CLINICAL TRIALS PROFILE FOR ESMOLOL HYDROCHLORIDE

All Clinical Trials for Esmolol Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00302692 ↗	Use of Beta Blockers in Elderly Trauma Patients	Unknown status	American Heart Association	Phase 2	2005-12-01	Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease. This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications. Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers. Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.

Clinical Trial Conditions for Esmolol Hydrochloride

Condition Name

Condition Name for Esmolol Hydrochloride
Intervention	Trials
Septic Shock	9
Postoperative Pain	6
Hypertension	6

Condition MeSH

Condition MeSH for Esmolol Hydrochloride
Intervention	Trials
Shock	12
Shock, Septic	11
Pain, Postoperative	9

Clinical Trial Locations for Esmolol Hydrochloride

Trials by Country

Trials by Country for Esmolol Hydrochloride
Location	Trials
United States	28
China	18
Egypt	15
Brazil	10
France	7

Trials by US State

Trials by US State for Esmolol Hydrochloride
Location	Trials
California	6
Illinois	5
Utah	2
North Carolina	2
New York	2

Clinical Trial Progress for Esmolol Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Esmolol Hydrochloride
Clinical Trial Phase	Trials
Phase 4	36
Phase 3	13
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Esmolol Hydrochloride
Clinical Trial Phase	Trials
Completed	44
Unknown status	25
Recruiting	18

Clinical Trial Sponsors for Esmolol Hydrochloride

Sponsor Name

Sponsor Name for Esmolol Hydrochloride
Sponsor	Trials
The University of Hong Kong	4
Ain Shams University	4
Baxter Healthcare Corporation	4

Sponsor Type

Sponsor Type for Esmolol Hydrochloride
Sponsor	Trials
Other	134
Industry	15

Esmolol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Esmolol Hydrochloride

Esmolol hydrochloride is a cardio-selective beta-blocker known for its rapid onset and short half-life, making it an ideal agent for acute heart rate control, particularly in perioperative settings and for managing conditions like supraventricular tachycardia and perioperative hypertension.

Clinical Trials Update

Supraventricular Tachycardia and Intraoperative/Postoperative Tachycardia

Esmolol hydrochloride has been extensively studied in clinical trials for its efficacy in managing supraventricular tachycardia and intraoperative/postoperative tachycardia. These trials have confirmed its effectiveness in reducing heart rate and maintaining cardiovascular stability during and after surgical procedures. The drug's rapid action and short duration make it a preferred choice in these settings[1][4].

Diabetic Foot Ulcers (DFUs)

A significant recent development involves the use of esmolol hydrochloride in the treatment of diabetic foot ulcers. A multicenter, randomized, double-blind clinical trial conducted from 2018 to 2020 showed that the addition of topical esmolol hydrochloride to standard of care significantly improved the healing of uninfected DFUs. The study found that 60.3% of participants in the esmolol group achieved target ulcer closure within 12 weeks, compared to 41.7% in the standard of care only group[3].

Ongoing Clinical Development

Esmolol hydrochloride is currently in Phase III clinical trials for the treatment of diabetic foot ulcers under the development of NovaLead Pharma. This topical formulation, known as Galnobax, has nitric oxide-potentiating activity and is developed using the Reverse Virtual High Throughput Screening (RVHTS) platform. While historical data for Phase III drugs in this indication is limited, the ongoing trials are crucial for determining its likelihood of approval and future market potential[5].

Market Analysis

Global Market Size and Growth

The global esmolol hydrochloride market is projected to experience steady growth driven by the increasing prevalence of cardiovascular diseases, rising surgical procedures, and advancements in critical care and anesthesiology. According to IndustryARC, the market size is estimated to reach $487.2 million by 2030, growing at a compound annual growth rate (CAGR) of 3.5% from 2024 to 2030[4].

Regional Market Performance

North America currently dominates the esmolol hydrochloride market, driven by the rising incidence of cardiovascular disorders, an increase in surgical strategies, and heightened recognition of effective treatment options. The Asia-Pacific region is expected to grow at the highest CAGR, driven by growing cardiovascular disease rates, an increase in surgical interventions, and improving healthcare access[2].

Market Segments

The esmolol hydrochloride market is segmented based on indication, end-user, and sales channels. Supraventricular tachycardia and non-compensatory sinus tachycardia are expected to dominate the market over the forecast period, while intraoperative and postoperative tachycardia is the fastest-growing segment. Hospitals and clinics are the primary end-users, with distributors and pharmaceutical companies being key sales channels[2][4].

Market Projections

Future Growth Drivers

The market growth for esmolol hydrochloride is expected to be driven by several factors:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of cardiovascular conditions will continue to drive the demand for effective heart rate control medications like esmolol hydrochloride.
• Advancements in Healthcare Infrastructure: Heightened investments in healthcare infrastructure, particularly in emerging economies, will enhance access to esmolol hydrochloride.
• Regulatory Approvals: Expanded indications and regulatory approvals across multiple geographies will further support market growth.
• Pharmaceutical Innovation: Improved formulations and delivery systems, such as topical gels for diabetic foot ulcers, will contribute to market expansion[2][4].

Challenges and Considerations

While esmolol hydrochloride offers significant benefits, there are several challenges and considerations:

• Adverse Reactions: Common adverse effects include hypotension, nausea, dizziness, and somnolence. In patients with pheochromocytoma, esmolol must be used with caution and in combination with an alpha blocker to avoid paradoxical increases in blood pressure[1].
• Peripheral Circulatory Disorders: Esmolol hydrochloride may aggravate peripheral circulatory disorders, such as Raynaud’s disease or peripheral occlusive vascular disease[1].

Key Takeaways

• Esmolol hydrochloride is a critical medication for acute heart rate control, particularly in perioperative settings.
• Clinical trials have shown its efficacy in managing supraventricular tachycardia, intraoperative/postoperative tachycardia, and diabetic foot ulcers.
• The global market is projected to grow at a CAGR of 3.5% from 2024 to 2030, driven by increasing cardiovascular disease prevalence and advancements in healthcare infrastructure.
• North America and the Asia-Pacific region are key markets, with the latter expected to grow at the highest CAGR.
• Regulatory approvals and pharmaceutical innovations will continue to support market growth.

FAQs

What is the primary use of esmolol hydrochloride?

Esmolol hydrochloride is primarily used for the rapid control of heart rate in conditions such as supraventricular tachycardia and perioperative hypertension.

What are the common adverse reactions associated with esmolol hydrochloride?

Common adverse reactions include hypotension, nausea, dizziness, and somnolence. Hypotension is the most significant and common adverse effect[1].

How is esmolol hydrochloride administered?

Esmolol hydrochloride can be administered via a loading dose followed by continuous infusion. The effective maintenance dose ranges from 50 to 200 mcg per kg per minute[1].

What is the current status of esmolol hydrochloride in treating diabetic foot ulcers?

Esmolol hydrochloride is in Phase III clinical trials for the treatment of diabetic foot ulcers, with promising results from earlier trials showing improved wound healing when used topically[3][5].

Which regions are expected to drive the growth of the esmolol hydrochloride market?

North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest CAGR due to increasing cardiovascular disease rates and improving healthcare access[2][4].

Sources

1. Drugs.com: Esmolol Injection: Package Insert / Prescribing Information.
2. Cognitive Market Research: Esmolol Hydrochloride Market Report 2024 (Global Edition).
3. PubMed: Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers.
4. IndustryARC: Esmolol Hydrochloride Market - Forecast(2024 - 2030).
5. Pharmaceutical Technology: Esmolol hydrochloride by NovaLead Pharma for Diabetic Foot Ulcers.