Clinical Trials

A completed Phase 2 clinical trial sponsored by National Cheng-Kung University Hospital evaluated fursultiamine in patients receiving concurrent chemoradiotherapy for esophageal squamous cell carcinoma. The study investigated the efficacy of this thiamine derivative as an adjunctive intervention to inhibit cancer stem cells when combined with standard chemoradiation protocols. Overall, clinical research into fursultiamine reflects an exploratory focus on its antineoplastic utility in gastrointestinal malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02423811 COMPLETED
Cancer Stem Cell
National Cheng-Kung University Hospital
 2015-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2019-03-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fursultiamine functions as a lipophilic thiamine prodrug that elevates intracellular thiamine diphosphate concentrations and disrupts thiamine-dependent metabolic pathways, leading to the downregulation of stemness-associated signaling and the loss of cancer stem cell viability. This blockade of stem cell maintenance pathways suppresses tumor self-renewal and enhances treatment responsiveness, providing a mechanistic foundation for its clinical evaluation in targeting cancer stem cells in esophageal squamous cell carcinoma.

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.