CLINICAL TRIALS PROFILE FOR EPINEPHRINE

All Clinical Trials for epinephrine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.
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.

Clinical Trial Conditions for epinephrine

Condition Name

Condition Name for epinephrine
Intervention	Trials
Pain	44
Postoperative Pain	35
Pain, Postoperative	31
Anesthesia, Local	20

Condition MeSH

Condition MeSH for epinephrine
Intervention	Trials
Pain, Postoperative	87
Pulpitis	35
Hemorrhage	25
Osteoarthritis	22

Clinical Trial Locations for epinephrine

Trials by Country

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Trials by Country for epinephrine
Location	Trials
United States	393
Canada	55
Egypt	43
Korea, Republic of	25
China	18

Trials by US State

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−

Trials by US State for epinephrine
Location	Trials
California	49
North Carolina	28
New York	27
Texas	24
Maryland	23

Clinical Trial Progress for epinephrine

Clinical Trial Phase

Clinical Trial Phase for epinephrine
Clinical Trial Phase	Trials
Phase 4	247
Phase 3	66
Phase 2/Phase 3	29

Clinical Trial Status

Clinical Trial Status for epinephrine
Clinical Trial Phase	Trials
Completed	358
Recruiting	91
Not yet recruiting	82

Clinical Trial Sponsors for epinephrine

Sponsor Name

Sponsor Name for epinephrine
Sponsor	Trials
University of California, San Diego	13
Cairo University	12
University of Minnesota	10

Sponsor Type

Sponsor Type for epinephrine
Sponsor	Trials
Other	929
Industry	81
NIH	26

Epinephrine: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update for Epinephrine

Anaphylm (Epinephrine) Sublingual Film

A significant development in the epinephrine market is the progress of Aquestive Therapeutics' Anaphylm, an epinephrine sublingual film designed for the treatment of severe allergic reactions, including anaphylaxis. Here are the key points from the clinical trials update:

• FDA Feedback and NDA Submission: Aquestive Therapeutics has received positive feedback from the FDA regarding its planned new drug application (NDA) submission for Anaphylm. The FDA has agreed with the content and format of the NDA, as well as the planned safety evaluation and the design of the single-dose pediatric trial currently underway in the U.S. and Canada[1][4].
• No Additional Adult Clinical Trials: The FDA has confirmed that no additional adult clinical trials are necessary prior to the NDA submission, which is slated for the first quarter of 2025[1][4].
• Pediatric Trial: The pharmacokinetic/pharmacodynamic (PK/PD) pediatric trial has commenced, and the FDA has provided guidance on additional data views to be included in the submission. Minor modifications to the pediatric trial protocol were requested, but these are not expected to impact the trial's timing[1][4].
• Potential Advisory Committee Meeting: Due to the novel route of administration and supporting data, the FDA noted that an advisory committee meeting may be necessary before a final decision[1][4].

Market Analysis for Epinephrine

Current Market Size and Growth

The epinephrine market is experiencing robust growth driven by several key factors:

• Global Market Size: As of 2024, the epinephrine market size was over USD 1.25 billion and is projected to exceed USD 5.77 billion by 2037, with a compound annual growth rate (CAGR) of over 12.3% during the forecast period from 2025 to 2037[2].
• Regional Dominance: The North America region is expected to hold the largest market share by 2037, primarily due to the increasing prevalence of respiratory diseases such as asthma and the growing population in the region[2].

Drivers of Market Growth

Several factors are driving the growth of the epinephrine market:

• Increasing Allergic Reactions: The global rise in severe allergic reactions and anaphylactic shock is a significant driver. According to health surveys, the number of asthma cases, for example, has seen a notable increase, with 21,030,480 cases in the U.S. alone between 2018 and 2020[2][3].
• Technological Advancements: Advancements in drug delivery technologies, such as auto-injectors, are enhancing the market. The demand for quick and effective administration of epinephrine during emergency situations is on the rise[3][5].
• Growing Awareness and Emergency Medical Services: Increasing awareness about the importance of immediate medical responses and the expanding availability of epinephrine auto-injectors in healthcare settings are further fueling market growth[5].

Market Segmentation

The epinephrine market is segmented by type, application, distribution channel, and geography:

• Geographical Analysis: The market is analyzed across regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Key countries like the U.S., Canada, Germany, France, and others are considered for micro and macro trends[5].

Market Projections for Epinephrine

Future Market Size

• Global Projections: By 2028, the global epinephrine market is expected to reach USD 4.76 billion at a CAGR of 8.7%[3].
• Long-Term Projections: By 2037, the market is projected to exceed USD 5.77 billion, and by 2032, it is expected to reach approximately USD 5.46 billion, driven by a CAGR of 9.96% from 2023 to 2032[2][5].

Regional Growth

• North America: This region is anticipated to maintain its dominance due to the escalating count of patients suffering from respiratory diseases and the rapidly expanding population[2].
• Other Regions: Europe, Asia-Pacific, and other regions are also expected to see significant growth driven by increasing awareness and the growing prevalence of severe allergies and cardiac arrests[5].

Impact of Anaphylm on the Market

If Anaphylm receives FDA approval, it will be the first and only orally delivered epinephrine product for treating severe allergic reactions, including anaphylaxis. This innovation could significantly impact the market by:

• Expanding Treatment Options: Providing an alternative to traditional auto-injectors, which could enhance patient compliance and ease of administration[1][4].
• Market Share: Potentially capturing a significant share of the growing epinephrine market, especially in regions with high prevalence of allergic reactions[2][5].

Key Takeaways

• Clinical Trials: Aquestive Therapeutics' Anaphylm is on track for NDA submission in Q1 2025, with no additional adult clinical trials required.
• Market Growth: The epinephrine market is expected to grow significantly, driven by increasing allergic reactions, technological advancements, and growing awareness.
• Regional Dominance: North America is projected to hold the largest market share.
• Future Projections: The global market is expected to reach USD 5.77 billion by 2037 and USD 5.46 billion by 2032.

FAQs

Q: What is the current status of Aquestive Therapeutics' Anaphylm (epinephrine) sublingual film?

A: The FDA has provided positive feedback on the NDA submission plan, and the pediatric trial is underway. No additional adult clinical trials are required before the NDA submission in Q1 2025[1][4].

Q: What are the key drivers of the epinephrine market growth?

A: The growth is driven by the increasing prevalence of severe allergic reactions, technological advancements in drug delivery, and growing awareness about immediate medical responses[2][3][5].

Q: Which region is expected to dominate the epinephrine market?

A: North America is projected to hold the largest market share due to the escalating count of patients suffering from respiratory diseases and the rapidly expanding population[2].

Q: What is the projected global market size for epinephrine by 2037?

A: The global epinephrine market is expected to exceed USD 5.77 billion by 2037[2].

Q: How does Anaphylm differ from existing epinephrine products?

A: If approved, Anaphylm will be the first and only orally delivered epinephrine product for treating severe allergic reactions, including anaphylaxis[1][4].

Sources

1. Patient Care Online: "NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says"
2. Research Nester: "Epinephrine Market Size & Share, Growth Forecasts 2025-2037"
3. BioSpace: "Epinephrine Market Size 2022-2028- Rapidly Rising Demand For Epinephrine Auto-Injectors"
4. Aquestive Therapeutics: "Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm™ (epinephrine) Sublingual Film"
5. SkyQuestT: "Epinephrine Market Size, Share, Growth Analysis - Industry Forecast"