CLINICAL TRIALS PROFILE FOR STROMECTOL

All Clinical Trials for STROMECTOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01570504 ↗	Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis	Completed	European Commission	Phase 3	2013-03-01	Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
NCT01570504 ↗	Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis	Completed	Centro per le Malattie Tropicali	Phase 3	2013-03-01	Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
NCT00921219 ↗	Ivermectin Solution Bioequivalence Study - With Food (Repeat)	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 1	2005-09-01	The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken after a standard meal. The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.
NCT00921154 ↗	Ivermectin Solution Bioequivalence Study - Fasted	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 1	2005-03-01	The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of ivermectin solution 1 mg/ml with a marketed reference formulation of ivermectin 3 mg tablets when taken after an overnight fast .The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.
NCT00921674 ↗	Ivermectin Solution Bioequivalence Study - With Food	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 1	2005-02-01	The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken after a standard meal. The study is designed in accordance with the EU Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001.

Clinical Trial Conditions for STROMECTOL

Condition Name

Condition Name for STROMECTOL
Intervention	Trials
Healthy	4
Malaria	2
Onchocerciasis	2
COVID-19	2

Condition MeSH

Condition MeSH for STROMECTOL
Intervention	Trials
Infections	4
COVID-19	3
Communicable Diseases	3
Coronavirus Infections	2

Clinical Trial Locations for STROMECTOL

Trials by Country

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−

Trials by Country for STROMECTOL
Location	Trials
United States	11
Spain	3
Italy	2
United Kingdom	2
Switzerland	2

Trials by US State

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−

Trials by US State for STROMECTOL
Location	Trials
California	4
Georgia	1
Minnesota	1
Indiana	1
Illinois	1

Clinical Trial Progress for STROMECTOL

Clinical Trial Phase

Clinical Trial Phase for STROMECTOL
Clinical Trial Phase	Trials
Phase 3	6
Phase 2/Phase 3	1
Phase 2	6

Clinical Trial Status

Clinical Trial Status for STROMECTOL
Clinical Trial Phase	Trials
Completed	10
Recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for STROMECTOL

Sponsor Name

Sponsor Name for STROMECTOL
Sponsor	Trials
Johnson & Johnson Consumer and Personal Products Worldwide	3
Barcelona Institute for Global Health	2
Pharmactive Ilac Sanayi ve Tic A.S.	1

Sponsor Type

Sponsor Type for STROMECTOL
Sponsor	Trials
Other	32
Industry	9
NIH	1

Stromectol (Ivermectin): Clinical Trials Update, Market Analysis, and Projections

Introduction to Stromectol (Ivermectin)

Stromectol, commonly known by its generic name ivermectin, is an antiparasitic drug that has been widely used for treating various parasitic infections in humans and animals. During the COVID-19 pandemic, ivermectin gained significant attention for its potential use as a treatment, although this has been a topic of intense debate.

Clinical Trials Update: Ivermectin and COVID-19

The PRINCIPLE Trial

One of the most comprehensive and rigorous clinical trials examining the efficacy of ivermectin in treating COVID-19 is the PRINCIPLE trial conducted by the University of Oxford. Here are the key findings:

• Participant Enrollment and Methodology: The trial involved over 11,700 participants, with 8,811 contributing to the primary analysis of the ivermectin evaluation. Participants were given a three-day course of ivermectin or no additional treatment, and their recovery time, hospitalizations, and deaths were monitored for 28 days, followed by follow-ups at 3, 6, and 12 months[4].
• Results: The trial concluded that ivermectin does not provide clinically meaningful benefits for treating COVID-19. The results showed that ivermectin did not significantly reduce recovery time, hospitalizations, or deaths compared to the control group[1][4].
• Challenges and Delays: The trial faced a delay due to customs issues with ivermectin shipments from the USA to the UK, but this did not affect the results. The final analysis was completed after a 12-month follow-up period, and the manuscript was submitted for publication in October 2023[4].

Implications of the PRINCIPLE Trial

The PRINCIPLE trial's findings are crucial for policymakers and healthcare professionals. According to Professor Chris Butler, Co-chief investigator of PRINCIPLE, "The results of this study add certainty to the existing evidence that ivermectin has no place in the treatment of COVID-19 in a largely vaccinated population." This underscores the importance of rigorous clinical trials in evaluating potential treatments and helps in making informed decisions about patient care and resource allocation[1].

Market Analysis for Ivermectin

Global Market Size and Growth

Despite the lack of efficacy in COVID-19 treatment, the global ivermectin market remains robust and is expected to grow significantly.

• Current Market Size: The global ivermectin market was estimated to be worth around $130 million in 2023[5].
• Projected Growth: The market is forecast to reach $213.7 million by 2030, with a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period of 2024-2030[5].

