Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 |
| Fasting | EXPERIMENTAL | Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route |
| Meal 1: Plumpy Nuts | EXPERIMENTAL | Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route |
| Meal 2: Rice + beans | EXPERIMENTAL | Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route |
| 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 |
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 an investigational small molecule being studied for Human African Trypanosomiasis, also known as sleeping sickness, caused by T.b. gambiense. It has been evaluated in a Phase 3 clinical trial for this condition. It is also being studied in healthy volunteers for pharmacokinetic purposes and in participants with hepatic impairment.
Fexinidazole is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi has sponsored clinical trials of Fexinidazole across multiple countries, including France, the Democratic Republic of the Congo, Guinea, and Bulgaria.
Fexinidazole has completed a Phase 3 clinical trial for Human African Trypanosomiasis due to T.b. gambiense, as well as Phase 1 trials for pharmacokinetic and hepatic impairment studies. It remains an investigational drug and is not approved for any use.
Fexinidazole has been studied in three completed clinical trials. NCT01340157 was a Phase 1 bioavailability study in healthy volunteers in France. NCT03025789 was a Phase 3 trial in patients with Human African Trypanosomiasis in the Democratic Republic of the Congo and Guinea. NCT05607173 was a Phase 1 pharmacokinetic study in participants with hepatic impairment.
Fexinidazole is the drug name used consistently across all clinical trials and publications. No alternative names have been established for this compound in the available clinical trial records.