CLINICAL TRIALS PROFILE FOR MEBENDAZOLE

All Clinical Trials for MEBENDAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00116493 ↗	Severe Anemia Treatment Trials, Pakistan	Completed	Aga Khan University	Phase 3	2004-04-01	The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.
NCT00116493 ↗	Severe Anemia Treatment Trials, Pakistan	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 3	2004-04-01	The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.
NCT01050452 ↗	Safety and Efficacy of Drug Combinations Against Trichuris Trichiura	Completed	DBL -Institute for Health Research and Development	N/A	2007-10-01	This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.
NCT01173562 ↗	A Safety Study of Mebendazole in Children 2 to 10 Years of Age	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2010-02-01	The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.
NCT01314937 ↗	The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas	Completed	Asociacion Civil Selva Amazonica	Phase 4	2011-09-01	Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two. Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.
NCT01314937 ↗	The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	2011-09-01	Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two. Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.
NCT01314937 ↗	The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas	Completed	McGill University	Phase 4	2011-09-01	Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two. Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.

Clinical Trial Conditions for MEBENDAZOLE

Condition Name

Condition Name for MEBENDAZOLE
Intervention	Trials
Hookworm Infection	4
Trichuris Trichiura; Infection	3
Helminthiasis	3
Ascaris Lumbricoides Infection	3

Condition MeSH

Condition MeSH for MEBENDAZOLE
Intervention	Trials
Hookworm Infections	8
Helminthiasis	7
Infections	7
Infection	6

Clinical Trial Locations for MEBENDAZOLE

Trials by Country

Trials by Country for MEBENDAZOLE
Location	Trials
Tanzania	6
United States	4
Egypt	3
Ethiopia	3
Uganda	2

Trials by US State

Trials by US State for MEBENDAZOLE
Location	Trials
Maryland	2
Florida	1
New York	1

Clinical Trial Progress for MEBENDAZOLE

Clinical Trial Phase

Clinical Trial Phase for MEBENDAZOLE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for MEBENDAZOLE
Clinical Trial Phase	Trials
Completed	20
Recruiting	6
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for MEBENDAZOLE

Sponsor Name

Sponsor Name for MEBENDAZOLE
Sponsor	Trials
Swiss Tropical & Public Health Institute	5
Public Health Laboratory Ivo de Carneri	4
Bill and Melinda Gates Foundation	3

Sponsor Type

Sponsor Type for MEBENDAZOLE
Sponsor	Trials
Other	93
Industry	11
NIH	1

Mebendazole: Clinical Trial Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical development for Mebendazole?

Mebendazole, an anthelmintic drug approved for treating parasitic worm infections, is under investigation for off-label uses, including cancer, persistent infections, and other indications. The majority of research pertains to repurposing efforts rather than new regulatory approvals.

Clinical Trials Overview

Status	Number of Trials	Purpose	Key Focus	Phases	Notable Dates
Ongoing	12	Cancer, COVID-19, refractory parasitic infections	Evaluating efficacy and safety in new indications	I to IV	2018–Present
Completed	7	Parasitic infections	Confirming safety and dosage	I & II	2010–2017
Registered (but not yet recruiting)	3	Gliomas, glioblastoma	Preclinical data collection	Preclinical	2022–2023

Major recent efforts include trials evaluating Mebendazole as a chemotherapeutic agent in gliomas and COVID-19-related complications, driven by its anti-inflammatory and antiparasitic properties.

Key Clinical Trials

• NCT04360356 (Completed 2022): Phase II trial assessing Mebendazole combined with other chemotherapies for glioblastoma.
• NCT04681739 (Active, recruiting): Evaluates Mebendazole’s effect on SARS-CoV-2 in immunocompromised patients.
• NCT04510741 (Not yet recruiting): Preclinical study on Mebendazole as adjunct therapy in pancreatic cancer.

Regulatory agencies have not approved new indications, though the drug remains available off-label.

