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.
NCT00927407 ↗	Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice	Completed	Taro Pharmaceuticals USA	Phase 1	2009-07-01	In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc. The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.

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
Solomon Islands	1
United Kingdom	1
India	1
Israel	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
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

MALATHION Market Analysis and Financial Projection

Last updated: April 24, 2026

Malathion: What Do Recent Clinical Trials, Market Data, and Projections Show?

What does the clinical-trials record show for Malathion?

Malathion is an established organophosphate insecticide/larvicide used in agriculture and for public-health vector control, and it also has a limited role in dermatology for pediculosis and scabies-adjacent indications in some jurisdictions. Across the modern clinical-trials record, the signal is dominated by:

• Formulation and local delivery studies (dermatology or topical delivery), and
• Toxicology/safety and exposure studies rather than new systemic therapeutic development.

Because Malathion is not a late-stage, brand-new “drug-like” pipeline candidate, the practical clinical-trials update is that development is mostly about formulations, dosing patterns, and safety under use conditions, not curative efficacy or new mechanisms.

Clinical trial activity pattern (practical read-through)

• Regulatory use history drives clinical relevance more than ongoing Phase 2/3 programs.
• Trials are typically smaller, application-specific, and completion-dominant, reflecting constrained innovation space.

No basis exists here to cite a credible, current-year, Malathion-specific Phase 3 efficacy program that would support a conventional “trial-to-market” projection. The available knowledge base for Malathion points away from an active late-stage pipeline that would materially move a modern investor-style forecast.

What is the market for Malathion, and where does demand come from?

Malathion demand is driven by use in:

• Agriculture (broad pest control categories depending on region and crop),
• Public health (vector control, including mosquito programs), and
• Topical dermatology applications in jurisdictions where it is marketed for ectoparasites.

Market outcomes are highly sensitive to:

• Regulatory approvals and re-evaluations by region (including restrictions, label changes, and use limitations),
• Resistance management needs (organophosphates face efficacy and resistance dynamics depending on pest species),
• Substitution pressure from newer insecticide classes (pyrethroids, neonicotinoids, insect growth regulators, and others).

Market structure

• B2G/B2B public-health procurement for vector control can be cyclical and program-based.
• Agriculture demand tends to follow crop cycles and pest severity.
• Dermatology use tends to be smaller and policy-driven versus the global agrochemical market.

Implication for business planning A Malathion “market projection” is best treated as a portfolio-level forecast tied to regulatory availability and procurement cycles, not as a smooth biologics-style adoption curve.

What are the key commercial risks that cap upside for Malathion?

Commercial upside is constrained by structural and regulatory factors typical for older organophosphate actives:

1. Regulatory scrutiny and label restrictions
   • Malathion has faced periodic reviews and limitations in multiple jurisdictions over time due to toxicology and exposure concerns.
2. Regulatory re-registration requirements
   • Older actives must remain compliant with evolving data standards.
3. Substitution by newer insecticide classes
   • Many markets shift away from organophosphates when alternatives deliver improved safety profiles, lower application burdens, or better resistance management.
4. Operational constraints in formulation and distribution
   • Safety handling, worker exposure rules, and end-user training can increase compliance costs.

What market projection can be made for Malathion?

No single credible projection can be produced without specific market-sizing sources (global and regional revenues/volumes, import/export baselines, and forward-looking forecasts from recognized aggregators). Under strict patent-analysis discipline, providing numeric forecasts without properly sourced figures would be non-actionable.

Actionable projection framework (non-numeric, decision-grade)

• Base case: demand tracks vector-control and agriculture label availability and stays largely “maintenance” rather than growth-led.
• Downside case: additional restrictions or higher compliance costs accelerate substitution.
• Upside case: short-cycle vector-control procurement spikes in regions with active program funding and where Malathion remains a permitted option.

What does patent positioning imply for future clinical-market development?

For Malathion as an active ingredient, the patent landscape usually matters less than regulatory and formulation branding because:

• The active ingredient is mature and long past typical primary invention cycles.
• Competitive differentiation tends to come from formulation, delivery systems, and local product registrations, not new molecular IP.

From a clinical perspective, “new trials” often do not translate into meaningful patent estates unless tied to:

• Specific novel formulations,
• Distinct dosing/administration regimens with defensible IP, or
• Geographically specific product registrations that are protected through local processes.

Key Takeaways

• Clinical-trials activity for Malathion is expected to skew toward formulation and safety/exposure work rather than late-stage therapeutic innovation.
• Market demand is driven by agriculture and public-health vector control, with dermatology use as a smaller, policy-dependent component.
• Regulatory restrictions and substitution risk cap growth, so projections are best treated as maintenance with cycle-driven procurement variability rather than adoption-led expansion.
• Patent-driven upside is usually limited for an established active ingredient, unless new defensible IP exists around formulations and regimens.

FAQs

1. Is Malathion currently in Phase 3 clinical development for a new indication?
   The clinical development profile for Malathion is not characterized by a mainstream, late-stage program for new therapeutic indications.

2. What drives Malathion demand most: agriculture or vector control?
   Both are major demand engines, with public-health procurement often program-based and agriculture tied to crop and pest cycles.

3. What are the biggest commercial threats to Malathion?
   Regulatory restrictions, exposure-related scrutiny, and substitution by newer insecticide classes.

4. Does Malathion have meaningful patent protection remaining?
   For the active ingredient, broad primary IP is typically expired; any remaining leverage is more likely in formulation, regimens, or local product-specific registrations.

5. How should investors model Malathion market projections?
   Use a scenario model tied to regulatory availability and procurement cycles rather than assuming rapid adoption growth.

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References

[1] US EPA. Malathion. (Pesticide product information and regulatory context). https://www.epa.gov/
[2] European Commission. EU pesticide database and active substance information (context for approval status and regulatory measures). https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/
[3] WHO. Vector control guidance and insecticide management resources (context for vector-control demand drivers). https://www.who.int/teams/control-of-neglected-tropical-diseases/vector-control
[4] ClinicalTrials.gov. Malathion search results (for trial activity overview and recruitment/completion patterns). https://clinicaltrials.gov/