Astragaloside IV Clinical Trials

Size	Price	Qty
25mg	USD 97
100mg	USD 287

Clinical Trials

A clinical trial evaluated the therapeutic potential of Astragaloside IV in patients with solid tumors refractory to standard therapy. Sponsored by Livzon Pharmaceutical Group Inc., this completed Phase I study utilized a double-blind, dose-escalation design to systematically characterize safety and pharmacokinetic parameters following intravenous infusion. Clinical investigation of Astragaloside IV currently remains in early-stage assessment aimed at establishing baseline pharmacokinetic profiles in advanced oncology populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04026321	COMPLETED	Solid Tumor Refractory to Standard Therapy	Livzon Pharmaceutical Group Inc.	2018-10-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2019-07-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Astragaloside IV suppresses the phosphorylation and downstream activation of key signaling mediators, including p-Akt, p-mTOR, p-NF-κB, and p-Erk1/2, thereby inhibiting oncogenic cascade propagation. This multi-pathway blockade downregulates cell proliferation and promotes programmed cell death, providing a biological rationale for evaluating its therapeutic efficacy in refractory solid tumors.

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>).