NDAORALTABLETPriority Review
Approved
Jul 2021
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
4
Mechanism of Action
Cytochrome P450 1A2 Inhibitors
Pharmacologic Class:
Nitroimidazole Antimicrobial
Clinical Trials (4)
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
Started Jan 2023
21 enrolled
Hepatic Function Abnormal
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
Started Nov 2016
174 enrolled
Trypanosomiasis, AfricanSleeping SicknessTrypanosomiasis; Gambian
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
Started Feb 2011
12 enrolled
PK in Healthy Volunteers
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
Started Sep 2009
108 enrolled
Human African Trypanosomiasis
Loss of Exclusivity
LOE Date
Jul 16, 2026
4 months away
Exclusivity Expiry
Jul 16, 2028