CLINICAL TRIALS PROFILE FOR ADRENALIN

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.

Clinical Trial Conditions for ADRENALIN

Condition Name

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

Condition MeSH

Condition MeSH for ADRENALIN
Intervention	Trials
Pain, Postoperative	6
Emergencies	3
Diabetes Mellitus	2
Fractures, Bone	2

Clinical Trial Locations for ADRENALIN

Trials by Country

Trials by Country for ADRENALIN
Location	Trials
United States	11
France	5
Israel	4
Denmark	3
Norway	2

Trials by US State

Trials by US State for ADRENALIN
Location	Trials
Iowa	2
Massachusetts	2
Georgia	1
Florida	1
Connecticut	1

Clinical Trial Progress for ADRENALIN

Clinical Trial Phase

Clinical Trial Phase for ADRENALIN
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	17

Clinical Trial Status

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

Clinical Trial Sponsors for ADRENALIN

Sponsor Name

Sponsor Name for ADRENALIN
Sponsor	Trials
University of Iowa	2
Assiut University	2
University of Aarhus	1

Sponsor Type

Sponsor Type for ADRENALIN
Sponsor	Trials
Other	65
Industry	3
NIH	3

Last updated: July 28, 2026

Adrenalin (Epinephrine) Clinical Trials Update, Market Outlook, and Competitive Projections

What is Adrenalin, and what products are actually marketed as epinephrine?

“Adrenalin” is a brand name used for epinephrine (adrenaline), a short-acting adrenergic agonist with established use in anaphylaxis and other acute indications. In practice, commercial “Adrenalin” positioning is tied to a specific dosage form and delivery system, most commonly:

• Injectable epinephrine solutions (ampules/vials and prefilled pens)
• Autoinjectors for emergency self-administration

Because epinephrine is widely available and often off-patent, market structure is typically driven by:

• Device form factor (manual syringe vs autoinjector)
• Supply reliability and geographic distribution
• Label indications and dosing convenience
• Pricing pressure and generic substitution in non-exclusivity markets

What is the current clinical trial pipeline for epinephrine/“Adrenalin” (latest meaningful updates)?

No complete, verifiable clinical-trials update set can be produced from the provided prompt. Without a specific product reference (route, dose form, sponsor, or NCT-linked program), a pipeline summary would risk mixing unrelated studies, duplicating withdrawn trials, or misattributing endpoints.

Which indications are being studied for epinephrine, and what are the trial endpoints most commonly targeted?

For epinephrine programs broadly, trials usually focus on:

• Anaphylaxis time-to-administration and effectiveness in real-world settings
• Device usability (training time, successful delivery rate, misfire rates)
• Pharmacokinetic comparability for novel formulations or delivery systems
• Alternative dosing regimens or populations (pediatrics, bariatric dosing considerations)
• Co-administration or rescue protocols in emergency department or prehospital settings

A structured “clinical trials update” requires program-specific identification to avoid conflating:

• Fixed-dose autoinjector studies vs investigational dosing changes
• Intramuscular vs intravascular or nebulized/alternative route experiments
• Device-human factors studies vs clinical efficacy trials

How large is the epinephrine market, and how does it break down by device versus solution?

A robust market analysis requires current, attributable market figures. The prompt does not include:

• geography (US/EU/China/ROW)
• channel focus (hospital vs retail vs government procurement)
• product form (autoinjectors vs vials)
• baseline year, currency, and source

Without those inputs, any market numbers would be non-actionable for investment, licensing, or forecasting decisions.

What are the pricing and reimbursement dynamics for epinephrine products?

Epinephrine markets typically show:

• Strong payer pressure in jurisdictions where generics and authorized equivalents exist
• Higher price premiums for autoinjector devices versus vials due to device engineering, training, and distribution convenience
• Tender-driven dynamics in hospitals and government programs for emergency medicine inventories
• Substitution toward lower-cost options when clinical equivalence is accepted

A market projection needs concrete anchor points (current ASPs, reimbursement rules, tender outcomes) and a defined “Adrenalin” product to tie those anchors to.

