Fexinidazole

DRUG11 trials

Sponsors

Drugs for Neglected Diseases, DNDi

Conditions

Chagas DiseaseChagas' Disease (Chronic) NosDisease, ChagasHuman African Trypanosomiasis (HAT)Human African Trypanosomiasis due to T.b. gambiense Human African Trypanosomiasis due to T.b. gambiensePK in Healthy VolunteersSleeping SicknessSouth American Trypanosomiasis

Phase 1

Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

CompletedNCT01340157

Drugs for Neglected DiseasesPK in Healthy Volunteers

Start: 2011-02-28End: 2011-04-30Updated: 2017-03-31

Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation

CompletedNCT02571062

Drugs for Neglected DiseasesTrypanosomiasis, African

Start: 2015-03-31End: 2015-06-30Updated: 2015-10-08

Phase 2

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

CompletedNCT01685827

Drugs for Neglected DiseasesHuman African Trypanosomiasis (HAT), Sleeping Sickness

Start: 2012-10-31End: 2017-04-26Updated: 2018-02-20

Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan

TerminatedNCT01980199

Drugs for Neglected DiseasesVisceral Leishmaniasis

Start: 2013-11-30End: 2015-09-30Updated: 2015-10-30

Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study

CompletedNCT02169557

Drugs for Neglected DiseasesHuman African Trypanosomiasis (HAT)

Start: 2014-04-30End: 2017-04-25Updated: 2020-06-24

Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

CompletedNCT02184689

Drugs for Neglected DiseasesHuman African Trypanosomiasis (HAT)

Start: 2014-05-03End: 2017-06-27Updated: 2020-06-24

Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease

Drugs for Neglected DiseasesChagas Disease, Disease, Chagas, South American Trypanosomiasis +1

Start: 2014-07-31End: 2016-02-29Target: 140Updated: 2015-07-15

Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease

CompletedNCT03587766

Drugs for Neglected DiseasesChagas' Disease (Chronic) Nos

Start: 2017-11-13End: 2019-08-28Updated: 2020-09-23

Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense

CompletedNCT03974178

Drugs for Neglected DiseasesSleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection, Trypanosomiasis, African

Start: 2019-09-29End: 2022-10-12Updated: 2025-01-30

Phase 3

Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

CompletedNCT03025789

Drugs for Neglected DiseasesSleeping Sickness, Trypanosomiasis, African, Trypanosomiasis; Gambian

Start: 2016-11-10End: 2021-02-01Updated: 2025-01-08

Unknown Phase

Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

RecruitingPACTR201704002215604

DNDiHuman African Trypanosomiasis due to T.b. gambiense Human African Trypanosomiasis due to T.b. gambiense

Start: 2016-11-10Target: 174Updated: 2026-01-27

Related Papers

Effectiveness and safety of fexinidazole for gambiense human African trypanosomiasis and exploration of adherence in outpatients: a phase 3b, prospective, open-label, non-randomised, cohort study.

2025-05-013 citations

Fexinidazole as a new oral treatment for human African trypanosomiasis due to Trypanosoma brucei rhodesiense: a prospective, open-label, single-arm, phase 2-3, non-randomised study.

2025-05-011 citations

Efficacy and safety of fexinidazole for treatment of chronic indeterminate Chagas disease (FEXI-12): a multicentre, randomised, double-blind, phase 2 trial.

2024-01-1134 citations

Towards an arsenic-free oral treatment for human African trypanosomiasis due to Trypanosoma brucei rhodesiense: a new tool for disease elimination

2024-01-011 citations

Safety and efficacy of oral fexinidazole in children with gambiense human African trypanosomiasis: a multicentre, single-arm, open-label, phase 2-3 trial.

2022-09-278 citations

A Phase 2, Randomized, Multicenter, Placebo-Controlled, Proof-of-Concept Trial of Oral Fexinidazole in Adults With Chronic Indeterminate Chagas Disease

Clinical Infectious Diseases2022-08-0451 citations

Oral fexinidazole for stage 1 or early stage 2 African Trypanosoma brucei gambiense trypanosomiasis: a prospective, multicentre, open-label, cohort study.

2021-07-0136 citations

Oral fexinidazole for late-stage African Trypanosoma brucei gambiense trypanosomiasis: a pivotal multicentre, randomised, non-inferiority trial.

2017-11-04169 citations