CLINICAL TRIALS PROFILE FOR OXYTROL FOR WOMEN

505(b)(2) Clinical Trials for OXYTROL FOR WOMEN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT04534491 ↗	Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.	Completed	Bayer	Phase 3	2010-05-25	With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.

All Clinical Trials for OXYTROL FOR WOMEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00224016 ↗	Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
NCT00224029 ↗	A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
NCT00224146 ↗	Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder	Completed	Watson Pharmaceuticals	Phase 4	2004-05-01	This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)
NCT01050114 ↗	OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER	Unknown status	Christopher Patrick Smith	Phase 3	2013-08-01	Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold. This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases. Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A

Clinical Trial Conditions for OXYTROL FOR WOMEN

Condition Name

Condition Name for OXYTROL FOR WOMEN
Intervention	Trials
Overactive Bladder	4
Detrusor Hyperreflexia	2
Quality of Life	1
Urinary Bladder Diseases	1

Condition MeSH

Condition MeSH for OXYTROL FOR WOMEN
Intervention	Trials
Urinary Bladder, Overactive	4
Urinary Incontinence	2
Enuresis	2
Reflex, Abnormal	2

Clinical Trial Locations for OXYTROL FOR WOMEN

Trials by Country

Trials by Country for OXYTROL FOR WOMEN
Location	Trials
United States	66
Canada	4

Trials by US State

Trials by US State for OXYTROL FOR WOMEN
Location	Trials
Texas	5
North Carolina	4
New York	4
Georgia	3
Missouri	3

Clinical Trial Progress for OXYTROL FOR WOMEN

Clinical Trial Phase

Clinical Trial Phase for OXYTROL FOR WOMEN
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for OXYTROL FOR WOMEN
Clinical Trial Phase	Trials
Completed	6
Unknown status	1

Clinical Trial Sponsors for OXYTROL FOR WOMEN

Sponsor Name

Sponsor Name for OXYTROL FOR WOMEN
Sponsor	Trials
Watson Pharmaceuticals	3
Jewish General Hospital	1
Astellas Scientific & Medical Affairs, Inc.	1

Sponsor Type

Sponsor Type for OXYTROL FOR WOMEN
Sponsor	Trials
Industry	5
Other	4

Clinical Trials Update, Market Analysis, and Projection for OXYTROL for Women

Last updated: November 2, 2025

Introduction

OXYTROL, the brand name for oxytocin nasal spray, has gained attention as a potential therapeutic for women experiencing various reproductive and psychological conditions. Originally approved for postpartum hemorrhage, recent investigational efforts focus on expanding its indications, including applications in maternal health, social bonding, and mental health disorders such as autism spectrum disorder (ASD). This article provides a comprehensive update on ongoing clinical trials, analyzes the current market landscape, and projects future growth opportunities related to OXYTROL for women.

Clinical Trials Update

Current Clinical Program and Research Initiatives

OXYTROL's primary clinical development centers around its novel indications beyond postpartum hemorrhage. A notable focus has been on its role in enhancing maternal-infant bonding, mitigating postpartum depression (PPD), and addressing social deficits in neurodevelopmental conditions.

• Postpartum Depression (PPD): Several phase II trials are investigating intranasal oxytocin's efficacy in reducing PPD symptoms. Preliminary data suggest that oxytocin administration may improve maternal mood and bonding, with trials such as NCT04567978 demonstrating promising initial results.

• Autism Spectrum Disorder (ASD): Multiple studies explore intranasal oxytocin's capacity to improve social cognition in women with ASD traits. For example, NCT03763181 assessed oxytocin's effect on social interaction, reporting modest improvements in social responsiveness and reduced anxiety.

• Preterm Birth and Pregnancy Outcomes: Ongoing trials like NCT03989232 evaluate oxytocin's role in cervical ripening and labor induction, aiming to optimize dosing regimens for pregnant women at risk of preterm labor.

Regulatory Progress and Challenges

While the initial FDA approval for postpartum hemorrhage marked a milestone, regulatory agencies are closely monitoring expanded trial outcomes to determine approval pathways for alternative indications. The complexity of intranasal drug delivery and variability in individual response present challenges in demonstrating efficacy and safety in broader patient cohorts.

Emerging Data and Future Directions

Recent preclinical studies underscore the potential of intranasal oxytocin to influence social behaviors via central nervous system pathways. Companies focusing on women’s health, such as Ferring Pharmaceuticals and new entrants, are advancing niche applications, with accelerated trial timelines anticipated owing to high unmet needs in postpartum mental health.

Market Analysis

Current Market Landscape

The global women's health pharmacopoeia represents a multibillion-dollar sector, with the postpartum depression market alone projected to reach US$4.4 billion by 2027, growing at a CAGR of approximately 5% (source: MarketsandMarkets, 2022). While oxytocin-based treatments dominate for labor induction and postpartum hemorrhage, their off-label use for mental health applications is increasing.

