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

d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride, oxybutynin, Oxybutynin (USAN/INN)

+ [44]

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

Allergan Sales LLCTeva Pharmaceuticals Europe BV

Hisamitsu Pharmaceutical Co., Inc.

+ [6]

Inactive Organization

ALZA Corp.

Antares Pharma, Inc.

Ortho-McNeil Pharmaceutical LLC

+ [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

Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.

Start Date01 Sep 2026

Sponsor / Collaborator

University of Arizona

[+5]

NCT07577661

/ Not yet recruitingPhase 1/2IIT

Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea: A Randomized-Controlled Trial.

Obstructive sleep apnea (OSA) is a common condition in which the airway repeatedly collapses during sleep, leading to poor sleep quality and reduced oxygen levels. Hypoglossal nerve stimulation (HGNS) is an approved treatment that uses a small implanted device to stimulate the genioglossus muscle and keep the airway open. However, some patients continue to have OSA despite using HGNS. Atomoxetine and oxybutynin, "AtoOxy", is a promising pharmacologcal therapy under investigation that has been shown to activate pharyngeal muscles-in particular non-genioglossus muscles--but appears more efficacious in some patients than others.
This study will test whether the combination of AtoOxy and HGNS can further improve breathing during sleep compared to either monotherapy alone. Participants with OSA and an HGNS device will be randomized to receive, in random order: HGNS+AtoOxy, HGNS alone (plus placebo), AtoOxy alone (HGNS device off), and placebo (HGNS device off), in a cross-over trial.
The main goal is to determine whether the combined treatment reduces the number of breathing events during sleep; the primary outcome test will compare HGNS+AtoOxy versus HGNS alone. The effect of each intervention versus placebo will also be presented.
The study will also examine how individual patient characteristics influence response to treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

NCT07391878

/ Not yet recruitingPhase 2

Open-Label Study to Evaluate the Safety and Efficacy of Two Doses of TRG-200 KIT in Patients With Refractory Overactive Bladder (OAB) : A Pilot Study

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.

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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1,743

Literatures (Medical) associated with Oxybutynin Chloride

01 Jul 2026·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Mechanism-directed pharmacotherapy in obstructive sleep apnea: insights from aroxybutynin/atomoxetine (AD109) intervention in the SynAIRgy trial

Communications

Author: Mokhlesi, Babak ; Mehra, Reena

10 Jun 2026·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

Pharmacological treatment of obstructive sleep apnea syndrome

Review

Author: Filin, A A ; Boldin, A V ; Tardov, M V ; Tardova, V M ; Bokova, I A ; Kotidis, I ; Bokova, O A

Obstructive sleep apnea syndrome (OSAS) is a potentially life-threatening condition that is increasingly prevalent in developed countries. OSAS treatment involves multiple components, including general lifestyle modifications and specific interventions such as intraoral fixation devices and continuous positive airway pressure (CPAP). Surgical treatments, including correction of nasopharyngeal and oropharyngeal structures, orthognathic operations, and bariatric surgery, are used under strict indications. Until recently, pharmacological management was limited to nasal decongestants for rhinitis exacerbation and modafinil for daytime sleepiness. However, low compliance with non-surgical therapies and limited efficacy of some surgical procedures highlight the need for effective drug treatments for OSAS. Despite decades of research, a highly effective pharmacological therapy was not available until the past 6—7 years, when new agents and their combinations were evaluated. Randomization by OSAS endotype is now recognized as crucial in clinical studies. This review summarizes recent advances in OSAS drug therapy, primarily based on randomized clinical trials, with a focus on agents such as semaglutide, tirzepatide, atomoxetine-oxybutynin, solriamfetol, sultiame, and acetazolamide, as well as established drugs. Further research with long-term follow-up and consideration of OSAS endotypes and drug side effects is needed. The importance of combining different therapeutic approaches for OSAS is emphasized.

