FK866 (Daporinad) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

A clinical trial sponsored by Valerio Therapeutics evaluated the therapeutic application of FK866 (also known as Daporinad or APO866). This completed, open-label Phase 1/Phase 2 investigation assessed the safety and tolerability of the compound in patients with refractory B-cell chronic lymphocytic leukemia who were no longer amenable to conventional therapeutic options. The trial highlights the targeted exploration of this small-molecule inhibitor in advanced hematologic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00435084	Completed	B-cell Chronic Lymphocytic Leukemia	Valerio Therapeutics	2007-02	Phase 1\|Phase 2

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

Check the FK866 (Daporinad) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FK866 selectively binds to and inhibits nicotinamide phosphoribosyltransferase, thereby blocking the salvage pathway of nicotinamide adenine dinucleotide biosynthesis and depleting intracellular adenosine triphosphate levels. This metabolic crisis leads to mitochondrial membrane depolarization, autophagy, and caspase-independent cytotoxicity, which underlies its potential therapeutic efficacy in treating B-cell chronic lymphocytic leukemia.

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>).