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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR IVERMECTIN


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505(b)(2) Clinical Trials for Ivermectin

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 Indication NCT05283954 ↗ Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea Not yet recruiting FundaciĆ³n FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĆ³n de la Salud y la Ciencia Phase 2/Phase 3 2022-05-01 The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.
New Indication NCT05283954 ↗ Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea Not yet recruiting National Department of Health, Papua New Guinea Phase 2/Phase 3 2022-05-01 The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.
New Indication NCT05283954 ↗ Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea Not yet recruiting Oriol Mitja Phase 2/Phase 3 2022-05-01 The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.
OTC NCT05643820 ↗ Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis Completed Combined Military Hospital Abbottabad Phase 1 2022-03-01 In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus, excoriation, cervical lymphadenopathy, and conjunctivitis1. It also has a number of negative social consequences, including parental anxiety and stigmatization of infested children2. It is a significant public health issue that primarily affects school-aged children aged 8 to 113. In developing nations, prevalence rates of up to 40% have been reported4. The four urban areas of KPK (NWFP) reported prevalence of 36.7%5. People with a low socioeconomic background and poor hygiene are more likely to be affected6. Pediculosis capitis has been treated using a variety of treatment modalities. They include both physician prescription and over-the-counter medications. Permethrin or ivermectin had been used topically or orally. Permethrin is a neurotoxin that is synthesized. It is a pyrethroid neurotoxic that targets voltage-sensitive Sodium ion receptors in the neurological system of the insect, triggering nerve depolarization, hyperexcitation, muscular paralysis, and, eventually, parasite death7. Ivermectin is antiparasitic medication, it is possible to treat diseases like lymphatic filariasis, and ectoparasite infestations, primarily scabies, with ivermectin because it binds to glutamate gated chloride ion receptors of invertebrates and disrupts neurotransmission8. The rationale of this study is to study while comparing effectiveness of oral ivermectin and topical permethrin in management of pediculosis. The topical medication usage is problematic and had reported drug resistance9. There has been less regional or national research on the effectiveness of oral Ivermectin, so doctors less frequently use it in our department. Instead, the patients are treated for pediculosis capitis with topical Permethrin.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ivermectin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00127504 ↗ Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness Completed Universidad del Valle, Guatemala Phase 2 2003-07-01 The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
NCT00127504 ↗ Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness Completed University of Alabama at Birmingham Phase 2 2003-07-01 The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
NCT00127504 ↗ Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness Completed Centers for Disease Control and Prevention Phase 2 2003-07-01 The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
NCT00207753 ↗ Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections Completed Universidad del Valle, Guatemala N/A 2005-02-01 The aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The World Bank, 1993). Infected children are more likely to have inadequate nutrition due to the worm infections and are more likely to be shorter in height and weigh less than children who are not infected. After collecting height and weight information, we will split the children into two groups. One group will receive albendazole and the other group will receive combined albendazole/ivermectin. Both groups will be receiving albendazole, the current standard of care treatment. Ivermection is expected to improve efficacy and nutritional benefit as well as add increased scope of treatment for the worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs would be a more efficient use of the opportunity to access schoolchildren and provide deworming treatment.
NCT00207753 ↗ Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections Completed Centers for Disease Control and Prevention N/A 2005-02-01 The aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The World Bank, 1993). Infected children are more likely to have inadequate nutrition due to the worm infections and are more likely to be shorter in height and weigh less than children who are not infected. After collecting height and weight information, we will split the children into two groups. One group will receive albendazole and the other group will receive combined albendazole/ivermectin. Both groups will be receiving albendazole, the current standard of care treatment. Ivermection is expected to improve efficacy and nutritional benefit as well as add increased scope of treatment for the worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs would be a more efficient use of the opportunity to access schoolchildren and provide deworming treatment.
NCT00215280 ↗ Epidemiology and Control of Mansonella Perstans Infection in Uganda Completed Ministry of Health, Uganda N/A 2005-11-01 Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the epidemiology of this infection, and of the morbidity it induces is poor, and no effective treatment is available. The study aims at providing data on diagnostic, epidemiological, morbidity and treatment aspects of M. perstans infections in Uganda.
NCT00215280 ↗ Epidemiology and Control of Mansonella Perstans Infection in Uganda Completed DBL -Institute for Health Research and Development N/A 2005-11-01 Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the epidemiology of this infection, and of the morbidity it induces is poor, and no effective treatment is available. The study aims at providing data on diagnostic, epidemiological, morbidity and treatment aspects of M. perstans infections in Uganda.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ivermectin

