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.
NCT00130910 ↗	Treatment of Helminth co-Infection: Short-Term Effects on HIV-1 Progression Markers and Immune Activation	Completed	University of Nairobi	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	University of Washington	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.
NCT00133458 ↗	RCT ALB for SA Cysticercosis	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	This study will enroll 120 individuals diagnosed with subarachnoid cysticercosis, a disease caused by the invasion of the basal part of your brain by a parasite named Taenia solium. Subarachnoid cysticercosis is usually treated with albendazole for one month to kill the parasite. This study will determine if two months of albendazole (ABZ) therapy is better than one-month. The study will last 3 years.

Clinical Trial Conditions for ALBENDAZOLE

Condition Name

Condition Name for ALBENDAZOLE
Intervention	Trials
Lymphatic Filariasis	17
Helminthiasis	14
Trichuriasis	10
Malaria	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	3

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
London School of Hygiene and Tropical Medicine	9
Jennifer Keiser	8

Sponsor Type

Sponsor Type for ALBENDAZOLE
Sponsor	Trials
Other	286
NIH	15
OTHER_GOV	8

Albendazole: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Albendazole, a broad-spectrum anthelmintic agent developed by SmithKline Beecham (now GlaxoSmithKline), has been a cornerstone in antiparasitic therapy since its approval in the 1980s. Its versatility in treating a wide range of helminth infections—including neurocysticercosis, echinococcosis, and soil-transmitted helminths—has cemented its importance within global health initiatives. This article provides an in-depth update on recent clinical trials, analyzes current market dynamics, and offers forward-looking projections for Albendazole's commercial and therapeutic landscape.

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Clinical Trials Update

Recent Clinical Investigations and Efficacy

Over the past three years, Albendazole has been subjected to numerous clinical assessments, emphasizing its expanding therapeutic scope and improved formulations.

• Neurocysticercosis (NCC): Multiple Phase III studies (e.g., conducted in endemic regions such as India, Latin America) explored Albendazole's efficacy combined with corticosteroids. Recent meta-analyses indicate that Albendazole reduces cyst burden and improves seizure control when used with steroids, with some trials demonstrating higher success rates than praziquantel monotherapy in certain patient populations [1].

• Echinococcosis: Several Phase II/III trials in Europe and the Middle East focus on Albendazole's role as a primary or adjunct therapy. Data suggest that prolonged courses (>6 months) enhance cyst resolution, particularly for hepatic echinococcosis, with acceptable safety profiles [2].

• Soil-Transmitted Helminths (STHs): Prevalence studies continue to support Albendazole’s role in mass drug administration (MDA). Recent trials in Africa and Southeast Asia verify its safety and efficacy in children, with negligible adverse events and sustained deworming effects over large populations [3].

Innovations in Formulation and Delivery

Recent research pivots toward improving drug bioavailability and targeting:

• Nanoformulations: Investigations into nanoparticle encapsulation aim to increase Albendazole's solubility and absorption, potentially reducing dosing frequency and side effects [4]. Preclinical data show promising pharmacokinetic enhancements but require validation in clinical settings.

• Combination Therapy Trials: Ongoing studies assess Albendazole with other antiparasitics, such as praziquantel and ivermectin, to address resistant strains, prevent reinfection, and improve cure rates.

Safety and Resistance Monitoring

While Albendazole remains well-tolerated, emerging concerns include potential resistance in certain parasite populations, prompting genomic surveillance efforts. Recent clinical trials incorporate molecular markers to monitor resistance-associated mutations, emphasizing the need for stewardship and alternative therapies [5].

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Market Analysis

Current Market Landscape

Albendazole's global market was valued at approximately USD 250 million in 2022, predominantly driven by endemic regions in Africa, Asia, and Latin America, where parasitic infections remain prevalent. The drug's affordability, wide availability through GSK’s distribution channels, and integration into global health programs underpin its sustained market presence.

• Major Regions and Segments:

  • Endemic Regions: Sub-Saharan Africa, South Asia, Latin America
  • Application Segments: MDA programs for STHs, targeted therapies for NCC and echinococcosis

• Key Players: GSK dominates the market, with generic manufacturers entering in regions with limited intellectual property constraints.

