CLINICAL TRIALS PROFILE FOR EPINASTINE HYDROCHLORIDE

All Clinical Trials for Epinastine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00407927 ↗	A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis	Completed	Merck Sharp & Dohme Corp.	Phase 2	2006-12-01	The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.
NCT00489398 ↗	Comparison of CL Wear Between Two Allergy Drops	Withdrawn	Merck Sharp & Dohme Corp.	Phase 4	2007-07-01	Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
NCT00489398 ↗	Comparison of CL Wear Between Two Allergy Drops	Withdrawn	Hom, Milton M., OD, FAAO	Phase 4	2007-07-01	Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
NCT00564421 ↗	Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-12-18	The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis
NCT01382654 ↗	Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis	Completed	Merck Sharp & Dohme Corp.	Phase 2	2006-09-01	The objectives of this study were to: - Examine the tolerability of two formulations and two dose concentrations of epinastine. - Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study. - Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.
NCT01569191 ↗	Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis	Completed	University of Worcester	Phase 4	2012-03-01	Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many people, caused by hypersensitivity to normally harmless substances such as pollen, and often accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy include artificial tear supplements (ATS) and cold compresses (CC). However, there is no evidence in the scientific literature that demonstrates their efficacy compared to no treatment or their combined effect with anti-allergic medication. Therefore the investigators aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication, and CC in combination with anti-allergic medication. In addition, the investigators also aim to determine the time course of ocular allergic reactions. At the end of the study the investigators will be able to see whether or not ATS and CC are effective in treating SAC.
NCT01569191 ↗	Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis	Completed	Aston University	Phase 4	2012-03-01	Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many people, caused by hypersensitivity to normally harmless substances such as pollen, and often accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy include artificial tear supplements (ATS) and cold compresses (CC). However, there is no evidence in the scientific literature that demonstrates their efficacy compared to no treatment or their combined effect with anti-allergic medication. Therefore the investigators aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication, and CC in combination with anti-allergic medication. In addition, the investigators also aim to determine the time course of ocular allergic reactions. At the end of the study the investigators will be able to see whether or not ATS and CC are effective in treating SAC.

Clinical Trial Conditions for Epinastine Hydrochloride

Condition Name

Condition Name for Epinastine Hydrochloride
Intervention	Trials
Rhinitis, Allergic, Perennial	4
Healthy	3
Seasonal Allergic Rhinitis	2
Allergic Conjunctivitis	2

Condition MeSH

Condition MeSH for Epinastine Hydrochloride
Intervention	Trials
Rhinitis, Allergic	7
Rhinitis	7
Rhinitis, Allergic, Perennial	4
Conjunctivitis	3

Clinical Trial Locations for Epinastine Hydrochloride

Trials by Country

Trials by Country for Epinastine Hydrochloride
Location	Trials
United Kingdom	1
United States	1

Trials by US State

Trials by US State for Epinastine Hydrochloride
Location	Trials
Texas	1

Clinical Trial Progress for Epinastine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Epinastine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Epinastine Hydrochloride
Clinical Trial Phase	Trials
Completed	14
Withdrawn	1

Clinical Trial Sponsors for Epinastine Hydrochloride

Sponsor Name

Sponsor Name for Epinastine Hydrochloride
Sponsor	Trials
Boehringer Ingelheim	9
Merck Sharp & Dohme Corp.	4
Hom, Milton M., OD, FAAO	1

Sponsor Type

Sponsor Type for Epinastine Hydrochloride
Sponsor	Trials
Industry	14
Other	3

Epinastine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Epinastine Hydrochloride

Epinastine hydrochloride is a selective histamine H1 receptor antagonist that also inhibits IgE receptor-mediated histamine release from mast cells. It is primarily used in the treatment of allergic conjunctivitis, providing relief from symptoms such as itching, redness, and swelling associated with ocular allergies.

Clinical Trials Update

Recent Phase III Clinical Trials

Several recent clinical trials have been conducted to evaluate the efficacy and safety of epinastine hydrochloride for the treatment of seasonal allergic conjunctivitis.

• Zhaoke Ophthalmology Limited's Trial: This multicenter, randomized, double-blind, positive-controlled Phase III clinical study involved approximately 14 centers and enrolled 266 patients. The trial aimed to evaluate the efficacy and safety of 0.05% epinastine hydrochloride eye drops. Patient enrollment was completed ahead of schedule, and the last patient visit was concluded on September 28, 2023[3].
• Non-Inferiority Trial: Another multicenter, randomized, double-blind, active control, non-inferiority clinical trial compared the efficacy of epinastine hydrochloride eye drops to azelastine hydrochloride eye drops in Chinese patients. Participants were treated with either epinastine hydrochloride or azelastine hydrochloride eye drops twice a day for 14 consecutive days. The study aimed to determine if epinastine hydrochloride is non-inferior to azelastine hydrochloride in treating seasonal allergic conjunctivitis[4].

Efficacy and Safety Findings

Previous studies have shown that epinastine hydrochloride is effective and safe for the treatment of allergic conjunctivitis. A study published in the American College of Allergy, Asthma & Immunology journal demonstrated that epinastine significantly inhibited ocular itching and conjunctival hyperemia induced by cedar pollen antigen. It also showed noninferiority to olopatadine and had a good safety profile with no adverse drug reactions or serious adverse events reported[1].

