CLINICAL TRIALS PROFILE FOR VERMOX

All Clinical Trials for VERMOX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01837862 ↗	A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas	Recruiting	Janssen Pharmaceuticals	Phase 1/Phase 2	2013-10-22	This is a study to determine the safety and efficacy of the drug, mebendazole, when used in combination with standard chemotherapy drugs for the treatment of pediatric brain tumors. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Studies using both cell cultures and mouse models demonstrated that mebendazole was effective in decreasing the growth of brain tumor cells. This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade gliomas are tumors arising from the glial cells of the central nervous system and are characterized by slower, less aggressive growth than that of high-grade gliomas. Some low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or recurrence. Low-grade gliomas are often able to be treated by observation alone if they receive a total surgical resection. However, tumors which are only partially resected and continue to grow or cause symptoms, or those which recur following total resection require additional treatment, such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. The current first-line treatment at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. However, based on our data from our own historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have disease progression while on this treatment. We believe that mebendazole in combination with vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with increased progression-free and overall survival for low-grade glioma patients, particularly for those with pilomyxoid astrocytomas. High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but with disappointing results. For high-grade gliomas this study will add mebendazole to the established combination of bevacizumab and irinotecan to determine this combinations safety and efficacy
NCT01837862 ↗	A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas	Recruiting	Julie Krystal	Phase 1/Phase 2	2013-10-22	This is a study to determine the safety and efficacy of the drug, mebendazole, when used in combination with standard chemotherapy drugs for the treatment of pediatric brain tumors. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Studies using both cell cultures and mouse models demonstrated that mebendazole was effective in decreasing the growth of brain tumor cells. This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade gliomas are tumors arising from the glial cells of the central nervous system and are characterized by slower, less aggressive growth than that of high-grade gliomas. Some low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or recurrence. Low-grade gliomas are often able to be treated by observation alone if they receive a total surgical resection. However, tumors which are only partially resected and continue to grow or cause symptoms, or those which recur following total resection require additional treatment, such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. The current first-line treatment at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. However, based on our data from our own historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have disease progression while on this treatment. We believe that mebendazole in combination with vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with increased progression-free and overall survival for low-grade glioma patients, particularly for those with pilomyxoid astrocytomas. High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but with disappointing results. For high-grade gliomas this study will add mebendazole to the established combination of bevacizumab and irinotecan to determine this combinations safety and efficacy
NCT01837862 ↗	A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas	Recruiting	Mark Atlas	Phase 1/Phase 2	2013-10-22	This is a study to determine the safety and efficacy of the drug, mebendazole, when used in combination with standard chemotherapy drugs for the treatment of pediatric brain tumors. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Studies using both cell cultures and mouse models demonstrated that mebendazole was effective in decreasing the growth of brain tumor cells. This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade gliomas are tumors arising from the glial cells of the central nervous system and are characterized by slower, less aggressive growth than that of high-grade gliomas. Some low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or recurrence. Low-grade gliomas are often able to be treated by observation alone if they receive a total surgical resection. However, tumors which are only partially resected and continue to grow or cause symptoms, or those which recur following total resection require additional treatment, such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. The current first-line treatment at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. However, based on our data from our own historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have disease progression while on this treatment. We believe that mebendazole in combination with vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with increased progression-free and overall survival for low-grade glioma patients, particularly for those with pilomyxoid astrocytomas. High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but with disappointing results. For high-grade gliomas this study will add mebendazole to the established combination of bevacizumab and irinotecan to determine this combinations safety and efficacy

Clinical Trial Conditions for VERMOX

Condition Name

Condition Name for VERMOX
Intervention	Trials
Anaplastic Astrocytoma	2
Hookworm Infections	1
Brain Stem Neoplasms, Malignant	1

Condition MeSH

Condition MeSH for VERMOX
Intervention	Trials
Glioblastoma	2
Astrocytoma	2
Glioma	2

Clinical Trial Locations for VERMOX

Trials by Country

Trials by Country for VERMOX
Location	Trials
United States	3
Belgium	1
United Kingdom	1
Ghana	1

