Amonafide Clinical Trials

Size	Price	Qty
10mg	USD 227

Clinical Trials

Amonafide (AS1413) has been evaluated in several clinical trials spanning Phase 1 through pivotal Phase 3, sponsored by academic and industry entities including Antisoma Research, Xanthus Pharmaceuticals, and Memorial Sloan Kettering Cancer Center. These studies assessed combination regimens and phenotype-guided dosing strategies across indications such as acute myeloid leukemia, secondary acute myeloid leukemia, metastatic breast cancer, and androgen-independent prostate cancer. Recorded trial recruitment statuses are listed as either completed or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01066494	UNKNOWN	Acute Myeloid Leukemia	Antisoma Research	2010-01	PHASE2
NCT00715637	UNKNOWN	Secondary Acute Myeloid Leukemia (Secondary AML, sAML)	Antisoma Research	2007-06	PHASE3
NCT01066494	Unknown status	Acute Myeloid Leukemia	Antisoma Research	2010-01	Phase 2
NCT00087854	COMPLETED	Prostate Cancer	Xanthus Pharmaceuticals, Inc.	2004-03	PHASE1; PHASE2
NCT00273884	Completed	Acute Myeloid Leukemia	Xanthus Pharmaceuticals Inc.	2005-08	Phase 2
NCT00087854	Completed	Prostate Cancer	Xanthus Pharmaceuticals Inc.	2004-03	Phase 1\|Phase 2
NCT00074100	COMPLETED	Breast Cancer	Memorial Sloan Kettering Cancer Center	2003-08	PHASE2
NCT00273884	COMPLETED	Acute Myeloid Leukemia	Xanthus Pharmaceuticals, Inc.	2005-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2011-01-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amonafide intercalates into DNA and binds to topoisomerase II, inducing protein-associated DNA double-strand breaks and inhibiting topoisomerase II-mediated DNA ligation without affecting topoisomerase I activity. This disruption of DNA replication and transcription triggers apoptotic cell death in rapidly proliferating malignant cells, providing the mechanistic foundation for its therapeutic application in acute myeloid leukemia, breast cancer, and prostate cancer.

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>).