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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR HEMABATE


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All Clinical Trials for Hemabate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00989027 ↗ Impact of Uterotonic Agents on Isolated Human Myometrium Completed Samuel Lunenfeld Research Institute, Mount Sinai Hospital N/A 2007-06-01 The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known. The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.
NCT01869556 ↗ Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress Completed Samuel Lunenfeld Research Institute, Mount Sinai Hospital N/A 2013-06-04 Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.
NCT02220361 ↗ Dexmedetomidine on Prevention of Side Effects of Hemabate Unknown status Jin Ni Phase 4 2014-09-01 Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hemabate

Condition Name

Condition Name for Hemabate
Intervention Trials
Postpartum Hemorrhage 3
Nausea and Vomiting 1
Fibroid Uterus 1
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Condition MeSH

Condition MeSH for Hemabate
Intervention Trials
Postpartum Hemorrhage 3
Hemorrhage 3
Leiomyoma 1
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Clinical Trial Locations for Hemabate

Trials by Country

Trials by Country for Hemabate
Location Trials
China 2
Canada 2
United States 1
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Trials by US State

Trials by US State for Hemabate
Location Trials
Illinois 1
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Clinical Trial Progress for Hemabate

Clinical Trial Phase

Clinical Trial Phase for Hemabate
Clinical Trial Phase Trials
Phase 4 2
N/A 3
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Hemabate
Clinical Trial Phase Trials
Completed 4
Unknown status 1
Recruiting 1
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Clinical Trial Sponsors for Hemabate

Sponsor Name

Sponsor Name for Hemabate
Sponsor Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital 2
Zhuhai Maternity & Child Healthcare Hospital 1
Baoan District People's Hospital of Shenzhen 1
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Sponsor Type

Sponsor Type for Hemabate
Sponsor Trials
Other 28
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Hemabate (Carboprost Tromethamine): Clinical Trials, Market Analysis, and Projections

Introduction

Hemabate, also known as carboprost tromethamine, is a prostaglandin analog used primarily in the management of postpartum hemorrhage (PPH) and for inducing abortion. Here, we delve into the clinical trials, market analysis, and future projections for this critical drug.

Clinical Trials and Efficacy

Clinical trials have been instrumental in establishing the efficacy and safety of Hemabate. Two significant open-label clinical trials were conducted to support its use in treating postpartum hemorrhage due to uterine atony.

  • First Clinical Trial: This multicentre study involved 115 patients with refractory postpartum hemorrhage in the USA. The results showed that Hemabate achieved haemostasis in 87.8% of patients, with 73.3% requiring only a single dose. Adverse events were dose-related but not serious[1][4].

  • Second Clinical Trial: Conducted as a post-marketing study over 12 months at 14 centers in the USA, this study evaluated 333 patients. Hemabate controlled postpartum hemorrhage in 83.8% of cases, with 81.4% of patients requiring only a single dose. Adverse events did not appear to be dose-related in this study[1].

These trials highlight the effectiveness of Hemabate in managing severe bleeding post-childbirth, often avoiding the need for surgical intervention.

Mechanism of Action

Hemabate works by inducing strong uterine contractions. It acts on the F receptor or the E2 receptor sites within the uterine muscles, leading to heightened contractions that help control bleeding. This mechanism is crucial for its application in both postpartum hemorrhage and abortion procedures[2].

Market Analysis

Current Market Size and Growth Projections

The global carboprost tromethamine market is expected to experience significant growth. Here are some key market insights:

  • Market Size: The global market is projected to reach USD 2,100.63 million by 2032, according to Polaris Market Research[2].
  • Segmentation: The market is segmented by application (postpartum hemorrhage treatment and pregnancy abortion), distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies), and region (North America, Europe, Asia-Pacific, South America, and the Middle East and Africa)[5].

Regional Dominance

  • North America: This region is expected to dominate the market during the forecast period due to its advanced healthcare system, stringent safety and effectiveness standards, and high demand for obstetric drugs[5].

Distribution Channels

  • Hospital Pharmacies: These held the largest market share (44%) and revenue (USD 0.88 billion) in 2023, as they are the primary distributors of carboprost tromethamine for postpartum hemorrhage treatment[5].

