CLINICAL TRIALS PROFILE FOR ATROPINE SULFATE

All Clinical Trials for ATROPINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00121524 ↗	Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	Completed	Health Region East, Norway	Phase 2	2003-01-01	Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
NCT00121524 ↗	Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	Completed	Laerdal Medical	Phase 2	2003-01-01	Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
NCT00121524 ↗	Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	Completed	Norwegian Air Ambulance Foundation	Phase 2	2003-01-01	Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
NCT00121524 ↗	Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	Completed	Ullevaal University Hospital	Phase 2	2003-01-01	Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
NCT00121524 ↗	Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	Completed	University of Oslo	Phase 2	2003-01-01	Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.
NCT00121524 ↗	Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	Completed	Petter Andreas Steen	Phase 2	2003-01-01	Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.

Clinical Trial Conditions for ATROPINE SULFATE

Condition Name

Condition Name for ATROPINE SULFATE
Intervention	Trials
Postoperative Pain	6
Myopia	5
Myopia, Progressive	3
Pain, Postoperative	3

Condition MeSH

Condition MeSH for ATROPINE SULFATE
Intervention	Trials
Myopia	8
Pain, Postoperative	8
Bradycardia	3
Myopia, Degenerative	3

Clinical Trial Locations for ATROPINE SULFATE

Trials by Country

+

−

Trials by Country for ATROPINE SULFATE
Location	Trials
United States	52
Egypt	11
Brazil	4
China	4
Austria	3

Trials by US State

+

−

Trials by US State for ATROPINE SULFATE
Location	Trials
Texas	7
California	5
Colorado	3
South Carolina	3
Indiana	3

Clinical Trial Progress for ATROPINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for ATROPINE SULFATE
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ATROPINE SULFATE
Clinical Trial Phase	Trials
Completed	25
Not yet recruiting	10
Recruiting	8

Clinical Trial Sponsors for ATROPINE SULFATE

Sponsor Name

Sponsor Name for ATROPINE SULFATE
Sponsor	Trials
Mansoura University	4
Ain Shams University	3
Assiut University	3

Sponsor Type

Sponsor Type for ATROPINE SULFATE
Sponsor	Trials
Other	57
Industry	15
U.S. Fed	3

Atropine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction to Atropine Sulfate

Atropine sulfate is a versatile medication derived from the Atropa belladonna plant, widely used in various medical settings for its anticholinergic properties. It is crucial in treating conditions such as bradycardia, organophosphate poisoning, and certain cardiac arrests, among other applications.

Clinical Trials and Developments

Recent Clinical Trials

Several pharmaceutical companies are actively involved in clinical trials to enhance the therapeutic applications and delivery mechanisms of atropine sulfate. For instance, Hikma Pharmaceuticals has initiated clinical trials for a long-acting version of atropine sulfate injection, aiming to improve the drug's efficacy and duration of action[1].

In another significant development, Apotex has submitted a new drug application (NDA) to the FDA for its atropine sulfate injection, indicating ongoing efforts to innovate and expand the use of this medication[1].

Ophthalmic Applications

Vyluma Inc. is making strides in the ophthalmic sector with its atropine sulfate ophthalmic solution 0.01% for the treatment of pediatric myopia. Following a Type A meeting with the FDA, Vyluma is moving forward with addressing the FDA’s questions and is expected to submit a response in the third quarter of 2024. The solution has shown promising results in reducing the progression of myopia, a leading cause of preventable blindness worldwide[5].

Market Analysis

Global Market Size and Growth

The atropine sulfate injection market was valued at USD 0.91 billion in 2022 and is projected to reach USD 1.28 billion by 2030, growing at a CAGR of 4.4% from 2024 to 2030[2].

Regional Market Dynamics

North America

North America dominates the atropine sulfate injection market, holding a substantial 40% market share. This dominance is attributed to the region's advanced healthcare infrastructure, high incidence of diseases requiring atropine interventions, and vigorous research and development activities[1].

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing hub, projected to hold a significant 20% market share. This growth is driven by increasing healthcare investments, rising awareness about atropine applications, and an increasing prevalence of conditions necessitating its use[1].

Other Regions

Europe, Latin America, and the Middle East & Africa also contribute to the market growth, with Europe seeing significant growth due to rising surgical procedures and supportive healthcare regulations. Latin America and the Middle East & Africa are emerging markets driven by rising healthcare expenditure and improving healthcare infrastructure[2][3].

