Clinical Trials

Benzophenone is currently evaluated in a clinical trial targeting breast cancer, specifically examining potential associations between breast and gut microbiota dysbiosis and cancer risk. Sponsored by an academic institution, the Universidad de Granada, this study has no reported phase and is currently active, not recruiting. Overall, the clinical landscape for benzophenone is characterized by limited academic research on physiological risk factors rather than interventional pharmaceutical development.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03885648 Active not recruiting
Breast Cancer
Universidad de Granada
2018-01-01 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzophenone functions as an ultraviolet light absorber by capturing energy across the UVA and UVB spectrums and dissipating it as harmless thermal energy, thereby protecting cellular structures from photo-induced degradation and DNA damage. By suppressing radiation-induced excitation and downstream cellular toxicity, this photoprotective mechanism helps maintain genomic integrity, which is relevant to mitigating oncogenic processes involved in breast cancer.

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.