NDAORALTABLETPriority Review
Approved
Jul 2021
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority Review
FEXINIDAZOLE (fexinidazole) by Sanofi is cytochrome p450 1a2 inhibitors [moa]. Approved for nitroimidazole antimicrobial [epc]. First approved in 2021.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fexinidazole is an oral nitroimidazole antimicrobial small molecule approved by the FDA in July 2021 for treating infections caused by susceptible organisms. It works by inhibiting cytochrome P450 1A2, disrupting pathogen metabolic pathways. The drug is administered as an oral tablet and targets patients requiring nitroimidazole-based therapy.
Post-LOEPost-LOE
Post-LOE status signals a mature, maintenance-focused commercial organization with reduced team expansion and emphasis on lifecycle management and cost optimization.
Mechanism of Action
Cytochrome P450 1A2 Inhibitors
Pharmacologic Class:
Nitroimidazole Antimicrobial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.