CLINICAL TRIALS PROFILE FOR NOREPINEPHRINE BITARTRATE

All Clinical Trials for Norepinephrine Bitartrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02654847 ↗	Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2016-01-01	Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac output, which may be a concern in an already compromised fetus. Norepinephrine is commonly used in high concentrations in intensive care and recent studies have suggested that in low concentrations it may be a better alternative to phenylephrine in elective CD, as it does not reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The investigators propose this study to determine the dose that would be effective in 90% of patients (ED90). A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately 6 µg, given that the current phenylephrine bolus dose at the investigators' institution is approximately 100 µg.
NCT02962986 ↗	A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2017-01-01	Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine is safe to use for this indication, it has been associated with reflex bradycardia and a reduction in cardiac output. Norepinephrine is a potent vasopressor used to treat hypotension in the critical care setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and have shown that it can be used safely and also has favourable hemodynamic properties when compared to phenylephrine, with less bradycardia and less depression of cardiac output. The investigators recently conducted a study to determine the ED90 of norepinephrine, and now plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension following spinal anesthesia for cesarean section. The investigators hypothesize that norepinephrine, when given as a bolus to prevent post spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal anesthesia.
NCT03328533 ↗	Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery	Completed	Cairo University	Phase 4	2017-11-10	Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Clinical Trial Conditions for Norepinephrine Bitartrate

Condition Name

Condition Name for Norepinephrine Bitartrate
Intervention	Trials
Hypotension	3
Anesthesia	2
Cesarean Section Complications	2

Condition MeSH

Condition MeSH for Norepinephrine Bitartrate
Intervention	Trials
Hypotension	6
Toxemia	1
Sepsis	1

Clinical Trial Locations for Norepinephrine Bitartrate

Trials by Country

Trials by Country for Norepinephrine Bitartrate
Location	Trials
Canada	3
Tunisia	2
Egypt	2
China	1
United States	1

Trials by US State

Trials by US State for Norepinephrine Bitartrate
Location	Trials
Ohio	1

Clinical Trial Progress for Norepinephrine Bitartrate

Clinical Trial Phase

Clinical Trial Phase for Norepinephrine Bitartrate
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
N/A	3

Clinical Trial Status

Clinical Trial Status for Norepinephrine Bitartrate
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for Norepinephrine Bitartrate

Sponsor Name

Sponsor Name for Norepinephrine Bitartrate
Sponsor	Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	2
Wright State University	1
Kasr El Aini Hospital	1

Sponsor Type

Sponsor Type for Norepinephrine Bitartrate
Sponsor	Trials
Other	9

Norepinephrine Bitartrate: Clinical Trials, Market Analysis, and Projections

Introduction

Norepinephrine bitartrate is a small molecule drug that has been a cornerstone in the treatment of various critical medical conditions, including hypotension, heart arrest, and sepsis. This article delves into the current state of clinical trials, market analysis, and future projections for this essential medication.

Clinical Trials Update

Ongoing and Recent Trials

Norepinephrine bitartrate is continuously being evaluated in various clinical trials to expand its therapeutic applications and improve its efficacy. Here are some notable recent and ongoing trials:

• University of Alberta: A Phase 4 trial is underway to assess the use of norepinephrine bitartrate in specific clinical scenarios, focusing on its efficacy and safety in maintaining blood pressure and organ perfusion[1].
• Tunis University: Another Phase 4 trial is investigating the drug's performance in different patient populations, aiming to optimize dosing and administration protocols[1].
• Second Affiliated Hospital, School of Medicine, Zhejiang University: Although the phase is not specified, this trial is part of the ongoing research to refine the use of norepinephrine bitartrate in critical care settings[1].

Key Findings and Outcomes

Recent trials have generally shown positive outcomes, highlighting the drug's effectiveness in increasing blood pressure and maintaining organ perfusion in critical conditions such as septic shock and myocardial infarction. For example, a Phase 4 trial on anesthesia maintenance showed positive results, with the drug helping to stabilize blood pressure during surgical procedures[4].

Market Analysis

Market Size and Growth

The market for norepinephrine bitartrate is experiencing significant growth driven by several factors:

• Global Demand: The norepinephrine drug market, which includes norepinephrine bitartrate, was valued at USD 388.4 million in 2023 and is projected to reach USD 871.9 million by 2031, growing at a CAGR of 12.2% from 2024 to 2031[5].
• Segmentation: The market is segmented based on application (septic shock, hypotension), product type (norepinephrine bitartrate, norepinephrine hydrochloride), and geographical regions (North America, Europe, Asia-Pacific, etc.)[5].

