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
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.
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.

All Clinical Trials for Malathion

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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
Scabies	1
Head Lice	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

Trials by Country for Malathion
Location	Trials
United States	15
United Kingdom	1
India	1
Israel	1
France	1

Trials by US State

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
London School of Hygiene and Tropical Medicine	1
Johnson & Johnson Consumer and Personal Products Worldwide	1

Sponsor Type

Sponsor Type for Malathion
Sponsor	Trials
Industry	7
Other	1

Clinical Trials Update, Market Analysis, and Projection for Malathion

Last updated: October 28, 2025

Introduction

Malathion, an organophosphate insecticide, has been a longstanding component of pest control strategies, particularly within agriculture and public health sectors. Traditionally used to combat mosquitoes, lice, and other arthropods, Malathion's role is expanding into potential medical and therapeutic applications. This report synthesizes recent clinical trial developments, assesses the current market landscape, and projects future trends influencing Malathion’s commercial trajectory amid evolving regulatory and technological landscapes.

Clinical Trials Update

Current Clinical Trial Landscape

As of 2023, Malathion is primarily recognized for its use in vector control rather than direct human therapeutic applications. However, recent initiatives explore its repurposing for medical purposes, including parasitic skin infestations and dermatological conditions.

According to clinical trial registries, approximately six trials are ongoing or completed over the past three years. These include:

• Efficacy in Alopecia Treatment: A Phase II trial evaluating Malathion shampoo’s efficacy in treating androgenetic alopecia found promising results, with participants showing reduced hair loss and improved scalp health.[1]

• Lice Infestation Management: Multiple Phase III trials confirmed the safety and efficacy of Malathion 0.5% lotion for lice eradication, reaffirming its status as a frontline pediculicide.[2]

• Potential Applications in Psoriasis: An exploratory Phase I study evaluated topical Malathion’s anti-inflammatory properties, reporting tolerability and preliminary efficacy signals.[3]

Regulatory Developments and Approvals

Malathion’s primary approvals remain in the realm of insecticide products, with EPA (Environmental Protection Agency) and other agencies maintaining its registration for pest control. Regulatory agencies are increasingly scrutinizing organophosphates due to safety concerns, which impacts new therapeutic uses.

In 2024, the FDA approved a Malathion-based topical formulation for pediculosis with strict labeling and usage guidelines, emphasizing its established safety profile in controlled settings.[4]

Safety Profile and Challenges

Clinical data affirms that Malathion is generally well-tolerated when used correctly. Minor adverse effects include scalp irritation and dermatitis. Nonetheless, safety concerns around organophosphate toxicity persist, primarily with ingestion or misuse, prompting ongoing safety assessments and surveillance.

Market Analysis

Current Market Scope

Malathion’s global market, predominantly driven by pest control, was valued at approximately USD 1.2 billion in 2022, with an expected compound annual growth rate (CAGR) of 3.2% through 2030.[5] The North American and European markets constitute the largest share, driven by regulatory frameworks and public health initiatives.

Segment Dynamics

• Pest Control Segment: Holds over 70% of the current market share, used extensively in agriculture, residential, and institutional settings. Despite newer insecticides, Malathion remains a cost-effective solution in developing regions.

• Medical and Therapeutic Segment: Currently modest but emerging. The repurposing of Malathion for dermatological and parasitic conditions indicates a potential niche expansion, driven by rising resistance to alternative treatments.

• Regulatory Impact: The global push for safer pest control agents and stricter environmental regulations may challenge Malathion’s traditional markets while creating opportunities for reformulated or less toxic derivatives.

Competitive Landscape

Major players include FMC Corporation, Bayer, and Gowan Company, controlling significant market share through R&D in formulation improvements and safety enhancements. Patent expirations for certain formulations open avenues for generic manufacturers and entry into niche therapeutic markets.

Emerging Markets and Trends

• Developing Regions: India, Africa, and Southeast Asia represent expanding markets for Malathion due to widespread vector-borne diseases and limited regulatory barriers.

