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	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

Last updated: May 20, 2026

Ivermectin clinical-trials update and market outlook: what is in flight, who is active, and how the revenue curve is projected across indications and geographies.

Ivermectin clinical trials update 2026: what studies are ongoing and what results are most likely to move the market?

As of 2026-05, ivermectin’s clinical pipeline is concentrated in (1) infectious disease repurposing (including parasitic and viral areas), (2) dermatology and ophthalmology formulations (topical and ocular delivery), and (3) combination regimens designed to improve dosing schedules and exposure.

Which ivermectin trials drive near-term regulatory and commercial milestones?

The highest commercial sensitivity clusters are studies that:

• target FDA-approvable endpoints with clear registrational pathways (e.g., controlled parasite efficacy endpoints for scabies, onchocerciasis, strongyloidiasis, or specific ocular outcomes for onchocerciasis-related disease);
• support differentiated formulations (topical, sustained-release, ocular);
• demonstrate dosing simplification (single-dose versus multi-dose regimens).

How to read the pipeline: registrational versus supportive trials

For business planning, the market-moving studies are typically:

• Phase 3 trials with randomized controlled designs and clinically meaningful primary endpoints;
• dose-ranging trials that set a fixed dosing claim for label expansion;
• trials with endpoints that map directly to existing regulatory precedent for ivermectin-based claims.

What indications are most active in clinical development?

Ivermectin development activity is most concentrated in:

• scabies (including pediatric and resistant or difficult-to-treat populations),
• onchocerciasis and onchocercal eye disease,
• strongyloidiasis (including immunocompromised cohorts),
• dermatologic parasite burdens (topical or modified-release approaches),
• ophthalmic delivery strategies for ocular onchocerciasis-related disease.

Viral repurposing: how it affects the risk profile

Ivermectin’s long history of viral-repurposing trials has not translated into durable, broad regulatory endorsements in major viral syndromes. The market impact of any new positive trial depends on whether endpoints and study design align with regulators’ requirements for causal efficacy and whether results replicate across geographies.

Ivermectin market analysis 2026: what is the current size, demand profile, and margin structure by indication?

Ivermectin is a mature antiparasitic across human and veterinary markets. Demand is driven by:

• endemic mass drug administration (MDA) programs in onchocerciasis and strongyloidiasis-adjacent ecosystems,
• intermittent but repeatable household and community treatment cycles for scabies,
• specialty prescribing in dermatology and ophthalmology where ivermectin is used for parasite-related morbidity and symptom control,
• veterinary use, which stabilizes total volume even when specific human-label expansions slow.

Demand drivers that support volume stability

• Patent-expired status across most jurisdictions for core ivermectin APIs generally lowers pricing pressure through high generic availability.
• Programmatic procurement for neglected tropical diseases (NTDs) and scabies control yields predictable procurement cycles.
• Formulation differentiation can create temporary pricing premiums where payers prefer specific delivery systems.

Margin structure: where profitability concentrates

In mature products, margins typically concentrate in:

• branded supply contracts where tender specifications require specific formulations,
• combination packs and fixed-dose regimens that reduce administration friction,
• higher-value markets where dosing reliability and patient adherence matter.

Pricing trend: generics constrain unit prices

Where ivermectin is broadly generic, the market behaves like a commodity. Differentiation generally relies on formulation, packaging, and supply reliability rather than patent-protected pricing.

When do ivermectin patents expire and what does that mean for exclusivity and generic entry risks?

Ivermectin’s core API and many older formulation and dosage patents are widely expired. Market exclusivity in the near term is therefore usually driven by:

• formulation-specific patents for topical or ocular delivery systems,
• manufacturing process claims,
• method-of-use claims for particular dosing regimens or specific indications,
• data exclusivity or regulatory exclusivity tied to new clinical programs, where applicable.

How exclusivity typically works in ivermectin’s landscape

For businesses modeling generic entry risk, ivermectin’s risk profile depends on whether a product is:

• an old generic with no new regulatory exclusivity tail,
• a new branded formulation with reformulation and/or clinical data packages.

Paragraph IV and ANDA dynamics: why they usually dominate the risk

Where an approved ivermectin drug is newly branded via reformulation, generics can target:

• ANDA pathways for formulation similarity,
• labeling carve-outs for non-overlapping claims,
• skin in litigation if Orange Book listed patents are present for the specific product/NDC.

(For an exact expiration and exclusivity schedule tied to specific NDCs and listed Orange Book patents, the analysis must be built on product-level listing data; without it, a complete and accurate patent-by-patent timetable cannot be produced.)

What is the Orange Book status of ivermectin products and how many patents cover each key NDC?

Ivermectin’s Orange Book coverage is product-specific. A complete NDC-by-NDC listing of listed patents and their expiration dates requires:

• the exact branded product names and strengths,
• the specific dosage forms and routes,
• the Orange Book listing IDs.

Without verified Orange Book listing data at the product/NDC level, any count of “how many patents cover ivermectin” would be incomplete and not decision-grade.

Ivermectin generic entry risks: which formulations and indications have the highest litigation probability?

The highest litigation probability tends to align with:

• reformulated products with Orange Book-listed formulation patents,
• new fixed-dose combinations or delivery systems with claims tied to clinical evidence,
• new label expansions that add method-of-use claims.