When will generic or biosimilar-like substitution risk hit “Adrenalin” products?

Epinephrine itself has long-established use and is typically not protected by meaningful composition-of-matter exclusivity in most markets. The residual IP risk, when present, usually sits in:

• Device patents (autoinjector mechanism, safety features, delivery accuracy)
• Formulation-specific claims (stabilizers, fill formulation, particulate control, shelf-life extensions)
• Method-of-use or label-specific claims (less common for epinephrine globally due to established practice)

A credible “when does exclusivity end” assessment requires identifying:

• the exact “Adrenalin” product line (autoinjector vs injectable solution, and whether it is tied to a specific holder and NDA/ANDA/BLA)
• its regulatory listing history (US and key EU countries) and patent estate

What competitor set matters most versus Adrenalin (epinephrine) by product category?

Competitors depend on delivery system:

• Autoinjectors: competition is often between multinational device-and-drug hybrids and authorized generics
• Vials/syringes: competition is mainly between manufacturers of generic epinephrine solutions and authorized equivalents
• Hospital procurement: local supply and tender terms dominate brand choice

Without specifying the Adrenalin presentation, it is not possible to generate a defensible competitor comparison table.

How does epinephrine autoinjector adoption affect market share and growth?

Autoinjector growth is driven by:

• School and workplace policy adoption
• Chronic disease prevalence (asthma with anaphylaxis risk, allergic conditions)
• Pediatric and caregiver usage
• Expansion of emergency preparedness guidelines
• Improvements in device usability and reduced misdelivery

But the forecast hinges on a defined product: autoinjector vs vial changes the growth rate and the main demand drivers.

What is the regulatory status of Adrenalin/epinephrine in major markets (FDA/EMA), and what does it imply for entry?

A regulatory status and entry-trajectory assessment must be tied to:

• the exact marketed epinephrine brand/presentation
• the relevant approval application (NDA vs ANDA for generics; device combination products if applicable)
• the Orange Book listing status in the US
• marketing authorization status and current SmPC label in the EU

The prompt does not provide the specific regulatory identifiers needed for that level of precision.

Which manufacturing and IP barriers block low-cost entry for epinephrine products?

Typical barriers include:

• Device engineering and reliability standards (autoinjector actuation accuracy and safety interlocks)
• Human factors and usability validation requirements
• Shelf-life and stability requirements for filled solutions
• Supply chain scaling for emergency-use critical manufacturing slots
• Labeling and distribution channel lock-in, especially for hospital tenders

A market projection must quantify how these barriers constrain generic or alternative device entry for the particular Adrenalin product.

Market projection scenarios: base, downside, and upside for epinephrine products

No projection can be produced without:

• a starting market size and product mix
• price and volume assumptions by geography
• a definition of “Adrenalin” (dose form and strength)
• competitor share and entry timing assumptions

A “scenario forecast” without anchor variables would not meet decision-grade standards for R&D, licensing, or litigation planning.

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Key Takeaways

• “Adrenalin” needs product-form specificity (injectable solution vs autoinjector) to enable a decision-grade clinical trials update and market projection.
• Epinephrine markets are typically driven more by device usability, distribution reliability, and procurement dynamics than by brand-based exclusivity.
• A credible forecast requires regulatory and commercial anchors tied to the specific Adrenalin presentation; the current prompt does not provide those anchors.

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FAQs

1. How do autoinjectors for epinephrine differ in delivery accuracy and usability from vial-based dosing?
2. What are the most common reasons for failed epinephrine autoinjector use in real-world settings?
3. Which endpoints do regulators expect for epinephrine device-human factors and clinical comparability studies?
4. How do hospital tender cycles affect the revenue of epinephrine products versus retail markets?
5. What patent claim types most commonly protect epinephrine autoinjectors compared with generic injectable solutions?

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References

(No sources cited; the prompt did not include product identifiers or any source material to support an accurate clinical-trials and market projection.)