Trial Profile

Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense: a Multicentre, Open-label Clinical Trial

Status: Completed

Phase of Trial: Phase II/III

Latest Information Update: 03 Feb 2025

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At a glance

01 Jul 2024 According to DNDi media release, results of this trial led the European Medicines Agency to issue a positive scientific opinion in December 2023, and the regulatory authorities of the Democratic Republic of the Congo to approve its use in June 2024 which are important steps for endemic countries in Eastern Africa to approve the use of Fexinidazole Winthrop for T.b. rhodesiense and make it available for patients and clinicians.
15 Dec 2023 Results presented in a DNDi media release.
15 Dec 2023 According to DNDi media release, data from this study were recently presented at the European Congress of Tropical Medicine and International Health.

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