Sesamin Clinical Trials

Size	Price	Qty
5mg	USD 110

Clinical Trials

An actively recruiting clinical trial sponsored by an academic institution, Taipei Medical University, is evaluating the therapeutic potential of sesamin in patients with low arousal threshold obstructive sleep apnea syndrome. Lacking a formal trial phase designation, this study investigates the effect of sesamin administration on sleep quality and systemic antioxidative parameters. Consequently, the clinical landscape for sesamin is currently defined by exploratory academic research focused on sleep architecture and oxidative stress mitigation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05678439	Recruiting	Sleeping Disorders	Taipei Medical University	2022-11-18	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sesamin acts as a naturally occurring lignan that inhibits pro-inflammatory lipid mediators and enhances intracellular antioxidant defense networks. By suppressing reactive oxygen species production and modulating metabolic signaling, sesamin mitigates systemic oxidative stress, supporting its potential clinical application in managing sleep quality and physiological markers in patients with sleeping disorders.

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>).