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Last Updated: March 22, 2025

CLINICAL TRIALS PROFILE FOR SPINOSAD


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All Clinical Trials for spinosad

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00545168 ↗ Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Completed ParaPRO LLC Phase 3 2007-09-01 A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).
NCT00410709 ↗ A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age Completed ParaPRO LLC Phase 1 2006-12-01 This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
NCT00311779 ↗ A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis Completed ParaPRO LLC Phase 2 2006-03-01 The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for spinosad

Condition Name

322000.511.522.53ScabiesPediculosis Capitis (Head Lice)Pediculosis[disabled in preview]
Condition Name for spinosad
Intervention Trials
Scabies 3
Pediculosis Capitis (Head Lice) 2
Pediculosis 2
[disabled in preview] 0
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Condition MeSH

63200123456Lice InfestationsScabiesParasitic Diseases[disabled in preview]
Condition MeSH for spinosad
Intervention Trials
Lice Infestations 6
Scabies 3
Parasitic Diseases 2
[disabled in preview] 0
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Clinical Trial Locations for spinosad

Trials by Country

+
Trials by Country for spinosad
Location Trials
United States 27
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Trials by US State

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Trials by US State for spinosad
Location Trials
Florida 9
California 4
Pennsylvania 2
Arkansas 2
Texas 2
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Clinical Trial Progress for spinosad

Clinical Trial Phase

25.0%50.0%25.0%000.511.522.533.54Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for spinosad
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 2
[disabled in preview] 0
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Clinical Trial Status

88.9%11.1%0012345678CompletedRecruiting[disabled in preview]
Clinical Trial Status for spinosad
Clinical Trial Phase Trials
Completed 8
Recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for spinosad

Sponsor Name

trials0123456789ParaPRO LLCConcentrics ResearchAccelovance[disabled in preview]
Sponsor Name for spinosad
Sponsor Trials
ParaPRO LLC 9
Concentrics Research 3
Accelovance 2
[disabled in preview] 0
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Sponsor Type

66.7%33.3%0024681012IndustryOther[disabled in preview]
Sponsor Type for spinosad
Sponsor Trials
Industry 12
Other 6
[disabled in preview] 0
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Spinosad: Clinical Trials, Market Analysis, and Projections

Introduction to Spinosad

Spinosad, a naturally occurring insecticide and acaricide, has been gaining significant attention in both the pharmaceutical and agricultural sectors. Derived from a soil microorganism, Saccharopolyspora spinosa, spinosad is known for its unique mechanism of action and safety profile.

Clinical Trials Update

Treatment of Scabies

Spinosad has recently been approved by the U.S. Food and Drug Administration (FDA) for the treatment of scabies infestations in adult and pediatric patients four years of age and older. This approval is based on two phase III, multicenter, randomized, double-blind, vehicle-controlled clinical trials.

  • Efficacy Results: These trials demonstrated that spinosad 0.9% topical suspension achieved a complete cure in 78.1% of index subjects 28 days after treatment, significantly higher than the vehicle control group at 39.6%[1][3].
  • Safety Profile: The trials also showed that spinosad 0.9% was well-tolerated by subjects as young as four years old, with no significant safety concerns reported[1][3].

Treatment of Head Lice

Spinosad has been established as a superior treatment for head lice compared to traditional over-the-counter (OTC) medications like permethrin.

  • Clinical Superiority: In two head-to-head, phase III clinical trials, spinosad 0.9% topical suspension demonstrated clinical superiority to permethrin 1%, with significantly more patients being lice-free 14 days after the last treatment without the need for nit combing[4].
  • Safety and Mechanism: Spinosad targets lice and nits in the stratum corneum without penetrating deep into the dermis or entering systemic circulation, making it a safe option even for young children. There is no evidence of neurotoxicity, developmental/reproductive toxicity, immunotoxicity, mutagenicity, or carcinogenicity associated with spinosad[4].

