Nifurtimox Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 490

Clinical Trials

Nifurtimox has been evaluated across multiple clinical trials assessing its efficacy, safety, and pharmacokinetics in parasitic infections—primarily Chagas disease and human African trypanosomiasis—as well as pediatric solid tumors like neuroblastoma and medulloblastoma. Spanning Phase 1 through Phase 4, these studies include completed, terminated, and not yet recruiting protocols. Investigations are funded by diverse sponsors, including pharmaceutical companies such as Bayer, non-profit organizations like Drugs for Neglected Diseases, and academic institutions including the University of Vermont and Epicentre.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03981523	COMPLETED	Trypanosoma Cruzi Infection; Chagas Disease	University of Texas, El Paso	2019-12-18	PHASE2
NCT00601003	COMPLETED	Neuroblastoma; Medulloblastoma	Giselle Sholler	2008-01-14	PHASE2
NCT03334838	COMPLETED	Chagas' Disease	Bayer	2019-06-10	PHASE1
NCT03334838	Completed	Chagas'' Disease	Bayer	2019-06-10	Phase 1
NCT03708133	COMPLETED	Bioequivalence	Bayer	2018-12-05	PHASE1
NCT03350295	COMPLETED	Chagas Disease	Bayer	2018-06-14	PHASE1
NCT02369978	UNKNOWN	Chagas Disease	Universidad Autónoma de Bucaramanga	2015-08	PHASE2; PHASE3
NCT02625974	COMPLETED	Chagas Disease	Bayer	2016-01-27	PHASE3
NCT03350295	Completed	Chagas Disease	Bayer	2018-06-14	Phase 1
NCT01685827	COMPLETED	Human African Trypanosomiasis (HAT); Sleeping Sickness	Drugs for Neglected Diseases	2012-10	PHASE2; PHASE3
NCT02606864	COMPLETED	Chagas Disease	Bayer	2015-12	PHASE1
NCT02625974	Completed	Chagas Disease	Bayer	2016-01-27	Phase 3
NCT02606864	Completed	Chagas Disease	Bayer	2015-12	Phase 1
NCT01927224	COMPLETED	Chagas Disease	Bayer	2013-11	PHASE1
NCT00906880	COMPLETED	Human African Trypanosomiasis	Drugs for Neglected Diseases	2009-04	PHASE4
NCT00146627	COMPLETED	Trypanosomiasis, African	Drugs for Neglected Diseases		PHASE3
NCT00486564	COMPLETED	Neuroblastoma	University of Vermont	2006-11	PHASE1
NCT00330148	TERMINATED	Trypanosomiasis, African	Epicentre	2001-03	PHASE3
NCT00489658	TERMINATED	Trypanosomiasis, African	Epicentre	2002-10	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2024-07-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nifurtimox undergoes bioreduction catalyzed by intracellular nitroreductase enzymes, generating unstable nitroradical intermediates and reactive oxygen species that cause extensive oxidative breakdown of vital biomolecules. This overwhelming oxidative stress leads to protozoal lysis and malignant cell death, providing the mechanistic rationale for its clinical application in Chagas disease, human African trypanosomiasis, and neuroblastoma.

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>).