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Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR PITOCIN


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All Clinical Trials for Pitocin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00263796 ↗ An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism Completed Anagnostou, Evdokia, M.D. Phase 1 2006-03-01 To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.
NCT00308711 ↗ Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor Completed Ferring Pharmaceuticals Phase 3 2006-04-01 The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
NCT00663039 ↗ Effects of Oxytocin Nasal Spray on Social Affiliation Completed National Institute of Mental Health (NIMH) Phase 2 2009-10-01 Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments. Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.
NCT00663039 ↗ Effects of Oxytocin Nasal Spray on Social Affiliation Completed University of Maryland Phase 2 2009-10-01 Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments. Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.
NCT00663039 ↗ Effects of Oxytocin Nasal Spray on Social Affiliation Completed University of Maryland, Baltimore Phase 2 2009-10-01 Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments. Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pitocin

Condition Name

Condition Name for Pitocin
Intervention Trials
Postpartum Hemorrhage 22
Osteoarthritis, Knee 7
Pregnancy 6
Induction of Labor 5
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Condition MeSH

Condition MeSH for Pitocin
Intervention Trials
Hemorrhage 28
Postpartum Hemorrhage 24
Rupture 7
Osteoarthritis, Knee 7
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Clinical Trial Locations for Pitocin

Trials by Country

Trials by Country for Pitocin
Location Trials
United States 87
Canada 19
Israel 9
India 2
Malaysia 2
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Trials by US State

Trials by US State for Pitocin
Location Trials
North Carolina 14
South Carolina 11
California 8
New York 6
Arizona 4
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Clinical Trial Progress for Pitocin

Clinical Trial Phase

Clinical Trial Phase for Pitocin
Clinical Trial Phase Trials
Phase 4 20
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Pitocin
Clinical Trial Phase Trials
Completed 50
Recruiting 21
Unknown status 15
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Clinical Trial Sponsors for Pitocin

Sponsor Name

Sponsor Name for Pitocin
Sponsor Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital 16
Wake Forest University Health Sciences 13
Medical University of South Carolina 10
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Sponsor Type

Sponsor Type for Pitocin
Sponsor Trials
Other 118
NIH 8
U.S. Fed 6
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Pitocin (Oxytocin): Clinical Trials, Market Analysis, and Projections

Introduction to Pitocin (Oxytocin)

Pitocin, commonly known as oxytocin, is a synthetic hormone that plays a crucial role in obstetrics, particularly in labor induction and the management of postpartum hemorrhage. Here, we will delve into the current clinical trials, market analysis, and future projections for this essential drug.

Clinical Trials Update

Labor Induction and PROM

A significant clinical trial currently underway is the "Pitocin or Oral Misoprostol for PROM IOL in Nulliparous Women with Unfavorable Cervical Exams" study. This randomized, single-center trial aims to determine whether Pitocin (oxytocin) or oral misoprostol results in a shorter interval to delivery after the start of induction in nulliparous women with premature rupture of membranes (PROM) and unfavorable cervical exams[1].

  • Primary Endpoint: The primary outcome is the time from the start of induction of labor (IOL) to delivery.
  • Secondary Endpoints: These include suspected intraamniotic infection, time from PROM to delivery, time from IOL to vaginal delivery, and cesarean delivery rates.
  • Methodology: The study involves 155 subjects and uses an intention-to-treat analysis with chi-square tests for categorical variables and two-sample t-tests for continuous variables.

Other Clinical Applications

Oxytocin is also being explored in various other clinical contexts beyond obstetrics. For example, Tonix Pharmaceuticals is conducting clinical trials for TNX-2900, an intranasal potentiated oxytocin formulation, to treat Prader-Willi syndrome (PWS) in children and adolescents. This study has been granted Orphan Drug designation by the FDA and is in the Phase 2 stage[3].

Additionally, intranasal oxytocin is being studied for its effects on suck and swallow competency in infants and children with PWS, with the hypothesis that it could improve feeding outcomes and reduce the need for gastrostomy tubes[4].

Market Analysis

Current Market Size

The global oxytocin market is substantial and growing. As of 2023, the market stood at USD 1.25 billion and is anticipated to grow with a Compound Annual Growth Rate (CAGR) of 6.72% through 2029[2].

Market Drivers

Several factors are driving the growth of the oxytocin market:

  • Increasing Childbirth Complications: The escalating incidence of childbirth-related issues such as prolonged labor and postpartum hemorrhage is a significant catalyst for the market.
  • Expanding Applications: Ongoing research into oxytocin's use in mental health disorders, chronic migraine, binge eating disorder, and other conditions is further fueling market growth[2][3].
  • Quality and Affordability: Initiatives to ensure the quality and affordability of oxytocin are also contributing to market expansion.

Distribution Channels

The oxytocin market is segmented by distribution channels, including hospital pharmacies, drug stores, and online pharmacies. Hospital pharmacies are a major segment due to the frequent use of oxytocin in obstetric care[2].

Market Projections

Future Growth

The global oxytocin market is expected to continue its growth trajectory. According to Polaris Market Research, the market is forecast to reach USD 193.02 million by 2032, expanding at a CAGR of 9.3% from 2024 to 2032[5].

Regional Analysis

The market growth will be influenced by regional factors, with different regions exhibiting varying growth rates. The report by TechSci Research provides detailed insights into the market structure and future growth potential across different regions[2].

Key Takeaways

  • Clinical Trials: Oxytocin is being evaluated in various clinical trials for its efficacy in labor induction, particularly in cases of PROM, and for other conditions like Prader-Willi syndrome.
  • Market Growth: The global oxytocin market is growing due to increasing childbirth complications, expanding applications, and initiatives to improve quality and affordability.
  • Future Projections: The market is expected to reach USD 193.02 million by 2032, with a CAGR of 9.3% from 2024 to 2032.

FAQs

What is the primary use of Pitocin (oxytocin) in clinical settings?

Pitocin (oxytocin) is primarily used for labor induction and the management of postpartum hemorrhage in obstetrics.

What is the current status of the clinical trial comparing Pitocin and oral misoprostol for PROM IOL?

The trial is ongoing, aiming to determine which medication results in a shorter interval to delivery in nulliparous women with unfavorable cervical exams and PROM.

What other conditions is oxytocin being studied for beyond obstetrics?

Oxytocin is being studied for its potential in treating Prader-Willi syndrome, chronic migraine, binge eating disorder, and other mental health conditions.

What is the projected growth rate of the global oxytocin market?

The global oxytocin market is expected to grow at a CAGR of 9.3% from 2024 to 2032.

Which distribution channels are significant for the oxytocin market?

Hospital pharmacies are a major distribution channel for oxytocin due to its frequent use in obstetric care.

Sources

  1. Pitocin or Oral Misoprostol for PROM IOL in Nulliparous Women with Unfavorable Cervical Exams - ClinicalTrials.gov
  2. Oxytocin Market to Grow with a CAGR of 6.72% through 2029 - TechSci Research
  3. Tonix Pharmaceuticals Announces IND Clearance by the FDA for TNX-2900 - Tonix Pharmaceuticals
  4. Intranasal Oxytocin - UF Health - UF Health
  5. Oxytocin Market Size Worth $193.02 Million By 2032 | CAGR: 9.3% - Polaris Market Research
Last updated: 2025-01-03

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