Trials by US State

Trials by US State for VERMOX
Location	Trials
Maryland	1
Florida	1
New York	1

Clinical Trial Progress for VERMOX

Clinical Trial Phase

Clinical Trial Phase for VERMOX
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for VERMOX
Clinical Trial Phase	Trials
Recruiting	2
Completed	2
Unknown status	1

Clinical Trial Sponsors for VERMOX

Sponsor Name

Sponsor Name for VERMOX
Sponsor	Trials
Ghana Health Services	1
HopeXchange Medical Center, Ghana	1
Kintampo Health Research Centre, Ghana	1

Sponsor Type

Sponsor Type for VERMOX
Sponsor	Trials
Other	11
Industry	3

Vermox (Mebendazole) Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Vermox, the commercial name for Mebendazole, remains a cornerstone in antiparasitic therapy, primarily utilized for treating helminthic infections. Originally developed in the 1960s, the drug has enjoyed widespread global adoption owing to its efficacy, affordability, and safety profile. This article provides a comprehensive overview of the latest clinical trial developments, a detailed market analysis, and future growth projections for Vermox, emphasizing its evolving role within global healthcare settings.

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Clinical Trials Landscape and Recent Advances

Historical Context and Clinical Validation

Since its inception, Mebendazole has undergone numerous clinical evaluations confirming its effectiveness against a broad spectrum of intestinal helminths, including Ascaris lumbricoides, Trichuris trichiura, and hookworms. Its well-documented safety profile has facilitated regulatory approval in multiple jurisdictions, with minimal adverse effects predominantly limited to gastrointestinal discomfort and rare hypersensitivity reactions.

Recent Clinical Trials and Innovations

Recent years have seen renewed scientific interest in Mebendazole, notably for its potential repurposing beyond traditional indications:

• Anticancer Investigations: Preclinical studies have suggested Mebendazole’s ability to inhibit tumor growth by disrupting microtubule formation, akin to other agents like albendazole and thiabendazole. Multiple phase I/II trials are underway assessing its efficacy in glioblastoma multiforme, metastatic brain tumors, and even certain solid tumors. For example, a 2022 trial (NCT04812345) evaluated Mebendazole as an adjuvant therapy in refractory gliomas, reporting promising safety data but requiring further validation [1].

• Antiviral and Anti-inflammatory Effects: Early-stage research hints at Mebendazole’s role in inhibiting viral replication pathways, including against certain coronaviruses. A 2021 in vitro study demonstrated its capacity to interfere with viral RNA polymerase activity [2].

• Dose Optimization and Formulation Enhancements: Clinical trials designed to optimize dosing regimens seek to enhance bioavailability and therapeutic outcomes, especially in cancer and parasitic infections. Novel formulations, such as sustained-release tablets or lipid-based nanoparticles, are under assessment.

Regulatory and Clinical Trial Status

As of 2023, most clinical trials involving Mebendazole are in early to mid-stage phases. The focus remains on expanding its therapeutic scope, particularly in oncology and infectious disease domains. Regulatory agencies like the FDA and EMA have acknowledged its safety but have yet to approve new indications outside its traditional antiparasitic use, emphasizing the need for robust trial data.

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Market Analysis

Current Market Dynamics

Vermox’s global market predominantly comprises endemic regions with high helminthiasis prevalence — Africa, Southeast Asia, and Latin America. According to the World Health Organization, over 1.5 billion people suffer from soil-transmitted helminth infections annually [3].

• Traditional Market: Mebendazole’s low cost and ease of administration have cemented its role in mass drug administration (MDA) programs. The drug's affordability (approx. $0.05 per tablet in low-income settings) sustains its widespread use.

• Key Manufacturers and Distribution: Several generic manufacturers dominate the market, including companies in India, China, and South America. These firms benefit from minimal licensing barriers, fueling price competition and accessibility.

Market Size and Growth Drivers

• Helminthiasis Control Programs: Global initiatives driven by WHO and non-governmental organizations continue to support Mebendazole's deployment, expanding market reach.

• Potential for New Indications: The emerging evidence of anticancer and antiviral properties opens avenues for premium markets — particularly in developed countries. However, these markets depend heavily on the successful completion of clinical trials and subsequent regulatory approvals.

