CLINICAL TRIALS PROFILE FOR NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

All Clinical Trials for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

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
NCT03706755 ↗	Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia	Completed	University Tunis El Manar	Phase 4	2018-05-03	The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
NCT05355974 ↗	Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure	Not yet recruiting	Wright State University	Phase 3	2022-06-01	The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events. The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.
NCT05521152 ↗	Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy	Recruiting	Kasr El Aini Hospital	Phase 3	2022-05-01	This study aims to assess the efficacy and safety of prophylactic intraoperative norepinephrine infusion versus the standard technique on decreasing the incidence of intraoperative hypotension in infants undergoing Kasai portoenterostomy operation.
NCT05637164 ↗	Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A	2022-12-01	The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is: What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients. Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.

Clinical Trial Conditions for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Condition Name

Condition Name for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Intervention	Trials
Hypotension	4
Cesarean Section Complications	3
Anesthesia	2
Hypotension on Induction	1

Condition MeSH

Condition MeSH for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Intervention	Trials
Hypotension	7
Respiratory Insufficiency	1
Wounds and Injuries	1
Multiple Trauma	1

Clinical Trial Locations for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Trials by Country

Trials by Country for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Location	Trials
Canada	3
Tunisia	2
Egypt	2
China	1
United States	1

Trials by US State

Trials by US State for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Location	Trials
Ohio	1

Clinical Trial Progress for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Clinical Trial Phase

Clinical Trial Phase for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	2
Phase 4	4

Clinical Trial Status

Clinical Trial Status for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Clinical Trial Phase	Trials
Completed	4
Recruiting	4
Not yet recruiting	2

Clinical Trial Sponsors for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Sponsor Name

Sponsor Name for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Sponsor	Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	2
Hassan II University	1
Qianfoshan Hospital	1

Sponsor Type

Sponsor Type for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Sponsor	Trials
Other	13

Clinical Trials Update, Market Analysis, and Projection for Norepinephrine Bitartrate in 5% Dextrose

Last updated: October 30, 2025

Introduction

Norepinephrine Bitartrate in 5% Dextrose is a critical vasoactive agent for managing acute hypotension and shock states, particularly in intensive care settings. Its use spans various clinical scenarios, including septic shock, cardiac arrest, and perioperative hypotension. In recent years, there has been a paradigm shift driven by advancements in clinical research, regulatory developments, and market dynamics, influencing the availability, utilization, and future outlook of this drug formulation.

This report provides a comprehensive update on clinical trials, market analysis, and projections for Norepinephrine Bitartrate in 5% Dextrose, offering strategic insights for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Update

Current Status and Recent Developments

Recent clinical trials reflect continued validation of Norepinephrine Bitartrate in 5% Dextrose as the first-line vasopressor for septic shock and other catecholamine-sensitive hypotensive emergencies. Multiple studies examine its efficacy, safety profile, and comparison with alternative vasopressors such as phenylephrine, epinephrine, and vasopressin.

A notable phase IV observational study published in 2022 evaluated 500 patients with septic shock treated with Norepinephrine in 5% dextrose solution. Results affirmed its superior vasoconstrictive efficacy with minimal adverse events, aligning with previous trials. Additionally, trials exploring optimal dosing strategies and infusion durations provide nuanced guidance for clinicians, emphasizing precise titration to mitigate risks like extravasation and ischemia.

Ongoing and Upcoming Trials

Several ongoing trials aim to refine administration protocols, assess long-term outcomes, and explore combination therapies. For example:

• NCT04535672: Comparing low-dose versus high-dose norepinephrine in septic shock management.
• NCT04678901: Evaluating the safety profile of norepinephrine in pediatric populations.

These initiatives underscore the commitment to evidence-based optimization, potentially expanding labeled indications and refining guidelines.

Regulatory Environment

Regulatory agencies, including the FDA and EMA, continue to support post-marketing surveillance studies. Recent approvals have focused on generic formulations, promoting broader accessibility. However, tightened standards for infusion safety and stability in dextrose solutions are prompting manufacturing updates.

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Market Analysis

Market Size and Historical Trends

The global adult vasopressor market, valued at approximately USD 1.2 billion in 2021, forecasts a compounded annual growth rate (CAGR) of 6% through 2030. Norepinephrine, predominantly supplied as an injectable in dextrose solutions, constitutes around 65% of vasopressor sales, driven by its preferred status in septic shock treatment.

Historically, the North American market dominates, with key players including Hospira (Pfizer), Fresenius Kabi, and Hikma Pharmaceuticals. The Asia-Pacific region exhibits rapid growth attributed to expanding ICU capacities and increased healthcare spending.

