N-desMethyl EnzalutaMide Clinical Trials

Size	Price	Qty
25mg	USD 507

Clinical Trials

Multiple clinical trials have investigated therapeutic regimens involving enzalutamide, of which N-desmethyl enzalutamide is a primary active metabolite. Spanning Phase I through Phase III evaluations, these studies targeted castration-resistant prostatic neoplasms, breast cancer, advanced hepatocellular carcinoma, and general neoplasms under major pharmaceutical sponsorship from Hoffmann-La Roche, Pfizer, Astellas Pharma, Medivation, and GlaxoSmithKline. Recorded trial statuses range from completed studies in prostate cancer, hepatocellular carcinoma, and general neoplasms to a withdrawn protocol in breast cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03016312	Completed	Prostatic Neoplasms Castration-Resistant	Hoffmann-La Roche	2017-01-10	Phase 3
NCT02929576	Withdrawn	Breast Cancer	Pfizer\|Astellas Pharma Inc\|Medivation Inc.	2016-09	Phase 3
NCT02528643	Completed	Advanced Hepatocellular Carcinoma	Astellas Pharma Global Development Inc.\|Pfizer\|Astellas Pharma Inc	2015-11-09	Phase 2
NCT02215096	Completed	Neoplasms	GlaxoSmithKline	2014-11-13	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As the active metabolite of enzalutamide, N-desmethyl enzalutamide binds to the androgen receptor and competitively inhibits androgen binding, preventing nuclear translocation and DNA binding of the receptor complex. This blockade suppresses androgen-dependent gene transcription and inhibits tumor cell proliferation, demonstrating clinical relevance across trials evaluating androgen-targeted therapy for castration-resistant prostate cancer, breast cancer, and advanced hepatocellular carcinoma.

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>).