Drugs / Benznidazole
Benznidazole
also known as
BZN · Abarax · BNZ · [14C]-Benznidazole · Abarax (Benznidazole 100mg or 50mg). · Benznidazol · Benznidazole (N-benzil-2-nitro-1-imidazolacetamida) · Benznidazolum · +6 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BENZNIDAZOLE | — | 2017-08-29 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 2 | NCT01377480 | Jul 2011 → Jul 2014 | Chagas disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT06339710 | Jan 2025 → Jan 2026 | Chagas disease | Evandro Chagas Institute of Clinical Research | Withdrawn | No outcome recorded |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 | Missed primary |
| 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 |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT06632600 Comparator | Apr 2025 → Jul 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 | Missed primary |
| Phase 2 | NCT01162967 Comparator | Sep 2010 → Dec 2012 | Chagas disease | Hospital Universitari Vall d'Hebron Research Institute | Completed | Missed primary |
| Phase 2/3 | NCT02369978 Comparator | Aug 2015 → Aug 2018 | Chagas disease | Universidad Autónoma de Bucaramanga | Unknown | No outcome recorded |
| Phase 3 | NCT02386358 Comparator | Mar 1999 → Dec 2012 | Chagas disease | Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben | Completed | No outcome recorded |
| Phase 4 | NCT01678599 Background | Apr 2011 → Dec 2012 | Chagas disease | Drugs for Neglected Diseases | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-04-06 | Drugs for Neglected Diseases | Results Chagas disease: Shorter treatment just as effective as longer one, according to study in Bolivia published by The Lancet | DNDi dndi.org ↗
A two-week treatment with the antiparasitic drug benznidazole for adults with chronic Chagas disease has similar efficacy and significantly fewer adverse effects than the current standard eight-week treatment, according to a study published by The Lancet Infectious Diseases. |
| 2019-03-13 | Drugs for Neglected Diseases | Results Study shows dramatically shorter treatment for Chagas disease could be just as effective, and significantly safer | DNDi dndi.org ↗
We’ve shown that shorter treatment could be just as effective, and much safer. |
| 2018-04-12 | Drugs for Neglected Diseases | Regulatory Drug approved in Argentina for treatment of Chagas disease in children | DNDi dndi.org ↗
Argentina has approved the paediatric indication of a drug used for treatment of Chagas disease, benznidazole, which will now be available in 12.5 mg pills, the dose required to treat children under the age of 2. |
| 2017-08-30 | Drugs for Neglected Diseases | Regulatory U.S. FDA approves Chemo Group’s benznidazole to treat children with Chagas disease | DNDi dndi.org ↗
On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research’s New Drug Application (NDA) for benznidazole. |
| 2013-11-13 | Drugs for Neglected Diseases | Results Drug Trial for Leading Parasitic Killer of the Americas Shows Mixed Results but Provides New Evidence for Improved Therapy | DNDi dndi.org ↗
On the other hand, standard therapy for Chagas, benznidazole, was shown to be effective in the long term but continued to be associated with side effects. |
| 2013-07-10 | Drugs for Neglected Diseases | Regulatory Three Neglected-Disease Treatments Newly Added to WHO Essential Medicines List for Paediatric Use | DNDi dndi.org ↗
This week the World Health Organization (WHO) released its newly updated 4th WHO Model List of Essential Medicines for Children (EMLc), in which three treatments developed by the Drugs for Neglected Diseases initiative (DNDi) and its partners have now been included. |
| 2011-12-01 | Drugs for Neglected Diseases | Regulatory New Child-Adapted Chagas Disease Treatment Approved for Registration | DNDi dndi.org ↗
Registration of this child-adapted formulation of benznidazole will be published on 12 December 2011. |
All press releases naming this drug 8 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Benznidazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01489228 ↗ |
| 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 20151“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 20201“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 20193“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 ↗ |