Market Analysis

Market Size and Growth Projections

The epinastine hydrochloride market is experiencing rapid and substantial growth. According to market research, the global epinastine hydrochloride market is projected to expand significantly from 2023 to 2031. The market size is categorized based on type (purity ≥ 98%, purity ≥ 99%), application (tablet, capsule, ophthalmic solution, others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Key Market Drivers

• Rising Prevalence of Allergic Conditions: The increasing prevalence of allergic conditions due to pollution and seasonal changes is a major driver for the epinastine hydrochloride market.
• Increasing Awareness of Ocular Health: Growing awareness about ocular health and the importance of treating allergic eye reactions effectively is boosting the demand for epinastine hydrochloride ophthalmic solutions.
• Advancements in Pharmaceutical Formulations: Rapid advancements in pharmaceutical formulations are providing opportunities for innovation, potentially enhancing efficacy and reducing side effects[5].

Market Restraints

• Supply Chain Vulnerabilities: Disruptions in the supply chain can lead to the unavailability of epinastine hydrochloride, which is a significant restraint.
• Economic Constraints: Economic factors, such as high production costs and pricing strategies, can affect the growth trajectory of the market.
• Adverse Side Effect Profiles: Consumer hesitance due to potential side effects can also hinder market growth[5].

Market Opportunities

• Targeted Therapy for Specific Demographics: Developing targeted therapies for specific demographics can expand the reach of epinastine products.
• Emerging Markets: Emerging markets present vast unexplored potential for epinastine hydrochloride ophthalmic solutions.
• Nonsurgical Alternatives: Increasing patient inclination towards nonsurgical alternatives fosters market growth prospects[5].

Competitive Landscape

The competitive landscape of the epinastine hydrochloride market involves both established and emerging players. Market share analysis and competitive assessments reveal that key players are focusing on strategic approaches, product range expansions, and technological advancements to maintain their market position.

Market Penetration and Development

The current market landscape is characterized by detailed data from key industry players. The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments. Recent product launches, untapped geographic regions, and strategic investments are also critical factors in market development[5].

Product Development and Innovation

The market is driven by ongoing research and development efforts aimed at improving product innovation. Notable advancements include the development of more effective formulations and the reduction of side effects. These innovations are crucial for maintaining a competitive edge in the market[5].

Key Takeaways

• Efficacy and Safety: Epinastine hydrochloride has been proven effective and safe for treating allergic conjunctivitis through various clinical trials.
• Market Growth: The global epinastine hydrochloride market is projected to experience significant growth from 2023 to 2031.
• Market Drivers: Rising prevalence of allergic conditions, increasing awareness of ocular health, and advancements in pharmaceutical formulations are key drivers.
• Market Restraints: Supply chain vulnerabilities, economic constraints, and adverse side effect profiles are significant restraints.
• Competitive Landscape: The market is competitive, with key players focusing on strategic approaches and technological advancements.

FAQs

What is epinastine hydrochloride used for?

Epinastine hydrochloride is primarily used for the treatment of allergic conjunctivitis, providing relief from symptoms such as itching, redness, and swelling associated with ocular allergies.

What are the key findings from recent clinical trials of epinastine hydrochloride?

Recent clinical trials have shown that epinastine hydrochloride is effective and safe for treating seasonal allergic conjunctivitis, demonstrating noninferiority to other antihistamine eye drops like azelastine and olopatadine[1][3][4].

What are the market growth projections for epinastine hydrochloride?

The global epinastine hydrochloride market is projected to expand significantly from 2023 to 2031, driven by rising prevalence of allergic conditions, increasing awareness of ocular health, and advancements in pharmaceutical formulations[2].

What are the main market drivers for epinastine hydrochloride?

The main market drivers include the rising prevalence of allergic conditions, increasing awareness of ocular health, and rapid advancements in pharmaceutical formulations[5].

What are the potential restraints for the epinastine hydrochloride market?

Supply chain vulnerabilities, economic constraints, and adverse side effect profiles are significant restraints that could affect the market growth[5].

Sources

1. American College of Allergy, Asthma & Immunology. "Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis." Journal of Allergy and Clinical Immunology: In Practice, 2014.
2. Market Research Intellect. "Global Epinastine Hydrochloride Market Size, Trends and Projections." Report ID: 1047793, December 2024.
3. Marketscreener. "Zhaoke Ophthalmology Limited Provides Updates on Phase III Clinical Trials for Tab014 and Epinastine Hcl." Marketscreener, October 3, 2023.
4. Veeva Systems. "A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Seasonal Allergic Conjunctivitis." ClinicalTrials.gov, January 19, 2024.
5. 360iResearch. "Epinastine Hydrochloride Ophthalmic Preparations Market by Application Area, Therapeutic Strength, Formulation Type, Distribution Channel, Patient Demographics, Packaging, User Preference - Global Forecast 2025-2030." SKUMRR-4654A89DBB9B, December 2024.

Last updated: 2024-12-31