Fexinidazole

Summary

Fexinidazole (CHEMBL1631694) is an approved small molecule (ATC P01CA03); indicated across 7 conditions including trypanosomiasis and human african trypanosomiasis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: P01CA03
• Indications: 7 conditions
• Clinical trials: 13
• Chemistry: 279.32 Da · C12H13N3O3S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1631694
Name	Fexinidazole
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	68792
ATC	P01CA03
Molecular formula	C12H13N3O3S
Molecular weight	279.32
InChIKey	MIWWSGDADVMLTG-UHFFFAOYSA-N

SMILES: CN1C(=CN=C1COC2=CC=C(C=C2)SC)[N+](=O)[O-]

IUPAC name: 1-methyl-2-[(4-methylsulfanylphenoxy)methyl]-5-nitroimidazole

Also known as: Fexinidazol, Fexinidazole, HOE 239, HOE-239, fexinidazole, FEXINIDAZOLE

Patent coverage: 74 distinct patent families (259 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

7 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
trypanosomiasis	4	MONDO:0000940	DOID:10113
human African trypanosomiasis	4	MONDO:0005459	EFO:0005225
leishmaniasis	4	MONDO:0011989	EFO:0005044
visceral leishmaniasis	2	MONDO:0005445	EFO:0005045
Chagas disease	2	MONDO:0001444	EFO:0008559

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 13.

Phase distribution

Phase	Trials
PHASE1	5
PHASE2/PHASE3	4
PHASE2	3
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01685827	PHASE2/PHASE3	COMPLETED	Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
NCT02169557	PHASE2/PHASE3	COMPLETED	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
NCT02184689	PHASE2/PHASE3	COMPLETED	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
NCT03025789	PHASE3	COMPLETED	Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
NCT03974178	PHASE2/PHASE3	COMPLETED	Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
NCT01980199	PHASE2	TERMINATED	Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
NCT02498782	PHASE2	UNKNOWN	Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease
NCT03587766	PHASE2	COMPLETED	Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease
NCT00982904	PHASE1	COMPLETED	Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
NCT01340157	PHASE1	COMPLETED	Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
NCT01483170	PHASE1	TERMINATED	Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food
NCT02571062	PHASE1	COMPLETED	Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
NCT05607173	PHASE1	COMPLETED	A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).