Articaine HCl Clinical Trials

Size	Price	Qty
50mg	USD 79

Clinical Trials

Multiple clinical trials have evaluated articaine for local anesthesia applications, assessing systemic exposure in healthy volunteers, anesthetic efficacy in irreversible pulpitis, and supplemental local infiltration for endodontic pain management. Spanning Phase 1, Phase 2/3, Phase 4, and non-applicable phase protocols, these completed or terminated studies are sponsored by academic and industry entities, including Cairo University, the University of Michigan, Dentsply International, American Genomics LLC, and the University of Illinois at Chicago.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04759339	Completed	Healthy	American Genomics LLC	2021-02-24	Phase 1
NCT04865848	Terminated	Anesthesia	University of Illinois at Chicago	2019-06-05	Not Applicable
NCT03174860	Completed	Pulpitis - Irreversible\|Anesthesia Local	Cairo University	2016-10	Phase 2\|Phase 3
NCT01496846	Completed	Irreversible Pulpitis	University of Michigan\|Dentsply International	2011-09	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Articaine reversibly binds to voltage-gated sodium channels on neuronal cell membranes, blocking the influx of sodium ions required for membrane depolarization. This inhibition halts the generation and propagation of action potentials along peripheral nerve fibers, producing localized loss of sensation relevant to its clinical use in managing irreversible pulpitis and procedural dental anesthesia.

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>).