Namodenoson (CF-102) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 367

Clinical Trials

Can-Fite BioPharma has sponsored several clinical trials evaluating the safety and therapeutic efficacy of Namodenoson across Phase 1/2 to Phase 3 development for liver conditions, including advanced hepatocellular carcinoma with cirrhosis, nonalcoholic steatohepatitis (NASH), and chronic hepatitis C. Completed investigations include Phase 2 studies in second-line advanced hepatocellular carcinoma and NASH. Currently, recruitment is active for a Phase 3 trial in advanced hepatocellular carcinoma with cirrhosis as well as a Phase 2B trial in NASH.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05201404	Recruiting	Hepatocellular Carcinoma\|Cirrhosis	Can-Fite BioPharma	2023-03-15	Phase 3
NCT04697810	Recruiting	NASH - Nonalcoholic Steatohepatitis	Can-Fite BioPharma	2021-12-10	Phase 2
NCT02927314	Completed	Non-alcoholic Steatohepatitis (NASH)	Can-Fite BioPharma	2017-11-27	Phase 2
NCT02128958	Completed	Hepatocellular Carcinoma	Can-Fite BioPharma	2014-09	Phase 2
NCT00790673	Completed	Chronic Hepatitis C	Can-Fite BioPharma	2009-07	Phase 1\|Phase 2
NCT00790218	Completed	Hepatocellular Carcinoma	Can-Fite BioPharma	2009-02	Phase 1\|Phase 2

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

Check the Namodenoson (CF-102) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Namodenoson acts as a selective agonist of the A3 adenosine receptor with a Ki of 0.33 nM, initiating receptor activation that deregulates downstream PI3K, NF-κB, and Wnt/β-catenin signaling pathways. This signaling deregulation suppresses inflammatory responses and cell survival pathways, conferring anti-inflammatory and antitumor effects relevant to its clinical evaluation in nonalcoholic steatohepatitis and hepatocellular carcinoma.

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>).