Market Drivers

• Global Health Initiatives: WHO's World Deworming Day and endemic country programs promote albendazole distribution.
• Increased Awareness: Rising awareness about parasitic infections drives demand, particularly in pediatric healthcare.
• Expanded Indications: Clinical trials extending Albendazole's approved indications enhance market scope.

Market Challenges

• Resistance Development: Emerging resistance in parasitic populations could impair efficacy, threatening long-term sustainability.
• Regulatory and Pricing Issues: Variability in regulatory approvals and pricing strategies across nations influences market accessibility.
• Limited Formulation Innovations: Smaller development pipelines suggest slow innovation, potentially constraining growth.

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Future Market Projections

Forecast Timeline and Assumptions

Based on current trends, the global Albendazole market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% over the next five years, driven by ongoing public health campaigns and expanding indications.

Growth Drivers

• Global deworming initiatives are expected to remain the primary growth catalyst, with the WHO aiming to expand MDA coverage to reach over 1 billion children annually.
• Enhanced formulations, such as sustained-release and targeted delivery, could command premium pricing and extended market opportunities.
• Expanding therapeutic use in parasitic infections that are emerging or re-emerging due to climate change and urbanization.

Potential Market Limiters

• Resistance issues might lead to the development and approval of alternative agents, potentially diminishing Albendazole’s market share.
• Patent expirations in certain jurisdictions could lead to increased generic competition, lowering prices and profit margins.

Emerging Opportunities

• Development of combination formulations for broad-spectrum antiparasitic action.
• Environmental and preventative applications, especially in integrated One Health strategies.
• Regulatory advancements facilitating faster approval pathways for new formulations and indications.

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Conclusion

Albendazole remains a vital antiparasitic agent with broad clinical utility. Recent clinical trials affirm its effectiveness in treating diseases like neurocysticercosis, echinococcosis, and soil-transmitted helminthiasis, and ongoing research continues to optimize its formulations and expand its application scope. The market outlook remains optimistic, fueled by global health initiatives and clinical demand, although resistance development and competitive pressures pose challenges. Strategic investments in innovation, resistance monitoring, and expanding indications will be vital to ensuring Albendazole’s sustained relevance.

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Key Takeaways

• Clinical research reinforces Albendazole’s efficacy, especially when combined with adjunct therapies or improved delivery systems.
• Market dynamics are driven by global deworming programs, with significant growth prospects in developing countries.
• Innovation prospects include nanotechnology-based formulations and combination therapies to enhance efficacy and target resistant strains.
• Challenges include emerging drug resistance and market commoditization through generics post-patent expiry.
• Future growth hinges on ongoing public health initiatives, regulatory support, and proactive resistance management.

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FAQs

1. What are the primary indications for Albendazole?
   Albendazole is primarily used to treat neurocysticercosis, echinococcosis, and soil-transmitted helminth infections, including ascariasis, hookworm, and whipworm.

2. Are there new formulations of Albendazole under clinical development?
   Yes, research into nanoformulations and sustained-release delivery systems aims to improve bioavailability and adherence.

3. What are the main challenges facing Albendazole’s market growth?
   Resistance development, limited innovation pipelines, regulatory variability, and generic competition are key challenges.

4. How does resistance impact Albendazole's efficacy?
   Resistance, particularly in certain parasite strains, can reduce drug effectiveness, necessitating surveillance and combination therapies.

5. What is the outlook for Albendazole in global health initiatives?
   Continued inclusion in mass drug administration programs and expanded indications are expected to sustain demand, especially in endemic regions.

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References

[1] Garcia, H. H. et al. (2021). Efficacy of albendazole in neurocysticercosis: a systematic review. Clin Infect Dis.

[2] Moro, P. et al. (2019). Management of echinococcosis with albendazole: a review. Parasitol Int.

[3] World Health Organization. (2020). Deworming programs and albendazole reach.

[4] Li, Y. et al. (2022). Nanoparticle-based albendazole formulations for enhanced therapy. J Nanomedicine.

[5] Doenhoff, M. J., & Hagan, P. (2019). Parasite resistance and drug development. Trends Parasitol.

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Note: The data presented herein are synthesized from recent clinical trial reports, market analyses, and strategic forecasts, emphasizing Albendazole’s evolving landscape in healthcare.