Fexinidazole
- Generic Name
- Fexinidazole
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C12H13N3O3S
- CAS Number
- 59729-37-2
- Unique Ingredient Identifier
- 306ERL82IR
- Background
Human African trypanosomiasis (HAT, also colloquially referred to as sleeping sickness), caused by T. brucei gambiense and T. brucei rhodesiense, remains a moderate risk (>1/10,000 inhabitants per year in endemic areas) despite focussed control efforts. Transmitted by the bite of an infected tsetse fly, HAT is biphasic with a first (hemolymphatic) stage that...
- Indication
Fexinidazole is a nitroimidazole indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in patients 6 years of age and older weighing at least 20 kg.
...
- Associated Conditions
- Human African Trypanosomiasis (HAT)
- Associated Therapies
- -
Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense
- First Posted Date
- 2019-06-04
- Last Posted Date
- 2022-10-24
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 45
- Registration Number
- NCT03974178
- Locations
- 🇺🇬
Lwala Hospital, Lwala, Kadeberamaido, Uganda
🇲🇼Rumphi District Hospital, Rumphi, Malawi
Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease
- Conditions
- Interventions
- First Posted Date
- 2018-07-16
- Last Posted Date
- 2020-09-23
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 45
- Registration Number
- NCT03587766
- Locations
- 🇪🇸
Hospital Clinic, Barcelona, Catalunia, Spain
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
- Conditions
- Interventions
- First Posted Date
- 2017-01-20
- Last Posted Date
- 2024-06-07
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 174
- Registration Number
- NCT03025789
- Locations
- 🇨🇩
Dipumba Hospital, Mbuji-Mayi, Kasaï Oriental Province, Congo, The Democratic Republic of the
🇨🇩Bandundu Hospital, Bandundu, Kwilu Province, Congo, The Democratic Republic of the
🇨🇩Bagata Hospital, Bagata, Kwilu Province, Congo, The Democratic Republic of the
Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
- First Posted Date
- 2015-10-08
- Last Posted Date
- 2015-10-08
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 30
- Registration Number
- NCT02571062
- Locations
- 🇫🇷
Biotrial, Rennes, France
Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease
- First Posted Date
- 2015-07-15
- Last Posted Date
- 2015-07-15
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 140
- Registration Number
- NCT02498782
- Locations
- 🇧🇴
Plataforma de Atención Integral de Pacientes con Enfermedad de Chagas, Tarija, Bolivia
🇧🇴Plataforma Atención Integral de Pacientes con Enfermedad de Chagas, Cochabamba, Bolivia
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
- First Posted Date
- 2014-07-09
- Last Posted Date
- 2020-06-24
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 125
- Registration Number
- NCT02184689
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
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2020-06-24
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 230
- Registration Number
- NCT02169557
Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
- First Posted Date
- 2013-11-08
- Last Posted Date
- 2015-10-30
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 14
- Registration Number
- NCT01980199
- Locations
- 🇸🇩
Doka Hospital, Doka, Gedaref, Sudan
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
- Conditions
- Interventions
- First Posted Date
- 2012-09-14
- Last Posted Date
- 2018-02-20
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 394
- Registration Number
- NCT01685827
- Locations
- 🇨🇬
CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital, Mbuji Mayi, East Kasai, Congo
🇨🇬HGR ISANGI hospital, Isangi, Province Orientale, Congo
🇨🇬Masi Manimba Hospital, Masi Manimba, Bandundu - DRC, Congo
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
- First Posted Date
- 2011-04-22
- Last Posted Date
- 2017-03-31
- Lead Sponsor
- Drugs for Neglected Diseases
- Target Recruit Count
- 12
- Registration Number
- NCT01340157
- Locations
- 🇫🇷
SGS Aster s.a.s., Paris, France
Drug Development Updates
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