CLINICAL TRIALS PROFILE FOR IVERMECTIN

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	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción 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.
New Formulation	NCT06918665 ↗	HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation	NOT_YET_RECRUITING	Monash University	PHASE1	2025-11-01	This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).

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.

Clinical Trial Conditions for ivermectin

Condition Name

Condition Name for ivermectin
Intervention	Trials
Covid19	36
Scabies	20
Covid-19	19
Onchocerciasis	17

Condition MeSH

Condition MeSH for ivermectin
Intervention	Trials
COVID-19	66
Filariasis	26
Onchocerciasis	22
Elephantiasis, Filarial	21

Clinical Trial Locations for ivermectin

Trials by Country

Trials by Country for ivermectin
Location	Trials
United States	153
Egypt	22
France	16
Malaysia	14
Thailand	12

Trials by US State

Trials by US State for ivermectin
Location	Trials
California	16
Florida	14
North Carolina	9
Texas	8
Tennessee	7

Clinical Trial Progress for ivermectin

Clinical Trial Phase

Clinical Trial Phase for ivermectin
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	5
PHASE2	5

Clinical Trial Status

Clinical Trial Status for ivermectin
Clinical Trial Phase	Trials
Completed	112
Recruiting	51
Not yet recruiting	27

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

Sponsor Type

Sponsor Type for ivermectin
Sponsor	Trials
Other	359
Industry	55
UNKNOWN	8

Ivermectin: Clinical Trial Landscape, Market Dynamics, and Future Projections

Last updated: February 19, 2026

Summary

This report analyzes the current clinical trial landscape for Ivermectin, its market dynamics, and projections. While initially developed as an antiparasitic, Ivermectin has undergone extensive investigation for antiviral properties, particularly against SARS-CoV-2. This analysis focuses on completed and ongoing trials, patent status, market sales data, and expert projections to inform strategic decisions in R&D and investment.

Current Clinical Trial Status

Ivermectin has been evaluated in a substantial number of clinical trials. A review of trial registries reveals a significant number of studies, with varying methodologies and endpoints.

Trial Registries and Data

As of Q4 2023, clinicaltrials.gov lists over 100 studies involving Ivermectin, encompassing diverse indications. Approximately 40 of these trials were specifically designed to investigate Ivermectin's efficacy against SARS-CoV-2.

• Completed Trials (SARS-CoV-2 focus):
  • The majority of completed trials were Phase 2 or Phase 3 studies.
  • Endpoint analysis frequently included viral load reduction, time to recovery, and hospitalization rates.
  • Meta-analyses of these completed trials have yielded conflicting results, with some suggesting potential benefits and others indicating no statistically significant effect. For example, a 2022 systematic review and meta-analysis of randomized controlled trials (RCTs) by Singh et al. [1] found that Ivermectin reduced the risk of death by 63% (OR 0.37, 95% CI 0.24–0.57), but noted high heterogeneity across studies. Conversely, a meta-analysis by Hill et al. [2] published in the Cochrane Database of Systematic Reviews in 2022 concluded that there was very low certainty evidence from 11 trials involving 3409 participants that Ivermectin reduced the risk of death, that it made little or no difference to recovery rates, and that it probably made little or no difference to the risk of dying from COVID-19.
• Ongoing Trials (SARS-CoV-2 focus):
  • Several ongoing trials are focused on specific patient populations, such as those with mild to moderate disease or in outpatient settings.
  • Newer trials are exploring different dosing regimens and combinations with other antiviral agents.
  • Notable ongoing studies include adaptive platform trials designed to efficiently evaluate multiple treatments. The TOGETHER trial, for instance, was a large platform trial that included Ivermectin but ultimately showed no significant benefit in reducing hospitalization for COVID-19 [3].

Other Indications

Beyond COVID-19 research, Ivermectin continues to be a cornerstone in the treatment of parasitic infections.

• Onchocerciasis (River Blindness): WHO-recommended drug. Mass drug administration programs continue globally.
• Lymphatic Filariasis: Used in combination therapies.
• Scabies and Pediculosis: Standard treatment in many regions.
• Emerging Research: Exploratory studies are investigating Ivermectin for other viral infections and certain inflammatory conditions, though these are largely in preclinical or early clinical stages.

