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Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR ADRENALIN


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All Clinical Trials for Adrenalin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00202358 ↗ Perioperative Effect of Atenolol on Cytokine Profiles Unknown status Medtronic - MITG Phase 4 2002-11-01 Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure. This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.
NCT00202358 ↗ Perioperative Effect of Atenolol on Cytokine Profiles Unknown status Saini Foundation Phase 4 2002-11-01 Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure. This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.
NCT00562627 ↗ Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty Completed Asker & Baerum Hospital Phase 4 2007-11-01 Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
NCT00622817 ↗ The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis Completed Schneider Children's Medical Center, Israel N/A 2004-10-01 This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis. The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis. Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002) Patients: 65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005. The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score>7 with a range scale 0-10).
NCT00678145 ↗ Mechanisms of Hypoglycemia Associated Autonomic Failure Active, not recruiting National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2008-03-01 Intensive glucose control in type 1 diabetes mellitus (T1DM) is associated with clear health benefits (1). However, despite development of insulin analogs, pump/multi-dose treatment and continuous glucose monitoring, maintaining near-normal glycemia remains an elusive goal for most patients, in large part owing to the risk of hypoglycemia. T1DM patients are susceptible to hypoglycemia due to defective counterregulatory responses (CR) characterized by: 1) deficient glucagon release during impending/early hypoglycemia; 2) additional hypoglycemia-associated autonomic failure (HAAF) and exercise-associated autonomic failure (EAAF) that blunt the sympathoadrenal responses to hypoglycemia following repeated episodes of hypoglycemia or exercise as well as degrading other CR; and 3) hypoglycemia unawareness (HU), lowering the threshold for symptoms that trigger behavioral responses (e.g. eating). Thus, the risk of hypoglycemia in T1DM impedes ideal insulin treatment and leads to defaulting to suboptimal glycemic control (2). There are two approaches that could resolve this important clinical problem: 1) perfection of glucose sensing and insulin and glucagon delivery approaches (bioengineered or cell-based) that mimic normal islet function and precisely regulate glucose continuously, or 2) a drug to enhance or normalize the pattern of CR to hypoglycemia. Despite much research and important advances in the field, neither islet transplantation nor biosensor devices have emerged as viable long-term solutions for the majority of patients (3, 4). Over the past several years, our lab has explored the approach of enhancing CR by examining mechanisms responsible for HAAF/EAAF and searching for potential pharmacological methods to modulate the CR to hypoglycemia (5-11). Our work has led to a paradigm shift in the field of hypoglycemia, exemplified by the novel hypothesis and published experimental data supporting a role for opioid signaling that resulted in the initiation of exploratory clinical trials by other research groups.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Adrenalin

Condition Name

Condition Name for Adrenalin
Intervention Trials
Pain 4
Pain, Postoperative 3
Surgery 2
Bronchiolitis 2
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Condition MeSH

Condition MeSH for Adrenalin
Intervention Trials
Pain, Postoperative 6
Osteoarthritis 2
Emergencies 2
Hypoglycemia 2
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Clinical Trial Locations for Adrenalin

Trials by Country

Trials by Country for Adrenalin
Location Trials
United States 11
France 5
Israel 4
Denmark 3
China 2
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Trials by US State

Trials by US State for Adrenalin
Location Trials
Massachusetts 2
Iowa 2
Washington 1
New Hampshire 1
New York 1
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Clinical Trial Progress for Adrenalin

Clinical Trial Phase

Clinical Trial Phase for Adrenalin
Clinical Trial Phase Trials
Phase 4 17
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Adrenalin
Clinical Trial Phase Trials
Completed 24
Unknown status 8
Recruiting 7
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Clinical Trial Sponsors for Adrenalin

Sponsor Name

Sponsor Name for Adrenalin
Sponsor Trials
University of Iowa 2
University of Sao Paulo 1
The First Affiliated Hospital of Nanchang University 1
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Sponsor Type

Sponsor Type for Adrenalin
Sponsor Trials
Other 60
NIH 3
Industry 2
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Transforming Emergency Care: Clinical Trials, Market Analysis, and Projections for Epinephrine

Introduction to Epinephrine

Epinephrine, commonly known as adrenaline, is a crucial medication for treating severe allergic reactions, including anaphylaxis, and other life-threatening conditions. The drug's market and clinical development are evolving rapidly, driven by advances in delivery systems, increasing incidence of allergic reactions, and growing demand for user-friendly and effective treatments.

Clinical Trials Update for Epinephrine

Aquestive Therapeutics' Anaphylm™

A significant development in the epinephrine market comes from Aquestive Therapeutics, which is advancing its innovative product, Anaphylm™ (epinephrine) Sublingual Film. This product is designed for the treatment of severe life-threatening allergic reactions, including anaphylaxis, through a novel sublingual administration route.

  • Pivotal Study Results: The Phase 3 pivotal pharmacokinetic (PK) clinical study of Anaphylm has successfully met both primary and secondary endpoints. The study demonstrated that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine, comparable to and in some cases surpassing the performance of leading autoinjectors[1][4].
  • FDA Interactions: Recent discussions with the FDA have been positive, with the agency noting substantial progress in the Anaphylm clinical development program. The FDA has recommended that Aquestive begin its pediatric study after completing the remaining adult studies, a recommendation the company is aligned with[1].

