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
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2021/10/11 | Not Applicable | Withdrawn | |||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2018/11/28 | Phase 2 | Withdrawn | |||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 |
|---|---|---|---|---|---|
| Mebendazole Chewable Tablets | 国药准字H45021031 | 化学药品 | 片剂(咀嚼) | 8/12/2020 | |
| Mebendazole Chewable Tablets | 国药准字H31022318 | 化学药品 | 片剂（咀嚼） | 4/17/2020 | |
| Mebendazole Chewable Tablets | 国药准字H31022319 | 化学药品 | 片剂（咀嚼） | 4/17/2020 | |
| Mebendazole Chewable Tablets | 国药准字H45021042 | 化学药品 | 片剂 | 8/10/2020 | |
| Mebendazole Tablets | 国药准字H31020288 | 化学药品 | 片剂 | 4/17/2020 | |
| Mebendazole Tablets | 国药准字H45020108 | 化学药品 | 片剂 | 8/12/2020 | |
| Mebendazole Tablets | 国药准字H41022548 | 化学药品 | 片剂 | 7/15/2020 | |
| Mebendazole Tablets | 国药准字H20045669 | 化学药品 | 片剂 | 7/18/2022 | |
| Mebendazole Tablets | 国药准字H44020462 | 化学药品 | 片剂 | 4/9/2020 | |
| Mebendazole Tablets | 国药准字H61022952 | 化学药品 | 片剂 | 5/28/2020 |
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 |
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