Benznidazole

Summary

Benznidazole (CHEMBL110) is an approved small-molecule antiprotozoal drug (ATC P01CA02); indicated across 4 conditions including chagas disease and trypanosomiasis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: P01CA02
• Indications: 4 conditions
• Clinical trials: 19
• Chemistry: 260.25 Da · C12H12N4O3

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL110
Name	Benznidazole
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	31593
ChEBI	CHEBI:133833
ATC	P01CA02
Molecular formula	C12H12N4O3
Molecular weight	260.25
InChIKey	CULUWZNBISUWAS-UHFFFAOYSA-N

SMILES: C1=CC=C(C=C1)CNC(=O)CN2C=CN=C2[N+](=O)[O-]

IUPAC name: N-benzyl-2-(2-nitroimidazol-1-yl)acetamide

ChEBI definition: A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2-nitroimidazol-1-yl)acetic acid with the aromatic amino group of benzylamine. Used for treatment of Chagas disease.

Pharmacological roles (ChEBI): antiprotozoal drug.

Also known as: Benznidazol, Benznidazole, Benznidazolum, Benzonidazol, NSC-299972, Radanil, Rochagan, benznidazol, benznidazole, benzonidazole, SID56320744, BENZNIDAZOLE

Patent coverage: 850 distinct patent families (3,668 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

Broader ChEMBL bioactivity targets: 4 (assay-derived). Sample: Beta-lactamase, Kappa-type opioid receptor, Cytochrome P450 2D6, Cytochrome P450 3A4.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 4 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
P00811	5.25	Potency	5623	nM	CHEMBL_ACT_4631336

Target pathways

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

Indications & clinical

Indications

4 indications (4 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
Chagas disease	4	MONDO:0001444	EFO:0008559
trypanosomiasis	4	MONDO:0000940	DOID:10113
leishmaniasis	4	MONDO:0011989	EFO:0005044

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

Clinical trials

Total trials: 19.

Phase distribution

Phase	Trials
PHASE2	7
PHASE3	5
PHASE4	2
PHASE1	2
Not specified	2
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01678599	PHASE4	COMPLETED	Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease
NCT01755403	PHASE4	COMPLETED	Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
NCT04024163	PHASE3	ACTIVE_NOT_RECRUITING	Prospective Study of Benznidazole for Chagas’ Disease Children With Chronic Indeterminate Chagas Disease
NCT04897516	PHASE3	RECRUITING	Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
NCT00123916	PHASE3	COMPLETED	BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas’ Disease
NCT02369978	PHASE2/PHASE3	UNKNOWN	CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)
NCT02386358	PHASE3	COMPLETED	Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial
NCT03672487	PHASE3	COMPLETED	Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age
NCT06632600	PHASE2	RECRUITING	A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
NCT01162967	PHASE2	COMPLETED	Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
NCT01377480	PHASE2	COMPLETED	A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
NCT01489228	PHASE2	UNKNOWN	Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
NCT03191162	PHASE2	COMPLETED	Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.
NCT03378661	PHASE2	UNKNOWN	BENDITA BEnznidazole New Doses Improved Treatment and Associations
NCT03981523	PHASE2	COMPLETED	New Therapies and Biomarkers for Chagas Infection
NCT03892213	PHASE1	COMPLETED	Pharmacokinetic Drug-Drug Interaction Study
NCT05523596	PHASE1	COMPLETED	A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults
NCT00699387	Not specified	COMPLETED	Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
NCT01755377	Not specified	COMPLETED	New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 1 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

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