OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Triclabendazole – Egaten®

DRUG CLASS

Anthelmintic Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NO.	MOLECULAR FORMULA	STRUCTURE
Triclabendazole	68786-66-3	C14-H9-Cl3-N2-O-S

ANNOTATED BIBLIOGRAPHY

References updated: 01 September 2021

• Zimmerman HJ. Anthelminthics. Hepatic injury from the treatment of infectious and parasitic disease. In, Zimmerman, HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999: pp. 626-8.

  (Expert review of anthelmintics discusses albendazole, mebendazole and thiabendazole but not triclabendazole, the bendazoles being often associated with transient liver enzyme elevations and rarely linked to acute, symptomatic cholestatic liver injury).
• Keiser J, McCarthy J, Hotez P. Chemotherapy of helminth infections. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1001-9.

  (Textbook of pharmacology and therapeutics mentions that liver dysfunction is the most common side effect of albendazole, but that the bendazoles as a group have excellent safety profiles).
• FDA. https://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2018/208711Orig1s000MultidisciplineR.pdf.

  (FDA review of efficacy and safety of triclabendazole in supports of its approval in the US, mentions that liver test abnormalities can be seen in some patients as a part of their Fasciola infection and some abnormalities arising shortly after treatment could be related to expulsion of the dead or dying flukes being associated with abdominal pain, urticaria and eosinophilia).
• Hien TT, Truong NT, Minh NH, Dat HD, Dung NT, Hue NT, Dung TK, et al. A randomized controlled pilot study of artesunate versus triclabendazole for human fascioliasis in central Vietnam. Am J Trop Med Hyg. 2008;78:388–92. [PubMed: 18337331]

  (Among 100 Vietnamese patients with chronic fascioliasis treated with artesunate or triclabendazole, cure rates at 3 months were 76% vs 92%; serum enzyme and bilirubin levels were similar between the two groups before and after therapy; side effects were not discussed).
• Keiser J, Sayed H, el-Ghanam M, Sabry H, Anani S, el-Wakeel A, Hatz C, et al. Efficacy and safety of artemether in the treatment of chronic fascioliasis in Egypt: exploratory phase-2 trials. PLoS Negl Trop Dis. 2011;5:e1285. [PMC free article: PMC3167773] [PubMed: 21909440]

  (Among 20 adults with chronic fascioliasis wo had failed therapy with artemether, response rates to triclabendazole were 67-75% while adverse events were similar to those with artemether, being abdominal pain, nausea, vomiting, diarrhea, headache and fatigue, and liver tests results showed ‘no significant differences following administration of triclabendazole”).
• Webb CM, Cabada MM. Recent developments in the epidemiology, diagnosis, and treatment of Fasciola infection. Curr Opin Infect Dis. 2018;31:409–414. [PubMed: 30113327]

  (Review of the fascioliasis, the most widely distributed trematode infection worldwide, the life-cycle of Fasciola hepatica, clinical course of the infection, diagnosis, and management; states that triclabendazole is the drug of choice for its therapy with response rates as high as 90%).
• Gandhi P, Schmitt EK, Chen CW, Samantray S, Venishetty VK, Hughes D. Triclabendazole in the treatment of human fascioliasis: a review. Trans R Soc Trop Med Hyg. 2019;113:797–804. [PMC free article: PMC6906998] [PubMed: 31638149]

  (Review of the efficacy and safety of triclabendazole for human fascioliasis, first used in veterinary medicine was evaluated in humans in the 1990s leading to approval for use in Egypt in 1997, in France in 2002 but not in the US until 2019; cure rates of 69-100% in human trials, it “appears to be well tolerated” most adverse events being due to expulsion of the dead or dying flukes).
• Caravedo MA, Cabada MM. Human fascioliasis: current epidemiological status and strategies for diagnosis, treatment, and control. Res Rep Trop Med. 2020;11:149–158. [PMC free article: PMC7705270] [PubMed: 33273878]

  (Review of the life-cycle, epidemiology, clinical features and therapy of fascioliasis).
• de Moraes J, Geary TG. FDA-Approved antiparasitic drugs in the 21st century: a success for helminthiasis? Trends Parasitol. 2020;36:573–575. [PubMed: 32387059]

  (Helminthiasis affects a sizeable proportion of the world’s population but largely in resource limited countries and among people living in poverty; the FDA has recently approved two novel agents for helminthic diseases including moxidectin for onchocerciasis in 2018 and triclabendazole for fascioliasis in 2019, agents that will play a very important role in world health).
• Terashima A, Canales M, Maco V, Marcos LA. Observational study on the effectiveness and safety of multiple regimens of triclabendazole in human fascioliasis after failure to standard-of-care regimens. J Glob Antimicrob Resist. 2021;25:264–267. [PubMed: 33862276]

  (Among 27 patients with chronic fascioliasis seen at a single center in Peru between 2002 and 2018, who had failed an initial standard of care course of triclabendazole and were treated with 1 to 9 repeated courses for longer period or with higher doses, 20 [74%] were ultimately cured and “it seemed to be well tolerated”).
• Morales ML, Tanabe MB, White AC Jr, Lopez M, Bascope R, Cabada MM. Triclabendazole treatment failure for Fasciola hepatica infection among preschool and school-age children, Cusco, Peru. Emerg Infect Dis. 2021;27:1850–1857. [PMC free article: PMC8237897] [PubMed: 34152949]

  (Among 53 Peruvian children with chronic fascioliasis treated with directly observed therapy with triclabendazole [usually single dose], only 54% achieved a cure with the first treatment and fewer with each subsequent treatment course, so that after 4 courses, 12% of children were still infected; no mention of adverse events).