DFDA

Fexinidazole

Treatment for African Trypanosomiasis

Typical Dosage: 1200 mg/day for 4 days, then 600 mg/day for 6 days (adults)

Effectiveness
95%
Safety Score
65%
Clinical Trials
10
Participants
700

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
65
DangerousModerateSafe
Treatment Details
Dosage Range
1200 mg/day for 4 days, then 600 mg/day for 6 days (adults)
Time to Effect
Within 2-4 weeks post-treatment
Treatment Duration
10 days
Evidence Quality
HIGH
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$200
Monitoring:$500
Side Effect Mgmt:$160
Total Annual:$860
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
EXCELLENT
QALYs Gained
5
Outcome-Based Costs
Cost per Responder
$905
Cost per Remission
$956
Comparison vs NECT
Cost Difference
$-943/year
Less expensive
QALY Difference
+1.00 QALYs
Better outcomes
Dominance
DOMINATESBetter + cheaper
Fexinidazole Outcomes

for African Trypanosomiasis

Efficacy Outcomes
Overall Effectiveness
+95%
Response Rate
+95%
Remission Rate
+90%
Common Side Effects
Nausea
+50%
Vomiting
+30%
Dizziness
+20%
Headache
+15%
Skin reactions
+10%

Sources:

dndi.org
nih.gov
dndi.org

WARNING: LIMITED TRIALS AVAILABLE

You can search for trials, but you probably can't join any because the 1% Treaty hasn't passed yet. Most trials are severely limited by lack of funding and bureaucratic barriers. Help change this!

Active Clinical Trials
No active trials currently recruiting for this treatment

No active trials found in ClinicalTrials.gov

Completed Clinical Trials
8 completed trials for Fexinidazole in African Trypanosomiasis

Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation

NCT02571062COMPLETEDPHASE1
View Study
30 participants
INTERVENTIONAL
Rennes, France
Started: Mar 1, 2015

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

NCT03025789COMPLETEDPHASE3
View Study
174 participants
INTERVENTIONAL
Mbuji-Mayi, Democratic Republic of the Congo +7 more
Started: Nov 10, 2016

Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole

NCT00982904COMPLETEDPHASE1
View Study
108 participants
INTERVENTIONAL
Paris, France
Started: Sep 1, 2009

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

NCT02169557COMPLETEDPHASE2, PHASE3
View Study
230 participants
INTERVENTIONAL
Kinshasa, Democratic Republic of the Congo
Started: Apr 30, 2014

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

NCT02184689COMPLETEDPHASE2, PHASE3
View Study
125 participants
INTERVENTIONAL
Kinshasa, Democratic Republic of the Congo
Started: May 3, 2014

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

NCT03974178COMPLETEDPHASE2, PHASE3
View Study
45 participants
INTERVENTIONAL
Rumphi, Malawi +1 more
Started: Sep 29, 2019

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

NCT01685827COMPLETEDPHASE2, PHASE3
View Study
394 participants
INTERVENTIONAL
Batangafo, Central African Republic +9 more
Started: Oct 1, 2012

Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

NCT01340157COMPLETEDPHASE1
View Study
12 participants
INTERVENTIONAL
Paris, France
Started: Feb 1, 2011