CLINICAL TRIALS PROFILE FOR OXYTOCIN

All Clinical Trials for Oxytocin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004363 ↗	Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus	Completed	Northwestern University		1995-12-01	OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
NCT00004363 ↗	Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus	Completed	National Center for Research Resources (NCRR)		1995-12-01	OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone. II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.
NCT00107874 ↗	Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section	Completed	Basel Women’s University Hospital	Phase 2	1999-01-01	Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.
NCT00107874 ↗	Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section	Completed	University Hospital, Basel, Switzerland	Phase 2	1999-01-01	Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.
NCT00114439 ↗	Lithium Cannabis Withdrawal Study	Completed	The University of New South Wales	Phase 2	2005-09-01	This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.
NCT00114439 ↗	Lithium Cannabis Withdrawal Study	Completed	Sydney South West Area Health Service	Phase 2	2005-09-01	This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.

Clinical Trial Conditions for Oxytocin

Condition Name

Condition Name for Oxytocin
Intervention	Trials
Postpartum Hemorrhage	85
Healthy	55
Schizophrenia	30
Oxytocin	21

Condition MeSH

Condition MeSH for Oxytocin
Intervention	Trials
Hemorrhage	161
Postpartum Hemorrhage	142
Disease	37
Schizophrenia	33

Clinical Trial Locations for Oxytocin

Trials by Country

Trials by Country for Oxytocin
Location	Trials
United States	366
Egypt	87
Canada	64
China	49
France	34

Trials by US State

Trials by US State for Oxytocin
Location	Trials
California	61
North Carolina	33
New York	31
Massachusetts	29
South Carolina	20

Clinical Trial Progress for Oxytocin

Clinical Trial Phase

Clinical Trial Phase for Oxytocin
Clinical Trial Phase	Trials
Phase 4	129
Phase 3	66
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for Oxytocin
Clinical Trial Phase	Trials
Completed	391
Recruiting	118
Unknown status	97

Clinical Trial Sponsors for Oxytocin

Sponsor Name

Sponsor Name for Oxytocin
Sponsor	Trials
University of Electronic Science and Technology of China	40
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	29
Cairo University	24

Sponsor Type

Sponsor Type for Oxytocin
Sponsor	Trials
Other	1000
Industry	52
NIH	39

Oxytocin: Clinical Trials, Market Analysis, and Projections

Introduction to Oxytocin

Oxytocin, a neuropeptide hormone, plays a crucial role in various physiological functions, including labor, lactation, and social behaviors. Its therapeutic applications are expanding, making it a significant focus in both clinical trials and market analyses.

Clinical Trials Update

Sublingual Oxytocin for Postpartum Hemorrhage

One of the most promising and critical clinical trials involving oxytocin is the Phase II trial conducted by Insud Pharma, funded by the Bill & Melinda Gates Foundation. This trial aims to determine the optimal dose of sublingual oxytocin to prevent postpartum hemorrhage (PPH), a leading cause of maternal mortality worldwide, affecting approximately 14 million women annually and causing around 70,000 deaths, mostly in low- and middle-income countries[1].

• Trial Details: The clinical trial is set to begin in the first quarter of 2025 and will include 180 participants. The Mundo Sano Foundation will contribute to raising awareness and facilitating the dissemination of the trial results, as well as ensuring access to sublingual oxytocin in areas with high maternal mortality rates.
• Impact: This trial is a milestone in maternal health research, particularly because it is being conducted in low-income countries where the need is most pressing.

Market Analysis

Current Market Size and Growth

The oxytocin market has been experiencing steady growth driven by several factors:

• Global Market Size: As of 2023, the oxytocin market was valued at USD 3.66 billion and is expected to grow at a compound annual growth rate (CAGR) of 4.3% from 2024 to 2030, reaching nearly USD 4.91 billion[3].
• Forecasted Growth: Another projection indicates that the global oxytocin market will grow from USD 94.97 million in 2024 to USD 193.02 million by 2032, exhibiting a CAGR of 9.3% during this period[5].

Key Drivers of Market Growth

Several factors are driving the growth of the oxytocin market:

• Increasing Awareness and Disposable Incomes: Rising awareness about pregnancy care products and increasing disposable incomes, especially in developing countries, are significant drivers. The widespread availability of oxytocin products and well-developed distribution channels also contribute to market expansion[3][5].
• Hospital Segment: The hospital segment is a major contributor, holding the largest market share. Induced births and the need for medical attention and 24/7 monitoring in hospitals are key factors supporting this growth[3].
• Geographical Trends: The Asia-Pacific region is expected to gain significant market share due to rising disposable incomes in countries like China and India, along with strong marketing activities by key players[3].