01 Jun 2026·JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM

Clinical Diabetic Peripheral Neuropathy: Can It Be Reversed? Arguments for and Against From a NEUROdiab Debate

Review

Author: Karlafti, Eleni ; D'Onofrio, Luca ; Callaghan, Brian ; Røikjer, Johan ; Ferdousi, Maryam ; Azmi, Shazli ; Perkins, Bruce A. ; Sloan, Gordon ; Kender, Zoltan ; Eid, Stephanie

ABSTRACT:

Diabetic peripheral neuropathy (DPN) is a prevalent and disabling complication of diabetes, yet whether established clinical DPN is reversible remains debated. At the 35th Annual Meeting of NEUROdiab, a formal debate examined arguments ‘for’ and ‘against’ the proposition that clinical DPN can be reversed. This review summarises both perspectives and considers their implications for clinical practice and future research. Evidence supporting the reversibility of clinical DPN draws on four main observations. Therapies for hereditary transthyretin amyloidosis demonstrate that substantial improvement in a progressive length‐dependent neuropathy is biologically achievable, providing a proof‐of‐concept in a different disease. Pancreatic transplantation in Type 1 diabetes leads to measurable improvements in large‐ and small‐fibre indices. Structured lifestyle interventions and bariatric surgery improve intraepidermal nerve fibre density, suggesting that metabolic correction can promote neural repair. Finally, emerging agents such as topical oxybutynin show early promise in improving surrogate outcomes, reinforcing the argument that clinical DPN may be partially reversible. Arguments opposing reversibility emphasise that DPN resembles other microvascular complications, in which early abnormalities may regress but established clinical disease is not reversed. Heterogeneity in diagnostic thresholds, phenotype variability and inconsistent outcome measures complicates defining what constitutes true reversal. Long‐term studies and major trials, including DCCT/EDIC and BARI 2D, demonstrate slowing of progression rather than restoration of normal nerve function. Moreover, numerous mechanistically promising agents have failed in human trials despite strong pre‐clinical results. Collectively, these limitations support the view that established clinical neuropathy remains largely irreversible to date. Overall, the debate underscores that reversibility depends on timing, definitions and outcome thresholds. While early‐stage dysfunction is more likely to be modifiable, complete restoration of established clinical DPN (such as full restoration of protective sensation) remains unproven. Future research should prioritise developing validated biomarkers and standardised endpoints in addition to searching for new therapeutics.

73

News (Medical) associated with Oxybutynin Chloride

31 Jul 2026

·www.fiercebiotech.com

Apnimed’s IPO dream comes true with upsized $192M IPO to fund sleep apnea pill launch

Apnimed has raised $192 million for its upsized IPO, with the proceeds earmarked to fund the launch of its sleep apnea pill. The Massachusetts-based company had set out plans earlier this week to offer 10 million shares priced between $14 and $16 apiece. The biotech announced Thursday evening that it is now offering 12 million shares, priced at the top end of this range. It means the IPO is set to rake in $192 million in gross proceeds—above the $134.6 million that the company had estimated on Monday. This haul could rise by a further $28.8 million if underwriters fully take up their option to buy an additional 1.8 million shares at the same price. Apnimed’s obstructive sleep apnea (OSA) therapy, Oxnimbi or AD109, is currently awaiting an FDA approval decision, with an answer from the regulator expected by February 2027. The daily pill has aced two phase 3 trials, including most recently cutting the number of nightly breath-stopping events by 46.8% in a study of 660 patients. The most common treatment for sleep apnea is a CPAP machine, which requires wearing an awkward mask all night. Should Oxnimbi get approved, it would become the first prescription drug designed specifically for the many millions of adults with sleep apnea. While Eli Lilly’s Zepbound became the first ever FDA-approved sleep apnea med in December 2024, it was only okayed for adults who also have obesity. Oxnimbi is a combination of aroxybutynin, a novel antimuscarinic; and atomoxetine, a noradrenaline reuptake inhibitor that is also used in attention-deficit/hyperactivity disorder. The pill targets the motor neurons that control breathing during sleep and boosts their activity so that throat muscles don’t relax, which is what disrupts breathing in patients with sleep apnea. Apnimed has been prepping for Oxnimbi’s launch for some time, bringing Pfizer veteran Graham Goodrich on board as chief commercial officer at the beginning of 2024. Apnimed had also been running a joint venture with Shionogi since 2023, with the companies kicking off a phase 2a trial of a sleep disorder candidate last year while adding a second asset to that entity’s pipeline. However, Apnimed agreed to sell its side of the venture to Shionogi for $100 million upfront in March. Apnimed’s upsized IPO this morning is a reminder of the healthy reception biotechs continue to receive on the public markets in a year that has seen record-breaking listings from the likes of Parabilis Medicines and Kailera Therapeutics. Beyond Apnimed, the likes of Braveheart Bio, Attovia Therapeutics and Vogenx have all lined up their own imminent listings.

