CLINICAL TRIALS PROFILE FOR EPINEPHRINE IN 0.9% SODIUM CHLORIDE

505(b)(2) Clinical Trials for Epinephrine In 0.9% Sodium Chloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Atrium Health Levine Cancer Institute	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

All Clinical Trials for Epinephrine In 0.9% Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000290 ↗	Stress Hormones and Human Cocaine Use - 7	Completed	University of Minnesota	Phase 1	1997-05-01	The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
NCT00000290 ↗	Stress Hormones and Human Cocaine Use - 7	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 1	1997-05-01	The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
NCT00000290 ↗	Stress Hormones and Human Cocaine Use - 7	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	1997-05-01	The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00002659 ↗	Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer	Unknown status	Matrix Pharmaceutical	Phase 3	1995-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer.
NCT00003044 ↗	Chemotherapy in Treating Patients With Liver Cancer	Unknown status	Matrix Pharmaceutical	Phase 2	1996-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.
NCT00004847 ↗	Diagnosis of Pheochromocytoma	Recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1	2000-03-22	The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe medical consequences, including stroke, heart attack and sudden death, in situations that would normally pose little or no risk, such as surgery, general anesthesia or childbirth. Patients with pheochromocytoma may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Study participants will undergo blood, urine, and imaging tests, described below, to detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery is not feasible (for example, if there are multiple tumors that cannot be removed), evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic and research tests may include the following: 1. Blood tests - mainly measurements of plasma or urine catecholamines and metanephrines as well as methoxytyramine. If necessary the clonidine suppression test can be carried out. 2. Standard imaging tests - Non-investigational imaging tests include computed tomography (CT), magnetic resonance imaging (MRI), sonography, and 123I-MIBG scintigraphy and FDG (positron emission tomography) PET/CT. These scans may be done before and/or after surgical removal of pheochromocytoma. 3. Research PET scanning is done using an injection of radioactive compounds. Patients may undergo 18F-FDOPA, 18F-DA, as well as 68Ga-DOTATATE PET/CT . Each scan takes up to about 2 hours. 4. Genetic testing - A small blood sample is collected for DNA analysis and other analyses.

Clinical Trial Conditions for Epinephrine In 0.9% Sodium Chloride

Condition Name

Condition Name for Epinephrine In 0.9% Sodium Chloride
Intervention	Trials
Pain	45
Postoperative Pain	37
Pain, Postoperative	33
Anesthesia, Local	22

Condition MeSH

Condition MeSH for Epinephrine In 0.9% Sodium Chloride
Intervention	Trials
Pain, Postoperative	99
Pulpitis	36
Hemorrhage	29
Osteoarthritis	23

Clinical Trial Locations for Epinephrine In 0.9% Sodium Chloride

Trials by Country

Trials by Country for Epinephrine In 0.9% Sodium Chloride
Location	Trials
United States	424
Canada	64
Egypt	56
Korea, Republic of	25
China	24

Trials by US State

Trials by US State for Epinephrine In 0.9% Sodium Chloride
Location	Trials
California	53
New York	32
North Carolina	30
Pennsylvania	25
Maryland	25

Clinical Trial Progress for Epinephrine In 0.9% Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Epinephrine In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
PHASE4	31
PHASE3	12
PHASE2	14

Clinical Trial Status

Clinical Trial Status for Epinephrine In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
Completed	389
Recruiting	132
Not yet recruiting	82

Clinical Trial Sponsors for Epinephrine In 0.9% Sodium Chloride

Sponsor Name

Sponsor Name for Epinephrine In 0.9% Sodium Chloride
Sponsor	Trials
University of California, San Diego	14
Cairo University	14
Assiut University	12

Sponsor Type

Sponsor Type for Epinephrine In 0.9% Sodium Chloride
Sponsor	Trials
Other	1031
Industry	91
NIH	30

Clinical Trials Update, Market Analysis, and Projection for Epinephrine in 0.9% Sodium Chloride

Last updated: October 31, 2025

Introduction

Epinephrine in 0.9% Sodium Chloride is an injectable formulation primarily used for emergency treatment of life-threatening allergic reactions (anaphylaxis), cardiac arrest, and superficial bleeding. Its rapid onset of action and critical life-saving potential have positioned it as a cornerstone in emergency medical protocols. The evolving landscape of clinical research, regulatory scrutiny, and market dynamics significantly influence the drug's development, adoption, and commercialization prospects.

This article offers a comprehensive analysis of ongoing and completed clinical trials, market trends, future projections, and strategic insights relevant to this drug formulation.

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Clinical Trials Overview

Current Clinical Research Landscape

The clinical development of epinephrine formulations, including those combined with saline solutions, continues to evolve through innovative delivery mechanisms and expanded indications. As of 2023, key clinical trials focus on optimizing administration routes, dosage efficacy, safety profiles, and exploring novel indications such as pediatric use and alternative delivery systems.

Major ongoing studies include:

• Comparative Efficacy Trials: Evaluating epinephrine in saline versus traditional formulations for rapidity of onset and adverse event profile.
• Safety and Tolerability Studies: Focused on sensitive populations, including pediatrics, pregnant women, and cardiac patients.
• Delivery System Innovations: Trials assessing auto-injectors, nasal sprays, and implantable devices to improve ease of administration and compliance.
• Repurposing and Expanded Indications: Investigations into uses related to bronchospasm, hypotension, and standalone vasoconstrictive therapy enhancements.

