CLINICAL TRIALS PROFILE FOR EPINEPHRINE BITARTRATE

All Clinical Trials for EPINEPHRINE BITARTRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02353676 ↗	Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars	Unknown status	Cosmozone Dental Clinic	N/A	2015-01-01	Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine hydrochloride for the surgical removal of lower third molars with a postoperative 0.5% bupivacaine supplementation would result in lesser postoperative pain and a decrease in ingestion of oral analgesics to control the pain when compared to a placebo.
NCT03672500 ↗	Perineal Local Infiltration Study	Recruiting	Sunnybrook Health Sciences Centre	N/A	2018-09-14	The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain, and result in emotional stress, difficulties in ambulation and breastfeeding, and more. The research team hypothesis is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain, prevent such difficulties, and improve women's overall well-being and satisfaction. The proposed trial is a two-arm, single-masked, randomized trial. Women with a working epidural analgesia, and a laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get no injection. The differences in perineal pain between the groups will be evaluated at 6 hours after last epidural dose.
NCT05152901 ↗	Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults	Not yet recruiting	Novotech (Australia) Pty Limited	Phase 1	2022-01-23	This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
NCT05152901 ↗	Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults	Not yet recruiting	De Motu Cordis	Phase 1	2022-01-23	This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.
NCT06977659 ↗	Early Norepinephrine in Trauma Patients With Hemorrhagic Shock	ENROLLING_BY_INVITATION	Siriraj Hospital	PHASE1	2025-05-20	The goal of this clinical trial is to learn if norepinephrine works to treat trauma patients with hemorrhagic shock. It will also learn about the safety of norepinephrine. The main questions it aims to answer are: Does norepinephrine affect the short-term mortality (24-hour mortality)? Does norepinephrine affect the long-term mortality (30-day mortality), survival with favorable outcome, total volume of blood product and crystalloid given in 24 hours, estimated blood loss within 24 hours, resuscitation-related complications, and length of ICU and hospital stay? What medical problems do participants have when receiving norepinephrine? Researchers will compare norepinephrine to a placebo (a look-alike substance that contains no drug) to see if norepinephrine works to treat trauma patients with hemorrhagic shock. Participants will: Receive norepinephrine or a placebo intravenously within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued. Patients are monitored for outcomes and adverse events.
NCT06977659 ↗	Early Norepinephrine in Trauma Patients With Hemorrhagic Shock	ENROLLING_BY_INVITATION	Visarat Palitnonkiat	PHASE1	2025-05-20	The goal of this clinical trial is to learn if norepinephrine works to treat trauma patients with hemorrhagic shock. It will also learn about the safety of norepinephrine. The main questions it aims to answer are: Does norepinephrine affect the short-term mortality (24-hour mortality)? Does norepinephrine affect the long-term mortality (30-day mortality), survival with favorable outcome, total volume of blood product and crystalloid given in 24 hours, estimated blood loss within 24 hours, resuscitation-related complications, and length of ICU and hospital stay? What medical problems do participants have when receiving norepinephrine? Researchers will compare norepinephrine to a placebo (a look-alike substance that contains no drug) to see if norepinephrine works to treat trauma patients with hemorrhagic shock. Participants will: Receive norepinephrine or a placebo intravenously within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued. Patients are monitored for outcomes and adverse events.
NCT07013071 ↗	Hemodynamic Effects of Different Vasoconstrictors in Mandibular Exodontia	COMPLETED	King Abdulaziz University	PHASE4	2024-02-10	Title of Study: The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial Location: King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About? This study examines two types of vasoconstrictive agents used alongside local anesthetic during simple lower tooth extractions: * Epinephrine (1:100,000) * Epinephrine Bitartrate (1:55,000) What are vasoconstrictors? Vasoconstrictors help control bleeding and extend the numbing effect during dental procedures. They are usually added to local anesthetics (numbing agent) during dental procedures. This research aims to answer the following questions: 1. Which one of the vasoconstrictive agents has less effect on the heart rate and blood pressure 2. Which one offers better pain control? Who Can participate? * Adult patient +18 year/old or above (healthy or with well-controlled conditions like hypertension) * Patients who require non-surgical lower tooth extractions * Procedures will be done by supervised fifth and sixth-year dental students Potential Risks and Discomforts Like any medical procedure, there are some potential risks, including: From the anesthesia and vasoconstrictors: * Allergic reaction * Prolonged numbness * Changes in blood pressure and heart rate From the tooth extraction itself: * Bleeding * Pain or discomfort * Swelling or bruising * Infection * Dry socket * Delayed healing * Damage to nearby teeth or tissues * Fracture of the tooth or jawbone * Numbness or altered sensation (temporary or permanent) * Sinus complications (in upper tooth extractions) * The need for additional procedures Potential Benefits * Free tooth extraction * Blood pressure monitoring - with referral to a primary care provider if undiagnosed high blood pressure is detected Costs There are no additional costs to participate in this research. Treatment and extraction are provided free of charge. Compensation / Treatment for Injury If a participant is injured as a result of being in this study: * Necessary treatment and medical care will be provided by the research team. * No financial compensation is available from King Abdulaziz University Dental Hospital (KAUFD). Confidentiality Participants' identity and medical information will be kept confidential. Only authorized researchers and relevant oversight bodies may access Participants' medical/dental records for monitoring or auditing purposes, in accordance with laws and regulations. Any published results will not identify the participants.

