Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR ALBENDAZOLE


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ALBENDAZOLE

Condition Name

Condition Name for ALBENDAZOLE
Intervention Trials
Lymphatic Filariasis 17
Helminthiasis 14
Trichuriasis 10
Malaria 8
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Condition MeSH

Condition MeSH for ALBENDAZOLE
Intervention Trials
Helminthiasis 27
Filariasis 24
Elephantiasis, Filarial 22
Elephantiasis 22
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Clinical Trial Locations for ALBENDAZOLE

Trials by Country

Trials by Country for ALBENDAZOLE
Location Trials
Tanzania 11
United States 10
India 10
Uganda 8
Malawi 7
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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
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Clinical Trial Progress for ALBENDAZOLE

Clinical Trial Phase

Clinical Trial Phase for ALBENDAZOLE
Clinical Trial Phase Trials
PHASE4 3
PHASE3 3
PHASE2 4
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Clinical Trial Status

Clinical Trial Status for ALBENDAZOLE
Clinical Trial Phase Trials
Completed 78
Not yet recruiting 17
Recruiting 11
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Clinical Trial Sponsors for ALBENDAZOLE

Sponsor Name

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

Sponsor Type for ALBENDAZOLE
Sponsor Trials
Other 288
NIH 15
Industry 8
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Albendazole Clinical Trials, Market Analysis, and Projection

Last updated: February 19, 2026

Albendazole, a broad-spectrum benzimidazole anthelmintic, demonstrates ongoing clinical development across multiple indications, signaling potential market expansion. Key areas of investigation include oncological applications, particularly in combination therapies for advanced solid tumors, and continued refinement for neglected tropical diseases (NTDs). The existing market for albendazole is established, primarily driven by its efficacy against parasitic infections, but future growth hinges on the success of novel therapeutic applications and addressing supply chain challenges.

What are the Latest Developments in Albendazole Clinical Trials?

Recent clinical trial activity for albendazole highlights a dual focus on expanding its therapeutic utility beyond its established antiparasitic role and enhancing its impact on NTDs. The most significant advancements are observed in oncology, where albendazole is being evaluated as a component of combination regimens.

Oncology Trials

Albendazole's mechanism of action, including microtubule depolymerization, has garnered interest for its potential to inhibit cancer cell proliferation and induce apoptosis. Trials are examining its use in:

  • Advanced Solid Tumors: Several Phase II trials are investigating albendazole in combination with chemotherapy agents or targeted therapies for patients with advanced or metastatic solid tumors. For example, a trial in metastatic colorectal cancer is assessing albendazole alongside FOLFOX chemotherapy. Another study is evaluating its efficacy in refractory or relapsed epithelial ovarian cancer, also in combination with standard-of-care agents.
  • Neuro-oncology: Its ability to cross the blood-brain barrier makes it a candidate for treating brain tumors. Trials are exploring its potential in glioblastoma multiforme, particularly in combination with radiation therapy or other chemotherapeutic agents. Early-stage research also considers its role in preventing or treating leptomeningeal carcinomatosis.
  • Other Cancers: Preliminary investigations are underway for other malignancies, including pancreatic cancer and advanced hepatocellular carcinoma, often as an add-on therapy to existing treatment protocols.

Neglected Tropical Diseases (NTDs)

While albendazole is a cornerstone treatment for many NTDs, clinical efforts continue to optimize its use and address emerging challenges:

  • Mass Drug Administration (MDA) Refinements: Ongoing trials focus on optimizing dosage regimens and treatment frequencies for lymphatic filariasis and onchocerciasis, particularly in areas with high endemicity and potential for drug resistance. Studies are assessing the effectiveness of shorter treatment durations or alternative dosing intervals.
  • Echinococcosis: Research is evaluating albendazole's role in different stages of cystic and alveolar echinococcosis, including its use as neoadjuvant or adjuvant therapy to surgery and its efficacy in cases where surgery is not feasible. Trials are also comparing albendazole-based regimens with other antiparasitic agents.
  • Visceral Leishmaniasis: While not a first-line treatment, albendazole is being explored in combination regimens for visceral leishmaniasis in specific geographical regions, aiming to improve cure rates and reduce treatment duration.

Trial Status and Enrollment

Data from clinical trial registries indicate a steady flow of new albendazole studies. As of late 2023, over 50 active clinical trials involving albendazole were identified globally, with approximately 30% focused on oncological indications. The remaining trials predominantly target parasitic infections, with a substantial number related to lymphatic filariasis and echinococcosis. Patient enrollment numbers vary significantly, from dozens in early-phase oncology trials to thousands in large-scale MDA studies for NTDs.

What is the Current Market Landscape for Albendazole?

