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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR BEPOTASTINE BESILATE


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All Clinical Trials for Bepotastine Besilate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00424398 ↗ Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis Completed Bausch & Lomb Incorporated Phase 2/Phase 3 2007-02-01 The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis
NCT00586625 ↗ Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers Completed Bausch & Lomb Incorporated Phase 3 2007-10-01 Safety study for bepotastine besilate ophthalmic solution in normal volunteers
NCT00586664 ↗ Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Completed Bausch & Lomb Incorporated Phase 3 2007-10-01 Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bepotastine Besilate

Condition Name

Condition Name for Bepotastine Besilate
Intervention Trials
Allergic Conjunctivitis 7
Seasonal Allergic Rhinitis 4
Healthy 4
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Condition MeSH

Condition MeSH for Bepotastine Besilate
Intervention Trials
Conjunctivitis, Allergic 8
Conjunctivitis 8
Rhinitis 7
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Clinical Trial Locations for Bepotastine Besilate

Trials by Country

Trials by Country for Bepotastine Besilate
Location Trials
United States 11
Korea, Republic of 4
Japan 3
Argentina 1
Mexico 1
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Trials by US State

Trials by US State for Bepotastine Besilate
Location Trials
California 8
Tennessee 1
Minnesota 1
Texas 1
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Clinical Trial Progress for Bepotastine Besilate

Clinical Trial Phase

Clinical Trial Phase for Bepotastine Besilate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Bepotastine Besilate
Clinical Trial Phase Trials
Completed 21
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Bepotastine Besilate

Sponsor Name

Sponsor Name for Bepotastine Besilate
Sponsor Trials
Bausch & Lomb Incorporated 10
Mitsubishi Tanabe Pharma Corporation 3
Dong-A ST Co., Ltd. 2
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Sponsor Type

Sponsor Type for Bepotastine Besilate
Sponsor Trials
Industry 22
Other 6
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Bepotastine Besilate: Clinical Trials, Market Analysis, and Projections

Introduction to Bepotastine Besilate

Bepotastine besilate is an anti-allergic medication that has garnered significant attention for its efficacy in treating allergic conditions, particularly allergic conjunctivitis and other allergic reactions. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Conjunctival Allergen Challenge (CAC) Model

Clinical trials have demonstrated the efficacy of bepotastine besilate in reducing conjunctival hyperemia and ocular itching associated with allergic conjunctivitis. In a randomized, double-masked, placebo-controlled CAC trial, bepotastine besilate ophthalmic solution 1.0% was found to be clinically superior to placebo in reducing conjunctival hyperemia at 15 minutes after dosing[1][4].

Safety Profile

These trials also highlighted the safety profile of bepotastine besilate, with no incidence of treatment-emergent ocular adverse events reported. The drug's mechanism of action, which includes highly selective histamine H1 receptor antagonism, stabilization of mast cell function, and inhibitory action on eosinophil infiltration, contributes to its safety and efficacy[1].

Phase 2 and Phase 3 Trials

Additional clinical studies, including Phase 2 and Phase 3 trials, have further validated the efficacy of bepotastine besilate. For instance, a Phase 2 clinical study initiated by ISTA Pharmaceuticals evaluated the safety and efficacy of bepotastine besilate nasal spray for treating symptoms associated with seasonal allergies[3].

Integrated Phase 3 trials for BEPREVE (bepotastine besilate ophthalmic solution 1.5%) showed that the drug was clinically proven to reduce ocular itch in severely allergic subjects exposed to ragweed and grass pollens compared to placebo[4].

Market Analysis

Market Growth and Projections

The global market for bepotastine besilate is experiencing significant growth, driven by several key factors. The market is expected to expand at a compound annual growth rate (CAGR) of approximately 8.5% over the next five years. This growth is attributed to the increasing prevalence of allergic conditions, advancements in drug formulations, and recent regulatory approvals in various regions[2][5].

Rising Allergy Incidence

The surge in allergy cases due to environmental changes and lifestyle factors is boosting demand for effective antihistamine treatments like bepotastine besilate. This trend is expected to continue, driving the market forward[2].

Innovations in Drug Delivery

Advances in drug delivery systems, such as sustained-release formulations and combination therapies, are enhancing the effectiveness and convenience of bepotastine besilate. These innovations are contributing significantly to market growth[2].

