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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE


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All Clinical Trials for Norepinephrine Bitartrate In 0.9% Sodium Chloride

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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Norepinephrine Bitartrate In 0.9% Sodium Chloride

Condition Name

Condition Name for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Intervention Trials
Hypotension 3
Anesthesia 2
Cesarean Section Complications 2
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Condition MeSH

Condition MeSH for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Intervention Trials
Hypotension 6
Sepsis 1
Biliary Atresia 1
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Clinical Trial Locations for Norepinephrine Bitartrate In 0.9% Sodium Chloride

Trials by Country

Trials by Country for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Location Trials
Canada 3
Egypt 2
Tunisia 2
China 1
United States 1
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Trials by US State

Trials by US State for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Location Trials
Ohio 1
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Clinical Trial Progress for Norepinephrine Bitartrate In 0.9% Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
N/A 3
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Clinical Trial Status

Clinical Trial Status for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Clinical Trial Phase Trials
Completed 4
Recruiting 3
Not yet recruiting 2
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Clinical Trial Sponsors for Norepinephrine Bitartrate In 0.9% Sodium Chloride

Sponsor Name

Sponsor Name for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Sponsor Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital 2
Second Affiliated Hospital, School of Medicine, Zhejiang University 1
Tunis University 1
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Sponsor Type

Sponsor Type for Norepinephrine Bitartrate In 0.9% Sodium Chloride
Sponsor Trials
Other 9
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Norepinephrine Bitartrate in 0.9% Sodium Chloride: Clinical Trials, Market Analysis, and Projections

Introduction

Norepinephrine bitartrate in 0.9% sodium chloride is a critical medication used primarily in the management of septic shock and other forms of hypotension. This article provides an update on the clinical trials, market analysis, and financial projections for this drug.

Clinical Trials Overview

Current and Ongoing Trials

Several clinical trials are currently underway or have recently been completed to evaluate the efficacy and safety of norepinephrine bitartrate in various clinical settings.

  • EA-NE-TUN Multicenter Trial: This randomized controlled trial (RCT) aims to assess whether early administration of low-dose norepinephrine in adult patients with sepsis can provide better control of shock within 6 hours compared to standard care. The trial involves patients randomized into two groups: an early norepinephrine group and a standard care group. The norepinephrine is prepared as 4 mg mixed with 250 ml of 5% glucose, resulting in a final concentration of 0.016 mg/ml, and is infused at a rate adjusted to achieve 0.05 microgram/kg/min[4].

  • Other Trials: Various other trials are listed, including those sponsored by the University of Alberta, Tunis University, and the Second Affiliated Hospital, School of Medicine, Zhejiang University. These trials are in different phases, including Phase 4, and focus on different aspects of norepinephrine bitartrate use in clinical practice[5].

Methodology and Outcomes

The EA-NE-TUN trial, for example, uses a single-blind protocol where the trial drug is not disclosed to the patient. Patients are randomized based on a computer-generated program, stratified by age and SOFA score. The primary endpoint is the percentage of patients whose hypotension is restored within 6 hours. The trial aims to determine if early norepinephrine administration can achieve this goal more effectively than standard care[4].

Market Analysis

Market Size and Growth

The global market for norepinephrine and noradrenaline, which includes norepinephrine bitartrate in 0.9% sodium chloride, was valued at USD 0.42 billion in 2023. This market is projected to grow to USD 0.55 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 3.4% during this period. This growth is driven by increasing demand for effective treatments in critical care settings[5].

Key Players and Patents

The drug is marketed by companies such as Inforlife and Long Grove Pharms. There are seven patents protecting this drug, with three patent family members in two countries. The generic ingredient, norepinephrine bitartrate, has five drug master file entries, and there are twenty-three suppliers listed for this compound[5].

Financial Projections

Revenue Forecast

Given the projected CAGR of 3.4%, the market for norepinephrine bitartrate in 0.9% sodium chloride is expected to see steady growth over the next decade. This growth will be driven by increased usage in hospitals and intensive care units, as well as potential expansions into new markets.

