Elesclomol (STA-4783) Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 237

Clinical Trials

Multiple clinical trials, sponsored by entities including Synta Pharmaceuticals Corp., the GOG Foundation, and Karolinska Institutet, have evaluated elesclomol across Phase 1 to Phase 3 for oncological indications such as melanoma, metastatic solid tumors, prostate cancer, acute myeloid leukemia, non-small cell lung cancer, and recurrent ovarian or fallopian tube carcinomas. Although early-phase trials reached completion, late-phase evaluations encountered obstacles. Notably, a pivotal Phase 3 study investigating combination therapy with paclitaxel in melanoma was terminated early due to safety concerns.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01280786	UNKNOWN	Acute Myeloid Leukemia	Synta Pharmaceuticals Corp.	2011-01	PHASE1
NCT00888615	COMPLETED	Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Fallopian Tube Undifferentiated Carcinoma; Ovarian Brenner Tumor; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Tumor; Ovarian Undifferentiated Carcinoma; Primary Peritoneal Serous Adenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma	GOG Foundation	2010-12-13	PHASE2
NCT00827203	SUSPENDED	Metastatic Solid Tumors	Synta Pharmaceuticals Corp.	2009-01	PHASE1
NCT00808418	COMPLETED	Prostate Cancer	Synta Pharmaceuticals Corp.	2008-11	PHASE1
NCT00522834	TERMINATED	Melanoma	Synta Pharmaceuticals Corp.	2007-08	PHASE3
NCT00827203	Suspended	Metastatic Solid Tumors	Synta Pharmaceuticals Corp.	2009-01	Phase 1
NCT00808418	Completed	Prostate Cancer	Synta Pharmaceuticals Corp.	2008-11	Phase 1
NCT00088114	COMPLETED	Neoplasms	Synta Pharmaceuticals Corp.	2003-01	PHASE1
NCT00088088	COMPLETED	Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer	Synta Pharmaceuticals Corp.	2004-03	PHASE1; PHASE2
NCT00087997	COMPLETED	Soft Tissue Sarcoma	Synta Pharmaceuticals Corp.	2004-07	PHASE2
NCT00084214	COMPLETED	Melanoma	Synta Pharmaceuticals Corp.	2004-05	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2014-02-03)

Check the Elesclomol (STA-4783) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elesclomol specifically binds the α2/α3 helices and β5 strand of ferredoxin 1 (FDX1) and functions as a copper ionophore, thereby inhibiting FDX1-mediated iron-sulfur cluster biosynthesis and generating reactive oxygen species that activate the mitochondrial apoptotic pathway. This induction of pro-apoptotic pathways and cuproptosis selective to malignant cells underpins its evaluation as a targeted anti-tumor strategy in clinical trials for melanoma, advanced non-small cell lung cancer, and other metastatic solid tumors.

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>).