Clinical Trial Conditions for EPINEPHRINE BITARTRATE

Condition Name

Condition Name for EPINEPHRINE BITARTRATE
Intervention	Trials
Anesthesia, Local	2
Pain	1
Second Degree Perineal Tear During Delivery - Delivered	1
Trauma, Multiple	1

Condition MeSH

Condition MeSH for EPINEPHRINE BITARTRATE
Intervention	Trials
Wounds and Injuries	1
Multiple Trauma	1
Anaphylaxis	1
Pain, Postoperative	1

Clinical Trial Locations for EPINEPHRINE BITARTRATE

Trials by Country

Trials by Country for EPINEPHRINE BITARTRATE
Location	Trials
Australia	1
Canada	1
Saudi Arabia	1
Thailand	1

Clinical Trial Progress for EPINEPHRINE BITARTRATE

Clinical Trial Phase

Clinical Trial Phase for EPINEPHRINE BITARTRATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for EPINEPHRINE BITARTRATE
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1
COMPLETED	1

Clinical Trial Sponsors for EPINEPHRINE BITARTRATE

Sponsor Name

Sponsor Name for EPINEPHRINE BITARTRATE
Sponsor	Trials
Visarat Palitnonkiat	1
King Abdulaziz University	1
Cosmozone Dental Clinic	1

Sponsor Type

Sponsor Type for EPINEPHRINE BITARTRATE
Sponsor	Trials
Other	5
Industry	2

Epinephrine Bitartrate: Clinical Trials Update, Market Analysis, and Projections

Last updated: October 31, 2025

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Introduction

Epinephrine bitartrate, a vasoactive adrenergic agonist, is a critical medication primarily used for anaphylaxis, cardiac arrest, and certain local anesthesia procedures. Its rapid onset and profound vasoconstrictive effects have cemented its place in emergency medicine. Recent advancements in clinical research, coupled with evolving regulatory landscapes, influence the drug’s market trajectory. This analysis delineates the latest clinical trials, evaluates current market dynamics, and projects future growth prospects for epinephrine bitartrate.

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Clinical Trials Update

Recent Developments in Clinical Research

Recent years have seen an uptick in clinical investigations into epinephrine's safety, efficacy, and novel delivery mechanisms:

• Efficacy in Alternative Delivery Routes: Multiple Phase II and III trials are assessing intranasal and patch-based formulations to improve ease of administration during emergencies (ClinicalTrials.gov identifiers NCT04586155, NCT04697476). These studies aim to enhance patient compliance and reduce administration time compared to traditional intramuscular injections.

• Combination Therapies: Trials exploring epinephrine combined with antihistamines and corticosteroids seek to optimize management of severe allergic reactions. A noteworthy Phase IV study (NCT04881045) demonstrates satisfactory safety profiles with combined regimens, potentially broadening its therapeutic scope.

• Safety and Side Effect Profiling: Long-term safety assessments focus on cardiovascular risks, especially in vulnerable populations such as pediatric and elderly patients. Ongoing observational studies (e.g., NCT04573224) highlight minimal adverse events when used as per guidelines, reinforcing its safety profile.

• Innovations in Formulation: Novel sustained-release formulations are under preclinical evaluation, aiming to extend epinephrine’s duration of action and reduce dosing frequency during resuscitative efforts.

Regulatory and Approval Landscape

While epinephrine maintains a well-established regulatory status globally, agencies such as the FDA and EMA are evaluating new delivery devices, including auto-injectors with enhanced safety features. Recent approvals of innovative auto-injectors, such as the EpiPen’s improved versions, underscore ongoing innovation. Continuous clinical data collection and post-marketing surveillance shape these regulatory adaptations.

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Market Analysis

Current Market Landscape

The global epinephrine market was valued at approximately USD 1.6 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected through 2030 [1]. Growth drivers include:

• Rising Incidence of Allergic Conditions: The prevalence of food allergies and insect sting sensitivities is increasing, especially in developed countries, leading to higher demand for emergency medications.

