CLINICAL TRIALS PROFILE FOR ALBENDAZOLE

505(b)(2) Clinical Trials for albendazole

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.

All Clinical Trials for albendazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002191 ↗	A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis	Completed	SmithKline Beecham	Phase 3	1969-12-31	To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.
NCT00004403 ↗	Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis	Completed	Johns Hopkins University	N/A	2000-05-01	OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis. II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain. III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.
NCT00130910 ↗	Treatment of Helminth co-Infection: Short-Term Effects on HIV-1 Progression Markers and Immune Activation	Completed	Kenya Medical Research Institute	N/A	2006-03-01	Identifying methods to slow disease progression in patients with HIV-1 infection remains a top priority in many regions of the world. In many countries, medications known to slow progression are not readily affordable or available. Many of the individuals living in these countries are also co-infected with a variety of other diseases such as tuberculosis, malaria and soil-transmitted helminths. There are data to suggest that infection with these agents may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid HIV disease progression. This study will evaluate the potential impact of treating helminths in HIV-1 seropositive individuals. Markers of disease progression and immune activation will be assessed. We will also measure the amount of virus in genital secretions to determine if treatment of co-infection can reduce the infectiousness of HIV in these individuals.
NCT00130910 ↗	Treatment of Helminth co-Infection: Short-Term Effects on HIV-1 Progression Markers and Immune Activation	Completed	Kenyatta National Hospital	N/A	2006-03-01	Identifying methods to slow disease progression in patients with HIV-1 infection remains a top priority in many regions of the world. In many countries, medications known to slow progression are not readily affordable or available. Many of the individuals living in these countries are also co-infected with a variety of other diseases such as tuberculosis, malaria and soil-transmitted helminths. There are data to suggest that infection with these agents may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid HIV disease progression. This study will evaluate the potential impact of treating helminths in HIV-1 seropositive individuals. Markers of disease progression and immune activation will be assessed. We will also measure the amount of virus in genital secretions to determine if treatment of co-infection can reduce the infectiousness of HIV in these individuals.

Clinical Trial Conditions for albendazole

Condition Name

Condition Name for albendazole
Intervention	Trials
Lymphatic Filariasis	17
Helminthiasis	14
Trichuriasis	10
Neurocysticercosis	8

Condition MeSH

Condition MeSH for albendazole
Intervention	Trials
Helminthiasis	27
Filariasis	24
Elephantiasis, Filarial	22
Elephantiasis	22

Clinical Trial Locations for albendazole

Trials by Country

Trials by Country for albendazole
Location	Trials
Tanzania	11
India	10
United States	10
Uganda	8
Malawi	7

Trials by US State

Trials by US State for albendazole
Location	Trials
Maryland	3
District of Columbia	2
Iowa	1
Colorado	1
New York	1

Clinical Trial Progress for albendazole

Clinical Trial Phase

Clinical Trial Phase for albendazole
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	3
PHASE2	4

Clinical Trial Status

Clinical Trial Status for albendazole
Clinical Trial Phase	Trials
Completed	78
Not yet recruiting	17
RECRUITING	11

Clinical Trial Sponsors for albendazole

Sponsor Name

Sponsor Name for albendazole
Sponsor	Trials
Washington University School of Medicine	17
Jennifer Keiser	9
London School of Hygiene and Tropical Medicine	9

Sponsor Type

Sponsor Type for albendazole
Sponsor	Trials
Other	288
NIH	15
Industry	8

Last updated: May 20, 2026

Albendazole Clinical Trials Update, Market Analysis, and Forecast (2026–2032)

Albendazole is an off-patent, WHO-recommended benzimidazole anthelmintic with multiple FDA-approved brands and large global volume driven by mass drug administration (MDA). As a result, the near-term competitive landscape is shaped less by patent exclusivity and more by formulation differentiation (bioavailability, pediatric dosing, chewables/suspensions) and by public-sector procurement cycles. Current “clinical trials update” activity clusters in (1) pediatric and lower-dose regimens, (2) co-administration strategies, and (3) combination products for neglected tropical diseases (NTDs) rather than new albendazole mechanisms.

What clinical trials are running for albendazole right now?

Albendazole trial activity is dominated by parasitology endpoints (cure rate, egg reduction, epg/epg reduction) across indications that include:

• Soil-transmitted helminths (STH): ascariasis (Ascaris), trichuriasis (Trichuris), hookworm (Ancylostoma/Necator)
• Lymphatic filariasis regimens where albendazole is paired with diethylcarbamazine (where applicable) or ivermectin depending on program design
• Neurocysticercosis (NCC) and hydatid disease (in combination with albendazole plus supportive anti-inflammatory and sometimes other regimen components)
• Strongyloidiasis, giardiasis, and other helminthic or co-infection studies, usually as combination or adjunct strategies

Featured snippet answer (trial focus): Most active albendazole clinical studies target dose optimization and combination regimens in NTDs/STH and pediatric populations, rather than first-in-class mechanistic innovation.

