Clinical Trials

The clinical trial landscape for N-desmethyltamoxifen currently includes a clinical trial recorded in the primary registry. Sponsored by industry sponsor AstraZeneca, this completed Phase 2 randomised, double-blind, placebo-controlled, parallel-group study evaluated the dose-response relationship of oral tablet therapy in patients with gynaecomastia and prostate cancer. There are currently no active or enrolling trials listed for this compound.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00637871 Completed
Gynaecomastia|Prostate Cancer
AstraZeneca
 2002-11 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

N-Desmethyltamoxifen functions as a potent inhibitor of protein kinase C and a regulator of ceramide metabolism, selectively blocking ceramide glycosylation, hydrolysis, and sphingosine phosphorylation to impair pro-survival signaling cascades. This disruption of downstream kinase signaling and lipid metabolic pathways suppresses cell proliferation, providing the biological basis for its therapeutic investigation in gynaecomastia 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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.