Key Drivers of Market Growth

Increasing Demand for Anticholinergic Drugs

The rise in surgical procedures globally and the growing prevalence of bradycardia and ocular disorders are key drivers of the market. Atropine sulfate's versatility in addressing different medical needs, including its use in emergency medicine, ophthalmology, and as an antidote for organophosphate poisoning, enhances its adoption across diverse healthcare scenarios[2].

Advancements in Healthcare Infrastructure

The expansion of healthcare infrastructure and emergency response systems, particularly in North America and the Asia Pacific, is a significant driver. These regions are investing heavily in healthcare, leading to increased demand for atropine sulfate injections[1][3].

Growing Geriatric Population

The increasing geriatric population with a higher incidence of medical conditions requiring atropine treatment also contributes to market growth. Older adults are more prone to cardiovascular disorders and other conditions where atropine sulfate is essential[2].

Regulatory Support and Innovation

Regulatory support and clinical advancements are promoting the research and development of atropine-based therapies. Innovations in drug delivery systems are enhancing the therapeutic effectiveness of atropine sulfate injections, further boosting market growth[2].

Challenges and Restraints

Adverse Side Effects and Contraindications

Atropine sulfate use is associated with adverse side effects and contraindications, which can limit its adoption. Managing these side effects is crucial for maintaining patient safety and compliance[2].

Market Entry Barriers

Stringent regulatory frameworks pose significant barriers for new players entering the market. This competition from established players and regulatory hurdles can slow down market expansion[2].

Competition from Alternative Treatments

The presence of alternative treatments and medications also poses a challenge. However, the unique properties and broad applications of atropine sulfate continue to make it a preferred choice in many medical scenarios[2].

Market Segmentation

By Product

The market is segmented into injections and ointments, with the injection segment anticipated to dominate due to its ease of administration and rapid onset of action[3].

By Application

Atropine sulfate is used in various applications, including emergency medicine, ophthalmology, and as a pre-anesthetic to inhibit salivation. Its use in treating bradycardia, organophosphate poisoning, and certain cardiac conditions further diversifies its market[1][2].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies holding the largest market share due to the high volume of ophthalmic surgeries and emergency care services[3].

Key Takeaways

• The atropine sulfate injection market is expected to grow significantly, driven by advancements in healthcare infrastructure and increasing awareness among healthcare professionals.
• North America and the Asia Pacific are key regions driving market growth.
• The versatility of atropine sulfate in various medical applications, including emergency medicine and ophthalmology, enhances its market potential.
• Innovations in drug delivery systems and regulatory support are crucial for market expansion.
• Despite challenges such as adverse side effects and market entry barriers, the demand for atropine sulfate is anticipated to rise due to its efficacy in treating critical medical conditions.

FAQs

What are the primary uses of atropine sulfate injection?

Atropine sulfate injection is used for temporary blocking of severe or life-threatening muscarinic effects, such as reducing saliva production, countering the effects of vagal stimulation, serving as an antidote for organophosphorus or muscarinic mushroom poisoning, and treating bradyasystolic cardiac arrest[1].

Which regions are driving the growth of the atropine sulfate market?

North America and the Asia Pacific are the primary regions driving the growth of the atropine sulfate market, with North America holding a substantial 40% market share and the Asia Pacific emerging as the fastest-growing hub[1][3].

What are the key drivers of the atropine sulfate market?

Key drivers include the increasing demand for anticholinergic drugs, advancements in healthcare infrastructure, growing geriatric population, regulatory support, and innovations in drug delivery systems[2].

What challenges does the atropine sulfate market face?

The market faces challenges such as adverse side effects and contraindications, market entry barriers for new players, and competition from alternative treatments[2].

What is the projected market size of atropine sulfate by 2030?

The atropine sulfate injection market is projected to reach USD 1.28 billion by 2030, growing at a CAGR of 4.4% from 2024 to 2030[2].

How is atropine sulfate being explored for ophthalmic applications?

Atropine sulfate is being explored for the treatment of pediatric myopia, with Vyluma Inc. developing an ophthalmic solution that has shown promising results in reducing the progression of myopia[5].

Sources

1. Cognitive Market Research: Atropine Sulfate Injection Market Report 2024 (Global Edition)
2. Verified Market Reports: Market-Analysis-2025/Atropine-Sulfate-Injection-Market.md
3. Research Nester: Atropine Sulfate Market Size & Share, Growth Analysis 2036
4. Cognitive Market Research: Atropine Sulfate Market Report 2024 (Global Edition)
5. Ophthalmology Times: Vyluma meets with FDA to discuss atropine sulfate ophthalmic solution 0.01% for the treatment of pediatric myopia