Which trial phases show the most activity?

• Phase 3: common for STH and helminth cure/egg reduction endpoints, often in public-health or multinational settings.
• Phase 2: used for regimen refinement, bioavailability comparisons, and safety characterization in pediatric subgroups.
• Bioequivalence/bioavailability studies: frequent across generic manufacturers, often for suspensions, chewables, and reformulations.

What endpoints are used most often?

• Cure rate by stool ova/parasite exam (baseline vs post-treatment)
• Percent reduction in eggs per gram (epg)
• Safety endpoints: adverse events, lab safety (liver enzymes, hematology)
• For NCC/hydatid: imaging-based outcomes and seizure control proxies, typically secondary

Where do trials tend to concentrate geographically?

Trial populations concentrate in endemic regions with high baseline prevalence and established MDA infrastructures: South Asia, sub-Saharan Africa, and parts of Latin America. Pediatric cohorts are common where dosing and tolerability differentiation is a procurement priority.

Which albendazole indications have the strongest clinical evidence today?

Albendazole is best established for:

• STH (ascariasis, trichuriasis, hookworm), with broad guideline endorsement
• Hydatid disease and neurocysticercosis, where dosing schedules and duration materially affect outcomes and safety monitoring

Evidence strength is reinforced by:

• Long clinical history and guideline support
• Extensive generic availability, enabling routine program usage rather than boutique trial dependence

Featured snippet answer (evidence focus): Clinical evidence is strongest for STH cure/egg reduction and for hydatid/NCC regimen-based outcomes under established dosing schedules.

How does albendazole’s clinical development compare with other anthelmintics (mebendazole, ivermectin)?

• Mebendazole: shares benzimidazole positioning but often competes on spectrum and procurement patterns; albendazole frequently wins on program usage and perceived efficacy in many STH contexts.
• Ivermectin: dominates in onchocerciasis and strong community MDA for certain NTD programs; albendazole is commonly paired or sequenced rather than substituted.
• Praziquantel: used for schistosomiasis; it competes only indirectly since indications differ.

Commercial implication: Even where clinical performance differs slightly, procurement and combination policy often dominate market choice. Albendazole’s market is structured around MDA budgets and tender cycles.

What is the market size for albendazole in 2026 and how is it growing?

Albendazole’s market is best described as a high-volume, low price-per-course segment with growth driven by:

• Continued expansion of NTD control programs
• Pediatric access initiatives and improved formulations
• Increased procurement compliance and supply chain stabilization in endemic countries

Featured snippet answer (growth driver): Market growth tracks NTD program coverage and MDA distribution volumes, with limited price-driven growth.

Key demand drivers

• WHO-aligned guidelines for STH control and NTD elimination strategies
• Government and NGO procurement of off-patent anthelmintics
• Replacement of older formulations with suspensions/chewables in pediatric programs

Key constraints

• Commodity pricing pressure due to broad generic supply
• Regulatory and quality assurance requirements for tenders (local approvals, GMP documentation)
• Manufacturing capacity and quality consistency in high-volume procurement

What is the albendazole market forecast for 2026–2032?

Base case forecast (industry-typical pattern for off-patent essential medicines):

• Low-to-mid single digit growth in value terms, driven by volume growth and modest mix shifts (formulation differentiation)
• Higher growth sensitivity in regional markets with scaling MDA coverage
• Limited growth from premium pricing because the active ingredient is commodity-like

Downside case:

• Budget tightening in endemic regions
• Procurement consolidation around fewer qualified suppliers
• Quality incidents that delay tender awards

Upside case:

• Expanded combination strategies and additional program indications
• Replacement of less effective or less acceptable local formulations
• Greater use in institutional treatment protocols beyond MDA

How many albendazole products are approved and who are the key manufacturers?

Albendazole is approved as multiple dosage forms and strengths across many countries. In major markets:

• Multiple generic manufacturers hold abbreviated-approval or local authorizations.
• Brand presence is more visible in the U.S. (where albendazole is marketed for approved indications) than in bulk global procurement, which is dominated by generics and local labels.

Featured snippet answer (competitive shape): The market is supplier-diverse but structurally commodity. Differentiation comes from formulation acceptability, regulatory dossier quality, and tender qualification, not from exclusive IP.

What patents protect albendazole, and when do they expire?

Albendazole’s core compound is long out of patent. Competitive barriers today are mostly:

• Formulation patents (bioavailability improvements, specific solid forms, pediatric palatability, taste-masking)
• Manufacturing process patents
• Orphan-like exclusivity only where applicable in specific jurisdictions, though the active ingredient itself is not meaningfully protected by new compound patents.

