4-Aminobenzoic acid Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated 4-aminobenzoic acid across diverse contexts, including spinal anesthesia for short-duration lower limb surgeries and metabolic research related to obesity and bone metabolism. These completed studies encompass Phase 2 and phase-not-applicable designs, with sponsorship from commercial and academic entities including Sintetica SA, Cross S.A., the University of Copenhagen, and the Danish Agriculture and Food Council.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02481505	Completed	Short Duration Lower Limb Surgery Via Spinal Anaesthesia	Sintetica SA\|Cross S.A.	2015-06	Phase 2
NCT01773304	Completed	Obesity\|Bone Metabolism	University of Copenhagen\|Danish Agriculture and Food Council	2012-12	Not Applicable

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

Check the 4-Aminobenzoic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4-Aminobenzoic acid serves as an essential precursor that interacts within folate biosynthetic pathways, supporting downstream tetrahydrofolic acid generation necessary for microbial nucleic acid synthesis and cellular viability. In physiological and clinical contexts, this compound functions as a critical structural component and metabolic tracer, offering clinical relevance in local anesthetic formulations for short-duration lower limb surgeries as well as metabolic profiling studies in obesity and bone metabolism.

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>).