Summary

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• Egaten (triclabendazole) is indicated for the treatment of fascioliasis in patients 6 years of age and older.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The study assessed the effects of triclabendazole on QTc interval prolongation in 45 healthy participants, finding the highest mean placebo-corrected change from baseline in QTcF (ΔΔQTcF) was 9.2 ms at the therapeutic dose and 21.7 ms at the supratherapeutic dose, with an upper limit of the two-sided 90% confidence interval exceeding 10 ms at all time points except predose on day 4 in the therapeutic group.
• No clinically significant effects on heart rate, cardiac conduction, or adverse events were observed, including no deaths, serious adverse events, or treatment-emergent adverse events leading to discontinuation.
• Cardiac Effects: Triclabendazole administration at therapeutic and supratherapeutic doses led to a mean placebo-corrected change in QTcF (ΔΔQTcF) of 9.2 ms and 21.7 ms, respectively, on day 4. The upper limit of the 90% confidence interval exceeded 10 ms at most time points, indicating a potential effect on cardiac repolarization, though no clinically significant effects on heart rate or cardiac conduction were observed.
• Adverse Events: No deaths, serious adverse events, study discontinuations due to treatment-emergent adverse events, or clinically relevant abnormalities in laboratory evaluations and vital signs were reported.
• There is no population types or subgroups information available in the reviewed studies.