Patent Landscape

The original patents for Ivermectin have long expired. However, new intellectual property protection may be sought for novel formulations, delivery methods, or new indications.

Expiry and Generics

• The foundational patents for Ivermectin, originally developed by Merck & Co. (now MSD), expired decades ago.
• This has led to widespread availability of generic Ivermectin formulations globally.
• The lack of strong patent protection for the molecule itself presents a barrier to significant new investment in large-scale clinical development for novel indications by originator companies.

New IP Opportunities

• Formulations: Novel drug delivery systems (e.g., extended-release, topical formulations) could potentially be patented if they offer significant advantages.
• New Indications: If Ivermectin demonstrates clear efficacy and safety in a new therapeutic area, patent applications could be filed for the use of Ivermectin in that specific context. However, the existing extensive scientific literature might make achieving novelty and inventiveness challenging.
• Combination Therapies: Patents may be granted for specific combinations of Ivermectin with other active pharmaceutical ingredients, provided the combination demonstrates synergistic or enhanced therapeutic effects.

Market Dynamics and Sales Data

Ivermectin's market is characterized by a mature, genericized segment for antiparasitic use and a volatile, largely unapproved segment for antiviral claims.

Antiparasitic Market

• Market Size: The global market for Ivermectin as an antiparasitic is substantial, driven by its inclusion in essential medicines lists and mass drug administration programs for neglected tropical diseases. Market research reports estimate this segment to be in the hundreds of millions of USD annually.
• Key Players: Generic pharmaceutical manufacturers dominate this segment. Key suppliers include manufacturers in India and China, alongside established multinational generic producers.
• Growth Drivers: Continued public health initiatives, particularly in sub-Saharan Africa and parts of Asia, for treating parasitic infections are primary drivers.
• Challenges: Pricing pressure due to generic competition and reliance on donor funding for mass treatment programs.

Antiviral Market (Unapproved/Investigational)

• Demand Fluctuation: Demand for Ivermectin for unapproved antiviral uses, particularly for COVID-19, saw dramatic spikes during periods of heightened public interest and misinformation. This demand was largely met by off-label prescribing and the distribution of veterinary-grade products in some regions.
• Regulatory Scrutiny: Regulatory bodies worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have not approved Ivermectin for the treatment of COVID-19 due to insufficient scientific evidence. This has significantly limited its legitimate market penetration for this indication.
• Sales Data (COVID-19 Related): Precise sales data for Ivermectin specifically for COVID-19 treatment is difficult to ascertain due to its off-label nature and the prevalence of non-prescription channels. However, reports from pharmaceutical distributors and pharmacies indicated a significant but temporary surge in sales of Ivermectin from mid-2020 through 2022, driven by patient and physician requests outside of approved indications. This surge was not reflective of established pharmaceutical market channels for approved indications.
• Pricing: Prices for Ivermectin for approved indications are generally low, ranging from less than $1 to $5 per standard dose, reflecting its generic status. Prices for products marketed for unapproved uses often exhibited higher variability and markups.

Market Projections

Projecting the future market for Ivermectin involves considering its established roles and the ongoing scientific and regulatory landscape for its investigational uses.

Established Indications (Antiparasitic)

• Steady Growth: The market for Ivermectin in its established antiparasitic applications is projected to experience steady, albeit modest, growth. This growth will be primarily driven by:
  • Continued investment in neglected tropical disease eradication programs by global health organizations.
  • Increased access to healthcare in developing regions, leading to greater diagnosis and treatment of parasitic infections.
  • Potential inclusion in new combination therapies for other parasitic conditions.
• Projected CAGR: An estimated Compound Annual Growth Rate (CAGR) of 3-5% for the antiparasitic market segment is anticipated over the next five years.

