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
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.
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.
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.
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	16
Helminthiasis	14
Trichuriasis	10
Malaria	8

Condition MeSH

Condition MeSH for ALBENDAZOLE
Intervention	Trials
Helminthiasis	27
Filariasis	23
Elephantiasis	22
Elephantiasis, Filarial	21

Clinical Trial Locations for ALBENDAZOLE

Trials by Country

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Trials by Country for ALBENDAZOLE
Location	Trials
Tanzania	11
United States	10
India	9
Uganda	8
Malawi	7

Trials by US State

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−

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
Phase 4	20
Phase 3	23
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for ALBENDAZOLE
Clinical Trial Phase	Trials
Completed	76
Not yet recruiting	17
Recruiting	6

Clinical Trial Sponsors for ALBENDAZOLE

Sponsor Name

Sponsor Name for ALBENDAZOLE
Sponsor	Trials
Washington University School of Medicine	16
London School of Hygiene and Tropical Medicine	9
Jennifer Keiser	8

Sponsor Type

Sponsor Type for ALBENDAZOLE
Sponsor	Trials
Other	263
NIH	15
U.S. Fed	5

Albendazole: Clinical Trials, Market Analysis, and Projections

Introduction

Albendazole, a widely used anti-parasitic drug, has been a cornerstone in the treatment of various parasitic infections, including those caused by helminths such as tapeworms, hookworms, and roundworms. Recent studies and market analyses reveal exciting developments in its clinical applications and market growth.

Clinical Trials and Therapeutic Potential

Repurposing for Cancer Treatment

A significant recent development involves the repurposing of albendazole for cancer treatment. High-throughput screening of FDA-approved drugs identified albendazole as a potent inhibitor of colon cancer progression. Albendazole demonstrated strong inhibitory effects on the tumorigenic potentials of colon cancer cells, sensitized chemoresistant cells to conventional chemotherapy agents like 5-fluorouracil and oxaliplatin, and modulated the expression of RNF20 to promote apoptosis in cancer cells[1].

Anti-Parasitic Efficacy

In the realm of parasitic infections, clinical trials continue to evaluate the efficacy of albendazole in combination therapies. A randomized, controlled trial in Côte d'Ivoire compared the efficacy of moxidectin-albendazole and ivermectin-albendazole combinations against albendazole monotherapy in treating Trichuris trichiura infections. The study found that moxidectin-albendazole and albendazole monotherapy yielded similar cure rates, while the ivermectin-albendazole combination showed lower efficacy[4].

Market Analysis

Market Size and Growth

The albendazole market is projected to experience robust growth. By 2032, the market is expected to reach USD 312.79 million, up from USD 171.51 million in 2024, with a Compound Annual Growth Rate (CAGR) of 7.8% during the forecast period[3].

Market Drivers

Several factors drive the growth of the albendazole market:

• Increasing Prevalence of Parasitic Infections: Rising cases of parasitic infections, particularly in regions with poor sanitation and hygiene, fuel the demand for effective antiparasitic treatments[3].
• Government Support and Public Health Initiatives: Government funding for mass drug administration programs and global health initiatives aimed at eradicating neglected tropical diseases (NTDs) significantly boost market growth[2][3].
• Pharmaceutical Innovations: Advancements in drug delivery systems, such as sustained-release formulations and nano-based delivery methods, enhance patient compliance and treatment outcomes[3].

Market Restraints

Despite the positive outlook, several challenges hinder market expansion:

• Stringent Regulatory Requirements: Varying global standards and stringent regulatory approvals can pose barriers to market growth[2][3].
• Adverse Side Effects and Resistance: Concerns over potential side effects and the emergence of parasite resistance to albendazole limit its widespread adoption[2][3].
• Generic Alternatives: The availability of generic alternatives to albendazole tablets can limit brand dominance and market share growth potential[2].

Market Segmentation and Coverage

Distribution Channels

Albendazole tablets are distributed through various channels, including hospitals, clinics, and home care environments. The market also includes significant contributions from pharmaceutical manufacturers, distributors, government public health programs, and non-governmental health organizations[2].

Geographical Analysis

The albendazole market is expected to witness robust growth in regions such as Asia-Pacific, Latin America, and Africa, where parasitic infections are more prevalent. Improved healthcare access and heightened focus on preventive healthcare measures in these regions are key drivers of market growth[3].

Market Trends

Cost-Effective Formulations

There is an increasing focus on developing cost-effective albendazole formulations, particularly in low-income and developing regions. Governments and non-profit organizations are actively involved in subsidizing and promoting access to affordable anti-parasitic drugs[3].

Combination Therapies

Healthcare providers are increasingly using albendazole in combination with other anti-parasitic agents to enhance treatment efficacy and address drug resistance issues. This trend is particularly prevalent in the treatment of diseases such as lymphatic filariasis[3].

Veterinary Applications

The use of albendazole in veterinary applications, including livestock and companion animals, is expanding. This growth is driven by the need for high-quality meat and dairy products and the increasing incidence of zoonotic diseases[3].

Recent Developments

New Formulations

A new chewable albendazole tablet has been launched, specifically designed for pediatric patients, improving compliance and ease of administration[3].

Partnerships and Collaborations

Pharmaceutical companies are partnering with global health organizations to supply albendazole for mass drug administration programs, aiming to reduce the prevalence of parasitic infections[3].

Sustained-Release Research

Ongoing research is focused on developing sustained-release formulations of albendazole to enhance its efficacy and duration of action[3].

Key Takeaways

• Albendazole shows strong therapeutic potential in treating colon cancer and parasitic infections.
• The market is driven by increasing prevalence of parasitic infections, government support, and pharmaceutical innovations.
• Challenges include stringent regulatory requirements, adverse side effects, and generic alternatives.
• The market is expected to grow significantly in regions with high parasitic infection rates.
• Trends include the development of cost-effective formulations, combination therapies, and expanding veterinary applications.

FAQs

What is the primary use of albendazole?

Albendazole is primarily used as an anti-parasitic agent to treat various parasitic infections caused by helminths such as tapeworms, hookworms, and roundworms.

Is albendazole being explored for other medical applications?

Yes, albendazole is being explored for its potential in treating colon cancer, showing promising results in inhibiting cancer progression and sensitizing chemoresistant cells to conventional chemotherapy.

What are the key drivers of the albendazole market?

Key drivers include the increasing prevalence of parasitic infections, government support for public health initiatives, and pharmaceutical innovations such as new drug delivery systems.

What challenges does the albendazole market face?

Challenges include stringent regulatory requirements, adverse side effects, potential parasite resistance, and the availability of generic alternatives.

Where is the albendazole market expected to grow the most?

The albendazole market is expected to witness robust growth in regions such as Asia-Pacific, Latin America, and Africa, where parasitic infections are more prevalent.

Sources

1. Albendazole inhibits colon cancer progression and therapy ... - PubMed
2. Albendazole Tablets Market Size & Share 2025-2030 - 360iResearch
3. Albendazole Market Size, Analysis, Trends to 2032 - Global Growth Insights
4. Efficacy and Safety of Moxidectin-Albendazole and Ivermectin ... - Oxford Academic
5. Albendazole Market Research Global Status - Ken Research