Clinical Trials

Multiple clinical trials spanning Phase 2, Phase 3, and Phase 4 evaluate the therapeutic application and experimental utility of streptozotocin. These completed studies focus on multi-agent therapeutic strategies for advanced malignancies and conditions such as neuroendocrine tumors, islet cell adenoma, Zollinger-Ellison syndrome, adrenocortical carcinoma, and diabetic complications like myocardial infarction. Sponsored by academic institutions, government health organizations such as the National Institute of Diabetes and Digestive and Kidney Diseases, collaborative research groups, and industry partners like Hoffmann-La Roche, all of these trials have reached completed recruitment status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07083232 COMPLETED
Diabetic; Myocardial Infarction
Al-Azhar University
2024-10-30 PHASE4
NCT02246127 COMPLETED
Neuroendocrine Tumors
Grupo Espanol de Tumores Neuroendocrinos
2014-10-27 PHASE3
NCT00448136 COMPLETED
Neoplasms
Hoffmann-La Roche
2007-07 PHASE2
NCT00094497 COMPLETED
Carcinoma, Adrenal Cortical
Collaborative Group for Adrenocortical Carcinoma Treatment
2004-06 PHASE3
NCT00001165 COMPLETED
Islet Cell Adenoma; Neoplasm Metastasis; Zollinger Ellison Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1978-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-08-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Streptozotocin is a glucosamine-nitrosourea compound that alkylates and methylates DNA, thereby disrupting genomic integrity and triggering cellular autophagy and apoptotic cell death pathways. This targeted cytotoxicity towards insulin-producing pancreatic beta cells and endocrine tumor cells underlies its clinical utility in treating neuroendocrine tumors and pancreatic islet cell neoplasms.

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.