Application Segments

  • Postpartum Hemorrhage: In 2023, this segment accounted for the largest market share (75%) and revenue (USD 1.50 billion) due to the widespread use of Hemabate in managing excessive bleeding following childbirth[5].

Market Dynamics

Drivers

  • Increasing Prevalence of Postpartum Hemorrhage: The rising incidence of PPH is a significant driver for the demand of carboprost tromethamine[5].

  • Infrastructure Expenditures: Increasing healthcare infrastructure expenditures present opportunities for market growth[5].

Restraints

  • High Cost: The high cost of carboprost tromethamine is a significant restraint, limiting access for patients without sufficient health insurance and in low- and middle-income nations[5].

Key Players

Several major pharmaceutical companies are involved in the global carboprost tromethamine market, including:

  • Amneal Pharmaceuticals LLP
  • ANGUS Chemical Company
  • BioSpectra, Inc.
  • ChemScene
  • Dr Reddy's Laboratories Ltd.
  • MANUS AKTTEVA BIOPHARMA LLP
  • Merck KGaA
  • Pfizer
  • Universal Biologicals
  • Woodward Pharma[5].

Recent Developments

  • Generic Version: Long Grove Pharmaceuticals introduced a generic version of Pfizer's Hemabate in 2023, which is another step in making this drug more accessible[5].

Adverse Reactions and Safety

The adverse effects of Hemabate are generally transient and reversible upon cessation of therapy. Common adverse effects include vomiting, diarrhea, and/or nausea, which occurred in about 19% of patients in clinical trials[1][4].

Conclusion

Hemabate is a crucial drug in the management of postpartum hemorrhage and abortion procedures. Clinical trials have demonstrated its efficacy and safety, and market projections indicate significant growth driven by increasing demand and advancements in healthcare infrastructure.

Key Takeaways

  • Efficacy: Hemabate is highly effective in controlling postpartum hemorrhage, with a high success rate in clinical trials.
  • Market Growth: The global carboprost tromethamine market is projected to reach USD 2,100.63 million by 2032.
  • Regional Dominance: North America is expected to dominate the market due to its advanced healthcare system.
  • Distribution Channels: Hospital pharmacies are the primary distributors of Hemabate.
  • Adverse Reactions: Common adverse effects are transient and reversible.

FAQs

What is Hemabate used for?

Hemabate (carboprost tromethamine) is used for the treatment of postpartum hemorrhage due to uterine atony and for inducing abortion between the 13th and 20th weeks of gestation[2][4].

How effective is Hemabate in treating postpartum hemorrhage?

Hemabate has been shown to achieve haemostasis in 87.8% of patients in one clinical trial and 83.8% in another, often avoiding the need for surgical intervention[1][4].

What are the common adverse effects of Hemabate?

Common adverse effects include vomiting, diarrhea, and/or nausea, which occurred in about 19% of patients in clinical trials[1][4].

Which region is expected to dominate the carboprost tromethamine market?

North America is expected to dominate the market during the forecast period due to its advanced healthcare system and high demand for obstetric drugs[5].

What is the projected market size of carboprost tromethamine by 2032?

The global carboprost tromethamine market is projected to reach USD 2,100.63 million by 2032[2].

Who are the key players in the global carboprost tromethamine market?

Key players include Amneal Pharmaceuticals LLP, ANGUS Chemical Company, BioSpectra, Inc., ChemScene, Dr Reddy's Laboratories Ltd., MANUS AKTTEVA BIOPHARMA LLP, Merck KGaA, Pfizer, Universal Biologicals, and Woodward Pharma[5].

Sources

  1. Therapeutic Goods Administration (TGA). Carboprost trometamol - Therapeutic Goods Administration (TGA).
  2. Polaris Market Research. Carboprost Tromethamine Market Set $2,100.63 Mn By 2032,CAGR ...
  3. GlobeNewswire. Hemophilia B Drug Market Size and Share to Grow by 2032,
  4. FDA. Hemabate® carboprost tromethamine injection, USP
  5. GlobeNewswire. Carboprost Tromethamine Market to Gain 2.96 Billion, by 2033 with 4 CAGR, States The Brainy Insights.

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