Skip to main content

Egaten FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 27, 2019.

FDA Approved: Yes (First approved February 13, 2019)
Brand name: Egaten
Generic name: triclabendazole
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Fascioliasis

Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.

Dosage and Administration

Clinical Studies
The efficacy of Egaten was demonstrated in an open label, randomized trial in Vietnam that compared the approved recommended dosage of triclabendazole to oral artesunate (4 mg/kg once daily for 10 days) in 100 patients (9 to 74 years of age) with acute symptomatic fascioliasis. After three months, 92% of the triclabendazole patients and 76% of the artesunate patients reported no clinical symptoms.
Additionally, six non-randomized, open label studies were conducted in Cuba, Bolivia, Peru, Chile, and Iran in a total of 245 adult and pediatric patients with stool-confirmed fascioliasis. Across these studies, there was found to be a dose response relationship, with the recommended two doses of 10 mg/kg of triclabendazole achieving a cure rate of 95.5% after 60 days.

Egaten should not be taken by patients with a known hypersensitivity to triclabendazole, other benzimidazole derivatives, or any of the other tablet ingredients.

Warnings and Precautions
Egaten may prolong the QT interval. Patients with a history of QT prolongation, or who are taking medications which prolong the QT interval should be ECG monitored.

Adverse Reactions
The most common adverse reactions were abdominal pain, hyperhidrosis, nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus.

Development timeline for Egaten

Feb 13, 2019Approval FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.