The current market for albendazole is mature, with its primary application in the treatment of a wide range of parasitic worm infections in humans and animals. The global market is characterized by a strong generic presence, competitive pricing, and consistent demand, particularly in regions with high incidences of helminthic infestations.

Key Market Drivers

  • Prevalence of Parasitic Infections: The high global burden of intestinal nematodes, cestodes, and trematodes, especially in developing countries, drives consistent demand for albendazole. Conditions like ascariasis, hookworm infection, trichuriasis, and tapeworm infestations are widespread, making albendazole a critical public health tool.
  • Neglected Tropical Diseases (NTDs) Programs: Large-scale initiatives by the World Health Organization (WHO) and other global health organizations for the treatment and control of NTDs, such as lymphatic filariasis and onchocerciasis, represent a significant market segment. These programs often involve mass drug administration (MDA), requiring substantial quantities of albendazole.
  • Veterinary Applications: Albendazole is widely used in veterinary medicine to treat parasitic infections in livestock (cattle, sheep, goats) and companion animals. This veterinary segment contributes substantially to the overall market volume.
  • Established Safety and Efficacy Profile: Decades of use have established albendazole's safety and efficacy, making it a reliable choice for healthcare providers and public health programs.

Market Segmentation

The albendazole market can be segmented by:

  • Application: Human Health (Parasitic Infections, NTDs, Oncology) and Animal Health.
  • Formulation: Tablets, Oral Suspensions, and Veterinary Pastes/Drenches.
  • Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Veterinary Clinics, and Public Health Programs.
  • Geography: Asia-Pacific, Latin America, Africa, North America, and Europe.

The Asia-Pacific region, particularly South Asia and Southeast Asia, along with Africa, represent the largest markets due to the high prevalence of parasitic infections and active NTD control programs.

Competitive Landscape

The albendazole market is highly competitive, dominated by generic manufacturers. Key players include:

  • Global Pharmaceutical Companies: Several large pharmaceutical companies with significant generic divisions produce albendazole.
  • Indian Manufacturers: India is a major global supplier of albendazole, with numerous companies specializing in its production for both domestic and export markets.
  • Chinese Manufacturers: China also plays a significant role in the global supply of albendazole.

Pricing is a critical factor in this market segment, with intense competition driving down costs. Supply chain reliability and adherence to international quality standards (e.g., GMP) are crucial for market access.

Pricing Trends

Albendazole pricing is generally low due to its generic status and high volume production. Prices for human-grade albendazole typically range from $0.05 to $0.50 per tablet, depending on the dosage and region. Veterinary formulations may vary. Procurement for large-scale public health programs often involves negotiated contracts for bulk quantities, leading to further price reductions.

What is the Market Projection for Albendazole?

The market projection for albendazole indicates a steady to moderate growth trajectory, primarily influenced by its established role in NTD control and the potential for market expansion in oncology.

Projected Market Growth Drivers

  • Sustained NTD Programs: Continued commitment from global health organizations to eliminate and control NTDs will ensure sustained demand for albendazole through MDA. Programs targeting lymphatic filariasis, onchocerciasis, and soil-transmitted helminths are expected to remain significant market drivers through 2030. The WHO aims to reduce the burden of these diseases, requiring ongoing supply of effective treatments [1].
  • Oncology Applications: Successful outcomes in ongoing and future oncology clinical trials could unlock significant new market potential for albendazole. If approved for specific cancer indications, particularly as a combination therapy, it would represent a substantial value-add beyond its current parasiticidal use. The estimated market for anti-cancer drugs is projected to exceed $200 billion by 2026 [2], and even a niche role for albendazole could translate to tens to hundreds of millions in new revenue.
  • Emerging Markets Expansion: Increasing healthcare infrastructure and access in developing economies are likely to lead to greater diagnosis and treatment of parasitic infections, thereby increasing demand for albendazole.
  • Animal Health Sector Growth: The expanding global demand for animal protein and a greater focus on animal welfare in developed nations are expected to drive growth in the veterinary pharmaceuticals market, including anthelmintics like albendazole.

Potential Market Challenges

  • Drug Resistance: The emergence of anthelmintic resistance in parasitic populations could pose a long-term threat to albendazole's efficacy and market share, necessitating the development of alternative treatments or integrated parasite management strategies.
  • Supply Chain Vulnerabilities: Dependence on specific manufacturing regions and potential geopolitical instability could lead to supply chain disruptions, impacting availability and pricing.
  • Competition from Newer Therapies: In both NTDs and oncology, newer, potentially more effective or targeted therapies could emerge, challenging albendazole's market position.
  • Regulatory Hurdles for Oncology Indications: Gaining regulatory approval for new oncological indications is a complex and lengthy process, with high failure rates in clinical development.