Phase 3Drug ApprovalPhase 2IPOAcquisition

27 Jul 2026

·www.fiercebiotech.com

Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears

Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill. In a filing with the Securities and Exchange Commission today, Apnimed announced it plans to sell 10 million shares at a price between $14 and $16 apiece. While $160 million is the upper bound of the potential cash haul, Apnimed expects to net $134.6 million from the stock sale, according to the filing, hitting $155.5 million if the underwriters fully exercise their option to purchase 1.5 million additional shares. The Massachusetts company revealed its intent to join the swelling biotech IPO chorus earlier this month. Apnimed’s obstructive sleep apnea (OSA) therapy, Oxnimbi or AD109, is currently awaiting an FDA approval decision, with an answer from the regulator expected by February. The daily pill has smashed two phase 3 trials, including most recently cutting the number of nightly breath-stopping events by 46.8% in a study of 660 patients. The most common treatment for sleep apnea is a CPAP machine, which requires wearing an awkward mask all night. Should Oxnimbi get approved, it would become the first prescription drug designed specifically for the many millions of adults with sleep apnea. While Eli Lilly’s Zepbound became the first ever FDA-approved sleep apnea med in December 2024, it is only okayed for adults who also have obesity. Oxnimbi is a combination of aroxybutynin, a novel antimuscarinic; and atomoxetine, a noradrenaline reuptake inhibitor that is also used in attention-deficit/hyperactivity disorder. The pill targets the motor neurons that control breathing during sleep and boosts their activity so that throat muscles don’t relax, which is what disrupts breathing in patients with sleep apnea. Apnimed has been prepping for Oxnimbi’s launch for some time, bringing Pfizer veteran Graham Goodrich on board as chief commercial officer at the beginning of 2024.

Drug ApprovalPhase 3

27 Jul 2026

·firstwordpharma.com

Apnimed aims for $150M IPO to support sleep apnoea drug launch

Apnimed has set terms for its upcoming public debut, which it hopes will fund regulatory activities for — and the potential commercial launch of — its obstructive sleep apnoea (OSA) candidate. The biotech on Monday proposed to sell 10 million shares between $14 and $16 each. At the midpoint, Apnimed would raise $150 million and hold a fully diluted market value of $665 million.Between the IPO proceeds and its existing cash on-hand, the company plans to put about $228.8 million behind Oxnimbi, also known as AD109. In April, Apnimed inked a $150-million debt financing with HealthCare Royalty Partners to fund development of the oral, once-daily, anti-apneic neuromuscular modulator, which is now under review at the FDA with a decision deadline of Feb. 28, 2027. Its application for Oxnimbi includes data from the Phase III LunAIRo and SynAIRgy studies, which both met their primary endpoints in patients with mild, moderate or severe OSA who are intolerant of or currently refuse continuous positive airway pressure (CPAP) therapy.In the six-month SynAIRgy trial, Oxnimbi — a fixed-dose combination of the antimuscarinic aroxybutynin and the selective norepinephrine reuptake inhibitor atomoxetine — demonstrated a statistically significant mean 55.6% reduction from baseline in the apnoea-hypopnea index (AHI) at 26 weeks.Findings from the 12-month LunAIRo trial showed the therapy achieved a mean reduction in AHI of 46.8% from baseline at week 26, with the reduction remaining significant at the end of the study at week 51.IPOs on the up-and-upApnimed is one of seven biotechs that have lined up this quarter to go public.Scribe Therapeutics was first through the IPO window, raising $128.7 million and seeing a 44% boost to its share price during its first day of trading Friday.Still waiting in the IPO queue are Latigo Biotherapeutics, BlossomHill Therapeutics, Vogenx, Attovia and Braveheart Bio. For related analysis on the surge of IPO activity this year, see – Spotlight On: Investors regain appetite for biotech IPOs.