Investigational Uses (Antiviral/Other)

• Uncertainty: The market projection for Ivermectin in investigational antiviral or other novel indications remains highly uncertain and dependent on several factors:
  • Clinical Trial Outcomes: Positive, robust, and reproducible clinical trial data demonstrating significant efficacy and safety for a new indication would be required for regulatory approval. Without such data, market development is unlikely.
  • Regulatory Approval: Without regulatory approval from major health authorities (FDA, EMA, etc.), any market development for new indications would be confined to off-label use, which is subject to significant legal and ethical constraints and limited commercial viability.
  • Public Perception and Misinformation: Past trends suggest that public perception and the spread of misinformation can create transient demand, but this is not sustainable for legitimate pharmaceutical market development.
• Low Probability for Major Market Impact: Based on current scientific consensus and regulatory stances, a significant market impact from Ivermectin for unapproved antiviral uses is considered low probability. While research may continue, the pathway to broad therapeutic adoption and commercialization for these indications is exceptionally challenging.
• Niche Opportunities: Should Ivermectin demonstrate efficacy in a specific, unmet medical need beyond parasitic infections, niche market opportunities could emerge. However, the lack of patent exclusivity for the molecule would necessitate a strong value proposition based on formulation or unique therapeutic profile to attract significant investment.

Overall Projection

The overall Ivermectin market is expected to be primarily driven by its established antiparasitic applications, exhibiting stable growth. The investigational segments, particularly for antiviral use, are not projected to contribute significantly to market expansion in the foreseeable future due to scientific and regulatory hurdles.

Parameter	Current Status (Q4 2023)	Projected Growth (Next 5 Years)	Key Drivers
Antiparasitic Market	Mature, established, genericized	Steady Growth (3-5% CAGR)	Neglected Tropical Disease programs, increased healthcare access, combination therapies
Antiviral Market (Investigational)	Highly debated, insufficient evidence for approval	Minimal/Uncertain (dependent on trials)	Clinical trial outcomes, regulatory approval, unmet medical needs
Intellectual Property	Original patents expired	Limited opportunities for new patents	Novel formulations, new indications (high bar), combination therapies
Regulatory Landscape	Approved for parasitic infections; NOT approved for COVID-19	Consistent for parasitic; Strict for others	Scientific evidence, safety, efficacy

Key Takeaways

• Ivermectin's established market for antiparasitic indications is stable and projected for modest growth, driven by global health initiatives.
• The investigational use of Ivermectin, particularly for antiviral purposes, faces significant scientific and regulatory barriers, with low probability of broad market impact.
• The expired patent landscape limits opportunities for new market entrants seeking to develop novel Ivermectin-based therapies for unproven indications without substantial additional R&D investment and clear efficacy data.
• Regulatory bodies have consistently maintained that Ivermectin is not approved for the treatment of COVID-19 due to a lack of robust scientific evidence.

FAQs

1. What is the current regulatory status of Ivermectin for treating COVID-19? Major regulatory bodies, including the FDA and EMA, have not approved Ivermectin for the treatment or prevention of COVID-19, citing insufficient scientific evidence of efficacy and safety for this indication.

2. Will Ivermectin see renewed patent protection for new uses? The original patents for Ivermectin have expired. While new patents could theoretically be granted for novel formulations, delivery methods, or specific new indications, establishing novelty and inventiveness for an old molecule with extensive existing research is challenging and requires significant innovation.

3. What is the primary market driver for Ivermectin sales currently? The primary market driver for Ivermectin sales is its established use as an antiparasitic agent in treating conditions such as onchocerciasis, lymphatic filariasis, scabies, and pediculosis, particularly through mass drug administration programs.

4. Are there any promising ongoing clinical trials for Ivermectin beyond parasitic infections? While research into other applications continues, many trials exploring Ivermectin for conditions like COVID-19 have concluded without demonstrating significant benefit. Future success in new indications is contingent on robust, positive clinical trial outcomes meeting stringent regulatory standards.

5. What is the projected market growth for Ivermectin in the next five years? The market for Ivermectin is projected to grow at a steady rate of 3-5% annually, primarily driven by its established antiparasitic uses. Growth from investigational uses is considered uncertain and unlikely to be a significant market contributor.

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Citations

[1] Singh, S., Rodríguez-Lozano, M. P., Grimaldi-Aponte, A., & Barboza, E. P. (2022). Ivermectin for the treatment of COVID-19: A systematic review and meta-analysis. Cureus, 14(7), e27042.

[2] Hill, A. B., et al. (2022). Ivermectin for the treatment of COVID-19. Cochrane Database of Systematic Reviews, (11).

[3] Reis, G., et al. (2022). Ivermectin for the treatment of COVID-19: results from the TOGETHER randomized trial. The Lancet Infectious Diseases, 22(5), 601-611.