2-Methoxyestradiol (2-MeOE2) Clinical Trials

Size	Price	Qty
10mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials have evaluated 2-Methoxyestradiol across Phase I and Phase II studies targeting taxane-refractory prostate cancer, advanced solid tumors, carcinoid tumors, metastatic renal cell carcinoma, and multiple myeloma across relapsed, refractory, and plateau stages. Contributions to this clinical development landscape encompass academic and government institutions, such as the National Cancer Institute, as well as industry sponsors including CASI Pharmaceuticals, Inc. All of these documented trials have achieved completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00328497	COMPLETED	Carcinoid Tumor	CASI pharmaceuticals, Inc.	2006-05	PHASE2
NCT00444314	COMPLETED	Metastatic Renal Cell Carcinoma	CASI pharmaceuticals, Inc.	2007-02	PHASE2
NCT00394810	COMPLETED	Prostate Cancer	CASI pharmaceuticals, Inc.	2006-11	PHASE2
NCT00592579	COMPLETED	Relapsed Multiple Myeloma; Plateau Phase Multiple Myeloma	CASI pharmaceuticals, Inc.	2001-03	PHASE2
NCT00028821	COMPLETED	Refractory Multiple Myeloma; Stage III Multiple Myeloma; Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2002-01	PHASE1
NCT00030095	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2001-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2010-03-10)

Check the 2-Methoxyestradiol (2-MeOE2) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Methoxyestradiol depolymerizes microtubules and prevents the nuclear accumulation of hypoxia-inducible factor 1-alpha, thereby suppressing downstream hypoxia-driven transcriptional activity, inducing reactive oxygen species, and triggering apoptotic cascades in proliferating cells. This concurrent disruption of tumor cell survival and endothelial angiogenesis inhibits tumor growth and vascularization, providing a clear biological basis for its investigation in solid tumors, prostate cancer, renal cell carcinoma, and multiple myeloma.

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>).