Clinical Trials

Several clinical trials evaluate conditions relevant to Cycloastragenol research, including Alzheimer's disease, acute ST-elevation myocardial infarction, Chopra-Amiel-Gordon syndrome, and periodontal diseases. Encompassing Phase 2 and non-applicable phase classifications, these actively recruiting and completed studies investigate cognitive function, retinal amyloid markers, rapid myocardial infarction identification, and periodontal tissue preservation. These initiatives are primarily sponsored by academic and medical institutions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05777083 Recruiting
ST Elevation Myocardial Infarction|Electrocardiogram
Ewha Womans University Mokdong Hospital
2023-01-01 Not Applicable
NCT05578443 Recruiting
Alzheimer''s Disease
Fujian Medical University Union Hospital
2022-10-01 Phase 2
NCT05528744 Recruiting
Genetic Disease|Chopra-Amiel-Gordon Syndrome|CAGS|ANKRD17
Boston Children''s Hospital
2022-08-27 --
NCT05533528 Recruiting
Periodontal Pocket|Periodontal Diseases|Periodontal Bone Loss
Universidad de Murcia
2022-05-03 Not Applicable
NCT05118009 Completed
Myocardial Infarction Acute
National Defense Medical Center Taiwan
2022-05-01 Not Applicable
NCT02530255 COMPLETED
Alzheimer Disease
Chippewa Valley Eye Clinic
2016-12-01

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cycloastragenol functions as a potent telomerase activator that stimulates telomerase enzymatic activity, thereby promoting telomere elongation and suppressing cellular senescence pathways. This enhancement of cellular lifespan and survival supports neuronal protection and tissue maintenance, demonstrating potential relevance in clinically studied conditions such as Alzheimer's disease and myocardial infarction.

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>).

Note: Technical data last updated: Sep 1, 2026.