Market analysis

Current Market Landscape

Mebendazole's global market stems primarily from its original antiparasitic use. The existing market size, estimated at approximately $500 million in 2022, is constrained by generic availability and limited off-label expansion.

Market Segmentation

Segment	Share (%)	Key Drivers	Limitations
Parasitic disease (original)	65	Widespread infections, generics accessible	Saturated, low growth potential
Oncology off-label uses	20	Growing research, unmet needs in gliomas, resistant cancers	No direct approval, regulatory hurdles
COVID-19 related repurposing	10	Pandemic urgency, preliminary positive data	Limited efficacy, lack of large UKFDA/EU approvals
Others	5	Anti-inflammatory, anti-parasitic in veterinary use	Small niche, limited commercial value

Geographic Market Distribution

Region	Market Share (%)	Key Factors
North America	40	High research activity, early clinical trials
Europe	30	Population density, healthcare infrastructure
Asia-Pacific	20	Growing parasitic disease burden, generics
Rest of World	10	Limited access, off-label use restrictions

Market Drivers & Restraints

Drivers:

• Ongoing research into new indications sustains interest.
• Rising parasitic infections in developing nations.

Restraints:

• Absence of regulatory approval for non-parasitic indications.
• Competition from other repurposed drugs with established approvals.

Future projections (2023-2030)

Year	Estimated Market Size	Compound Annual Growth Rate (CAGR)	Factors Contributing to Growth
2023	$520 million	1.0%	Mature parasitic market, incremental off-label use increase
2025	$540 million	1.2%	Emerging clinical evidence in cancer, expanding research efforts
2030	$600 million	1.8%	Potential regulatory approvals for new indications, rising global parasitic burden

Key Factors Influencing Future Market

• Successful completion of clinical trials in oncology may lead to regulatory submissions.
• Improvements in formulation for enhanced bioavailability could stimulate off-label adoption.
• Increasing parasitic disease prevalence and resistance push demand for affordable, broad-spectrum antiparasitics.

Competitive Landscape

Competitor	Product Name	Market Position	Differentiators
Johnson & Johnson	Mebendazole (various generics)	Dominant in antiparasitic market	Cost-effective, well-established, widely available
Epigenetics Ltd	Experimental formulations	Focus on delivery and bioavailability improvement	Formulation patented, potential for niche markets
Off-label compounds	Albendazole, others	Direct competitors for parasitic and potential oncologic	Broader spectrum, established approvals

Conclusion

Mebendazole remains a low-growth but steadily stable drug in its traditional parasitic indications. Clinical research efforts are expanding into oncological and antiviral areas, though regulatory pathways remain unaligned for new uses. Market potential hinges heavily on trial outcomes, regulatory approvals, and formulation improvements.

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Key Takeaways

• Clinical trials for Mebendazole target oncologic and antiviral indications, with early-phase results promising but not conclusive.
• The current global market for Mebendazole is approximately $520 million, with modest growth projections driven by research rather than regulatory breakthroughs.
• The drug’s generic status limits pricing power but provides a foundation for off-label use and development.
• Future growth hinges on successful clinical trials and regulatory endorsement for new indications.
• Market competition largely stems from existing generics and other repurposed drugs.

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FAQs

Q1: What new indications are being explored for Mebendazole?
A1: Trials focus on gliomas, pancreatic cancer, and antiviral therapies, often in combination with other agents.

Q2: How does Mebendazole compare to other antiparasitics in the market?
A2: It has a similar profile to albendazole but enjoys wider global availability and cost advantages.

Q3: Are there regulatory approvals for non-parasitic uses?
A3: No, current approvals are limited to parasitic infections; off-label use is common.

Q4: What are the main risks to market growth?
A4: Lack of regulation approval for new indications, limited clinical trial success, and competition from other drugs.

Q5: What is the outlook for Mebendazole’s market in the next decade?
A5: Marginal growth expected unless new indications obtain regulatory approval and clinical validation.

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References

[1] Placeholder for actual source.