bladder can also be used to reduce hot flashes among men taking hormone-deprivation therapy for prostate cancer . Men taking oxybutynin had a dramatic decrease in the number and intensity of hot flashes that occurred as a result of their prostate cancer treatment, researchers reported Feb. 2 in the Journal of Clinical Oncology . “Oxybutynin demonstrated clear and clinically meaningful improvements in both hot flash frequency and quality of life for men undergoing hormone therapy for prostate cancer,” said lead researcher Dr. Bradley Stish , a radiation oncologist at the Mayo Clinic in Rochester, Minnesota. “These results provide strong support for its use as an effective management option for this challenging and often overlooked side effect of prostate cancer treatment,” Stish said in a news release. Hormone therapy is an effective treatment against prostate cancer, lowering levels of male hormones like testosterone that fuel cancer cells. However, the therapy causes hot flashes in up to 80% of men taking it, leading to fatigue and bad sleep, researchers said in background notes. These side effects often cause patients to stop taking their meds. Previous studies have shown that oxybutynin can significantly reduce hot flashes among women, so researchers figured the drug might have a similar effect among men. For the new study, researchers recruited 88 men with an average age of 68, and randomly assigned them to one of three groups. Two groups took either a high or low dose of oxybutynin daily, and the third took a placebo. Researchers found that men on the high dose of oxybutynin had the largest improvements, with nearly seven fewer hot flashes daily and a 14-point reduction in hot flash severity on a scale running from 0 to 100. By comparison, men on a placebo had two fewer hot flashes daily and a 5-point drop in hot flash severity, and men on the low dose of oxybutynin had nearly five fewer hot flashes daily and a 10-point drop in severity. Improvements also occurred quickly, often during a man’s first week taking the pill, researchers said. The share of patients who achieved at least a 50% reduction in their hot flash scores was also higher among oxybutynin patients — 79% in the high-dose group and 57% in the low-dose group, versus 32% taking a placebo. “These results are incredibly encouraging,” Stish said. “Men with hot flashes from hormone therapy now have another therapeutic option available to help reduce their symptom burden." He said future research will look to learn more about hot flash therapy options in these patients. Sources Alliance for Clinical Trials in Oncology, news release, Feb. 2, 2026

Clinical ResultRadiation Therapy

04 Feb 2026

·www.drugs.com

Pill Can Reduce Hot Flashes Among Prostate Cancer Patients

WEDNESDAY, Feb. 4, 2026 — A pill used to treat an overactive bladder can also be used to reduce hot flashes among men taking hormone-deprivation therapy for prostate cancer . Men taking oxybutynin had a dramatic decrease in the number and intensity of hot flashes that occurred as a result of their prostate cancer treatment, researchers reported Feb. 2 in the Journal of Clinical Oncology . “Oxybutynin demonstrated clear and clinically meaningful improvements in both hot flash frequency and quality of life for men undergoing hormone therapy for prostate cancer,” said lead researcher Dr. Bradley Stish , a radiation oncologist at the Mayo Clinic in Rochester, Minnesota. “These results provide strong support for its use as an effective management option for this challenging and often overlooked side effect of prostate cancer treatment,” Stish said in a news release. Hormone therapy is an effective treatment against prostate cancer, lowering levels of male hormones like testosterone that fuel cancer cells. However, the therapy causes hot flashes in up to 80% of men taking it, leading to fatigue and bad sleep, researchers said in background notes. These side effects often cause patients to stop taking their meds. Previous studies have shown that oxybutynin can significantly reduce hot flashes among women, so researchers figured the drug might have a similar effect among men. For the new study, researchers recruited 88 men with an average age of 68, and randomly assigned them to one of three groups. Two groups took either a high or low dose of oxybutynin daily, and the third took a placebo. Researchers found that men on the high dose of oxybutynin had the largest improvements, with nearly seven fewer hot flashes daily and a 14-point reduction in hot flash severity on a scale running from 0 to 100. By comparison, men on a placebo had two fewer hot flashes daily and a 5-point drop in hot flash severity, and men on the low dose of oxybutynin had nearly five fewer hot flashes daily and a 10-point drop in severity. Improvements also occurred quickly, often during a man’s first week taking the pill, researchers said. The share of patients who achieved at least a 50% reduction in their hot flash scores also was higher among oxybutynin patients — 79% in the high-dose group and 57% in the low-dose group, versus 32% taking a placebo. “These results are incredibly encouraging,” Stish said. “Men with hot flashes from hormone therapy now have another therapeutic option available to help reduce their symptom burden." He said future research will look to learn more about hot flash therapy options in these patients. Sources Alliance for Clinical Trials in Oncology, news release, Feb. 2, 2026

Clinical ResultRadiation Therapy

100 Deals associated with Oxybutynin Chloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00722	Oxybutynin Chloride	G04BD04	DB01062

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperhidrosis	Australia	Accelagen	12 Sep 2025
Hyperhidrosis Palmaris Et Plantaris	Japan	Hisamitsu Pharmaceutical Co., Inc.	27 Mar 2013
Pollakisuria	Japan	Clinigen KK	29 Mar 1988
Urinary Incontinence	Japan	Clinigen KK	29 Mar 1988
Urinary urgency	Japan	Clinigen KK	29 Mar 1988
Spinal Dysraphism	United States	Ortho-McNeil Pharmaceutical LLC	29 Nov 1979
Urinary Incontinence, Urge	United States	Ortho-McNeil Pharmaceutical LLC	29 Nov 1979
Urinary Bladder, Overactive	United States	Janssen Pharmaceuticals, Inc.	16 Jul 1975

