Cinobufotalin Clinical Trials

Size	Price	Qty
1mg	USD 337
5mg	USD 997

Clinical Trials

Multiple clinical trials have evaluated the therapeutic application of cinobufotalin across Phase I and Phase III investigations targeting gastrointestinal and hepatic malignancies, including metastatic small intestine cancer and advanced hepatitis B virus-related hepatocellular carcinoma. Sponsored by academic and industry organizations such as the Shanghai University of Traditional Chinese Medicine and Beijing Shenogen Biomedical Co., Ltd., these studies focus on traditional Chinese medicine paradigms and comparative treatment efficacy. The recruitment status for these trials is currently listed as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03236636	UNKNOWN	Advanced HBV-Related Hepatocellular Carcinoma (HCC)	Beijing Shenogen Biomedical Co., Ltd	2017-09-08	PHASE3
NCT03189992	UNKNOWN	Malignant Tumor of Small Intestine Metastatic to Liver	Shanghai University of Traditional Chinese Medicine	2014-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2021-01-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cinobufotalin directly targets and inhibits sterol regulatory element-binding protein 1 (SREBP1), thereby disrupting downstream de novo lipogenesis pathways and metabolic homeostasis in malignant cells. This impairment of lipid biosynthesis suppresses tumor cell proliferation and survival, providing a mechanistic basis for its investigation in advanced HBV-related hepatocellular carcinoma and secondary liver metastases.

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>).