Benzoic Acid Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple completed Phase 1 clinical trials have evaluated benzoic acid across distinct therapeutic indications in early-stage investigations sponsored by major pharmaceutical companies, including GlaxoSmithKline and Sanofi. These studies assessed the pharmacokinetic profile of topical benzoic acid in subjects with acne vulgaris, as well as systemic drug disposition and cardiac interval effects in patients presenting with advanced solid tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01527123	Completed	Acne Vulgaris	GlaxoSmithKline	2012-02-28	Phase 1
NCT01161836	Completed	Advanced Solid Tumors	Sanofi	2010-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Benzoic acid passively permeates microbial and cellular membranes, where it dissociates to release hydrogen ions, thereby acidifying the cytoplasm and inhibiting essential metabolic enzymes. This disruption of intracellular pH homeostasis and cellular energy production suppresses proliferation and compromises survival, providing the mechanistic rationale for its investigation in dermatological disorders such as acne vulgaris and oncology studies targeting 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>).