PFK158 Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 690

Clinical Trials

A clinical trial sponsored by Advanced Cancer Therapeutics is evaluating PFK158 for therapeutic applications in patients with advanced solid malignancies. This open-label, multi-center, dose-escalation Phase 1 study focuses on safety, tolerability, and dosing evaluation, though its recruitment status is currently documented as unknown. Overall, clinical research regarding PFK158 remains centered on early-phase safety and dosing for advanced cancer conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02044861	UNKNOWN	Cancer	Advanced Cancer Therapeutics	2014-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2015-06-23)

Check the PFK158 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PFK158 functions as a potent and selective inhibitor of 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3), directly blocking glycolytic flux and reducing intracellular fructose-2,6-bisphosphate levels. This inhibition of tumor glycolysis triggers metabolic stress and suppresses cell proliferation, providing the mechanistic rationale for its therapeutic application and clinical evaluation in advanced solid malignancies.

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>).