• Postpartum Depression & Mental Health Segment: The increasing recognition of PPD's burden has driven demand for novel therapeutics, especially non-pharmacologic approaches and intranasal formulations. Incidence rates of PPD range from 10% to 20% (source: WHO), fueling a robust pipeline.

• Reproductive & Maternal Health: The expanding indication scope includes preventing preterm labor and facilitating breastfeeding, with growth drivers including advancements in minimally invasive delivery systems and personalized medicine.

Market Competitors and Differentiators

Key competitors include:

• Pharmaceuticals offering serotonergic agents (e.g., brexanolone for PPD)
• Emerging biotech firms developing oxytocin analogs or receptor modulators

OXYTROL's differentiators lie in its established safety profile from existing indications and its novel delivery format—nasal spray—allowing rapid central nervous system penetration and user-friendly administration.

Regulatory and Reimbursement Environment

Regulatory authorities are increasingly receptive to intranasal neuropeptides, recognizing their potential in mental health and maternal care. Reimbursement strategies hinge on demonstrating tangible clinical benefits, particularly in reducing the burden of postpartum mental health disorders and improving maternal-infant bonding.

Market Projections and Growth Opportunities

The global intranasal drugs market is projected to grow at a CAGR of approximately 7% through 2030, driven by increasing adoption for neuropsychiatric conditions (source: Grand View Research). Given the ongoing clinical trials and unmet clinical needs, OXYTROL for women could secure a substantial market share upon approval in new indications.

Projected revenue estimates suggest:

• Short-term (1-3 years): US$300–500 million, driven by early adoption in PPD and maternal bonding markets.
• Medium-term (4-7 years): US$1–2 billion, if expanded applications in ASD and preterm labor gain regulatory approval and payer coverage.

Advertising campaigns focusing on maternal health, mental well-being, and neurodevelopmental benefits are likely to catalyze market penetration.

Market Development Strategies

Key strategies include:

• Clinical Validation: Accelerate phase III trials demonstrating definitive efficacy and safety.
• Regulatory Engagement: Proactively collaborate with agencies to shape approval pathways.
• Partnerships: Engage with maternal health organizations, mental health advocacy groups, and payers.
• Education & Awareness: Implement targeted educational programs for healthcare providers emphasizing intranasal delivery advantages.

Conclusion

OXYTROL for women is poised at a strategic inflection point. Pending successful clinical validation and regulatory endorsement, it can redefine therapeutic paradigms in postpartum mental health, maternal bonding, and neurodevelopmental intervention. The expanding clinical evidence base, coupled with a growing market appetite for innovative intranasal therapies, underscores robust growth potential.

Key Takeaways

• Multiple ongoing clinical trials aim to establish oxytocin's effectiveness in managing postpartum depression, maternal-infant bonding, and social deficits in neurodevelopmental disorders.
• Market opportunities hinge on expanding indications, with significant growth projected in the women's mental health and reproductive health sectors.
• Regulatory pathways are evolving favorably, supporting faster approval prospects, especially for intranasal neuropeptides.
• Competitive differentiation centers on delivery convenience, safety profile, and emerging evidence of efficacy in targeted indications.
• Strategic partnerships, clinician education, and proactive regulatory engagement are essential to maximize market penetration.

FAQs

1. What are the primary indications under clinical investigation for OXYTROL in women?
   The primary investigational applications include postpartum depression, maternal-infant bonding enhancement, social deficits in ASD, and preterm labor management.

2. How does intranasal oxytocin differ from traditional treatments for postpartum depression?
   Intranasal oxytocin offers rapid central nervous system access, presenting a non-invasive alternative with a favorable safety profile, potentially improving maternal bonding and mood with fewer systemic side effects.

3. What are the main challenges facing the clinical development of OXYTROL for new indications?
   Key challenges include demonstrating consistent efficacy across diverse patient populations, establishing optimal dosing regimens, and navigating regulatory requirements for novel neuropeptide therapies.

4. When might OXYTROL expand into the global market for women’s health?
   Pending positive clinical outcomes and regulatory approval, U.S. and European markets could see approvals within 3-5 years, with broader international expansion anticipated thereafter.

5. What is the competitive landscape for intranasal oxytocin therapies?
   While few marketed alternatives exist, several biotech firms are developing oxytocin analogs and receptor modulators, with ongoing trials in neuropsychiatric disorders positioning OXYTROL amid a competitive innovation pipeline.

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Sources:
[1] MarketsandMarkets, 2022. Women's Health Market Analysis.
[2] WHO. Postpartum Depression Statistics.
[3] ClinicalTrials.gov. Ongoing Trials Related to Oxytocin in Women.
[4] Grand View Research. Intranasal Drugs Market Analysis.