Condition Name

Condition Name for Ivermectin
Intervention Trials
Covid19 36
COVID-19 19
Onchocerciasis 16
Lymphatic Filariasis 15
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Condition MeSH

Condition MeSH for Ivermectin
Intervention Trials
COVID-19 66
Filariasis 24
Elephantiasis 21
Elephantiasis, Filarial 20
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Clinical Trial Locations for Ivermectin

Trials by Country

Trials by Country for Ivermectin
Location Trials
United States 152
Egypt 22
France 16
Malaysia 14
Thailand 10
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Trials by US State

Trials by US State for Ivermectin
Location Trials
California 16
Florida 14
Texas 8
North Carolina 8
Tennessee 7
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Clinical Trial Progress for Ivermectin

Clinical Trial Phase

Clinical Trial Phase for Ivermectin
Clinical Trial Phase Trials
Phase 4 26
Phase 3 55
Phase 2/Phase 3 20
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Clinical Trial Status

Clinical Trial Status for Ivermectin
Clinical Trial Phase Trials
Completed 106
Recruiting 46
Not yet recruiting 27
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Clinical Trial Sponsors for Ivermectin

Sponsor Name

Sponsor Name for Ivermectin
Sponsor Trials
Washington University School of Medicine 13
London School of Hygiene and Tropical Medicine 11
Jennifer Keiser 7
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Sponsor Type

Sponsor Type for Ivermectin
Sponsor Trials
Other 323
Industry 53
NIH 8
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Ivermectin: Clinical Trials, Market Analysis, and Projections

Introduction to Ivermectin

Ivermectin is an antiparasitic drug that has been widely used for the treatment of various parasitic infections and certain skin conditions. In recent years, it has garnered significant attention for its potential use in treating COVID-19, although its efficacy and safety for this purpose are still under intense scrutiny.

Clinical Trials and Efficacy for COVID-19

Early Studies and Controversies

Early studies suggested that ivermectin might have clinical benefits in the treatment of COVID-19, including improved survival rates, faster clinical recovery, and reduced hospitalizations. However, these findings have been marred by controversies surrounding the quality and integrity of the data.

Meta-Analyses and Bias

A meta-analysis published in Open Forum Infectious Diseases in 2021 analyzed data from 23 randomized clinical trials involving 3349 patients. However, this study was later retracted due to the discovery of fraudulent data in one of the largest studies included in the analysis. Subsequent analyses have shown that the significant effects of ivermectin on survival and clinical recovery were largely dependent on poor-quality studies[1][3].

Current Recommendations

Both the World Health Organization (WHO) and the European Medicines Agency (EMA) advise against the use of ivermectin for the prevention or treatment of COVID-19 outside randomized clinical trials. The EMA has concluded that the available data do not support its use for COVID-19, and it is only authorized for treating certain parasitic worm infestations and skin conditions, as well as for veterinary use[4].

Ongoing Trials

Despite the controversies, a network of large clinical trials is ongoing to validate the results seen to date. These trials are crucial for determining the true efficacy and safety of ivermectin in the context of COVID-19.

Market Analysis

Current Market Size

The global market for ivermectin was estimated to be worth approximately US$ 130 million in 2023. This market is driven by its established use in treating parasitic infections and skin conditions, as well as the ongoing interest in its potential for COVID-19 treatment[2].

Market Projections

The ivermectin market is forecasted to grow to US$ 213.7 million by 2030, with a compound annual growth rate (CAGR) of 7.3% during the period from 2024 to 2030. This growth is anticipated due to the increasing demand for antiparasitic medications and the potential expansion of ivermectin's use into new therapeutic areas[2].

Key Players

The main players in the ivermectin market include Hero Pharmaceutical, MERCK, HuBei YuanCheng SaiChuang, ENN, and LAND. These companies are involved in the production and distribution of ivermectin and are likely to benefit from the growing demand for this drug[2].

