FPS-ZM1 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 347

Clinical Trials

The clinical landscape for FPS-ZM1 is currently defined by a clinical trial sponsored by the City of Hope Medical Center, which is currently not yet recruiting. This Phase I, first-in-human study investigates the application of FPS-ZM1 for managing post-operative cerebral edema in patients with glioblastoma, malignant glioma, and their recurrent forms. The trial aims to establish the preliminary therapeutic utility and safety of targeted RAGE inhibition in advanced neuro-oncology indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07791264	NOT_YET_RECRUITING	Glioblastoma; Malignant Glioma; Recurrent Glioblastoma; Recurrent Malignant Glioma	City of Hope Medical Center	2027-02-17	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the FPS-ZM1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FPS-ZM1 is a blood-brain barrier-permeable compound that selectively binds with high affinity to the V domain of the Receptor for Advanced Glycation Endproducts (RAGE), effectively blocking amyloid-beta interaction and suppressing downstream pro-inflammatory signaling cascades. By attenuating RAGE-driven inflammatory activation and cellular dysfunction, this inhibition reduces pathological vascular permeability, offering therapeutic relevance for controlling post-operative cerebral edema in glioblastoma and malignant glioma patients.

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>).