Key Applications and Regions

• Applications: Ivermectin is widely used in the treatment of parasitic infections such as hookworms, threadworms, and whipworms in humans. It is also used in veterinary medicine due to its anthelmintic action. Additionally, there is ongoing research into its potential use in cancer treatment and other scientific applications[2][5].
• Regions: North America is expected to account for the largest revenue CAGR due to increasing clinical trials, funding, and pharmaceutical industry activities. Europe also shows steady revenue growth driven by research and development, with major producers like Merck headquartered in Germany[2].

Market Drivers

• Healthcare Sector: The healthcare sector is a significant driver, with ivermectin being used extensively in hospitals for treating various parasitic infections[2].
• Research and Development: Ongoing research, particularly in cancer treatment and other scientific applications, is driving market growth. For instance, collaborations between the US government and the National Cancer Institute to develop anti-cancer drugs using ivermectin are promising[2].
• Pharmaceutical Industry: Major pharmaceutical companies such as Merck, Hero Pharmaceutical, and HuBei YuanCheng SaiChuang are key players in the ivermectin market, contributing to its growth through their production and distribution efforts[5].

Regional Market Insights

North America

• Clinical Trials and Funding: North America, particularly the US, is a hub for clinical trials and pharmaceutical research. Universities like Duke University, Northwestern University, and UCLA are conducting significant research, including studies on ivermectin's potential in cancer treatment[2].
• Personalized Medicine: The increasing preference for personalized medicine, which involves using metabolomic, proteomic, and genomic data to tailor treatments, is also driving the market in this region[3].

Europe

• Research and Development: Europe is known for its strong emphasis on research and development, with significant investments in R&D. The European Union invested around $40.79 billion in R&D in 2020, supporting the growth of the pharmaceutical sector, including ivermectin production[2].
• Major Producers: Companies like Merck, Galderma, and Boehringer Ingelheim are major contributors to the ivermectin market in Europe[2].

Asia Pacific

• Clinical Research: The Asia Pacific region is emerging as a promising market for clinical trials due to its diverse patient population and ease of recruitment. Constant developments and advancements in clinical research are driving the growth of the ivermectin market here[3].

Future Prospects and Challenges

Cancer Research

• Potential in Cancer Treatment: Ongoing research into ivermectin's properties to kill cancer cells, particularly in liposomal cancer, holds significant potential for future market growth[2].

Regulatory and Market Challenges

• Regulatory Approval: Despite its potential, ivermectin faces regulatory challenges, especially in the context of COVID-19 treatment. The lack of clinical evidence supporting its use against COVID-19 has led to it not being recommended as a treatment[1][4].
• Market Competition: The ivermectin market is competitive, with multiple producers. However, the low production costs, especially in countries like India, keep prices competitive and support widespread use[2].

Key Takeaways

• Clinical Efficacy: Ivermectin has been shown to lack clinically meaningful benefits in treating COVID-19, as evidenced by the PRINCIPLE trial.
• Market Growth: The global ivermectin market is expected to grow, driven by its use in treating parasitic infections and ongoing research in cancer treatment.
• Regional Insights: North America, Europe, and the Asia Pacific are key regions driving market growth due to clinical trials, research, and development activities.
• Future Prospects: Ivermectin's potential in cancer treatment and other scientific applications offers promising future growth opportunities.

FAQs

What are the findings of the PRINCIPLE trial regarding ivermectin and COVID-19?

The PRINCIPLE trial found that ivermectin does not provide clinically meaningful benefits for treating COVID-19, showing no significant reduction in recovery time, hospitalizations, or deaths compared to the control group[1][4].

What is the current market size and projected growth of the global ivermectin market?

The global ivermectin market was estimated to be worth $130 million in 2023 and is forecast to reach $213.7 million by 2030, with a CAGR of 7.3% during the forecast period[5].

Which regions are driving the growth of the ivermectin market?

North America, Europe, and the Asia Pacific are key regions driving the growth of the ivermectin market due to clinical trials, research, and development activities[2][3].

What are the main applications of ivermectin?

Ivermectin is widely used in the treatment of parasitic infections such as hookworms, threadworms, and whipworms in humans, as well as in veterinary medicine. It is also being researched for its potential in cancer treatment[2][5].

Who are the major players in the ivermectin market?

Major players include Hero Pharmaceutical, Merck, HuBei YuanCheng SaiChuang, ENN, and LAND[5].

What are the future prospects for ivermectin in cancer treatment?

Ongoing research into ivermectin's properties to kill cancer cells, particularly in liposomal cancer, holds significant potential for future market growth[2].

Sources

1. University of Oxford: New study shows ivermectin lacks meaningful benefits in COVID-19 treatment.
2. Reports and Data: Ivermectin Market Facts, Figures And Analytical Insights 2030.
3. Biospace: Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034.
4. PRINCIPLE Trial: Examining the Evidence: Ivermectin and COVID-19 in the PRINCIPLE Trial.
5. Valuates Reports: Ivermectin - Market, Report Size, Worth, Revenue, Growth, Industry.