SN-6 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 570

Clinical Trials

A completed Phase 4 clinical trial, sponsored by an academic medical center (Hospital Oftalmologico de Brasilia), evaluated refractive assessment in patients undergoing ophthalmic surgical procedures. Specifically, researchers examined post-operative visual performance parameters following the implantation of aspheric multifocal diffractive intraocular lenses. Overall, human research on this entity remains anchored in a clinical trial focused on visual performance and refractive outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01065064	Completed	Refractive Assessment	Hospital Oftalmologico de Brasilia	2009-01	Phase 4

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

Check the SN-6 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SN-6 selectively binds to and inhibits the sodium-calcium exchanger, targeting NCX1, NCX2, and NCX3 with IC50 values of 2.9 μM, 16 μM, and 8.6 μM, respectively. This inhibition disrupts downstream cellular sodium and calcium transport dynamics, thereby suppressing calcium flux and abolishing acetylcholine-induced vasodilation. By modulating calcium-dependent vascular and cellular responses, this mechanism provides physiological context relevant to clinical evaluations concerning refractive assessment and visual performance.

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>).