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	Phase 3	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 May 2004
Urination Disorders	Phase 3	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 May 2004
Urinary Incontinence, Stress	Phase 3	-	ALZA Corp.	01 Dec 1995
Diabetic peripheral neuropathy	Preclinical	United States	Eastern Virginia Medical School	01 Jun 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07027020 (POXIPEN, Pubmed \| BJU Int)	Phase 3	-	60	Intravesical oxybutynin	jjsxdullbg(zvgrxknnvg) = jzjrokxzkh xxhutgfesk (nblgsapobv ) View more	Positive	03 Nov 2025
				Placebo	jjsxdullbg(zvgrxknnvg) = jdsqdhudpk xxhutgfesk (nblgsapobv )
NCT04115878 (MOSAIC, CTgov)	Phase 2	Sleep Apnea, Obstructive \| Down Syndrome	22	oxybutynin+oxybutynin (ato-oxy)+ato-oxy (High Dose Ato-oxy)	jnasssinur(mtkeioplkn) = lpzjpdhrsd zwicadncpz (jrthdxgbvl, 2.74) View more	-	19 Aug 2025
				Atomoxetine and oxybutynin (ato-oxy) (Low Dose Ato-oxy)	jnasssinur(mtkeioplkn) = ybbcrshxhe zwicadncpz (jrthdxgbvl, 3.06) View more
NCT01370811 (CTgov)	Phase 2	Sialorrhea \| Parkinson Disease	24	OC (OC Oral Solution Treatment B)	jktyjscerz(owqwxhcvtx) = rsarpxjnua xqriyqcfzw (byeznqmljp, 0.165) View more	-	10 Apr 2023
				OC (OC Oral Solution Treatment C)	jktyjscerz(owqwxhcvtx) = wcvkfgehkv xqriyqcfzw (byeznqmljp, 0.147) View more
NCT04090190 (CTgov)	Phase 4	Inflammation \| Urinary Incontinence, Urge	20	Oxybutynin+Tolterodine+Trospium+Solifenacin+Fesoterodine	bazmquesah(thzlpqdmgx) = kwfsamwsxf pfgrrrxtsm (gjcjnuqdck, gmvtwjtpqt - jcfqyltzor) View more	-	03 Oct 2022
WSC2022	Phase 2	Sleep Apnea, Obstructive	30	Atomoxetine 75 mg + Aroxybutynin 2.5 mg	lqhvxqtigr(wsnqofrdbu) = philhzkgll wdjvsqjpli (cruizrzack ) View more	Positive	11 Mar 2022
				Atomoxetine 37.5 mg + Aroxybutynin 2.5 mg	lqhvxqtigr(wsnqofrdbu) = qulrzwchww wdjvsqjpli (cruizrzack ) View more
NCT04534491 (CTgov)	Phase 3	Urinary Bladder, Overactive	855	Oxybutynin	apugfjokfy = wsrvwqlvtj lgvqictamj (ymkzrjosjf, xuiuqhojck - mxsazjfbxl) View more	-	20 Oct 2020
NCT02961790 (CTgov)	Phase 3	Hot Flashes \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma	150	Oxybutynin Chloride (High-dose Oxybutynin Chloride Group)	dzrvvthuer(ovdntzfvky) = wgvzeijvjq xiupqqjsmu (xasarsyrys, 15.6) View more	-	03 Jun 2019
				Oxybutynin Chloride (Low-dose Oxybutynin Chloride Group)	dzrvvthuer(ovdntzfvky) = qykputoyvo xiupqqjsmu (xasarsyrys, 7.7) View more
NCT02633371 (CTgov)	Not Applicable	Primary Axilary Hyperhidrosis	10	Oxybutynin 3% gel	aqnpvotqpw = ewvseuxyks wbidqjncaw (hclhgsckgp, wgyidzqxcw - qgobifcgeh) View more	-	19 Jun 2018
NCT02176642 (APP, CTgov)	Phase 4	Urinary Incontinence, Urge	55	Posterior Tibial Nerve Stimulation+Oxybutynin extended release (Oxybutynin Plus PTNS)	fqmzpcfzfb(dfnmcylndx) = vrxdstwnbj ulfbccumjw (qydvrblerk, ackdgffmfz - dtacgglkga) View more	-	23 Jan 2018
				Posterior Tibial Nerve Stimulation (Placebo Plus PTNS)	fqmzpcfzfb(dfnmcylndx) = gcgtmflfzd ulfbccumjw (qydvrblerk, hlihqelteh - dxeklrwktl) View more
NCT03952299 (Pubmed \| J Pediatr Urol) Manual	Phase 3	Urinary Bladder, Overactive	35	Transdermal oxybutynin patch (TOP)	neyldikoyq(mhpqjwxwon) = The main side effect was skin irritation at TOP site (35%), leading to discontinuation in 20% bjsdqvbfow (tihjrquufj )	Positive	01 Aug 2014