Scyllo-Inositol Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials evaluate scyllo-inositol across distinct pathological contexts, targeting metabolic pathways, diabetic complications, and neurodegenerative conditions. A clinical trial sponsored by Aristotle University of Thessaloniki is actively recruiting to investigate plasma proteomics in pediatric type 1 diabetes and diabetic peripheral neuropathy without a designated trial phase. Additionally, a completed clinical trial supported by the National Institute on Aging and the National Institutes of Health Clinical Center evaluated biomarkers and metabolic parameters in Alzheimer's disease, obesity, and diabetes mellitus under a phase classification of not applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04257877	Recruiting	Diabetes Type 1\|Proteomics\|Diabetic Peripheral Neuropathy	Aristotle University Of Thessaloniki	2018-11-20	--
NCT02460783	Completed	Alzheimer''s Disease\|Obesity\|Diabetes Mellitus	National Institute on Aging (NIA)\|National Institutes of Health Clinical Center (CC)	2015-06-22	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Scyllo-inositol directly interacts with misfolded amyloid-beta peptide conformers, blocking their further polymerization into neurotoxic protofibrils and preventing membrane disruption in central neurons. By inhibiting toxic protein aggregation and preserving intracellular osmotic balance, this compound targets biochemical cascades key to neurodegenerative and metabolic disorders such as Alzheimer's disease and diabetic peripheral neuropathy.

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>).