Clinical Trials

Several clinical trials evaluate benznidazole for Chagas disease, chronic indeterminate Chagas disease, and drug transfer during lactation across Phases 1, 2, and 4, encompassing both adult and pediatric pharmacokinetic assessments. Sponsored by non-profit research consortia, hospital networks, and pharmaceutical entities—including the Drugs for Neglected Diseases initiative and Eisai Co. Ltd.—the majority of these studies are completed, while others have unknown status. These trials collectively provide critical safety and pharmacokinetic insights across diverse patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03892213 Completed
Chagas Disease
Drugs for Neglected Diseases|PhinC Development
 2014-10 Phase 1
NCT01755403 Completed
Chagas Disease
Barcelona Centre for International Health Research
 2012-12 Phase 4
NCT01547533 Completed
Chagas Disease|Lactation
Hospital de Niños R. Gutierrez de Buenos Aires
 2011-08 --
NCT01489228 Unknown status
Chronic Chagas Disease Indeterminate
Drugs for Neglected Diseases|Eisai Co. Ltd.
 2011-06 Phase 2
NCT00699387 Completed
Chagas Disease
Hospital de Niños R. Gutierrez de Buenos Aires|Thrasher Research Fund|The Hospital for Sick Children|Fundacion Bunge y Born (Argentina)|Universidad Nacional de La Plata|Consejo de Investigacion en Salud Gobierno de Buenos Aires
 2007-04 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Benznidazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benznidazole is a nitroimidazole derivative that undergoes metabolic activation to impair parasite protein biosynthesis, modify host cytokine production, and stimulate host phagocytosis. This disruption of key biochemical pathways reduces intracellular parasite viability and clears pathogen burden, providing the biological basis for its clinical application in managing Chagas disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.