CLINICAL TRIALS PROFILE FOR VERMOX

All Clinical Trials for VERMOX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02644291 ↗	Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors	Recruiting	Sidney Kimmel Comprehensive Cancer Center	Phase 1	2016-05-01	This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that include medulloblastoma and high grade glioma, that are no longing responding to standard therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet. It is already approved to treat parasitic infections. The purpose of this study is to determine the safety and side effects for increasing doses of mebendazole, followed by the treatment of an additional 12 patients at the best tolerated dose.
NCT02051738 ↗	A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants	Completed	Janssen Research & Development, LLC	Phase 1	2014-02-01	The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
NCT02420574 ↗	Assessment of Drug Efficacy of Local Albendazole	Completed	University Ghent	N/A	2014-02-01	Infections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson & Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The main objective of the present study is to compare the efficacy of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX (India, Cipla)
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
Brain Stem Neoplasms, Malignant	1
Idiopathic Pruritus Ani	1
Brainstem Glioma	1

Condition MeSH

Condition MeSH for VERMOX
Intervention	Trials
Astrocytoma	2
Glioma	2
Glioblastoma	2
Communicable Diseases	1

Clinical Trial Locations for VERMOX

Trials by Country

+

−

Trials by Country for VERMOX
Location	Trials
United States	3
Ghana	1
Belgium	1
United Kingdom	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
Completed	2
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for VERMOX

Sponsor Name

Sponsor Name for VERMOX
Sponsor	Trials
Janssen Pharmaceuticals	1
Yale University	1
Julie Krystal	1

Sponsor Type

Sponsor Type for VERMOX
Sponsor	Trials
Other	11
Industry	3

Vermox: Clinical Trials, Market Analysis, and Projections

Introduction to Vermox

Vermox, commonly known by its active ingredient mebendazole, is an anthelmintic drug used to treat various parasitic infections. Originally developed to combat helminth infections, mebendazole has also shown promise in oncology, particularly in the treatment of certain types of cancer.

Clinical Trials and Efficacy

Oncology Applications

Recent clinical trials have explored the potential of mebendazole as an anti-cancer agent. A phase 1 study published in 2024 investigated the safety and efficacy of mebendazole in combination with bevacizumab and irinotecan in patients with high-grade gliomas (HGG)[1].

• Patient Enrollment and Dosage: The study enrolled 10 subjects aged 1-21 years, with mebendazole doses ranging from 50 mg/kg/day to 200 mg/kg/day. Patients received mebendazole orally twice daily, while bevacizumab and irinotecan were administered intravenously on specific days of a 28-day cycle.
• Safety and Tolerability: The study found that mebendazole was safe and well-tolerated at doses up to 200 mg/kg/day, with no dose-limiting toxicities observed. Common adverse events included neutropenia and lymphopenia.
• Efficacy: The overall response rate was 33%, with two subjects achieving a partial response and one subject achieving a complete response sustained for 10 months. The mean progression-free survival (PFS) and overall survival (OS) were 4.7 and 11.4 months, respectively.

Pre-Clinical Evidence

Pre-clinical studies have demonstrated mebendazole's efficacy against various cancer cell lines. For instance, mebendazole induced dose- and time-dependent apoptotic responses in lung, breast, ovary, colon carcinomas, and osteosarcoma cell lines. It also showed significant activity against glioblastoma multiforme (GBM) in both in vitro and in vivo models[4].

Market Analysis

Global Mebendazole Market

The global mebendazole market is experiencing steady growth driven by its dual use in treating parasitic infections and its emerging role in oncology.

• Market Size and Growth: As of 2023, the global mebendazole market was valued at US$ 117.6 million and is projected to reach US$ 173 million by 2030, growing at a CAGR of 5.6% during the forecast period 2024-2030[5].
• Competitive Landscape: Key players in the mebendazole market include Johnson & Johnson, Amneal Pharmaceuticals, Cadila Pharmaceuticals, Eipico, Esteve Pharmaceuticals, and Tenry[2].

Anthelmintic Drugs Market

The broader anthelmintic drugs market, which includes mebendazole, is also growing due to the increasing prevalence of helminth infections globally.

• Market Size and Growth: The global anthelmintic drugs market was valued at $1 billion in 2022 and is expected to reach $1.5 billion by 2032, growing at a CAGR of 3.8% from 2023 to 2032. The benzimidazoles segment, which includes mebendazole, dominated the market in 2022 and is expected to maintain its dominance during the forecast period[3].

Market Projections

Drivers of Growth

Several factors are driving the growth of the mebendazole market:

• Increasing Prevalence of Parasitic Infections: The growing prevalence of helminth infections, particularly in regions with poor sanitation and limited access to healthcare, is a significant driver. According to the World Health Organization, an estimated 1.5 billion people worldwide are infected with soil-transmitted helminths[3].
• Emerging Oncology Applications: The potential of mebendazole as an anti-cancer agent is opening new avenues for its use, which is expected to contribute to market growth.
• Technological Advances: Innovations in drug formulation, diagnostics, and treatment methods are also boosting the market.

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

• Resistance to Existing Treatments: The increasing resistance of parasites to existing treatments is driving the need for new and effective anthelmintic drugs, including mebendazole[3].
• Research and Development: Ongoing R&D efforts, particularly in combination therapies and novel formulations, are expected to enhance the efficacy and safety of mebendazole, further expanding its market potential.

Key Takeaways

• Safety and Efficacy: Mebendazole has shown safety and efficacy in clinical trials, particularly in combination with other drugs for treating high-grade gliomas.
• Market Growth: The global mebendazole market is projected to grow at a CAGR of 5.6% from 2024 to 2030.
• Emerging Applications: Mebendazole's potential in oncology is a significant growth driver.
• Competitive Landscape: Key players include Johnson & Johnson, Amneal Pharmaceuticals, and others.
• Drivers of Growth: Increasing prevalence of parasitic infections, emerging oncology applications, and technological advances are key drivers.

FAQs

What is Vermox used for?

Vermox, or mebendazole, is primarily used to treat parasitic infections caused by helminths such as roundworms, tapeworms, and certain flukes. It is also being explored for its potential in treating certain types of cancer.

What are the key findings from the phase 1 clinical trial of mebendazole in oncology?

The phase 1 trial found that mebendazole was safe and well-tolerated when combined with bevacizumab and irinotecan in patients with high-grade gliomas, with an overall response rate of 33% and mean PFS and OS of 4.7 and 11.4 months, respectively[1].

What is the projected market size of the global mebendazole market by 2030?

The global mebendazole market is expected to reach US$ 173 million by 2030, growing at a CAGR of 5.6% from 2024 to 2030[5].

Who are the main players in the mebendazole market?

Key players in the mebendazole market include Johnson & Johnson, Amneal Pharmaceuticals, Cadila Pharmaceuticals, Eipico, Esteve Pharmaceuticals, and Tenry[2].

What are the main drivers of growth for the mebendazole market?

The main drivers include the increasing prevalence of parasitic infections, emerging applications in oncology, and technological advances in drug formulation and treatment methods[3][5].

What are the potential challenges for the mebendazole market?

Challenges include the increasing resistance of parasites to existing treatments and the need for continuous R&D to maintain and enhance the drug's efficacy and safety[3].