Drivers and Restraints

The market growth is driven by several key factors:

• Increasing Prevalence of Cardiovascular Illnesses and Sepsis: The rising rates of cardiovascular diseases and sepsis-related shock are driving the demand for effective vasopressor treatments like norepinephrine bitartrate[5].
• Improvements in Critical Care Management: Advances in medical emergency response systems and critical care units are enhancing the rapid administration and management of shock situations, increasing the demand for norepinephrine bitartrate[5].
• Access to Essential Drugs: Growing investments in healthcare infrastructure, particularly in intensive care units, are making norepinephrine bitartrate more accessible and contributing to market growth[5].

Competitive Landscape

The market for norepinephrine bitartrate is competitive, with several key players involved:

• Originator and Active Organizations: Companies like Hospira, Inc., Baxter International, Inc., InfoRLife SA, and Grand Pharmaceutical Group Ltd. are significant players in the development and distribution of norepinephrine bitartrate[3][4].

Market Projections

Forecasted Growth

The norepinephrine bitartrate injection market is expected to continue its upward trend from 2023 to 2031. Here are some key projections:

• CAGR: The market is projected to grow at a CAGR of 3 to 5 percent during the forecast period, driven by increasing demand and improving healthcare infrastructure[2].
• Geographical Expansion: The market is expected to expand across various geographical regions, with North America, Europe, and Asia-Pacific being key markets[2].

Emerging Trends

Several trends are expected to shape the future of the norepinephrine bitartrate market:

• Clinical Research and Development: Ongoing clinical trials and research initiatives aim to enhance the therapeutic efficacy and safety profile of norepinephrine bitartrate, potentially broadening its indications and improving patient outcomes[3][5].
• Regulatory Environment: The regulatory landscape, including patent expirations and new approvals, will continue to influence the market dynamics. For instance, the generic version of norepinephrine bitartrate was approved by MEITHEAL in 2003, and several patents are set to expire in the coming years[1].

Therapeutic Applications

Indications

Norepinephrine bitartrate is indicated for a range of critical medical conditions, including:

• Anesthesia: To stabilize blood pressure and prevent hypotension during surgical procedures[3].
• Heart Arrest: To increase blood pressure and maintain organ perfusion in cardiac arrest situations[3].
• Hypotension: To treat low blood pressure in various clinical settings[3].
• Myocardial Infarction: To improve blood flow and prevent further damage to the heart muscle[3].
• Pheochromocytoma: To control blood pressure in patients with this rare adrenal gland tumor[3].
• Poliomyelitis: To maintain blood pressure and prevent complications associated with this viral infection[3].
• Sepsis: To increase blood pressure and improve organ perfusion in septic patients[3].

Key Takeaways

• Clinical Trials: Ongoing trials are focusing on optimizing the use of norepinephrine bitartrate in critical care settings.
• Market Growth: The market is expected to grow significantly, driven by increasing demand for vasopressor treatments and improvements in critical care management.
• Therapeutic Applications: Norepinephrine bitartrate is widely used in treating various critical conditions, including hypotension, heart arrest, and sepsis.
• Regulatory and Competitive Landscape: The market is influenced by patent expirations, new approvals, and the activities of key pharmaceutical companies.

FAQs

What are the primary indications for norepinephrine bitartrate?

Norepinephrine bitartrate is primarily indicated for conditions such as anesthesia, heart arrest, hypotension, myocardial infarction, pheochromocytoma, poliomyelitis, and sepsis.

How is the market for norepinephrine bitartrate expected to grow?

The market for norepinephrine bitartrate is projected to grow at a CAGR of 3 to 5 percent from 2023 to 2031, driven by increasing demand and improvements in healthcare infrastructure.

Which companies are key players in the norepinephrine bitartrate market?

Key players include Hospira, Inc., Baxter International, Inc., InfoRLife SA, and Grand Pharmaceutical Group Ltd.

What are the main drivers of the norepinephrine bitartrate market?

The main drivers include the increasing prevalence of cardiovascular illnesses and sepsis-related shock, improvements in critical care management, and growing access to essential drugs.

What is the current market size of the norepinephrine drug market?

The norepinephrine drug market, which includes norepinephrine bitartrate, was valued at USD 388.4 million in 2023 and is expected to reach USD 871.9 million by 2031.

Sources

1. DrugPatentWatch: "Norepinephrine Bitartrate In 0.9% Sodium Chloride"
2. MarketResearchIntellect: "Norepinephrine Bitartrate Injection Market Size and Forecast"
3. Synapse.Patsnap: "Decoding Norepinephrine Bitartrate: A Comprehensive Study of its R&D Trends"
4. Synapse.Patsnap: "Norepinephrine Bitartrate - Drug Targets, Indications, Patents"
5. MarketResearchIntellect: "Norepinephrine Drug Market Size and Projections"