Featured snippet answer (patent reality): Active-ingredient patents for albendazole have largely expired; most ongoing patent landscapes relate to specific formulations and processes rather than the drug substance.

What is the Orange Book status of albendazole in the U.S.?

Albendazole’s status in the U.S. is largely characterized by:

• A mix of approved generics and branded products
• Expired or non-blocking exclusivities for most products due to long age of the drug
• Remaining differentiation is often not linked to enforceable blocking exclusivity for the active ingredient

Featured snippet answer (Orange Book behavior): Most albendazole entries show limited practical exclusivity for new-to-market barriers, with the market dominated by generics and formulation-level variation.

What formulations of albendazole are most commercially important?

Most commercial differentiation is dosage-form driven:

• Tablets (core adult dosing)
• Suspensions (pediatric and administration flexibility)
• Chewables (compliance and palatability)
• Higher-strength dosing for regimen simplification where permitted

Featured snippet answer (commercial differentiation): Formulation that improves pediatric acceptability and bioavailability consistency tends to attract procurement preferences.

What generic entry risks exist for albendazole?

Because albendazole is off-patent:

• New entrants face mainly regulatory and quality risks, not patent exclusivity.
• The main barriers are:
  • Satisfying CMC and bioequivalence expectations
  • Achieving stable, high-throughput manufacturing
  • Passing regulatory inspections and tender qualification audits

What patent litigation affects albendazole?

At the active-ingredient level, litigation risk is limited. Where litigation exists, it is typically:

• Formulation-specific patent disputes
• Supplementary protection in select jurisdictions for specific dosage forms or process claims

Commercial takeaway: Litigation is not usually the gating factor for albendazole market access; supply and regulatory approval are.

How strong is the albendazole patent estate for investors?

From a business perspective, the investable patent value is:

• Low for the active ingredient itself
• Higher for companies that have successfully staked enforceable positions in:
  • Bioavailability-enhancing formulations
  • Pediatric-friendly dosage forms with demonstrated performance
  • Protected manufacturing or particle-engineering steps

Which albendazole combination products are gaining traction?

Combination products are designed around program policy and co-infection control:

• STH control regimens with other NTD drugs (program-specific)
• Hydatid/NCC supportive combination protocols (clinical protocol-driven rather than patent-driven)
• Trials studying sequencing and co-administration to improve tolerability and adherence

Market implication: Combination positioning can create short-term differentiation through guideline adoption, even when albendazole itself is generic.

Albendazole vs mebendazole vs praziquantel: how does market positioning differ?

• Albendazole: STH and some parasitic systemic infections; strong MDA backbone.
• Mebendazole: STH as well; competes on procurement and local guideline preferences.
• Praziquantel: schistosomiasis-specific demand; tends to be program-driven and separate from albendazole tender cycles.

Commercial implication: Replacement risk is not a simple “drug substitution” story; it is more about program and tender assignment by endemic disease strategy.

What is the regulatory status of albendazole globally (FDA, EMA, and major emerging markets)?

Albendazole is widely approved for key indications in major jurisdictions and is included in standard formularies for NTD programs. The regulatory process today focuses on:

• Demonstrating bioequivalence for generics
• CMC compliance and impurity control for high-volume supply
• Pediatric labeling and administration guidance

Featured snippet answer: Regulatory status is mature, with ongoing updates focused on formulation variants and quality consistency.

Key Takeaways

• Albendazole is an off-patent, high-volume NTD cornerstone with clinical activity concentrated in dose optimization, pediatric acceptability, and combination or regimen studies.
• Market growth is driven by continued MDA and NTD control program expansion, not by premium pricing or active-ingredient patent exclusivity.
• Commercial differentiation is mostly formulation and execution: bioequivalence quality, pediatric dosing convenience, and tender qualification.
• Patent and litigation leverage is largely formulation- and process-specific, with limited compound-level blocking power.
• Forecast 2026–2032 points to low-to-mid single digit value growth patterns, with volume sensitivity to endemic program budgets and procurement cycles.

FAQs

1. Why is albendazole used in mass drug administration programs for soil-transmitted helminths?
2. What dosing forms of albendazole are preferred for pediatric administration in endemic countries?
3. How do bioequivalence requirements differ for albendazole tablets versus suspensions?
4. What combination regimens commonly include albendazole for lymphatic filariasis or broader NTD control?
5. What quality and CMC criteria most affect albendazole tender qualification for government procurement?

References

1. World Health Organization. (2023). Guideline for the control of soil-transmitted helminth infections. WHO.
2. World Health Organization. (2023). Model List of Essential Medicines. WHO.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Albendazole (accessed via FDA database). FDA.