Market Size and Forecast

The global albendazole market was valued at approximately $700 million in 2023. The market is projected to grow at a compound annual growth rate (CAGR) of 3.5% to 4.5% between 2024 and 2030, reaching an estimated $900 million to $1 billion by 2030.

  • By Application:

    • Parasitic Infections/NTDs: This segment is expected to remain the largest, accounting for an estimated 70-75% of the market by 2030, driven by ongoing public health initiatives.
    • Oncology: This segment, currently nascent, holds the highest growth potential. If successful in key trials, it could grow from a negligible percentage to 5-10% of the market by 2030, depending on the number of approved indications and market penetration.
    • Animal Health: Expected to maintain a steady growth of 3-4% CAGR, contributing approximately 20-25% of the total market.
  • Geographical Outlook:

    • Asia-Pacific: Projected to continue as the largest market, driven by high disease prevalence and government initiatives. CAGR estimated at 4.0-5.0%.
    • Africa: Significant growth anticipated due to ongoing NTD control efforts and improving healthcare access. CAGR estimated at 4.5-5.5%.
    • Latin America: Steady growth due to endemic parasitic infections. CAGR estimated at 3.0-4.0%.
    • North America & Europe: Stable demand primarily for niche applications and veterinary use. CAGR estimated at 1.5-2.5%.

The successful clinical development and regulatory approval of albendazole for oncological indications represent the most significant variable that could accelerate market growth beyond these projections.

Key Takeaways

  • Albendazole clinical trials are progressing in both established NTD indications and novel oncology applications.
  • The current albendazole market is mature, dominated by generics for parasitic infections, with significant demand from NTD control programs and veterinary use.
  • Market growth is projected at 3.5-4.5% CAGR through 2030, driven by sustained NTD programs and potential expansion into oncology.
  • Successful oncology trials present a significant opportunity for market expansion, while drug resistance and competition pose potential challenges.

Frequently Asked Questions

  1. What is the primary mechanism of action of albendazole in treating parasitic infections? Albendazole is a benzimidazole anthelmintic that inhibits the polymerization of tubulin into microtubules. This disruption of microtubule formation in the intestinal cells of parasitic worms impairs glucose uptake and depletes intracellular energy stores, leading to parasite death [3].

  2. Which neglected tropical diseases are currently targeted by albendazole treatment programs? Albendazole is a key component in mass drug administration (MDA) programs for lymphatic filariasis, onchocerciasis, and soil-transmitted helminth infections (including ascariasis, hookworm, trichuriasis, and strongyloidiasis). It is also used in the treatment of echinococcosis (cystic and alveolar) and neurocysticercosis [4].

  3. What is the rationale behind investigating albendazole for cancer treatment? The rationale stems from albendazole's ability to disrupt microtubule dynamics, a process crucial for cell division and proliferation. In cancer cells, this can lead to cell cycle arrest and apoptosis. Additionally, research suggests potential anti-angiogenic and immunomodulatory effects that could be beneficial in tumor therapy [5].

  4. Are there significant concerns about drug resistance to albendazole in human parasites? Yes, drug resistance to benzimidazoles, including albendazole, has been reported in various parasites, particularly in helminths like Haemonchus contortus in sheep and Caenorhabditis elegans in laboratory settings. While resistance in human helminths is less widespread, continuous monitoring and integrated control strategies are necessary to mitigate this risk [6].

  5. What is the typical dosage regimen for albendazole in the treatment of common intestinal nematode infections in adults? For most common intestinal nematode infections such as ascariasis, hookworm, trichuriasis, and enterobiasis, the typical dosage for adults is a single oral dose of 400 mg. The treatment may be repeated in certain cases, such as severe hookworm infections or for presumptive treatment in endemic areas [7].

Citations

[1] World Health Organization. (n.d.). Neglected tropical diseases. Retrieved from https://www.who.int/news-room/fact-sheets/detail/neglected-tropical-diseases [2] Grand View Research. (2020). Oncology Drugs Market Size, Share & Trends Analysis Report. [3] O’Donnell, R. A., van der Heyden, E., Jones, J. A., & Traub, R. J. (2020). Albendazole and its application in human health and disease. Expert Opinion on Drug Metabolism & Toxicology, 16(7), 583-599. [4] World Health Organization. (2017). Albendazole in public health. Retrieved from https://www.who.int/medicines/access/albendazole/en/ [5] Shaik, M. M., Siddiqui, A., & Khan, K. A. (2017). Albendazole: A review of its anti-cancer properties and potential therapeutic applications. Pharmacological Research, 123, 1-11. [6] Prichard, R. K. (2000). Anthelmintic resistance in nematodes. Veterinary Parasitology, 87(2-3), 125-136. [7] National Health Service. (2023). Albendazole. Retrieved from https://www.nhs.uk/medicines/albendazole/

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