Benzamide Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

A clinical trial sponsored by Sanofi evaluated this small-molecule agent in patients with advanced solid tumors. This completed Phase 1 study investigated systemic disposition and electrocardiographic QT/QTc interval parameters following a radiolabeled dose, providing foundational clinical pharmacology and safety data. Overall, clinical development for this compound remains focused on early-phase pharmacokinetic characterization and safety assessments in advanced solid malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01161836	Completed	Advanced Solid Tumors	Sanofi	2010-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzamide binds to poly(ADP-ribose) polymerase with an IC50 of 3.3 μM, thereby inhibiting enzymatic catalytic activity and blocking downstream poly(ADP-ribosyl)ation required for single-strand DNA break repair. This interruption of DNA damage resolution induces toxic double-strand break accumulation and apoptotic cell death, leading to suppressed cellular proliferation and tumor growth in advanced 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>).