Market Trends and Drivers

Increasing Demand for Antiparasitic Medications

The global demand for antiparasitic medications is on the rise, driven by the prevalence of parasitic infections in various regions. This trend is expected to continue, contributing to the growth of the ivermectin market.

Potential Expansion into New Therapeutic Areas

While ivermectin's use for COVID-19 is still under investigation, any positive outcomes from ongoing clinical trials could significantly expand its market. Additionally, research into other potential therapeutic uses of ivermectin could further drive market growth.

Regulatory Environment

The regulatory environment plays a crucial role in the ivermectin market. Recommendations from health organizations such as the WHO and EMA will significantly influence the use and acceptance of ivermectin for various indications.

Challenges and Restraints

Quality of Clinical Trials

The quality of clinical trials has been a significant challenge for ivermectin, with several studies being identified as potentially fraudulent. Ensuring the integrity and quality of future trials is essential for establishing the drug's efficacy and safety.

Public Perception and Misuse

Public interest in ivermectin for COVID-19 treatment has led to its misuse in some cases. This misuse can result in adverse effects and undermine public health efforts, highlighting the need for clear guidelines and public education.

Regional Analysis

The demand for ivermectin varies by region, with higher demand in areas where parasitic infections are more prevalent. The market is also influenced by regional regulatory environments and the availability of healthcare resources.

Competitive Landscape

The competitive landscape of the ivermectin market is characterized by a mix of established pharmaceutical companies and smaller players. The main competitors are Hero Pharmaceutical, MERCK, HuBei YuanCheng SaiChuang, ENN, and LAND, each with their own strengths and market strategies[2].

Conclusion

Ivermectin remains a drug of significant interest, both for its established uses and its potential in new therapeutic areas, particularly COVID-19. However, its use for COVID-19 is currently not recommended outside clinical trials due to concerns over the quality of available data. The market for ivermectin is expected to grow, driven by increasing demand for antiparasitic medications and potential new uses.

Key Takeaways

  • Clinical Trials: Ongoing trials are crucial for determining the efficacy and safety of ivermectin for COVID-19.
  • Market Size: The global ivermectin market was valued at US$ 130 million in 2023 and is projected to reach US$ 213.7 million by 2030.
  • Growth Rate: The market is expected to grow at a CAGR of 7.3% from 2024 to 2030.
  • Key Players: Hero Pharmaceutical, MERCK, HuBei YuanCheng SaiChuang, ENN, and LAND are the main players in the market.
  • Regulatory Environment: Recommendations from health organizations like the WHO and EMA significantly influence the use of ivermectin.

FAQs

Q: What is the current status of ivermectin in treating COVID-19?

A: Ivermectin is not recommended for the treatment or prevention of COVID-19 outside randomized clinical trials due to concerns over the quality of available data.

Q: What is the projected market size of ivermectin by 2030?

A: The global ivermectin market is forecasted to reach US$ 213.7 million by 2030.

Q: Who are the main players in the ivermectin market?

A: The main players include Hero Pharmaceutical, MERCK, HuBei YuanCheng SaiChuang, ENN, and LAND.

Q: Why have some studies on ivermectin been retracted?

A: Some studies have been retracted due to the discovery of fraudulent data, which has compromised the integrity of the findings.

Q: What is the CAGR of the ivermectin market from 2024 to 2030?

A: The ivermectin market is expected to grow at a CAGR of 7.3% from 2024 to 2030.

Sources

  1. Hill, et al. "Meta-analysis of Randomized Trials of Ivermectin to Treat SARS-CoV-2 Infection." Open Forum Infectious Diseases, Volume 8, Issue 11, November 2021.
  2. Valuates Reports. "Ivermectin - Market, Report Size, Worth, Revenue, Growth, Industry Analysis."
  3. Open Forum Infectious Diseases. "Ivermectin for COVID-19: Addressing Potential Bias and Medical Fraud," January 2022.
  4. European Medicines Agency. "Public-health advice on COVID-19 medicines," March 2021.
  5. Cognitive Market Research. "Ivermectin Market Report 2024 (Global Edition)," January 2023.

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