CLINICAL TRIALS PROFILE FOR ALBENZA

All Clinical Trials for ALBENZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03014167 ↗	Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)	Recruiting	Bill and Melinda Gates Foundation	Phase 3	2017-10-04	Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.
NCT03014167 ↗	Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)	Recruiting	Blantyre Institute for Community Ophthalmology (BICO)	Phase 3	2017-10-04	Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.
NCT02725255 ↗	Design and Clinical Evaluation of a School Meal With Deworming Properties	Completed	Bill and Melinda Gates Foundation	Phase 2/Phase 3	2015-05-01	Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.
NCT02725255 ↗	Design and Clinical Evaluation of a School Meal With Deworming Properties	Completed	United States Agency for International Development (USAID)	Phase 2/Phase 3	2015-05-01	Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.
NCT02725255 ↗	Design and Clinical Evaluation of a School Meal With Deworming Properties	Completed	Kenya Medical Research Institute	Phase 2/Phase 3	2015-05-01	Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.

Clinical Trial Conditions for ALBENZA

Condition Name

Condition Name for ALBENZA
Intervention	Trials
Helminthiasis	2
Anemia	1
Filariasis	1
Lymphatic Filariases	1

Condition MeSH

Condition MeSH for ALBENZA
Intervention	Trials
Filariasis	2
Helminthiasis	2
Scabies	1
Elephantiasis, Filarial	1

Clinical Trial Locations for ALBENZA

Trials by Country

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Trials by Country for ALBENZA
Location	Trials
India	1
Benin	1
Papua New Guinea	1
Malawi	1

Clinical Trial Progress for ALBENZA

Clinical Trial Phase

Clinical Trial Phase for ALBENZA
Clinical Trial Phase	Trials
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ALBENZA
Clinical Trial Phase	Trials
Completed	2
Recruiting	1

Clinical Trial Sponsors for ALBENZA

Sponsor Name

Sponsor Name for ALBENZA
Sponsor	Trials
London School of Hygiene and Tropical Medicine	2
University of Washington	2
Bill and Melinda Gates Foundation	2

Sponsor Type

Sponsor Type for ALBENZA
Sponsor	Trials
Other	15
U.S. Fed	1

Albendazole (ALBENZA): Clinical Trials, Market Analysis, and Projections

What is Albendazole?

Albendazole, marketed under the brand name ALBENZA, is a widely used antiparasitic medication. It is crucial in treating various parasitic infections, including intestinal worms, cystic echinococcosis, and neurocysticercosis[2].

Clinical Trials Update

Adverse Reactions and Efficacy

Clinical trials have shown that Albendazole is generally well-tolerated, although it can cause some adverse reactions. In trials, approximately 16% of patients experienced mild to moderate elevations of hepatic enzymes. Other common adverse reactions include gastrointestinal issues, and in some cases, treatment discontinuations were necessary due to leukopenia or hepatic abnormalities[1].

A recent clinical trial highlighted the efficacy of Albendazole in reducing microfilaraemia in patients with Loa loa infections. The study demonstrated a 90% reduction in microfilaraemia when Albendazole was administered twice daily for five weeks. The combination of Albendazole with ivermectin also showed promising results, indicating that these regimens are safe and effective[4].

Safety and Tolerability

The safety and tolerability of Albendazole have been well-documented. Studies have shown that Albendazole-based regimens are well-tolerated, with minimal severe adverse effects. This makes Albendazole a reliable choice for treating parasitic infections, especially in regions where such infections are prevalent[4].

Market Analysis

Market Size and Growth

The global Albendazole market was valued at USD 159.1 million in 2023 and is projected to grow to USD 171.51 million by 2024. By 2032, the market is expected to reach USD 312.79 million, reflecting a robust compound annual growth rate (CAGR) of 7.8% during the forecast period from 2024 to 2032[2][3].

In the U.S., the Albendazole market was valued at approximately $400 million in 2022, with a projected CAGR of 6.5% from 2023 to 2030. The market is driven by increasing demand for effective antiparasitic treatments, particularly in human medicine and veterinary applications[2].

Key Segments

The Albendazole market is segmented into human medicine, veterinary applications, and bulk drug production. The human medicine segment is a significant driver, given the high prevalence of parasitic infections globally. Veterinary applications are also growing, driven by the need for high-quality treatments in livestock and companion animals[2].