Average Wholesale Price

The average wholesale price for norepinephrine bitartrate in 0.9% sodium chloride can vary based on region and supplier. However, the stability and demand for this medication ensure that it remains a lucrative product in the pharmaceutical market.

Product Formulations and Stability

Formulations

Norepinephrine bitartrate in 0.9% sodium chloride is supplied as a clear, colorless sterile solution in 250 mL non-PVC infusion bags. The solution comes in various strengths, such as 4 mg base/250 mL, 8 mg base/250 mL, and 16 mg base/250 mL. The formulation includes excipients like edetate disodium (EDTA) to prevent oxidation of norepinephrine[2].

Stability and Quality Control

The stability data and statistical analysis demonstrate that the proposed product is stable for a period of 24 months when stored at 20 – 25ºC (68 – 77ºF) in the proposed container closure system. The product undergoes rigorous testing for critical quality attributes such as appearance, identity, assay for L-norepinephrine, enantiomeric impurity, related substance, pH, osmolality, particulate matter, sterility, and bacterial endotoxins[2].

Clinical Implications and Guidelines

Uniform Formulation

A joint task force position statement by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine advocates for a uniform norepinephrine-base formulation for global use. This is crucial for ensuring consistency in clinical care, dose calculations, and results of datasets reporting maximal norepinephrine equivalents across different countries[1].

Clinical Use

Norepinephrine bitartrate is a key component in the management of septic shock. It is used to increase blood pressure and ensure adequate perfusion of vital organs. The early initiation of norepinephrine, as studied in the EA-NE-TUN trial, may offer better control of shock and improved patient outcomes[4].

Key Takeaways

  • Clinical Trials: Ongoing trials like the EA-NE-TUN multicenter RCT are evaluating the efficacy of early norepinephrine administration in septic patients.
  • Market Growth: The global market for norepinephrine bitartrate in 0.9% sodium chloride is projected to grow at a CAGR of 3.4% from 2023 to 2032.
  • Product Formulations: The drug is available in various strengths and is formulated to ensure stability and prevent oxidation.
  • Clinical Implications: Uniform formulation and early initiation of norepinephrine are critical for optimal patient care and outcomes.

FAQs

What is the primary use of norepinephrine bitartrate in 0.9% sodium chloride?

Norepinephrine bitartrate in 0.9% sodium chloride is primarily used to manage septic shock and other forms of hypotension by increasing blood pressure and ensuring adequate perfusion of vital organs.

What is the projected market growth for norepinephrine bitartrate in 0.9% sodium chloride?

The market is projected to grow from USD 0.42 billion in 2023 to USD 0.55 billion by 2032, with a CAGR of 3.4%.

What are the key formulations of norepinephrine bitartrate in 0.9% sodium chloride?

The drug is supplied as a clear, colorless sterile solution in 250 mL non-PVC infusion bags, available in strengths of 4 mg base/250 mL, 8 mg base/250 mL, and 16 mg base/250 mL.

Why is uniform formulation of norepinephrine important?

Uniform formulation is crucial for ensuring consistency in clinical care, dose calculations, and results of datasets reporting maximal norepinephrine equivalents across different countries.

What is the significance of the EA-NE-TUN multicenter trial?

The EA-NE-TUN trial aims to assess whether early administration of low-dose norepinephrine in adult patients with sepsis can provide better control of shock within 6 hours compared to standard care.

Sources

  1. Position Paper on the Reporting of Norepinephrine Formulations in Clinical Practice. PubMed, 2024.
  2. Norepinephrine in Sodium Chloride Injection. FDA, 2022.
  3. PRODUCT QUALITY REVIEW(S) for Norepinephrine Bitartrate in 5% Dextrose Injection. FDA, 2021.
  4. Multicenter randomized clinical trial (EA-NE-S-TUN) study protocol. PLOS ONE, 2024.
  5. Norepinephrine Bitartrate In 0.9% Sodium Chloride. DrugPatentWatch, 2023.

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