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Vermox

(Mebendazole)

ApprovedSmall molecule

Mebendazole is used to treat infections caused by parasitic worms, such as roundworms, hookworms, and whipworms. It works by killing the worms and is commonly used in both children and adults.[2] Vermox is currently approved and in use across 11 indications[4].[1]

Vermox is one of 249 small molecule programs targeting Ulcerative Colitis. It is currently in Approved.

11

Indications

21

Total Trials

5

Active Trials

248

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Ulcerative ColitisActive, not recruiting

Hookworm Infectious DiseaseApproved

Malignant GliomaApproved

Anemia (phenotype)Approved

NecatoriasisApproved

Colorectal CancerApproved

Hepatocellular CarcinomaActive, not recruiting

Adjuvant TreatmentRecruiting

AstrocytomaActive, not recruiting

HelminthiasisCompleted

Ulcerative ColitisPreclinical

Active, not recruiting

Hookworm Infectious DiseaseApproved

Approved

Malignant GliomaApproved

Approved

Anemia (phenotype)Approved

Approved

NecatoriasisApproved

Approved

Colorectal CancerApproved

Approved

Hepatocellular CarcinomaPreclinical

Active, not recruiting

Adjuvant TreatmentPhase 3

Recruiting

AstrocytomaPreclinical

Active, not recruiting

HelminthiasisApproved

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Vermox

Stivarga

Wellcovorin

EEastern Cooperative Oncology Group

Wellcovorin

GGlaxo Dba Glaxosmithkline

Tecentriq

Acetylsalicylic Acid

Mitosol

UUroGen Pharma Ltd.

5-Fu

TToray Industries, Inc

SHR-A1811

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Biological Check-up

UUniversity Hospital, Bordeaux

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Not yet recruiting

Trichuris Trichiura; Infection

NCT06800248

PreclinicalActive, not recruiting

Astrocytoma

NCT01837862

Q4 2028

Phase 3Recruiting

Adjuvant Treatment

NCT03925662

Clinical

Trials by Indication[1]

Efficacy and Safety3 trials

Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura

Completed·JJennifer Keiser·Phase 2·NCT06720259·163 enrolled

Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

Completed·SSwiss Tropical & Public Health Institute·Phase 2·NCT03995680·397 enrolled

A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02034162·295 enrolled

Hookworm Infection2 trials

Triple Combinations Against Hookworm Infections in Lao

Completed·SSwiss Tropical & Public Health Institute·Phase 4·NCT03278431·420 enrolled

Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana

Withdrawn·PPATH·Phase 4·NCT03261596

Trichuris Trichiura; Infection2 trials

A Phase III Single-center, Randomized, Double-Blinded, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis

Not yet recruiting·SSwiss Tropical & Public Health Institute·Phase 3·NCT06800248·315 enrolled

A Phase III Single-center, Randomized, Double-blinded, Parallel-group, Active-controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis

Active, not recruiting·SSwiss Tropical & Public Health Institute·Phase 3·NCT06736691·315 enrolled

Pediatric Brain Tumor1 trial

Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02644291·16 enrolled

Ulcerative Colitis1 trial

Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine

Recruiting·TTanta University·N/A·NCT06335160·46 enrolled

12 more indications

Hepatocellular Carcinoma1 trial

To Study the Effects of Addition of Mebendazole to Lenvatinib in Cirrhotics With Advanced Hepatocellular Carcinoma.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04443049·170 enrolled

Infections1 trial

The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia

Completed·UUniversity Ghent·Phase 4·NCT01327469·2,250 enrolled

Growth1 trial

The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT01314937·1,760 enrolled

Treatment1 trial

Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2

Completed·UUniversity Ghent·Phase 4·NCT01379326·250 enrolled

Glioma1 trial

Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT01729260·24 enrolled

Helminthiasis1 trial

Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02385058·100 enrolled

Anemia1 trial

Severe Anemia Treatment Trials, Pakistan

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT00116493·1,009 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

Completed·DDBL -Institute for Health Research and Development·N/A·NCT01050452·750 enrolled

Children1 trial

A Safety Study of Mebendazole in Children 2 to 10 Years of Age

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT01173562·397 enrolled

Adjuvant Treatment1 trial

Mebendazole as Adjuvant Treatment for Colon Cancer

Recruiting·SSherief Abd-Elsalam·Phase 3·NCT03925662·40 enrolled

Pruritus1 trial

RDD1609 as a Treatment for Idiopathic Pruritus Ani

Withdrawn·RRDD Pharma Ltd·Phase 2·NCT03757403

Astrocytoma1 trial

A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas

Active, not recruiting·JJulie Krystal·Preclinical·NCT01837862·10 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

VERMOX

NDA NDA017481

Oct 19, 2016

VERMOX

NDA NDA208398

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Mebendazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vermox drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mebendazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mebendazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208398). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tubulin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

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