Market Trends

Several trends are shaping the Albendazole market:

• Cost-Effective Formulations: There is an increasing focus on developing cost-effective Albendazole formulations, especially in low-income and developing regions. Governments and non-profit organizations are involved in subsidizing and promoting access to affordable anti-parasitic drugs[3].

• Combination Therapies: The use of Albendazole in combination with other anti-parasitic agents is becoming more prevalent. This approach enhances treatment efficacy and addresses drug resistance issues, particularly in diseases like lymphatic filariasis[3].

• Advanced Drug Delivery Systems: Innovations in drug delivery systems, such as sustained-release formulations and nano-based delivery methods, are gaining traction. These advancements improve patient compliance and treatment outcomes[3].

Market Dynamics and Challenges

Regulatory Hurdles

Stringent FDA guidelines and compliance with Good Manufacturing Practices (GMP) can slow down the approval process for new Albendazole formulations and increase production costs[2].

Competition from Alternatives

Other antiparasitic medications like ivermectin and praziquantel provide competition to Albendazole. Additionally, there is a growing interest in natural and alternative treatments, which could challenge Albendazole's market dominance[2].

High Manufacturing Costs

The cost of sourcing high-quality raw materials and maintaining production standards affects the pricing of Albendazole. Dependence on imports for raw materials can also make the supply chain vulnerable to disruptions[2].

Geographical Growth

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. Increasing governmental support, improved healthcare access, and heightened focus on preventive healthcare measures in these regions are key factors driving market growth[3].

Future Outlook

The future of the Albendazole market looks promising, driven by several factors:

• Technological Advancements: Rapid technological advancements in the pharmaceutical sector are expected to further propel the Albendazole market. New drug delivery systems and formulations aimed at enhancing drug efficacy and patient compliance are anticipated to drive innovation[3].

• Research and Development: Ongoing research and development activities aimed at expanding Albendazole's applications in treating new and emerging parasitic infections are poised to support long-term market growth. This includes the development of new variants of Albendazole and sustained-release formulations[3].

• Strategic Collaborations: Companies are focusing on overcoming regulatory and competitive challenges through strategic collaborations, mergers, and acquisitions, which are likely to enhance their competitive advantage and market presence[3].

Key Takeaways

• Market Growth: The Albendazole market is driven by increasing awareness and healthcare investments, with a projected CAGR of 7.8% from 2024 to 2032.
• Top Players: The market is led by a mix of global giants and specialized manufacturers, such as GSK and Salius Pharma.
• Future Outlook: Sustainable practices and innovation will shape the Albendazole market's trajectory, with a focus on cost-effective formulations, combination therapies, and advanced drug delivery systems.

FAQs

What is the current market size of Albendazole?

The global Albendazole market was valued at USD 159.1 million in 2023 and is projected to grow to USD 171.51 million by 2024[2][3].

What are the primary applications of Albendazole?

Albendazole is used in human medicine to treat parasitic infections such as intestinal worms, cystic echinococcosis, and neurocysticercosis. It is also used in veterinary applications for livestock and companion animals[2].

What are the common adverse reactions associated with Albendazole?

Common adverse reactions include mild to moderate elevations of hepatic enzymes, gastrointestinal issues, and in some cases, leukopenia or hepatic abnormalities[1].

How is the Albendazole market expected to grow in the future?

The market is expected to reach USD 312.79 million by 2032, reflecting a CAGR of 7.8% during the forecast period from 2024 to 2032[2][3].

What are the key trends shaping the Albendazole market?

Key trends include the development of cost-effective formulations, the use of combination therapies, and advancements in drug delivery systems such as sustained-release formulations and nano-based delivery methods[3].

Sources

1. FDA Label: "ALBENZA (albendazole) Tablets" - FDA Label[1].
2. Global Growth Insights: "Top 10 Albendazole Companies in Global 2025" - Global Growth Insights[2].
3. Global Growth Insights: "Albendazole Market Size, Analysis, Trends to 2032" - Global Growth Insights[3].
4. PLOS Neglected Tropical Diseases: "Efficacy, safety, and tolerability of albendazole and ivermectin based regimens for the treatment of Loa loa microfilaraemia" - PLOS Neglected Tropical Diseases[4].