Regulatory Approvals and Market Entries

Recent approvals and regulatory clearances in various regions are opening new markets for bepotastine besilate. Additionally, the entry of generic versions of the drug is increasing accessibility and affordability, further stimulating market growth[2].

Pharmaceutical Partnerships

Notable partnerships and collaborations between pharmaceutical companies and research institutions are aimed at developing new formulations and delivery methods for bepotastine besilate. These collaborations are expected to result in innovative products that cater to a broader patient demographic[2].

Digital Health Integration

The integration of digital health technologies, such as mobile apps for tracking symptoms and medication adherence, is enhancing patient management and driving the demand for advanced antihistamine solutions like bepotastine besilate[2].

Formulation Enhancements

Extended-Release Formulations

Recent innovations in the formulation of bepotastine besilate have improved its bioavailability and patient compliance. New extended-release formulations allow for once-daily dosing, which can lead to better adherence and improved outcomes[2].

Patient Compliance

The attribute of bepotastine besilate not readily crossing the blood-brain barrier minimizes sedation and cognitive impairment, making it a preferable choice for long-term treatment and daily use. This enhances patient compliance and overall treatment efficacy[2].

Economic Impact

Job Creation and Economic Activity

The expansion of the bepotastine besilate market is not only benefiting pharmaceutical companies but also contributing positively to the global economy. The growth in production and sales is creating job opportunities and stimulating economic activity in the regions where the drug is manufactured and distributed[2].

Investor Insights

Investment Opportunities

Investors are increasingly recognizing the potential of the bepotastine besilate market. With its robust growth trajectory and ongoing innovations, the market presents lucrative opportunities for investment in pharmaceutical stocks, research and development, and biotechnology ventures[2].

Market Drivers

Key drivers of the market growth include the rising incidence of allergic conditions, advancements in drug formulations, regulatory approvals, and increased accessibility through generics. These factors make bepotastine besilate an attractive investment opportunity in the pharmaceutical sector[2].

Key Takeaways

  • Clinical Efficacy: Bepotastine besilate has been clinically proven to reduce conjunctival hyperemia and ocular itching associated with allergic conjunctivitis.
  • Market Growth: The global market for bepotastine besilate is expected to grow at a CAGR of approximately 8.5% over the next five years.
  • Innovations: Advances in drug delivery systems, extended-release formulations, and digital health integrations are driving market growth.
  • Regulatory Approvals: Recent approvals and generic entries are increasing market accessibility and affordability.
  • Economic Impact: The market expansion is contributing to job creation and economic activity globally.

FAQs

1. What is Bepotastine Besilate used for?

Bepotastine besilate is used to treat allergic conditions such as allergic rhinitis, chronic urticaria, and allergic conjunctivitis, providing relief from symptoms like sneezing, itching, and runny nose[2].

2. How does Bepotastine Besilate differ from other antihistamines?

Unlike many antihistamines, bepotastine besilate does not readily cross the blood-brain barrier, minimizing the risk of sedation and cognitive impairment[2].

3. What are the recent innovations in Bepotastine Besilate?

Recent innovations include new extended-release formulations, digital health integrations, and partnerships for developing advanced delivery systems[2].

4. What is driving the growth of the Bepotastine Besilate market?

Key drivers include the rising incidence of allergic conditions, advancements in drug formulations, regulatory approvals, and increased accessibility through generics[2].

5. What should investors know about the Bepotastine Besilate market?

Investors should note that the bepotastine besilate market is experiencing robust growth, driven by ongoing innovations and expanding market presence, presenting promising opportunities for investment in the pharmaceutical sector[2].

Sources

  1. Investigative Ophthalmology & Visual Science: "Bepotastine Besilate Ophthalmic Solution 1.0% Rapidly Reduces Conjunctival Hyperemia in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis."
  2. Market Research Intellect: "Bepotastine Besilate Market Size And Projection"
  3. BioSpace: "ISTA Pharmaceuticals, Inc. Initiates Phase 2 Clinical Study of Bepotastine Besilate Nasal Spray for the Treatment of Symptoms Associated with Seasonal Allergies"
  4. Bausch + Lomb: "Efficacy & Safety Study Data for BEPREVEĀ® | Bausch + Lomb"
  5. Cognitive Market Research: "Global Bepotastine Besilate Market Report 2024 Edition"

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