CLINICAL TRIALS PROFILE FOR DEXCHLORPHENIRAMINE MALEATE

All Clinical Trials for dexchlorpheniramine maleate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01257061 ↗	Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment	Completed	EMS	Phase 3	2012-09-06	Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.
NCT01233934 ↗	Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites	Unknown status	Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3	2011-02-01	Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.
NCT00995397 ↗	Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms	Unknown status	Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3	1969-12-31	Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.
NCT01085851 ↗	Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms	Unknown status	Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3	1969-12-31	Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.
NCT01237925 ↗	Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms	Unknown status	Mantecorp Industria Quimica e Farmaceutica Ltd.	Phase 3	1969-12-31	Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

Clinical Trial Conditions for dexchlorpheniramine maleate

Condition Name

Condition Name for dexchlorpheniramine maleate
Intervention	Trials
Insect Bites	2
Sunburn	2
Eczema	1

Condition MeSH

Condition MeSH for dexchlorpheniramine maleate
Intervention	Trials
Sunburn	2
Insect Bites and Stings	2
Eczema	1

Clinical Trial Locations for dexchlorpheniramine maleate

Trials by Country

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Trials by Country for dexchlorpheniramine maleate
Location	Trials
Brazil	5

Clinical Trial Progress for dexchlorpheniramine maleate

Clinical Trial Phase

Clinical Trial Phase for dexchlorpheniramine maleate
Clinical Trial Phase	Trials
Phase 3	5

Clinical Trial Status

Clinical Trial Status for dexchlorpheniramine maleate
Clinical Trial Phase	Trials
Unknown status	4
Completed	1

Clinical Trial Sponsors for dexchlorpheniramine maleate

Sponsor Name

Sponsor Name for dexchlorpheniramine maleate
Sponsor	Trials
Mantecorp Industria Quimica e Farmaceutica Ltd.	4
EMS	1

Sponsor Type

Sponsor Type for dexchlorpheniramine maleate
Sponsor	Trials
Industry	5

Dexchlorpheniramine Maleate: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Dexchlorpheniramine Maleate is a small molecule drug that has been a staple in the treatment of various allergic conditions for decades. Approved in Japan in 1964, it has since gained global recognition for its efficacy in targeting the H1 receptor, thereby alleviating symptoms associated with allergic reactions. This article delves into the latest updates on clinical trials, market analysis, and projections for Dexchlorpheniramine Maleate.

Clinical Trials and Efficacy

Historical Efficacy Studies

Dexchlorpheniramine Maleate has been extensively studied in clinical trials to establish its efficacy. A notable study compared dexchlorpheniramine maleate with terfenadine in controlling hay fever symptoms. The results indicated that dexchlorpheniramine at doses of 6 mg twice daily was significantly more effective than terfenadine in controlling symptoms of ragweed hay fever[3].

Current Clinical Trials

Recent clinical trials have focused on the topical application of dexchlorpheniramine maleate. A non-inferiority clinical trial aimed to compare the efficacy and safety of a new 1% lotion formulation of dexchlorpheniramine maleate with the standard 1% cream formulation for the relief of sunburn-related symptoms. This study, conducted in Brazil, sought to demonstrate the non-inferiority of the lotion formulation in relieving symptoms such as erythema, itch, and burning sensations associated with sunburn[4].

Therapeutic Applications

Dexchlorpheniramine Maleate is approved for use in a wide range of therapeutic areas, including:

Immune System Diseases

It is effective in treating conditions such as allergic rhinitis, vasomotor rhinitis, and urticaria.

Infectious Diseases

It can be used to alleviate symptoms associated with infectious diseases that trigger allergic reactions.

Eye Diseases

Dexchlorpheniramine Maleate is used to treat allergic conjunctivitis.

Skin and Musculoskeletal Diseases

Conditions like dermatitis, eczema, and pruritus are effectively managed with this drug.

Respiratory Diseases

It provides relief from symptoms of respiratory diseases triggered by allergic reactions.

Otorhinolaryngologic Diseases

Dexchlorpheniramine Maleate is also used in the treatment of otorhinolaryngologic diseases such as allergic rhinitis and common cold[1].

