Spermine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate spermine across diverse diagnostic and therapeutic applications, investigating conditions such as prostate cancer, urothelial carcinoma, major depression, premature birth, and necrotizing enterocolitis. Academic and institutional sponsors—including the Chinese University of Hong Kong, Indiana University, and University Hospital Montpellier in partnership with INSERM—lead these early-stage studies, which feature Early Phase 1, unspecified, or Not Applicable designs. The overall portfolio spans recruiting, completed, terminated, and withdrawn trials, encompassing research on urinary biomarkers in prostate cancer as well as fetal gut epithelial maturation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04339920	Withdrawn	Prostate Cancer	Chinese University of Hong Kong	2021-09-01	--
NCT04004091	COMPLETED	Premature Birth; NEC	dr. Riana Pauline Tamba, SpB(K)BA	2019-03-01	EARLY_PHASE1
NCT03914391	Recruiting	Prostate Cancer	Chinese University of Hong Kong	2019-01-16	--
NCT04960956	Terminated	Prostate Cancer\|Urothelial Carcinoma	Indiana University	2016-10-13	--
NCT02855918	Completed	Major Depression	University Hospital Montpellier\|Institut National de la Santé Et de la Recherche Médicale France\|Sys2Diag Mixt laboratory CNRS/Alcediag Montpellier	2016-09-23	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous polyamine, spermine binds to negatively charged cellular components including nucleic acids, membrane phospholipids, and specific ion channels, thereby modulating essential downstream metabolic pathways, gene expression, and intracellular signaling required for cell survival. This fundamental involvement in cellular growth regulation and metabolic turnover underscores its relevance as a diagnostic biomarker in prostate cancer and urothelial carcinoma, as well as a candidate modulator in fetal gut epithelial development and major depression.

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>).