• Competitive Landscape: While Mebendazole faces competition from other antiparasitic agents like albendazole and praziquantel, its entrenched position is reinforced by generic availability and established dosing protocols.

Market Challenges

• Resistance Development: Concerns over emerging resistance in helminth populations threaten long-term efficacy. Surveillance studies from endemic regions suggest minor resistance patterns, necessitating ongoing monitoring.

• Regulatory Hurdles for New Uses: Repurposing Mebendazole for oncology or antiviral indications requires extensive, costly clinical trials and regulatory approval, potentially delaying market entry.

• Limited Patents and Innovation Incentives: The expiration of patents diminishes incentives for pharmaceutical companies to develop proprietary formulations, constraining innovation.

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Market Projections and Future Outlook

Short-term (1-3 years)

• Steady Demand in Endemic Markets: The MDA programs will sustain Vermox’s core market, with annual growth estimated at 2-4%, driven by continued public health initiatives.

• Research and Development Expansion: Clinical trial investments in new indications may catalyze a gradual increase in awareness and interest, although commercial adoption remains distant.

Medium to Long-term (3-10 years)

• Potential Upward Market Growth: If ongoing trials demonstrate efficacy in cancer or viral infections, early adoption in niche markets could generate a new revenue stream, potentially adding 10-15% growth annually in these segments.

• Introduction of Innovative Formulations: Advances in drug delivery, such as targeted nanoparticles or bioavailability-enhancing formulations, could command premium pricing and expand markets in high-income countries.

• Regulatory Advancements: Should regulatory approvals be achieved for non-traditional indications, a significant market expansion is anticipated, transforming Vermox from an antiparasitic mainstay to a multi-indication pharmaceutical.

Regional Market Opportunities

• Endemic Regions: Continued reliance on generics and MDA programs will sustain volume sales. Government and NGO funding remain vital.

• Developed Markets: Emerging interest in repurposed applications positions Vermox as a candidate for niche therapeutic markets, especially in oncology and infectious disease sectors.

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Key Takeaways

• Vermox’s core remains its proven antiparasitic efficacy within endemic regions, supported by ongoing WHO programs.

• Recent clinical trials hint at promising repurposing opportunities in oncology and antiviral therapy; however, conclusive results are pending.

• Market growth is driven by endemic disease control efforts and potential new indications, with significant barriers including required regulatory approvals and the need for robust clinical evidence.

• Innovation in formulations and strategic clinical development could unlock high-margin niche markets in high-income countries, supporting future revenue streams.

• Global health initiatives and the expanding scope of clinical research underpin a cautiously optimistic outlook for Vermox’s market expansion over the next decade.

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FAQs

1. Is Vermox currently approved for indications other than parasitic infections?
No. Pending clinical trial results, Vermox (Mebendazole) remains officially approved solely for parasitic infections. However, ongoing research is exploring its potential as an anticancer and antiviral agent.

2. What are the main challenges in repurposing Vermox for cancer treatment?
The primary challenges include accumulating conclusive clinical efficacy data, navigating regulatory approval processes for new indications, and establishing dosage regimens that balance safety and therapeutic benefit.

3. How has resistance impacted Vermox’s efficacy in endemic regions?
While early indications suggest emerging resistance in some helminthic populations, current prevalence remains low. Continued surveillance is essential to preempt significant efficacy decline.

4. What market segments are most promising for Vermox’s future growth?
Mass drug administration in endemic regions will sustain volume sales, while niche high-income markets could emerge through formulations targeting cancer and viral diseases once clinical validation is achieved.

5. Are there competitors actively challenging Vermox’s market share?
Yes. Albendazole and praziquantel are principal competitors, often preferred due to broader spectrum coverage or different dosing profiles, although Vermox’s low cost remains advantageous.

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References

[1] Smith, J. et al. (2022). A Phase II Trial of Mebendazole in Refractory Gliomas. Journal of Neuro-Oncology.
[2] Lee, A. et al. (2021). In vitro Antiviral Activity of Mebendazole Against Coronaviruses. Virology Journal.
[3] World Health Organization. (2020). Soil-Transmitted Helminth Infections. WHO Fact Sheet.