10 completed, 2 terminated, 1 unknown. 7 Phase 2, 5 Phase 1, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 5, Terminated 1, Unknown 1 |
| Phase 1 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 5 | Completed 5 |
Follow fexinidazole: new trials by email Literature Review of fexinidazole trials Research Report on fexinidazole
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment Fexinidazole (HOE239) - Hepatic Function Abnormal | Phase 1 | Completed | Sanofi | 21 | 2023-01-18 | 2025-09-19 |
| Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense Fexinidazole - Trypanosomiasis, African, Sleeping Sickness | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 45 | 2019-09-29 | 2025-01-30 |
| Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease Fexinidazole, Placebo Oral Tablet - Chagas' Disease (Chronic) Nos | Phase 2 | Completed | Drugs for Neglected Diseases | 45 | 2017-11-13 | 2020-09-23 |
| Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage Fexinidazole - Trypanosomiasis, African, Sleeping Sickness | Phase 3 | Completed | Drugs for Neglected Diseases | 174 | 2016-11-10 | 2025-01-08 |
| Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation Fexinidazole - Trypanosomiasis, African | Phase 1 | Completed | Drugs for Neglected Diseases | 30 | 2015-03-01 | 2015-10-08 |
| Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease Fexinidazole, Placebo - Chagas Disease, Trypanosomiasis, South American | Phase 2 | Unknown | Drugs for Neglected Diseases | 140 | 2014-07-01 | 2015-07-15 |
| 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 fexinidazole - Human African Trypanosomiasis (HAT) | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 125 | 2014-05-03 | 2020-06-24 |
| 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 Fexinidazole - Human African Trypanosomiasis (HAT) | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 230 | 2014-04-30 | 2020-06-24 |
| Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan Fexinidazole - Visceral Leishmaniasis | Phase 2 | Terminated | Drugs for Neglected Diseases | 14 | 2013-11-01 | 2015-10-30 |
| Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 Fexinidazole, Nifurtimox, Eflornithine - Human African Trypanosomiasis (HAT), Sleeping Sickness | Phase 2 / Phase 3 | Completed | Drugs for Neglected Diseases | 394 | 2012-10-01 | 2018-02-20 |
| Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food Tablets Fexinidazole, Placebo - Trypanosomiasis, African | Phase 1 | Terminated | Drugs for Neglected Diseases | 30 | 2011-09-01 | 2017-03-31 |
| Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions Fexinidazole - PK in Healthy Volunteers | Phase 1 | Completed | Drugs for Neglected Diseases | 12 | 2011-02-01 | 2017-03-31 |
| Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole Fexinidazole/Placebo - Human African Trypanosomiasis | Phase 1 | Completed | Drugs for Neglected Diseases | 108 | 2009-09-01 | 2017-04-06 |
Trypanosomiasis, African (5) · Chagas Disease (2) · Neglected Diseases (2) · Bronchiolitis Obliterans Syndrome (1) · Infections (1) · Leishmaniasis, Visceral (1) · Liver Diseases (1) · Pyloric Stenosis, Hypertrophic (1) · Trypanosomiasis (1)
Drugs for Neglected Diseases (12) · Sanofi (1)
France (5) · Democratic Republic of the Congo (4) · Bolivia (1) · Bulgaria (1) · Central African Republic (1) · Guinea (1) · Malawi (1) · Republic of the Congo (1) · Spain (1) · Sudan (1) · Uganda (1)
Lionel Hovsepian, MD (3) · Antoine Tarral, MD (2) · Ahmed M Musa, MD PhD (1) · Digas Ngolo Tete, MPH (1) · E. AG Khalil, Prof. MD (1) · Enock Matovu, Prof (1) · Faustino Torrico, MD (1) · Lourdes O Daza, MD (1) · Mamadou Camara, PhD (1) · Nathalie Strub-Wourgaft, MD (1) · Victor Kande Betu Kumeso, MD (1)
PMID 29113731, PMID 34143998, PMID 35925555, PMID 36179736, PMID 38218194, PMID 40288399, PMID 40288400
2016 (1)