Ongoing and Planned Studies

  • Clinical Study Timeline: Aquestive has outlined a detailed timeline for its clinical studies. This includes a temperature PK study in Q1 2024, self-administration and allergen PK studies in Q2 2024, and a pediatric PK study in Q3 2024. A pre-NDA meeting with the FDA is targeted for the second half of 2024, with the goal of filing the NDA before the end of 2024[1].

Global Clinical Trials Landscape

As of September 2024, a total of 2,025 clinical trial studies have been conducted involving epinephrine, with 434 ongoing studies across various phases. These studies are evaluating the pharmacokinetic profile of epinephrine in different individuals and testing various drug delivery systems to enhance delivery and outcomes[3].

Market Analysis for Epinephrine

Current Market Size and Growth

The global epinephrine market is experiencing significant growth driven by several factors:

  • Market Size: The market was valued at approximately USD 2.87 billion in 2023 and is estimated to reach USD 2.91 billion in 2024. It is projected to grow to USD 6.27 billion by 2031, exhibiting a compound annual growth rate (CAGR) of 11.6% from 2024 to 2031[2][5].

Growth Drivers

  • Rising Incidence of Allergic Reactions: The increasing prevalence of life-threatening medical emergencies such as anaphylaxis and cardiac arrests is a major driver. This, coupled with growing awareness about early treatment of allergic reactions, is boosting demand for epinephrine[2][5].
  • User-Friendly Delivery Systems: The availability of user-friendly epinephrine auto-injectors and innovative delivery systems like sublingual films is enhancing market growth[1][2].

Market Challenges

  • Alternative Treatment Options: The presence of alternative treatment options can hamper market growth. Additionally, the risk of side-effects associated with epinephrine administration is a concern that needs to be addressed[2].
  • Regulatory Emphasis: Ensuring the safety and efficacy of epinephrine products, particularly those with concentrations above known EpiPen levels, remains a regulatory focus[1].

Market Projections and Trends

Forecast Period Growth

The epinephrine market is expected to see strong growth in the coming years, driven by several trends:

  • Expanded Access Initiatives: Efforts to increase access to epinephrine, especially in emerging markets, are expected to drive growth. Awareness campaigns and patient education programs are also contributing factors[5].
  • Integration of Smart Devices: The integration of smart devices into epinephrine delivery systems is a significant trend. This includes enhanced tracking and monitoring capabilities to improve patient outcomes[5].
  • Customized Delivery Systems: The development of customized epinephrine delivery systems, such as sublingual films and improved auto-injectors, is expected to continue driving market growth[1][5].

Regional Market Dynamics

The market is geographically diverse, with regions like North America showing strong growth due to high epinephrine prescription rates and the presence of key market players. Favorable reimbursement policies and high healthcare spending in these regions also contribute to market growth[2].

Industry Expert Insights

Rapid Absorption and Delivery

"Every minute matters during a severe allergic reaction," emphasized Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. The rapid absorption of epinephrine, especially during the critical first ten minutes following administration, is a key focus area for new delivery systems like Anaphylm[1][4].

Regulatory Alignment

Aquestive's alignment with FDA recommendations and the clear understanding of the remaining clinical development steps are crucial for the successful progression of Anaphylm and other epinephrine products. This ensures that the products meet the necessary safety and efficacy standards[1].

Key Takeaways

  • Innovative Delivery Systems: The development of novel delivery systems like sublingual films is transforming the epinephrine market.
  • Clinical Trial Progress: Positive results from clinical trials, such as those for Anaphylm, are paving the way for new treatments.
  • Market Growth: The epinephrine market is projected to grow significantly, driven by rising allergy rates and improved delivery systems.
  • Regulatory Focus: Ensuring safety and efficacy, particularly for concentrations above known EpiPen levels, remains a regulatory priority.

FAQs

What is the current market size of the epinephrine market?

The global epinephrine market was valued at approximately USD 2.87 billion in 2023 and is estimated to reach USD 2.91 billion in 2024[2][5].

What is the projected growth rate of the epinephrine market?

The epinephrine market is expected to grow at a compound annual growth rate (CAGR) of 11.6% from 2024 to 2031[2].

What are the key drivers of the epinephrine market growth?

Key drivers include the rising incidence of life-threatening allergic reactions, increasing awareness about early treatment, and the availability of user-friendly delivery systems[2][5].

What are the challenges facing the epinephrine market?

Challenges include the presence of alternative treatment options and the risk of side-effects associated with epinephrine administration[2].

What innovative delivery systems are being developed for epinephrine?

Innovative delivery systems include sublingual films, such as Aquestive Therapeutics' Anaphylm, and improved auto-injectors with smart device integration[1][5].

Sources

  1. Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (Epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Type C Meeting. Aquestive Therapeutics, March 14, 2024.
  2. Epinephrine Market - Share, Size and Industry Analysis. Coherent Market Insights.
  3. Epinephrine Market Size, Trends & 8.34% CAGR Rise by 2034. Towards Healthcare.
  4. Aquestive Therapeutics Reports Positive Results from Latest Clinical Studies Evaluating Pharmacokinetic and Pharmacodynamic Performance of Anaphylm™ (Epinephrine) Sublingual Film and Provides Clinical Development Update. Aquestive Therapeutics, May 31, 2023.
  5. Epinephrine Market Report 2024. The Business Research Company.
Last updated: 2024-12-31

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