Where generic risk is usually lowest

• Novel ocular or topical delivery systems with formulation and manufacturing claims.
• Products where clinical endpoints support a unique dosing regimen and the label is tightly connected to those data.

Where generic risk is usually highest

• Oral ivermectin products where bioequivalence and manufacturing similarity are straightforward.
• Indications without formulation differentiation and with minimal claim coverage.

Ivermectin vs competitors: how does the ivermectin commercial position compare with other antiparasitics and scabicides?

Ivermectin competes in a fragmented antiparasitic landscape that includes:

• topical agents for scabies and dermatologic infestations,
• other oral anthelmintics in strongyloidiasis and onchocerciasis-adjacent parasitology settings,
• veterinary ivermectin formulations and combinations.

Competitive edge in practice

Ivermectin’s typical competitive advantages:

• ease of dosing in many regimens,
• broad clinician familiarity,
• programmatic procurement compatibility for NTD use.

Competitive pressure in commoditized markets

Generic competition compresses prices for oral ivermectin. Formulation competition shifts differentiation toward:

• topical convenience,
• patient adherence,
• adverse event management and tolerability.

What formulations are protected for ivermectin and what patent/IP barriers matter for topical and ocular delivery?

IP barriers are usually highest for:

• sustained-release or controlled-release formulations that alter drug release kinetics,
• ocular formulations requiring specific excipient systems and sterility/manufacturing standards,
• topical formulations designed for improved skin penetration or reduced irritation.

Common patent claim areas

• polymer or excipient systems enabling release modulation,
• manufacturing process steps controlling particle size, stability, or uniformity,
• method-of-use claims tied to specific dosing frequency and duration for the new delivery system.

How do settlement agreements and patent litigation affect ivermectin availability and timelines?

In mature API markets, litigation tends to concentrate on:

• Orange Book-listed formulation patents for newer branded formulations,
• method-of-use claims for new indications or regimen changes.

What to model for market timing

For projections, companies typically model:

• delayed generic launch due to preliminary injunctions or settlement-triggered “design-around” timelines,
• shortened or modified label claims negotiated in settlement,
• NDC-level entry timing rather than company-wide entry timing.

(Accurate settlement timing for ivermectin requires product- and case-level docket data, which is not present in the current prompt.)

FDA regulatory pathway for ivermectin indications: what is the route to approval and how fast can new label claims move?

Ivermectin is typically developed and approved through:

• generic ANDA routes for established indications and products with bioequivalence pathways,
• 505(b)(2) routes for reformulations or partial reliance on existing data,
• full 351(a) pathways for genuinely new indications requiring independent clinical evidence.

What governs speed to approval

• completeness of pivotal Phase 2/3 packages,
• whether endpoints are accepted with established regulatory precedent,
• whether safety datasets support broader populations (pediatrics, pregnancy, immunocompromised cohorts).

Market projection for ivermectin through 2030: what revenue trajectory is most defensible by scenario?

Because ivermectin is heavily generic in most markets, projections should be built around:

• volume growth from population-level access and program procurement,
• partial price resilience in niche branded or formulation-differentiated segments,
• timing of any new formulation approvals,
• substitution risk where competitor products or topical regimens shift prescribing patterns.

Scenario framework for revenue curves

A decision-grade projection requires product-level and geography-level assumptions. Without those product/NDC data, only scenario directionality can be stated:

• Base case: modest growth driven by NTD and scabies program continuity plus incremental formulation premiums where available; pricing remains capped by generics.
• Upside: faster-than-expected adoption of differentiated delivery systems or new regimen approvals for high-burden populations.
• Downside: continued price compression from expanded generic supply, slower adoption of formulation-differentiated products, or lack of regulatory breakthrough in high-profile repurposing attempts.

Key metrics to monitor for ivermectin commercial steering (clinical, regulatory, and competitive)

For investors and licensing teams, the most actionable KPIs are:

• protocol-level endpoints in Phase 2/3 scabies and ocular/NTD studies,
• label expansion status and timeline signals from FDA review milestones,
• Orange Book patent expirations per NDC for reformulated brands,
• generic launch announcements and court/settlement updates affecting NDC availability,
• tender/MLD procurement contract awards by region.

Key Takeaways

• Ivermectin’s clinical development focus is primarily on parasitic indications and differentiated delivery systems rather than durable viral repurposing outcomes.
• Commercial growth is mostly volume-driven in mature markets; unit pricing is constrained by widespread generic competition.
• Market-moving exclusivity is likely to be formulation- and NDC-specific; a decision-grade patent and exclusivity schedule requires product-level Orange Book and litigation datasets.
• The highest IP and litigation risk concentrates in reformulated topical/ocular products and method-of-use claims tied to new label regimens.

FAQs

1. Which ivermectin indications have the most credible Phase 3 registrational endpoints?
2. How does NDC-level Orange Book listing affect generic launch timing for reformulated ivermectin?
3. What delivery-system changes (topical or ocular) most influence patentability and bioequivalence risk?
4. How should scabies program tender cycles be modeled in ivermectin revenue forecasts?
5. What litigation patterns are most common for generic challenge of formulation patents in mature antiparasitics like ivermectin?

References

1. FDA Orange Book. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. ClinicalTrials.gov. U.S. National Library of Medicine. https://clinicaltrials.gov