L-SelenoMethionine Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 490

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate L-selenomethionine's therapeutic potential in autoimmune thyroiditis, prostate cancer, follicular lymphoma, precancerous prostatic conditions, and human nutritional requirements. Predominantly sponsored by academic medical centers and public research entities, these studies incorporate varied recruitment statuses, including completed phase 3 prostate cancer chemoprevention and phase 4 pediatric thyroiditis evaluations, alongside withdrawn and unknown statuses in specialized oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02644707	COMPLETED	Autoimmune Thyroiditis	Aristotle University Of Thessaloniki	2014-08	PHASE4
NCT02302768	UNKNOWN	Thyroiditis Autoimmune	University of Siena	2012-12	PHASE2
NCT00736164	WITHDRAWN	Prostate Cancer	Roswell Park Cancer Institute	2008-08	PHASE2
NCT00030901	COMPLETED	Precancerous/Nonmalignant Condition; Prostate Cancer	SWOG Cancer Research Network	2000-02	PHASE3
NCT00455416	UNKNOWN	Follicular Lymphoma	Oslo University Hospital	2007-04	PHASE2
NCT00217516	COMPLETED	Prostate Cancer	Roswell Park Cancer Institute	2005-03	PHASE1
NCT00803699	COMPLETED	Nutritional Requirements	USDA Grand Forks Human Nutrition Research Center	2005-11
NCT00271427	COMPLETED	Autoimmune Thyroiditis; Hashimotos Thyroiditis	Ege University	2004-12

(data from https://clinicaltrials.gov, updated on 2020-02-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a naturally occurring organoselenium compound, L-selenomethionine serves as a primary precursor for incorporation into crucial selenoproteins such as glutathione peroxidase, thereby bolstering endogenous antioxidant defenses and neutralizing reactive oxygen species. This attenuation of oxidative stress and cellular damage underlies its clinical relevance in reducing inflammatory activity in autoimmune thyroiditis and inhibiting oxidative progression in 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>).