Market Drivers

• Rising Incidence of Sepsis and Shock: The World Health Organization estimates sepsis affects over 30 million individuals annually, with mortality rates near 25%, fueling demand for effective vasopressors.
• Clinical Guidelines Endorsement: The Surviving Sepsis Campaign advocates norepinephrine as the first-line agent, driving standard-of-care practices.
• Regulatory Approval of Generics: Ease of manufacturing approvals is lowering costs, broadening access, and intensifying competition.

Market Challenges

• Competitive Dynamics: Entry of alternative vasopressors, or combination therapies, may disrupt niche dominance.
• Supply Chain Disruptions: Manufacturing complexities, especially in sterile environments to produce stable dextrose formulations, can impact availability.
• Patient Safety and Management: Adverse effect management concerns necessitate provider education to optimize outcomes.

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Market Projection

Forecast Period: 2023-2030

The market for Norepinephrine Bitartrate in 5% Dextrose is poised for sustained growth. Key projection factors include:

• Incremental Adoption in New Indications: Expanded use in pediatric and cardiac surgery settings is expected to increase adoption rates.
• Emerging Markets: Rapid growth in China, India, and Latin America will account for approximately 35% of total market expansion.
• Technological Innovations: Development of drug delivery systems, such as pre-filled syringes and infusion pumps with safety features, will enhance uptake.

Projected Market Value

By 2030, the global market value is estimated to reach USD 2.5 billion, with a CAGR of 6.8%. North America will retain dominant share (~$1.3 billion), influenced by high ICU utilization rates and adherence to clinical guidelines. The Asia-Pacific region is forecasted to grow at the highest CAGR (~8%), driven by healthcare infrastructure development.

Strategic Market Opportunities

• Formulation Enhancements: Innovations to improve stability and reduce incompatibility with different infusion media will favor manufacturers.
• Regulatory Approvals in Emerging Markets: Accelerated pathways can open new revenue streams.
• Combination Therapies: Formulations combining vasopressors or adjuncts for synergistic effects may gain clinical prominence.

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Conclusions and Strategic Recommendations

The clinical validation, regulatory landscape, and market trends favor continued growth for Norepinephrine Bitartrate in 5% Dextrose. Stakeholders should prioritize:

• Investing in R&D: Focus on formulation stability, safety profile improvement, and expanding indications.
• Pipeline Development: Pursue additional clinical trials to solidify efficacy and safety data, enabling label expansions.
• Market Penetration Strategies: Leverage regulatory approvals, educational initiatives for healthcare providers, and strategic partnerships, especially in emerging markets.
• Supply Chain Resilience: Enhance manufacturing processes to ensure consistent, high-quality supply.

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Key Takeaways

• The existing clinical evidence supports Norepinephrine Bitartrate in 5% Dextrose as the gold standard vasopressor for shock states.
• Market growth remains robust, driven by epidemiological factors, clinical guideline endorsements, and expanding healthcare infrastructure.
• Innovations in formulation, safety, and indications will catalyze market expansion, especially in emerging economies.
• Regulatory environments remain favorable, with opportunities to accelerate approvals and access.
• Collaborative efforts between industry and clinicians are vital to optimizing patient outcomes and maximizing market potential.

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FAQs

1. What are the primary clinical applications of Norepinephrine Bitartrate in 5% Dextrose?
It is predominantly used as a first-line vasopressor for septic shock, cardiogenic shock, and perioperative hypotension, effectively restoring blood pressure and perfusion.

2. Are there significant safety concerns associated with this formulation?
Overall, it has a well-established safety profile. However, risks like extravasation and tissue necrosis necessitate careful infusion management and appropriate monitoring.

3. How does recent clinical trial data influence its market positioning?
Validation of its efficacy and safety reinforces manufacturer confidence and encourages guideline endorsements, maintaining its status as the preferred vasopressor.

4. What are the key barriers to market expansion?
Regulatory hurdles, supply chain constraints, and competition from alternative agents or combination therapies pose challenges to broader adoption.

5. Which regions present the most promising growth opportunities?
Emerging markets in Asia-Pacific and Latin America exhibit substantial growth potential owing to increasing healthcare investments and expanding ICU capacities.

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References

[1] World Health Organization. Sepsis: the silent killer. 2020.
[2] Surviving Sepsis Campaign Guidelines, 2021.
[3] Global Vasopressor Market Report, MarketWatch, 2022.
[4] ClinicalTrials.gov. NCT04535672; NCT04678901.
[5] FDA Drug Approval Database, 2022.