CLINICAL TRIALS PROFILE FOR MALATHION

505(b)(2) Clinical Trials for MALATHION

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00927472 ↗	Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2009-08-01	In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
New Formulation	NCT00963508 ↗	Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2009-08-01	In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
OTC	NCT00244439 ↗	Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2005-12-01	Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

All Clinical Trials for MALATHION

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00752973 ↗	Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice	Completed	Taro Pharmaceuticals USA	Phase 2/Phase 3	2008-09-01	In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.
NCT00291057 ↗	Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice	Terminated	Taro Pharmaceuticals USA	Phase 2	2006-02-01	In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.
NCT00244439 ↗	Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2005-12-01	Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
NCT00819520 ↗	Ivermectin in the Treatment of Head Lice	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 3	2004-02-01	The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.

Clinical Trial Conditions for MALATHION

Condition Name

Condition Name for MALATHION
Intervention	Trials
Pediculosis	4
Lice Infestations	3
Head Lice	1
Scabies	1

Condition MeSH

Condition MeSH for MALATHION
Intervention	Trials
Lice Infestations	8
Parasitic Diseases	3
Scabies	1

Clinical Trial Locations for MALATHION

Trials by Country

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Trials by Country for MALATHION
Location	Trials
United States	15
France	1
Ireland	1
Solomon Islands	1
United Kingdom	1

Trials by US State

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Trials by US State for MALATHION
Location	Trials
Arkansas	3
Florida	3
Ohio	2
New York	2
Arizona	2

Clinical Trial Progress for MALATHION

Clinical Trial Phase

Clinical Trial Phase for MALATHION
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for MALATHION
Clinical Trial Phase	Trials
Completed	7
Terminated	1

Clinical Trial Sponsors for MALATHION

Sponsor Name

Sponsor Name for MALATHION
Sponsor	Trials
Taro Pharmaceuticals USA	6
Johnson & Johnson Consumer and Personal Products Worldwide	1
London School of Hygiene and Tropical Medicine	1

Sponsor Type

Sponsor Type for MALATHION
Sponsor	Trials
Industry	7
Other	1

Clinical Trials and Market Analysis for Malathion

Introduction to Malathion

Malathion is a widely used organophosphate insecticide, employed in various sectors including agriculture, residential, and public health programs. While it is not typically associated with clinical trials in the pharmaceutical sense, its use and market dynamics are crucial for understanding its impact and future projections.

Current Use and Applications of Malathion

Malathion is primarily used as a pesticide to control a wide range of insects and pests. Its applications span across:

• Agriculture: To protect crops from pests, thereby increasing crop yields and food security.
• Residential: For pest control in homes and gardens.
• Public Health: In programs aimed at controlling vector-borne diseases such as malaria and dengue fever[5].

Market Analysis for Malathion

Global Market Size and Growth

The global malathion market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.5% from 2021 to 2028, reaching a value of USD 0.53 billion by 2028. This growth is driven by several key factors:

• Increasing Demand for Food: The rising global population and subsequent increase in food demand have escalated the need for effective pest control measures, thereby boosting the malathion market[5].
• Broad Range of Pest Control Applications: Malathion's versatility in controlling various pests makes it a preferred choice in agricultural and residential settings[5].
• Decrease in Price and Ease of Accessibility: The reduction in price and improved accessibility of malathion have further propelled its market growth[5].

Market Segmentation

The malathion market is segmented by product form (liquid, powder, emulsion, and others) and application (agriculture, residential, and others). Here are some key insights:

• Product Forms: Liquid and powder forms are the most commonly used, with emulsions also gaining traction due to their ease of application[5].
• Applications: Agriculture remains the largest segment, followed by residential use. Other applications include public health programs and industrial pest control[5].

Geographic Analysis

The malathion market is analyzed across various regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and South and Central America.

• Asia-Pacific: This region is expected to be a significant market due to the large agricultural sector and high population density, leading to increased demand for pest control measures[5].
• North America and Europe: These regions also show substantial demand, particularly in the residential and agricultural sectors[5].

Challenges and Restraints

Despite the growth prospects, the malathion market faces several challenges:

• Health and Environmental Concerns: Malathion is known to have adverse effects on the nervous system in both animals and humans, which can impede market growth. Regulatory bodies are increasingly scrutinizing the use of such chemicals due to environmental and health concerns[5].
• Safer Replacements: The development of safer and more environmentally friendly alternatives could reduce the demand for malathion[5].
• Economic Factors: Unstable economies and fluctuating raw material prices can also impact the market negatively[5].

Future Projections and Opportunities

Market Drivers

• Increasing Population and Food Demand: The growing global population will continue to drive the demand for effective pest control measures, providing opportunities for the malathion market[5].
• Technological Advances: Improvements in production, packaging, and application technologies can enhance the efficiency and safety of malathion use[2].

Potential Regional Markets

• Emerging Markets: Regions such as Asia-Pacific, Africa, and South America offer significant growth opportunities due to their large agricultural sectors and growing populations[5].

Conclusion

The malathion market is poised for growth driven by increasing demand for food and the broad range of pest control applications. However, it faces challenges related to health and environmental concerns, as well as the emergence of safer alternatives.

Key Takeaways

• Market Growth: The global malathion market is expected to grow at a CAGR of 5.5% from 2021 to 2028.
• Key Drivers: Increasing food demand, broad range of applications, and decreasing prices.
• Challenges: Health and environmental concerns, safer replacements, and economic instability.
• Future Opportunities: Emerging markets in Asia-Pacific, Africa, and South America.

FAQs

What is the current market size of the global malathion market?

The global malathion market is expected to reach USD 0.53 billion by 2028[5].

What are the primary applications of malathion?

Malathion is primarily used in agriculture, residential settings, and public health programs[5].

What are the main challenges facing the malathion market?

The main challenges include health and environmental concerns, the availability of safer replacements, and economic instability[5].

Which regions are expected to drive the growth of the malathion market?

Asia-Pacific, Africa, and South America are expected to be significant drivers due to their large agricultural sectors and growing populations[5].

How is the malathion market segmented?

The market is segmented by product form (liquid, powder, emulsion, etc.) and application (agriculture, residential, etc.)[5].

References

1. Research and Markets: Malathion Market Size, Competitors, Trends & Forecast Report[2].
2. Data Bridge Market Research: Global Malathion Market – Industry Trends and Forecast to 2028[5].
3. Straits Research: Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2033[3].