NDAORALTABLETPriority Review
Approved
Jul 2021
Lifecycle
LOE Approaching
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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fexinidazole is an oral nitroimidazole antimicrobial small molecule approved by FDA in July 2021 for treatment of African Trypanosomiasis (sleeping sickness). It works as a cytochrome P450 1A2 inhibitor and represents a significant therapeutic advance for a rare parasitic disease endemic to sub-Saharan Africa.
LOE Approaching2mo to LOE
As LOE approaches in July 2026 (0.2 years remaining), the brand team will shift focus toward lifecycle management, cost optimization, and preparation for generic entry in a niche rare disease market with minimal commercial scale.
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.