Tetracaine HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate Tetracaine HCl across indications such as pain management, anesthesia, and local anesthesia during intratympanic steroid injections for Meniere disease and idiopathic sudden sensorineural hearing loss. Spanning Early Phase 1, Phase 2, and Phase 4, these studies are sponsored by both academic institutions and pharmaceutical companies to evaluate topical drops, intranasal pharmacokinetics, and patch delivery systems. Across these trials, recruitment statuses include completed, active but not recruiting, and suspended.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04794842	Active not recruiting	Intratympanic Steroid Injection\|Idiopathic Sudden Sensorineural Hearing Loss\|Meniere Disease	Our Lady of the Lake Hospital\|Louisiana State University Health Sciences Center - New Orleans	2021-08-01	Early Phase 1
NCT01952990	Completed	Anesthesia	St. Renatus LLC\|Triligent International\|Analytical Bio-Chemistry Laboratories Inc.\|Rho Inc.	2013-09	Phase 2
NCT01304316	Completed	Anesthesia	St. Renatus LLC\|Ground Zero Pharmaceuticals\|Rho Inc.	2010-09	Phase 2
NCT00747669	Suspended	Pain	ZARS Pharma Inc.	2008-09	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetracaine HCl acts as a potent local anesthetic and allosteric channel inhibitor that binds to voltage-gated sodium channels and ryanodine receptors, suppressing inward sodium currents and preventing calcium release from intracellular stores. By blocking the generation and conduction of nerve action potentials in sensory fibers, the compound prevents pain signal transmission to the brain, establishing its clinical utility as a local anesthetic for pain management and procedural analgesia across various clinical trial settings.

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>).