albendazole
Trade name: Albenza
Approved
Jun 11, 1996
ALBENZA (albendazole) is an orally administered anthelmintic drug. Chemically, it is methyl 5¬ (propylthio)-2-benzimidazolecarbamate, is indicated to treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. In addition, treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. Albendazole binds to the colchicine-sensitive site of β-tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites decreases their absorptive function, especially the uptake of glucose by the adult and larval forms of the parasites, and depletes glycogen storage. Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate (ATP) and the parasite eventually dies. Albendazole developed in 1975. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. The incidence of side effects reported in the published literature is very low, with only gastrointestinal side effects occurring with an overall frequency of just >1% . Albendazole's unique broad-spectrum activity is exemplified in the overall cure rates calculated from studies employing the recommended doses for hookworm (78% in 68 studies: 92%, for A. duodenale in 23 studies and 75% for N. americanus in 30 studies), A. lumbricoides (95% in 64 studies), T. trichiura (48% in 57 studies), E. vermicularis (98% in 27 studies), S. stercoralis (62% in 19 studies), H. nana (68% in 11 studies), and Taenia spp. (85% in 7 studies). — NCATS
Clinical trial activity
121 trials · 167 clinical orgs · 14 marketing orgs
Earliest trial started Apr 1, 1994 (NCT00396500)
Timeline
1990s
- Jan 1, 1994
Earliest Phase 3 Sponsor(trial)
- Jan 17, 1996
Orphan Drug Designation
- Jun 11, 1996
Earliest FDA Approval
- Jun 11, 1996
Impax Laboratories — NDA Secondary Org
2010s
- Jun 11, 2015
Amedra Pharmaceuticals — NDA Secondary Org
- Sep 21, 2018
Cipla — Marketing Organization
- Dec 7, 2018
Strides Pharma Science — Marketing Organization
- Dec 14, 2018
Zydus Discovery DMCC — Marketing Organization
- May 14, 2019
Edenbridge Pharms — Marketing Organization
- May 20, 2019
Actavis — Marketing Organization
- May 20, 2019
Allergan PLC (2015) — Marketing Organization
2020s
- Jun 10, 2020
Lupin — Marketing Organization
- Jun 10, 2020
Chartwell Pharmaceuticals — Marketing Organization
- Jan 22, 2021
MSN Laboratories — Marketing Organization
- Jan 26, 2021
Dr. Reddy's Laboratories — Marketing Organization
- Sep 4, 2024
Alembic — Marketing Organization
Indications
Studied for
- Anemia · Phase 4
- Arachnoiditis · Phase 3
- Ascariasis · Phase 4
- Attention Deficit and Disruptive Behavior Disorders · Phase 4
- Cholera · Phase 1/Phase 2
- Chronic Periodontitis · Phase 4
- Clonorchiasis · Phase 4
- COVID-19 · Phase 2/Phase 3
- Diarrhea · Phase 4
- Disease Transmission, Infectious · Phase 4
- Drug Combinations · Phase 1
- Elephantiasis, Filarial · Phase 4
- Epilepsy · Phase 2/Phase 3
- Filariasis · Phase 4
- Healthy Volunteers · Phase 3
- Helminthiasis · Phase 4
- HIV · Phase 3
- HIV Infections · Phase 3
- Hookworm Infections · Phase 4
- Intestinal Diseases · Phase 4
- Intestinal Diseases, Parasitic · Phase 4
- Loiasis · Phase 3
- Malaria · Phase 4
- Malnutrition · Phase 3
- Nematode Infections · Phase 4
- Neoplasms · Phase 2
- Neurocysticercosis · Phase 4
- Onchocerca · Phase 2
- Onchocerciasis · Phase 3
- Onchocerciasis, Ocular · Phase 2
- Pediatrics · Phase 4
- Pharmacokinetics · Phase 1
- Pregnancy Complications · Phase 4
- Protozoan Infections · Phase 3
- Scabies · Phase 3
- Schistosomiasis · Phase 4
- Strongyloides · Phase 3
- Strongyloidiasis · Phase 3
- Tinea Capitis · Phase 2/Phase 3
- Toxocariasis · Phase 3
- Trachoma · Phase 4
- Trichuriasis · Phase 4
- Trichuris · Phase 4
- Tropical Medicine · Phase 1
- Typhoid Fever · Phase 1/Phase 2
- Wounds and Injuries · Phase 2
- Wuchereria bancrofti · Phase 2
- Yaws · Phase 3
Mechanism of action
Approval history
- approvedPriority reviewJun 11, 1996
Chemistry & pharmacology
SMILES
CCCSC1=CC2=C(C=C1)N=C(NC(=O)OC)N2- Mol. weight