Market Analysis

Global Market Size and Growth

The global spinosad market is experiencing robust growth driven by several factors:

  • Current Market Size: As of 2024, the global spinosad market size is estimated to be USD 751.2 million[2].
  • Growth Rate: The market is projected to grow at a compound annual growth rate (CAGR) of 8.00% from 2024 to 2031[2].
  • Regional Dominance: North America currently dominates the market, accounting for around 40% of the global revenue, due to increasing demand for organic products and concerns over chemical pesticides. The Asia Pacific region is the fastest-growing, with a CAGR of 10.0% from 2024 to 2031[2].

Market Segmentation

The spinosad market is segmented based on type, application, and sales channels.

  • Applications: The key applications include agricultural chemicals, veterinary drugs, and sanitary pest control. The pharmaceutical preparations segment is particularly growing due to the expansion of the agriculture industry, pest resistance to synthetic pesticides, and regulatory approvals[2][5].
  • Sales Channels: Online retail channels are dominating the market due to their convenience and accessibility, facilitating wider distribution and consumer reach[2].

Key Players

The main players in the spinosad market include:

  • Qilu Pharmaceutical (Inner Mongolia) Co., Ltd.
  • Baicao Biotech Co., Ltd.
  • Corteva Agriscience

These companies are driving innovation and production in the spinosad market[5].

Market Projections

Future Growth

The spinosad market is expected to continue its upward trajectory:

  • Projected Market Size: By 2030, the global spinosad active ingredient market is projected to grow to USD 303.7 million, with a CAGR of 8.9% from 2024 to 2030[5].
  • Regional Growth: The Asia Pacific region is expected to remain the fastest-growing, driven by the expanding agriculture industry, growing demand for organic products, and government regulations favoring safer alternatives[2].

Emerging Trends

Several trends are expected to influence the spinosad market in the coming years:

  • Integrated Pest Management: The adoption of integrated pest management practices is increasing, which favors the use of spinosad due to its effectiveness and safety profile[2].
  • Regulatory Approvals: Continued regulatory approvals and R&D efforts are expected to further diversify the market potential of spinosad, particularly in pharmaceutical preparations[2][5].

Key Takeaways

  • Clinical Efficacy: Spinosad has demonstrated high efficacy in treating scabies and head lice, with significant superiority over traditional treatments.
  • Safety Profile: Spinosad is well-tolerated and does not penetrate deep into the skin, making it safe for use in pediatric patients.
  • Market Growth: The global spinosad market is growing at a CAGR of 8.00% from 2024 to 2031, driven by increasing demand for organic and safer alternatives.
  • Regional Dominance: North America and the Asia Pacific region are key markets, with the latter being the fastest-growing.
  • Emerging Trends: Integrated pest management and regulatory approvals are expected to drive future growth.

FAQs

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

The global spinosad market size is estimated to be USD 751.2 million as of 2024[2].

Which region dominates the spinosad market?

North America currently dominates the spinosad market, accounting for around 40% of the global revenue[2].

What is the projected growth rate of the spinosad market from 2024 to 2031?

The spinosad market is projected to grow at a CAGR of 8.00% from 2024 to 2031[2].

What are the main applications of spinosad?

The main applications include agricultural chemicals, veterinary drugs, and sanitary pest control, with pharmaceutical preparations being a rapidly growing segment[2][5].

Is spinosad safe for use in pediatric patients?

Yes, spinosad has been shown to be well-tolerated and safe for use in pediatric patients as young as four years old[1][3][4].

References

  1. Seiler JC, et al. J Am Acad Dermatol. 2021; doi:10.1016/j.jaad.2021.07.074.
  2. Cognitive Market Research. Spinosad Market Report 2024.
  3. ParaPRO. Natroba™ (spinosad) Topical Suspension, 0.9% for the Treatment of Scabies.
  4. SpinosadRx. Today's Head Lice Standard of Care.
  5. Valuates Reports. Global Spinosad Active Ingredient Market Insights, Forecast to 2030.

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