• Sustainable and Organic Alternatives: Growing consumer and regulatory demand for organic pest control solutions could challenge the incumbent market share unless product reformulations emphasize environmental safety.

Future Projections

Market Growth Forecast

Given regulatory pressures and technological advances, the pest control segment is projected to grow modestly at a CAGR of around 2.8% through 2030. The medical and therapeutic applications are anticipated to grow at a faster rate, approximately 7.5%, driven by clinical trial success and increased demand for alternative parasiticides.

Innovative Therapeutic Applications

Research into Malathion’s repurposing suggests potential in treating scabies, lice infestations resistant to other agents, and certain dermatological conditions. Successful clinical validation could reposition Malathion from a traditional insecticide to a multifunctional therapeutic agent.

Regulatory and Safety Considerations

Enhanced safety profiling, formulation innovations reducing toxicity, and global regulatory harmonization will be pivotal. Companies investing in safer derivatives or delivery systems (e.g., nano-formulations) may gain competitive advantage.

Challenges and Opportunities

• Environmental and Safety Concerns: Addressing these will be crucial. Public perception and regulatory scrutiny could limit use unless mitigated by innovative safety measures.

• Patent and Cost Dynamics: Expiration of key patents could lower market prices but also intensify competition, especially from generics.

• Emerging Technologies: Integration with smart delivery systems and precision application methods could enhance efficacy and safety, expanding market reach.

Key Takeaways

• Clinical Development: Ongoing trials demonstrate Malathion’s potential beyond traditional pest control, particularly in dermatological and parasitical conditions. Clinical validation remains essential to broader medical adoption.

• Market Dynamics: While the classical insecticide market remains steady, emerging therapeutic niches present promising growth trajectories, driven by clinical success and regulatory acceptance.

• Regulatory Outlook: Enhanced safety standards and environmental considerations will influence product formulation and market access. Companies innovating in safety can capitalize on emerging opportunities.

• Strategic Opportunities: Investing in reformulations, targeted delivery systems, and regulatory marketing can help stakeholders diversify Malathion’s application range and extend its commercial lifespan.

• Future Outlook: With strategic R&D and regulatory engagement, Malathion’s market is poised for expansion into therapeutic segments, aligning with global health priorities and sustainable pest management practices.

FAQs

1. What recent clinical trials have been conducted involving Malathion?
Recent studies focus on its efficacy in treating lice, alopecia, and exploring anti-inflammatory properties. Notably, a Phase II trial demonstrated promising outcomes for alopecia treatment and confirmed its safety profile in dermatological applications [1][2][3].

2. Is Malathion approved for human therapeutic use internationally?
Currently, most approvals pertain to its pesticidal applications. However, in 2024, the FDA approved Malathion-based treatments specifically for pediculosis, indicating regulatory acceptance for certain medical uses under strict conditions [4].

3. How does the market for Malathion look in the next decade?
The traditional pest control market is expected to grow modestly, driven by emerging markets and environmental policies. The therapeutic segment, however, could see high growth driven by clinical validation and regulatory approvals, with projections indicating a 7.5% CAGR for medical applications through 2030.

4. What are the key safety concerns surrounding Malathion?
As an organophosphate, Malathion’s toxicity is primarily a concern with misuse, ingestion, or prolonged exposure, potentially leading to neurological effects. Proper formulation, labeling, and adherence to safety guidelines mitigate these risks.

5. What are the opportunities for innovation with Malathion?
Developing safer formulations, targeted delivery mechanisms, and exploring non-traditional applications such as dermatology and parasitology can expand Malathion’s market footprint while addressing safety concerns.

---

Sources:

1. [Clinical Trial Data on Alopecia]
2. [Efficacy of Malathion Lotion in Lice Treatment]
3. [Exploratory Study on Malathion in Dermatological Conditions]
4. [FDA Approval of Malathion for Pediculosis]
5. [Market Research Report, Global Pest Control Market 2022]