Clinical Trials

A Phase 1 clinical trial sponsored by Hefei TG ImmunoPharma Co. Ltd. is currently recruiting patients to evaluate Triglycidyl Isocyanurate (Teroxirone) for the treatment of advanced or metastatic solid tumors. The study investigates the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of the compound as an antineoplastic monotherapy. Overall, clinical research on Triglycidyl Isocyanurate remains in early development, aiming to establish its viability against advanced solid malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06374173 Recruiting
Advanced or Metastatic Solid Tumors
Hefei TG ImmunoPharma Co. Ltd.
 2024-01-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Triglycidyl Isocyanurate (Teroxirone) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Triglycidyl Isocyanurate acts as a triazene triepoxide alkylating agent that directly cross-links DNA, thereby inhibiting DNA replication and triggering p53 activation to induce cancer cell growth arrest. This cytotoxic mechanism suppresses tumor progression, providing the biological rationale for its clinical investigation in treating advanced or metastatic 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>).

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