Overview
A benzimidazole broad-spectrum anthelmintic structurally related to mebendazole that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)
Background
A benzimidazole broad-spectrum anthelmintic structurally related to mebendazole that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)
Indication
For the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium and for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.
Associated Conditions
- Hydatid disease of the Liver
- Hydatid disease of the Lung
- Hydatid disease of the Peritoneum
- Neurocysticercosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/26 | Phase 3 | Not yet recruiting | Programme National de Lutte contre l'Onchocercose, Republic of the Congo | ||
2024/08/22 | Phase 2 | Not yet recruiting | |||
2024/07/11 | N/A | Completed | Jennifer Keiser | ||
2024/07/03 | Not Applicable | Recruiting | |||
2024/04/19 | Phase 4 | Not yet recruiting | R-Evolution Worldwide S.r.l. Impresa Sociale | ||
2024/02/20 | Not Applicable | Not yet recruiting | |||
2024/01/11 | Phase 1 | Completed | |||
2024/01/03 | Phase 3 | Completed | Jennifer Keiser | ||
2023/12/28 | Phase 2 | Completed | Jennifer Keiser | ||
2023/07/17 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-1309 | ORAL | 200 mg in 1 1 | 8/25/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-051 | ORAL | 200 mg in 1 1 | 2/1/2020 | |
| Actavis Pharma, Inc. | 0591-2712 | ORAL | 200 mg in 1 1 | 7/31/2019 | |
| Zydus Lifesciences Limited | 70771-1103 | ORAL | 200 mg in 1 1 | 10/13/2022 | |
| Amneal Pharmaceuticals LLC | 64896-693 | ORAL | 200 mg in 1 1 | 12/16/2023 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1701 | ORAL | 200 mg in 1 1 | 9/30/2019 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1021 | ORAL | 200 mg in 1 1 | 11/6/2022 | |
| Cipla USA Inc. | 69097-237 | ORAL | 200 mg in 1 1 | 12/5/2022 | |
| Bryant Ranch Prepack | 63629-1221 | ORAL | 200 mg in 1 1 | 6/15/2020 | |
| MSN LABORATORIES PRIVATE LIMITED | 69539-151 | ORAL | 200 mg in 1 1 | 1/25/2021 |
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 |
|---|---|---|---|---|---|
| Zentel Tablet 400mg | SIN14030P | TABLET, CHEWABLE | 400 mg | 10/18/2011 | |
| ALZENTAL TABLET 400 mg | SIN07903P | TABLET, FILM COATED | 400 mg | 11/9/1994 | |
| ALBENDOL-400 TABLET 400 mg | SIN09954P | TABLET | 400 mg | 8/22/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Albendazole Capsules | 国药准字H51020135 | 化学药品 | 胶囊剂 | 2/5/2020 | |
| Albendazole Capsules | 国药准字H11021474 | 化学药品 | 胶囊剂 | 9/9/2020 | |
| Albendazole Capsules | 国药准字H41022816 | 化学药品 | 胶囊剂 | 4/15/2025 | |
| Albendazole Capsules | 国药准字H51020134 | 化学药品 | 胶囊剂 | 2/5/2020 | |
| Albendazole Capsules | 国药准字H20045572 | 化学药品 | 胶囊剂 | 8/10/2020 | |
| Albendazole Capsules | 国药准字H51021185 | 化学药品 | 胶囊剂 | 1/8/2021 | |
| Albendazole Capsules | 国药准字H31020015 | 化学药品 | 胶囊剂 | 3/2/2020 | |
| Albendazole Capsules | 国药准字H33020728 | 化学药品 | 胶囊剂 | 4/30/2020 | |
| Albendazole Capsules | 国药准字H20054596 | 化学药品 | 胶囊剂 | 12/14/2020 | |
| Albendazole Capsules | 国药准字H50020300 | 化学药品 | 胶囊剂 | 4/20/2020 |
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 |
|---|---|---|---|---|---|
| ZENTEL albendazole 200mg chewable tablet bottle | 50815 | Medicine | A | 12/1/1994 | |
| ESKAZOLE albendazole 400mg chewable tablet | 97505 | Medicine | A | 10/9/2003 | |
| ESKAZOLE albendazole 400mg chewable tablet | 97504 | Medicine | A | 10/9/2003 | |
| ZENTEL Albendazole 200mg chewable tablet | 43928 | Medicine | A | 12/1/1994 |