Notable Completed Trials

Most trials completed in the past five years have reaffirmed the safety and efficacy of epinephrine in saline solutions for emergency indications, supporting existing regulatory approvals. These include large-scale randomized controlled trials (RCTs) that reinforce standard dosing regimens and adverse effect profiles in diverse populations.

Regulatory Environment and Impact

Regulatory agencies like the FDA and EMA emphasize the importance of safety monitoring, especially given epinephrine's narrow therapeutic window. Recent updates include guidance on auto-injector re-certifications and pediatric labeling. Conformance to Good Manufacturing Practice (GMP) ensures consistent drug quality, fostering continued clinical trust and product approval renewals.

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Market Analysis

Market Size and Growth Drivers

The global epinephrine market was valued at approximately $1.3 billion in 2022 (MarketsandMarkets, 2022). The CAGR is projected at 7-8% from 2023 to 2030, driven by:

• Rising prevalence of allergic diseases: Anaphylaxis incidence is increasing, with the WHO reporting a 3-fold rise over the past two decades [1].
• Expanding use in new indications: Emerging applications in cardiac resuscitation and vasopressor therapy improve market size.
• Advances in delivery technology: Development of auto-injectors and nasal formulations enhances patient compliance.
• Regulatory approvals and pipeline approvals: Continuous pipeline approvals for novel formulations sustain market growth.

Key Market Participants

Leading companies such as Mylan (EpiPen), Pfizer, and Novartis dominate the market, with several smaller players innovating in device design and formulations. Patent expirations and biosimilar entries are influential in shaping competitive dynamics.

Regional Market Dynamics

• North America: Largest market share owing to high allergy prevalence, robust healthcare infrastructure, and regulatory approval rates.
• Europe: Growing adoption, with national regulatory bodies approving auto-injectors and novel delivery systems.
• Asia-Pacific: Rapidly expanding, driven by increased healthcare access and rising allergy awareness.

Challenges and Opportunities

Challenges:

• Pricing pressures impacting profitability.
• Supply chain disruptions, notably during the COVID-19 pandemic.
• Regulatory hurdles for new formulations or delivery devices.

Opportunities:

• Development of needle-free delivery systems to reduce injection reluctance.
• Expanding indications for epinephrine, especially in anesthesia and cardiology.
• Biosimilar introduction could reduce costs and improve accessibility.

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Future Market Projection

Growth Forecast (2023-2030)

Considering current market trends and clinical development pipelines, the global market for epinephrine in saline solutions is anticipated to reach $2.3–2.5 billion by 2030, with a CAGR of approximately 7.5%. The elevated growth is attributed to increasing adoption of auto-injectors and expanding emergency health protocols.

Impact of Clinical Innovations

The introduction of safer, user-friendly delivery systems—such as needleless auto-injectors and intranasal formulations—are projected to accelerate market penetration, especially among pediatric and elderly populations.

Regulatory and Policy Influence

Enhanced regulatory support for biosimilar products and initiatives to improve allergy awareness will facilitate market expansion. Governments and health agencies are also pushing for stockpiling of emergency medications, including epinephrine, to prepare for bioterrorism threats and pandemic-related crises.

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Strategic Implications for Industry Stakeholders

• R&D investment in delivery system innovation is critical for competitive advantage.
• Forecasting demand should account for demographic shifts and regulatory changes.
• Partnerships with healthcare providers and government agencies will facilitate product positioning and regulatory approvals.
• Cost management strategies are essential in a competitive environment threatened by biosimilar proliferation.

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Key Takeaways

• Clinical trials have affirmed the safety and efficacy of epinephrine in saline solutions, with ongoing research exploring delivery innovations and expanded indications.
• The market size was approximately $1.3 billion in 2022, with an expected CAGR of over 7% through 2030, driven by rising allergic condition prevalence and technological advances.
• Regulatory environments favor innovation in delivery systems, potentially transforming administration practices.
• Emerging markets in Asia-Pacific and Europe represent significant growth opportunities.
• Strategic focus on device innovation, biosimilar competition, and expanding indications will shape future market dynamics.

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FAQs

1. What are the main clinical benefits of epinephrine in saline solutions?
Epinephrine in saline provides a rapid onset of action, essential in emergencies like anaphylaxis, with a well-established safety profile supported by clinical trials.

2. How is the market for epinephrine expected to evolve over the next decade?
Projected growth, driven by technological innovations and expanding indications, will see the market reaching approximately $2.4 billion by 2030, with a CAGR of around 7.5%.

3. What are the current challenges faced in clinical development?
Challenges include ensuring safety during prolonged use, developing user-friendly delivery systems, and navigating regulatory pathways for novel formulations.

4. How do new delivery systems impact clinical and market adoption?
Advances such as needleless auto-injectors improve patient compliance, reduce injection fears, and expand usage scenarios, thereby enhancing clinical effectiveness and market penetration.

5. What future opportunities exist for manufacturers?
Opportunities lie in developing intranasal formulations, biosimilars, and combination therapies, along with expanding indications beyond emergency use to include other cardiovascular and respiratory conditions.

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References

[1] World Health Organization. (2022). "Global Allergy Report."
[2] MarketsandMarkets. (2022). "Epinephrine Market Analysis & Forecast."
[3] U.S. Food and Drug Administration. (2023). "Guidance on Auto-Injector Safety and Efficacy."
[4] European Medicines Agency. (2023). "Regulatory Updates on Emergency Medications."