Clinical Trials

Multiple clinical trials evaluate Gboxin for aggressive central nervous system malignancies, specifically targeting glioblastoma multiforme, diffuse midline glioma with H3 K27M mutations, gliosarcoma, and diffuse brainstem glioma. Sponsored by Andrey Petrov, this research includes a Phase I pilot study and an expanded access program. Recruitment for these studies is currently designated as suspended or no longer available, reflecting early-phase clinical exploration of this compound in high-grade gliomas.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06806228 SUSPENDED
Glioblastoma Multiforme; Diffuse Midline Glioma, H3 K27M-Mutant; Gliosarcoma; Giant Cell Glioblastoma; GBM
Petrov, Andrey
2026-05-20 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gboxin selectively binds and inhibits mitochondrial F0F1 ATP synthase, thereby impairing oxidative phosphorylation and disrupting cellular ATP production. This metabolic suppression selectively arrests the growth of primary glioblastoma cells while sparing non-cancerous neural cells, rendering it clinically relevant for targeting metabolic vulnerabilities in glioblastoma multiforme and diffuse midline gliomas.

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>).

Note: Technical data last updated: Sep 1, 2026.