Challenges and Opportunities

Despite the growth, the oxytocin market faces several challenges:

• Stringent Regulations: Regulatory hurdles and limited access in developing regions pose significant challenges to market growth[5].
• Innovations in Drug Delivery: Innovations in drug delivery systems and formulations, such as sublingual oxytocin, offer opportunities for market expansion and improved patient outcomes[1][5].

Market Segments and Distribution Channels

Indications and Distribution Channels

The oxytocin market is segmented based on indications, distribution channels, and regions:

• Indications: Oxytocin is primarily used in obstetrics and gynecology for labor induction and the prevention of postpartum hemorrhage. Its therapeutic potential is also being explored in mental health disorders, such as combining oxytocin with psychotherapy to reduce depressive symptoms[4][5].
• Distribution Channels: Hospitals and institutional settings are the primary distribution channels, accounting for the largest market share. The availability of compensation and reimbursement on medications in hospitals further supports this segment's growth[3].

Regional Market Analysis

Key Markets

• North America and Europe: These regions have been key markets for oxytocin due to established healthcare systems and high awareness of the drug's benefits[5].
• Asia-Pacific: This region is expected to show significant growth due to rising disposable incomes, well-established distribution channels, and increasing awareness of oxytocin products through strong marketing activities[3].

Key Players

The oxytocin market is dominated by several key players:

• Pfizer, Novartis, Ferring, Fresenius Kabi, Hikma Pharmaceuticals: These companies are leading the market with their extensive product portfolios and strong distribution networks[5].

Future Projections and Trends

Market Expansion

The oxytocin market is poised for gradual recovery and expansion post-pandemic. Innovations in drug delivery systems, increasing awareness of therapeutic benefits, and expanding distribution channels are expected to drive market growth.

• Technological Advancements: Advances in the neurobiology of oxytocin effects and innovations in drug delivery systems will continue to enhance the market's revenue potential[3][5].

Global Health Impact

Ensuring access to oxytocin, especially in low- and middle-income countries, is critical for reducing maternal and infant mortality. Initiatives like the sublingual oxytocin trial by Insud Pharma are crucial for providing practical and accessible solutions for postpartum emergencies[1].

"Ensuring that women have a safe delivery through PPH prevention, with access to quality healthcare and effective drugs - such as oxytocin - is critical to reducing maternal and infant mortality and improving the development of any community and country."[1]

Key Takeaways

• Clinical Trials: The ongoing Phase II trial for sublingual oxytocin to prevent PPH is a significant step in reducing maternal mortality.
• Market Growth: The oxytocin market is expected to grow at a CAGR of 4.3% to 9.3% over the next several years, driven by increasing awareness and improving distribution channels.
• Key Drivers: Rising disposable incomes, hospital segment growth, and innovations in drug delivery systems are key drivers of market expansion.
• Regional Trends: The Asia-Pacific region is expected to show significant growth, while North America and Europe remain key markets.

FAQs

What is the primary use of oxytocin in clinical settings?

Oxytocin is primarily used in obstetrics and gynecology for labor induction and the prevention of postpartum hemorrhage.

What is the current market size of the oxytocin market?

As of 2023, the oxytocin market was valued at USD 3.66 billion and is projected to grow to nearly USD 4.91 billion by 2030[3].

Which regions are expected to drive the growth of the oxytocin market?

The Asia-Pacific region, along with North America and Europe, is expected to drive market growth due to rising disposable incomes and well-established distribution channels[3][5].

What are the key challenges facing the oxytocin market?

Stringent regulations, limited access in developing regions, and patent expirations are some of the challenges facing the oxytocin market[5].

Who are the key players in the oxytocin market?

Key players include Pfizer, Novartis, Ferring, Fresenius Kabi, and Hikma Pharmaceuticals[5].

Sources

1. New Alliance for the Development of a Sublingual Oxytocin Formulation to Prevent Postpartum Hemorrhage. Biospace, 2024.
2. Oxytocin Market - Forecasts from 2021 to 2026. ResearchAndMarkets, 2021.
3. Oxytocin Market :Global Industry Analysis and Forecast (2024-2030). Maximize Market Research, 2024.
4. Could intranasal oxytocin enhance the effects of psychotherapy in individuals with psychiatric disorders? PubMed, 2024.
5. Oxytocin Market Opportunities, Growth Analysis Report, 2024-2032. Polaris Market Research, 2024.