- 265.331 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaAlbendazole ↗
- NCATSF4216019LN ↗
- ChEMBLCHEMBL1483 ↗
Also known as
- (5-(propylthio)-1h-benzimidazol-2-yl)carbamic acid methyl ester
- (5-(propylthio)-1h-benzimidazol-2-yl)carbamic acid methyl ester
- 5-(propylthio)-2-carbomethoxyaminobenzimidazole
- 5-(propylthio)-2-carbomethoxyaminobenzimidazole
- albamelin
- albendazol
- albendazol
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazole
- albendazolum
- albendazolum
- albendol
- albenza
- albenza
- albenza
- albenza
- eskazole
- eskazole
- eskazole
- o-methyl n-(5-(propylthio)-2-benzimidazolyl)carbamate
- o-methyl n-(5-(propylthio)-2-benzimidazolyl)carbamate
- proftril
- proftril
- sk&f 62979
- sk&f 62979
- sk&f-62979
- sk&f-62979
- valbazen
- valbazen
- zental
- zental
- zentel
- zentel
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07159373 | Phase 3 | Mar 31, 2026 | Medicines Development for Global Health, Murdoch University, University of New South Wales |
| NCT07258173 | Phase 2 | Jan 15, 2026 | Bayer, Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS), University of Basel |
| NCT07074444 | Phase 4 | Jul 22, 2025 | Government of China, Guangxi Medical University, Hacettepe University |
| NCT07045493 | Phase 2 | Jul 10, 2025 | Cures Within Reach, International Center for Diarrheal Disease Research |
| NCT06613997 | Phase 3 | Jan 15, 2025 | Government of Congo, Government of France, Programme National de Lutte contre l'Onchocercose (PNLO) |
| NCT06565507 | Phase 2/Phase 3 (Phase 3) | Dec 15, 2024 | Cayetano Heredia University, Oxfendazole Development Group |
| NCT06376396 | Phase 4 | Jun 30, 2024 | Ghent University, Muhimbili University, National Institute for Medical Research, Tanzania, R-Evolution Worldwide S.r.l. Impresa Sociale, Sokoine University of Agriculture, University of Zambia |
| NCT06188715 | Phase 3 | May 14, 2024 | University of Basel |
| NCT06265870 | N/A | May 1, 2024 | Prince of Songkla University |
| NCT06184399 | Phase 2 | Feb 29, 2024 | University of Basel |
| NCT06483880 | N/A | Feb 1, 2024 | Ain Shams University |
| NCT06070116 | Phase 2 | Jan 15, 2024 | Washington University in St. Louis |
| NCT06037876 | Phase 3 | Oct 9, 2023 | University of Basel |
| NCT06201559 | Phase 1 | Aug 21, 2023 | GlaxoSmithKline |
| NCT05949190 | N/A | Aug 18, 2023 | Government of Sierra Leone, Open Philanthropy Project, Project Peanut Butter, United States Department of Agriculture, Washington University in St. Louis |
| NCT05914363 | N/A | Apr 12, 2023 | International Centre of Insect Physiology and Ecology, Mbita, Kenya, JKUAT Nairobi, Jomo Kenyatta University of Agriculture and Technology, Kenya Medical Research Institute, University of London |
| NCT05538767 | Phase 2 | Sep 16, 2022 | University of Basel |
| NCT05453045 | N/A | Jul 18, 2022 | Fundación Mundo Sano, Universidad Nacional de Salta |
| NCT05354258 | N/A | Jun 16, 2022 | University of London |
| NCT05208333 | N/A | May 31, 2022 | Pham Ngoc Thach University of Medicine |
Organizations
Research & Development (167)
Marketing (15)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | May 20, 2019 |
| Alembic | For profit | MKTG | Sep 4, 2024 |
| Allergan PLC (2015) | For profit | MKTG | May 20, 2019 |
| Amedra Pharmaceuticals | For profit | NDA2 | Jun 11, 2015 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 10, 2020 |
| Cipla | For profit | MKTG | Sep 21, 2018 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jan 26, 2021 |
| Edenbridge Pharms | For profit | MKTG | May 14, 2019 |
| Impax Laboratories | For profit | NDA2 | Jun 11, 1996 |
| Lupin | For profit | MKTG | Jun 10, 2020 |
| MSN Laboratories | For profit | MKTG | Jan 22, 2021 |
| SmithKline Beecham | For profit | NDA | — |
| Strides Pharma Science | For profit | MKTG | Dec 7, 2018 |
| Strides Pharma Science | For profit | SYN | Dec 7, 2018 |
| Zydus Discovery DMCC | For profit | MKTG | Dec 14, 2018 |