albendazole

Trade name: Albenza

Small moleculeapprovedOrphan Drug FDA

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

Phase 1
6
Phase 2
43
Phase 3
30
Phase 4
23

Earliest trial started Apr 1, 1994 (NCT00396500)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  2. Jan 17, 1996

    Orphan Drug Designation

  3. Jun 11, 1996

    Earliest FDA Approval

  4. Jun 11, 1996

    Impax Laboratories — NDA Secondary Org

2000s

  1. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 11, 2015

    Amedra Pharmaceuticals — NDA Secondary Org

  2. Sep 21, 2018

    Cipla — Marketing Organization

  3. Dec 7, 2018

    Strides Pharma Science — Marketing Organization

  4. Dec 14, 2018

    Zydus Discovery DMCC — Marketing Organization

  5. May 14, 2019

    Edenbridge Pharms — Marketing Organization

  6. May 20, 2019

    Actavis — Marketing Organization

  7. May 20, 2019

    Allergan PLC (2015) — Marketing Organization

2020s

  1. Jun 10, 2020

    Lupin — Marketing Organization

  2. Jun 10, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  3. Jan 22, 2021

    MSN Laboratories — Marketing Organization

  4. Jan 26, 2021

    Dr. Reddy's Laboratories — Marketing Organization

  5. Sep 4, 2024

    Alembic — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewJun 11, 1996

Chemistry & pharmacology

Loading structure…

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

Prodrug

Sources

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 IDPhaseStart dateSponsor(s)
NCT07159373Phase 3Mar 31, 2026Medicines Development for Global Health, Murdoch University, University of New South Wales
NCT07258173Phase 2Jan 15, 2026Bayer, Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS), University of Basel
NCT07074444Phase 4Jul 22, 2025Government of China, Guangxi Medical University, Hacettepe University
NCT07045493Phase 2Jul 10, 2025Cures Within Reach, International Center for Diarrheal Disease Research
NCT06613997Phase 3Jan 15, 2025Government of Congo, Government of France, Programme National de Lutte contre l'Onchocercose (PNLO)
NCT06565507Phase 2/Phase 3 (Phase 3)Dec 15, 2024Cayetano Heredia University, Oxfendazole Development Group
NCT06376396Phase 4Jun 30, 2024Ghent University, Muhimbili University, National Institute for Medical Research, Tanzania, R-Evolution Worldwide S.r.l. Impresa Sociale, Sokoine University of Agriculture, University of Zambia
NCT06188715Phase 3May 14, 2024University of Basel
NCT06265870N/AMay 1, 2024Prince of Songkla University
NCT06184399Phase 2Feb 29, 2024University of Basel
NCT06483880N/AFeb 1, 2024Ain Shams University
NCT06070116Phase 2Jan 15, 2024Washington University in St. Louis
NCT06037876Phase 3Oct 9, 2023University of Basel
NCT06201559Phase 1Aug 21, 2023GlaxoSmithKline
NCT05949190N/AAug 18, 2023Government of Sierra Leone, Open Philanthropy Project, Project Peanut Butter, United States Department of Agriculture, Washington University in St. Louis
NCT05914363N/AApr 12, 2023International Centre of Insect Physiology and Ecology, Mbita, Kenya, JKUAT Nairobi, Jomo Kenyatta University of Agriculture and Technology, Kenya Medical Research Institute, University of London
NCT05538767Phase 2Sep 16, 2022University of Basel
NCT05453045N/AJul 18, 2022Fundación Mundo Sano, Universidad Nacional de Salta
NCT05354258N/AJun 16, 2022University of London
NCT05208333N/AMay 31, 2022Pham Ngoc Thach University of Medicine
Showing 20 of 121 trials
Page 1 / 7

Organizations

Research & Development (167)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of BaselAcademic/Hospital141242009
Washington University in St. LouisAcademic/Hospital131042011
University of LondonAcademic/Hospital10632006
Case Western Reserve UniversityAcademic/Hospital9542012
Cayetano Heredia UniversityAcademic/Hospital7322006
Kenya Medical Research InstituteAcademic/Hospital6132006
University of CopenhagenAcademic/Hospital6522005
Ghent UniversityAcademic/Hospital5422009
International Center for Diarrheal Disease ResearchAcademic/Hospital5522006
National Institute of Allergy and Infectious Diseases (NIAID)Government5522005
Universidad Nacional de SaltaAcademic/Hospital5532010
Bill and Melinda Gates FoundationAcademic/Hospital4032014
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)Academic/Hospital4022018
Emory UniversityAcademic/Hospital4122009
University of WashingtonAcademic/Hospital4222006
Fundación Mundo SanoAcademic/Hospital3012010
Lihir Medical CentreAcademic/Hospital3322018
National Institute of Neurological Disorders and Stroke (NINDS)Government3022001
Natural History Museum, United KingdomAcademic/Hospital3222006
United States Agency for International DevelopmentGovernment3021994
167 organizations
Page 1 / 9

Marketing (15)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGMay 20, 2019
AlembicFor profitMKTGSep 4, 2024
Allergan PLC (2015)For profitMKTGMay 20, 2019
Amedra PharmaceuticalsFor profitNDA2Jun 11, 2015
Chartwell PharmaceuticalsFor profitMKTGJun 10, 2020
CiplaFor profitMKTGSep 21, 2018
Dr. Reddy's LaboratoriesFor profitMKTGJan 26, 2021
Edenbridge PharmsFor profitMKTGMay 14, 2019
Impax LaboratoriesFor profitNDA2Jun 11, 1996
LupinFor profitMKTGJun 10, 2020
MSN LaboratoriesFor profitMKTGJan 22, 2021
SmithKline BeechamFor profitNDA
Strides Pharma ScienceFor profitMKTGDec 7, 2018
Strides Pharma ScienceFor profitSYNDec 7, 2018
Zydus Discovery DMCCFor profitMKTGDec 14, 2018