Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. FDA label
Also known as Fexinidazole (HOE239)
Fexinidazole · 3 trials · 5 indications
Treatment outcome at Month 18 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. Success rate at Month 18 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 18. An estimate of the success rate at Month 18 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided.
Maximum plasma concentration observed (Cmax)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
| Arm | Type | Description |
|---|---|---|
| Inpatients | EXPERIMENTAL | Participants received fexinidazole orally for 10 days as inpatients (at the hospital) |
| Outpatients | EXPERIMENTAL | Participants received fexinidazole orally for 10 days as outpatients (at home) |
| Participants with mild HI | EXPERIMENTAL | Mild HI is defined as a total score ranging from 5 to 6, inclusive (Child-Pugh score A) |
| Participants with moderate HI | EXPERIMENTAL | Moderate HI is defined as a total score ranging from 7 to 9, inclusive (Child-Pugh score B) |
| Participants with normal hepatic function | EXPERIMENTAL | Participants with normal hepatic function matched to participants |
| Fexinidazole | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fexinidazole | DRUG | Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food) |
| Fexinidazole (HOE239) | DRUG | Route of administration: oral; pharmaceutical form: tablet |
| Fexinidazole/Placebo | DRUG | - |
Inclusion Criteria: * Male or female patient, including breastfeeding or pregnant women in the second or third trimester. * ≥ 6 years of age. * ≥ 20 kg body weight. * Signed Informed Consent Form and Assent Form for patients less than 18 years of age * Trypanosomes detected in any body fluid. * Phy...
Fexinidazole is used for the treatment of human African trypanosomiasis, also known as sleeping sickness, including disease caused by Trypanosoma brucei gambiense at any stage. It has also been studied in adults with mild and moderate hepatic impairment to assess its pharmacokinetics and tolerability.
Fexinidazole is developed by Sanofi, which trades under the ticker SNY. Sanofi has sponsored clinical research on the drug, including a Phase 3 study in human African trypanosomiasis and Phase 1 studies in healthy volunteers and in participants with hepatic impairment.
Fexinidazole has been studied across Phase 1 and Phase 3 clinical development. Its Phase 3 trial in human African trypanosomiasis is completed, and Phase 1 work has covered first-in-man testing and a pharmacokinetic study in adults with mild and moderate hepatic impairment.
Fexinidazole has been evaluated in completed trials including NCT03025789, a Phase 3 study in human African trypanosomiasis due to T.b. gambiense at any stage, NCT00982904, a first-in-man Phase 1 trial, and NCT05607173, a Phase 1 pharmacokinetic and tolerability study in adults with hepatic impairment.
Yes, Fexinidazole is also known as HOE239. Both names refer to the same small molecule, and searches using either name point to the same drug candidate developed by Sanofi for human African trypanosomiasis and related research in hepatic impairment.
Across the reported clinical studies, 174 participants were enrolled in the Phase 3 trial of Fexinidazole in human African trypanosomiasis, with additional Phase 1 studies enrolling 108 healthy volunteers and 21 adults with hepatic impairment.