GMX1778 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 397

Clinical Trials

A Phase 1 clinical trial sponsored by the European Organisation for Research and Treatment of Cancer (EORTC) evaluated the safety and pharmacokinetics of GMX1778 in patients with unspecified adult solid tumors. However, recruitment for this early-stage study was ultimately withdrawn before trial completion. Consequently, no completed clinical trial data or advanced investigations for GMX1778 in this solid tumor population are available under this record.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00003979	WITHDRAWN	Unspecified Adult Solid Tumor, Protocol Specific	European Organisation for Research and Treatment of Cancer - EORTC	1999-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2012-07-11)

Check the GMX1778 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GMX1778 binds potently to nicotinamide phosphoribosyltransferase (NAMPT), inhibiting the key rate-limiting enzyme in the NAD+ salvage pathway and triggering programmed cell death with apoptotic features. By depleting vital intracellular NAD+ pools and impairing cellular bioenergetics, this targeted metabolic disruption provides the biochemical rationale for exploring GMX1778 as a potential therapeutic agent against adult solid tumors.

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>).