Overview
A benzimidazole that acts by interfering with carbohydrate metabolism and inhibiting polymerization of microtubules. [PubChem]
Indication
For the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.
Associated Conditions
- Ancylostoma caninum infection
- Ancylostoma duodenale infection
- Ascaris lumbricoides infection
- Capillariasis
- Enterobius vermicularis infection
- Filariasis
- Giardiasis
- Necatoriasis due to necator americanus
- Strongyloides Stercoralis Infection
- Taenia solium infection
- Toxocariasis
- Whipworm infection
Research Report
Mebendazole (DB00643): A Comprehensive Pharmacological and Clinical Monograph
Section 1: Drug Identification and Physicochemical Profile
This section establishes the fundamental chemical and physical identity of mebendazole, providing the nomenclature, identifiers, and properties that underpin its formulation, pharmacokinetic behavior, and mechanism of action.
1.1 Nomenclature and Identifiers
Mebendazole is a synthetic small molecule compound recognized across numerous chemical and pharmacological databases by a standardized set of identifiers.[1] Its formal chemical name according to the International Union of Pure and Applied Chemistry (IUPAC) is Methyl (5-benzoyl-1H-benzimidazol-2-yl)carbamate, though it is also cited as methyl N-(6-benzoyl-1H-benzimidazol-2-yl)carbamate.[1] The compound is uniquely identified by its Chemical Abstracts Service (CAS) Registry Number, 31431-39-7.[1]
In pharmaceutical and biomedical research, it is cataloged under DrugBank Accession Number DB00643.[1] Other key identifiers include PubChem Compound ID 4030, UNII 81G6I5V05I, and ChEMBL ID CHEMBL685.[1] During its development and in research contexts, it has been referred to by codes such as R 17635 and NSC 184849, and by synonyms including 5-Benzoyl-2-benzimidazolecarbamic acid methyl ester.[3]
Commercially, mebendazole is marketed globally under a wide array of brand names. The most prominent include Vermox, Ovex, and Emverm.[1] Other international brand names include Pantelmin, Lomper (Spain), Surfont (Germany), Bendax (Egypt), Mebex (India), and Antiox (Philippines), reflecting its worldwide use.[5]
1.2 Chemical Structure and Formula
Mebendazole is a synthetic derivative of the benzimidazole class of compounds, which is characterized by a fused benzene and imidazole ring system.[2] Its molecular formula is
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/01/29 | Phase 3 | Not yet recruiting | |||
2024/12/17 | Phase 3 | Not yet recruiting | |||
2024/12/06 | Phase 2 | Completed | Jennifer Keiser | ||
2024/03/28 | Not Applicable | Not yet recruiting | |||
2021/10/11 | Not Applicable | Withdrawn | |||
2020/06/23 | Not Applicable | UNKNOWN | |||
2019/06/24 | Phase 2 | Completed | |||
2019/04/24 | Phase 3 | Recruiting | Sherief Abd-Elsalam | ||
2018/11/28 | Phase 2 | Withdrawn | |||
2017/09/11 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Amneal Pharmaceuticals LLC | 64896-669 | ORAL | 100 mg in 1 1 | 12/16/2023 | |
Physicians Total Care, Inc. | 54868-3732 | ORAL | 100 mg in 1 1 | 3/30/2011 | |
Janssen Pharmaceuticals, Inc. | 50458-675 | ORAL | 500 mg in 1 1 | 9/30/2021 | |
DARMERICA, LLC | 71052-169 | NOT APPLICABLE | 1 kg in 1 kg | 4/22/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
NOUMED WORM TREATMENT mebendazole 100mg tablet blister pack | 61577 | Medicine | A | 10/9/1997 | |
BLOOMS THE CHEMIST WORM TREATMENT mebendazole 100 mg chewable tablet blister pack (new formulation) | 408660 | Medicine | A | 5/9/2023 | |
COMBANTRIN-1 mebendazole 100mg chocolate squares block sachet | 72602 | Medicine | A | 1/11/2000 | |
AMCAL WORM TREATMENT mebendazole 100mg chewable tablet blister pack | 222321 | Medicine | A | 4/10/2014 | |
PHARMACY ACTION WORM TREATMENT mebendazole 100mg tablet blister pack | 202686 | Medicine | A | 11/5/2012 | |
BLOOMS THE CHEMIST WORM TREATMENT mebendazole 100mg chewable tablet blister pack | 304100 | Medicine | A | 6/8/2018 | |
TRUST DEWORM mebendazole 100mg chewable tablet blister pack | 175665 | Medicine | A | 9/10/2010 | |
VERMOX CHOC CHEWS mebendazole 100 mg chewable tablet blister pack | 176298 | Medicine | A | 9/30/2010 | |
VERMOX mebendazole 20 mg/mL banana flavour oral suspension bottle | 54703 | Medicine | A | 3/12/1996 | |
PHARMACY HEALTH WORM TREATMENT mebendazole 100mg tablet blister pack | 151452 | Medicine | A | 4/3/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
VERMOX | 00556734 | Tablet - Oral | 100 MG | 12/31/1982 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
LOMPER 20 mg/ml SUSPENSION ORAL | 53775 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
LOMPER 100 mg COMPRIMIDOS | 51200 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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