Clinical Trials

Multiple clinical trials sponsored by investigator Andrey Petrov evaluate S-Gboxin for aggressive high-grade central nervous system tumors, including glioblastoma multiforme, gliosarcoma, diffuse brainstem gliomas, and diffuse midline gliomas with H3 K27M or K28M mutations. A Phase 1 pilot study assessing S-Gboxin combined with standard care is currently marked as suspended. Additionally, an expanded access program evaluating a lyophilized formulation for diffuse midline glioma is recorded with an unassigned phase and a recruitment status of no longer available.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

S-Gboxin acts by selectively inhibiting mitochondrial oxidative phosphorylation, which suppresses downstream metabolic bioenergetics and disrupts cellular energy homeostasis. This metabolic blockade leads to diminished cancer cell viability and growth inhibition, providing a biochemical rationale for targeting metabolic dependencies in aggressive central nervous system cancers such as glioblastoma 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>).

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