Phase 3Clinical ResultIPODrug Approval

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


NCT05658874 (CTgov)	Phase 3	Cystitis, Interstitial \| Blepharospasm \| Chronic pelvic pain syndrome	26	Behavioral health consultation/therapy+heparin+gentamicin+sodium bicarb+Kenalog+Vaginal estrogen+Gabapentin+Oxybutynin+Detrol+Mirabegron+lidocaine+Amitriptyline+Trospium+Methenamine (Multimodal Care Bundle)	quhzjcqzdq(plgptwypjh) = ykrsaxzttt tluwnbgraw (emiwhhsnzg, 7.11) View more	-	01 Apr 2026
				Usual Urogynecologic care (Usual Care)	quhzjcqzdq(plgptwypjh) = zqymccirlr tluwnbgraw (emiwhhsnzg, 7.34) View more
NCT04600336 (Alliance A222001, Pubmed \| J Clin Oncol)	Phase 2	Hot Flashes \| Prostatic Cancer	88	Oxybutynin 2.5 mg	cmtoyyyqkv(rhfeibrwzc) = lwndrysglz ymutttnoum (sifcsxqtrh ) View more	Positive	26 Jan 2026
				Oxybutynin 5 mg	cmtoyyyqkv(rhfeibrwzc) = vdttpcrihr ymutttnoum (sifcsxqtrh ) View more
NCT04115878 (MOSAIC, CTgov)	Phase 2	Sleep Apnea, Obstructive \| Down Syndrome	22	oxybutynin+oxybutynin (ato-oxy)+ato-oxy (High Dose Ato-oxy)	rdsorjjizc(mrhviimuuq) = gaawhudscu vpaeuyuhvc (hsfubnwnmu, 2.74) View more	-	19 Aug 2025
				Atomoxetine and oxybutynin (ato-oxy) (Low Dose Ato-oxy)	rdsorjjizc(mrhviimuuq) = slwdhlaidz vpaeuyuhvc (hsfubnwnmu, 3.06) View more
NCT01370811 (CTgov)	Phase 2	Sialorrhea \| Parkinson Disease	24	OC (OC Oral Solution Treatment B)	ajdqzoydwo(aqfjltkeiy) = qcpurgcvxe ulhrjvzagt (kvufbjweuc, 0.165) View more	-	10 Apr 2023
				OC (OC Oral Solution Treatment C)	ajdqzoydwo(aqfjltkeiy) = woxqqzdznn ulhrjvzagt (kvufbjweuc, 0.147) View more
NCT04090190 (CTgov)	Phase 4	Inflammation \| Urinary Incontinence, Urge	20	Oxybutynin+Tolterodine+Trospium+Solifenacin+Fesoterodine	rdpzsbvbtk(knrmkrnlgb) = rugieotzma ogfiyskuna (hviteubwyn, qxsannqcul - jwtwhwkjvf) View more	-	03 Oct 2022
WSC2022	Phase 2	Sleep Apnea, Obstructive	30	Atomoxetine 75 mg + Aroxybutynin 2.5 mg	zyhmplaglo(grwlbfhyge) = vggqievflp czfpubwgql (kokdxrxmii ) View more	Positive	11 Mar 2022
				Atomoxetine 37.5 mg + Aroxybutynin 2.5 mg	zyhmplaglo(grwlbfhyge) = xdkyjoytig czfpubwgql (kokdxrxmii ) View more
NCT04534491 (CTgov)	Phase 3	Urinary Bladder, Overactive	855	Oxybutynin	lgvtpsskmu = pdpghzucgb ogjahxqmuw (oeqbdspfme, otdmqnanzk - ooglarwnpi) View more	-	20 Oct 2020
NCT02961790 (CTgov)	Phase 3	Hot Flashes \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma	150	Oxybutynin Chloride (High-dose Oxybutynin Chloride Group)	zhiikdrifp(ptwwytasgm) = zymzkdtwvm conrguzdfb (iitmqulrff, 15.6) View more	-	03 Jun 2019
				Oxybutynin Chloride (Low-dose Oxybutynin Chloride Group)	zhiikdrifp(ptwwytasgm) = amwxcaicmn conrguzdfb (iitmqulrff, 7.7) View more
NCT02633371 (CTgov)	Not Applicable	Primary Axilary Hyperhidrosis	10	Oxybutynin 3% gel	jxoalgofmi = uqrhtpunpg jsdiipprmd (sowgjhvkow, sqeicwhfdy - wrvtghiqld) View more	-	19 Jun 2018
NCT02176642 (APP, CTgov)	Phase 4	Urinary Incontinence, Urge	55	Posterior Tibial Nerve Stimulation+Oxybutynin extended release (Oxybutynin Plus PTNS)	hhgpirfbxv(oiwkiqhnqk) = vfbwlrqxty jnvuyvcbun (vqirjbuunv, fpmjbvixoo - yrizhuthot) View more	-	23 Jan 2018
				Posterior Tibial Nerve Stimulation (Placebo Plus PTNS)	hhgpirfbxv(oiwkiqhnqk) = caeotampyr jnvuyvcbun (vqirjbuunv, gwbghswolj - dhkayapsqj) View more