Drugs / Benznidazole
last change Jun 2026 re-read 2 minutes ago

Benznidazole

Small molecule

Developed for
Chagas disease · heart disorder
Investigated by
Drugs for Neglected Diseases · Insud Pharma · Andrea Silvestre de Sousa · Barcelona Centre for International Health Research · Barcelona Institute for Global Health · Canadian Institutes of Health Research (CIHR)
+28 more · Chemo Research · Consejo de Investigacion en Salud Gobierno de Buenos Aires · Evandro Chagas Institute of Clinical Research · Exeltis France · Food and Drug Administration (FDA) · Fundacion Bunge y Born (Argentina) · Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES) · Hospital Universitari Vall d'Hebron Research Institute · Hospital de Niños R. Gutierrez de Buenos Aires · IC-MedTech Corporation · Institute for Clinical Effectiveness and Health Policy · Institute of Parasitology and Biomedicine Lopez Neyra · Instituto Dante Pazzanese de Cardiologia · LAT Research · Laboratorio Elea Phoenix S.A. · Merck Sharp & Dohme LLC · Mundo Sano Foundation · National Institute of Allergy and Infectious Diseases (NIAID) · National University of La Plata · PhinC Development · Population Health Research Institute · The Hospital for Sick Children · Thrasher Research Fund · Tulane University School of Public Health and Tropical Medicine · University of California, San Diego · University of Sao Paulo · University of Texas, El Paso · World Health Organization

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BENZNIDAZOLE 2017-08-29 fda.gov

Trials 15 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05523596 Aug 2023 → Oct 2025 IC-MedTech Corporation Completed No outcome recorded
Phase 1 NCT03739541 Jul → Sep 2018 Exeltis France Completed No outcome recorded
Phase 1 NCT03892213 Oct → Dec 2014 Chagas disease Drugs for Neglected Diseases Completed No outcome recorded
Phase 24 trials
Phase 2 NCT03981523 Dec 2019 → May 2024 Chagas disease University of Texas, El Paso Completed No outcome recorded
Phase 2 NCT03191162 Apr 2017 → Sep 2020 Chagas disease Hospital Universitari Vall d'Hebron Research Institute Completed No outcome recorded
Phase 2 NCT03378661 Nov 2016 → Jan 2018 Chagas disease Drugs for Neglected Diseases Unknown No outcome recorded
Phase 2 NCT01377480 Jul 2011 → Jul 2014 Chagas disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 35 trials
Phase 3 NCT06339710 Jan 2025 → Jan 2026 Chagas disease Evandro Chagas Institute of Clinical Research Withdrawn No outcome recorded
Phase 3 NCT04897516 Jul 2021 → Jun 2026 overdue Chagas disease Laboratorio Elea Phoenix S.A. Recruiting No outcome recorded
Phase 3 NCT04024163 Sep 2019 → Aug 2027 expected Chagas disease Insud Pharma Active not recruiting No outcome recorded
Phase 3 NCT03672487 Jun 2019 → May 2024 Chagas disease Tulane University School of Public Health and Tropical Medicine Completed No outcome recorded
Phase 3 NCT00123916 Nov 2004 → Jul 2015 Chagas disease, heart disorder Population Health Research Institute Completed No outcome recorded
Phase 42 trials
Phase 4 NCT01755403 Dec 2012 → Nov 2013 Chagas disease Barcelona Centre for International Health Research Completed No outcome recorded
Phase 4 NCT01549236 May 2011 → Aug 2012 Chagas disease Drugs for Neglected Diseases Completed No outcome recorded
Phase not applicable1 trial
NCT00699387 Apr 2007 → May 2011 Chagas disease Hospital de Niños R. Gutierrez de Buenos Aires Completed No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT06632600 Comparator Apr 2025 → Mar 2027 expected Chagas disease Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 2 NCT01489228 Comparator Jun 2011 → Aug 2012 Chagas disease Drugs for Neglected Diseases Unknown No outcome recorded
Phase 2 NCT01162967 Comparator Sep 2010 → Dec 2012 Chagas disease Hospital Universitari Vall d'Hebron Research Institute Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02369978 Comparator Aug 2015 → Aug 2018 Chagas disease Universidad Autónoma de Bucaramanga Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT02386358 Comparator Mar 1999 → Dec 2012 Chagas disease Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben Completed No outcome recorded
Phase 41 trial
Phase 4 NCT01678599 Background Apr 2011 → Dec 2012 Chagas disease Drugs for Neglected Diseases Completed No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as Benznidazole ClinicalTrials.gov intervention name — accepted as the source's own label NCT02369978
20

NCT01549236

NCT05523596

NCT04897516

NCT04024163

NCT01489228

NCT03672487

NCT03378661

NCT00123916

NCT03981523

NCT00699387

NCT01162967

NCT06632600

NCT01755403

NCT02386358

NCT03191162

NCT03739541

NCT01377480

NCT03892213

NCT01678599

NCT06339710

Known as [14C]-Benznidazole “A Phase I, Open-label, Study of the Absorption, Metabolism and Excretion, of [14C]-Benznidazole (BNZ) Following a Single Oral Dose in Healthy Male Subjects” NCT03739541
Known as Abarax “This study was a prospective, open-label, single-center clinical trial approved by the local ethics committee. Patients received BNZ at 2.5 mg/kg of body weight/12 h (Abarax,...” PMID 25824212 Mar 2015
1

“Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 2 weeks.” NCT04897516

Known as Abarax (Benznidazole 100mg or 50mg). “Abarax® (Benznidazole 100mg or 50mg).” NCT03892213
Known as Benznidazol ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Known as Benznidazole (N-benzil-2-nitro-1-imidazolacetamida) Benznidazole (N-benzil-2-nitro-1-imidazolacetamida)NCT01489228
Known as Benznidazolum ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Known as Benzonidazol ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Known as BNZ “Despite the modest cure rates in adult chronic patients and its safety profile, benznidazole (BNZ) is still the drug of choice.” PMID 32293523 Apr 2020
1

“benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose)” NCT01377480

Known as BZN “Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection.” PMID 31307503 Jul 2019
3

“Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN).” PMID 41027700 Sep 2025

“Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load.” PMID 32831069 Aug 2020

“Current approved specific treatments for CD include nifurtimox (NFX) and benznidazole (BZN)” NCT03981523

Known as NSC-299972 ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Known as RADANIL “benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days” NCT00699387
Known as RO 07-1051 ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Known as RO-7-1051 ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Known as Rochagan ChEMBL registry synonym — accepted as the source's own label CHEMBL110
Modality Small molecule “Benznidazole, a nitroimidazole derivative, has been recommended for the treatment of acute and congenital Trypanosoma cruzi infection (Chagas' disease).” PMID 8937280 Nov 1996
Route Oral “Daily po Benznidazole” NCT00123916