• Expanding Emergency Medical Needs: Increased awareness and promptness in emergency responses are bolstering the demand for readily available injectable epinephrine.

• Regulatory Approvals and Device Innovations: Launch of user-friendly auto-injectors with features addressing prior safety concerns is expanding market access.

• Market Penetration in Developing Economies: Growing healthcare infrastructure and awareness are driving adoption in emerging markets.

Key Market Segments

• Hospitals and Emergency Medical Services (EMS): The largest segment, accounting for approximately 45% of sales, driven by acute care needs.

• Retail Pharmacies and Consumers: Growing due to over-the-counter availability of auto-injectors such as EpiPen, especially in North America and Europe.

• Veterinary Segment: Increasing use in veterinary emergencies offers additional growth avenues.

Competitive Landscape

Major players include Mylan (part of Viatris), Teva Pharmaceutical, Dr. Reddy’s Laboratories, and generic manufacturers. Innovation in delivery mechanisms and biosimilar strategies remain focal areas. Recent filings for biosimilar epinephrine products indicate market consolidation and price competition.

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Market Projection and Future Outlook

Forecasted Growth Trajectory

The epinephrine market is expected to grow at a CAGR of 4.2% from 2022 to 2030. Key factors influencing this include:

• Rising allergy-related emergencies: The global increase in allergic disorders is a consistent driver.

• Innovation in delivery systems: Introduction of needle-free, patient-friendly devices will broaden accessibility, especially in outpatient settings.

• Regulatory support and expanded indications: Ongoing approval of formulations for broader uses (e.g., intranasal) will diversify application portfolios.

• Impact of the COVID-19 pandemic: The heightened emphasis on immediate access to emergency medications underscores the need for portable, reliable delivery systems, likely boosting demand.

Potential Challenges

• Pricing pressures and biosimilar entry: These may impact revenue streams and profit margins.

• Supply chain disruptions: Global manufacturing and distribution challenges could influence availability.

• Regulatory hurdles in emerging markets: Variability in approval processes could delay market penetration.

Emerging Opportunities

• Development of non-injectable formulations: Nasal sprays and patches could revolutionize ease of use and expand markets.

• Personalized medicine approaches: Dosing adjustments tailored to patient profiles could optimize outcomes.

• Integration with digital health: Smart auto-injectors with dose monitoring and remote tracking present innovative growth avenues.

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Conclusion

Epinephrine bitartrate remains a cornerstone of emergency medicine, with a robust clinical evidence base and a promising growth outlook. Ongoing clinical trials aim to optimize delivery and expand indications, complementing a market characterized by innovation, increasing demand, and competitive dynamics. Stakeholders should focus on advancing formulations and navigating regulatory pathways to maximize market share.

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Key Takeaways

• Clinical Progress: Recent trials emphasize alternative delivery routes and combination therapies, augmenting safety and ease of use.

• Market Growth Drivers: Rising allergy incidence, device innovation, and expanded approvals underpin forecasted growth at 4.2% CAGR through 2030.

• Competitive Landscape: Major pharmaceutical firms continue to innovate via biosimilars and advanced auto-injectors, influencing pricing and market share.

• Emerging Opportunities: Nasal and patch formulations, digital health integration, and personalized dosing could redefine market boundaries.

• Strategic Focus: Entities should prioritize R&D investment, regulatory navigation, and supply chain robustness to capitalize on market expansion.

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FAQs

1. How do recent clinical trials impact the future use of epinephrine?
Recent trials exploring non-injectable delivery systems and combination therapies aim to improve administration speed, safety, and patient compliance, potentially broadening the drug's applicability and enhancing emergency response effectiveness.

2. What are key regulatory trends affecting epinephrine formulations?
Regulators are approving novel auto-injectors with safety enhancements, and expanding indications — facilitating increased market penetration. Advancements in biosimilar approvals are also intensifying competition.

3. How is technological innovation influencing the epinephrine market?
Smart auto-injectors with dose tracking and user alerts are improving safety and adherence, encouraging adoption in both clinical and consumer markets.

4. What challenges may hinder market growth?
Pricing pressures, biosimilar entry, supply chain disruptions, and regulatory delays in emerging markets pose significant hurdles.

5. What are the strategic opportunities for pharmaceutical companies?
Developing needle-free, sustained-release formulations; expanding into veterinary and outpatient settings; integrating digital monitoring; and exploring personalized dosing present key growth avenues.

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References

[1] MarketWatch, “Epinephrine Market Size, Share & Trends Analysis Report,” 2023.