Market Analysis

Market Size and Growth

The Dexchlorpheniramine Maleate market has experienced significant growth in recent years. As of 2023, the market size was valued at several billion USD and is projected to reach even higher values by 2031. This growth is driven by the increasing demand for effective antihistamines and the expanding global healthcare market[2][5].

Market Segmentation

The market is segmented based on type (powder, liquid) and application (tablets, injections). Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The API (Active Pharmaceutical Ingredient) market for Dexchlorpheniramine Maleate is also segmented based on purity levels (0.98, 0.99, others) and applications (injections, tablets, others)[2][5].

Market Dynamics

The market dynamics are influenced by several factors, including drivers such as the increasing prevalence of allergic diseases, advancements in pharmaceutical technology, and growing healthcare expenditure. However, restraints like side effects associated with antihistamines (e.g., drowsiness, dry mouth) and regulatory challenges also impact the market. Opportunities for growth include the development of new formulations and the expansion into emerging markets[2][5].

Competitive Landscape

Key Players

The market for Dexchlorpheniramine Maleate is competitive, with several key players involved. Companies like GSK Plc, Sanofi, and Bayer AG are among the fastest-growing entities in this segment. The competitive landscape is characterized by multiple companies with approved drugs, indicating a highly competitive market[1].

Regional Development

China is currently the fastest-developing country in the H1 receptor target market, followed by the United States and Japan. This regional growth is driven by increasing healthcare needs and advancements in pharmaceutical research[1].

Projections and Future Outlook

Market Growth Projections

The Dexchlorpheniramine Maleate market is expected to continue its upward trend from 2023 to 2031, driven by robust growth rates. The positive momentum in market dynamics and the anticipated sustained expansion signal significant development in the foreseeable future[2][5].

Emerging Trends

The market is likely to see the emergence of new formulations, such as topical creams and lotions, which are being tested for their efficacy in relieving sunburn and other skin irritations. Additionally, the focus on improving the safety and efficacy profiles of existing formulations will continue to drive innovation in this market[4].

Key Takeaways

• Clinical Efficacy: Dexchlorpheniramine Maleate has been proven effective in various clinical trials, especially in treating allergic conditions.
• Therapeutic Applications: It is used in a broad range of therapeutic areas, including immune system diseases, infectious diseases, eye diseases, and more.
• Market Growth: The market is experiencing significant growth and is projected to continue this trend until 2031.
• Competitive Landscape: The market is highly competitive with key players like GSK Plc, Sanofi, and Bayer AG.
• Regional Development: China, the United States, and Japan are leading in the development and use of Dexchlorpheniramine Maleate.

FAQs

What is Dexchlorpheniramine Maleate used for?

Dexchlorpheniramine Maleate is used to treat a variety of allergic conditions, including allergic rhinitis, vasomotor rhinitis, urticaria, and allergic conjunctivitis.

When was Dexchlorpheniramine Maleate first approved?

Dexchlorpheniramine Maleate was first approved in Japan in May 1964.

What are the common side effects of Dexchlorpheniramine Maleate?

Common side effects include drowsiness, dry mouth, and blurred vision.

What is the current market size of Dexchlorpheniramine Maleate?

As of 2023, the market size is valued at several billion USD and is projected to grow further by 2031.

Which companies are leading in the Dexchlorpheniramine Maleate market?

Companies like GSK Plc, Sanofi, and Bayer AG are among the fastest-growing entities in this segment.

Sources

1. Unleashing the Power of Dexchlorpheniramine Maleate: A Comprehensive Review on R&D Breakthroughs. Synapse Patsnap.
2. Dexchlorpheniramine Maleate Market Size, Scope And Forecast. Market Research Intellect.
3. Comparative study of the efficacy, tolerance and side-effects of dexchlorpheniramine and terfenadine in the treatment of hay fever. PubMed.
4. Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn. ClinicalTrials.gov.
5. Dexchlorpheniramine Maleate API Market Size, Scope And Forecast. Market Research Intellect.