(20R)-Protopanaxadiol Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

A Phase 1 clinical trial sponsored by the biopharmaceutical company Careseng Biotech Co. Ltd. evaluates the safety, tolerability, and dose escalation of Careseng 1370 ((20R)-Protopanaxadiol) in healthy volunteers. Intended to address chemotherapy-induced myelosuppression, the recruitment status for this early-phase study is currently documented as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03974516	Unknown status	Chemotherapy-induced Myelosuppression	Careseng Biotech Co. Ltd.	2020-05-01	Phase 1

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

Check the (20R)-Protopanaxadiol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a dammarane-type triterpenoid sapogenin derived from Panax ginseng, (20R)-Protopanaxadiol modulates intracellular signaling cascades and cellular stress response pathways, suppressing oxidative damage and apoptosis in vulnerable tissues. This protective cellular action helps preserve hematopoietic cell viability and tissue integrity, providing clinical relevance for mitigating chemotherapy-induced myelosuppression and myocardial ischemia.

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>).