Prilocaine Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

The clinical trial landscape for prilocaine includes a clinical trial evaluating its utility as a local anesthetic agent during specialized diagnostic procedures. Specifically, an actively recruiting Phase IV study sponsored by an academic hospital, Hospital General Universitario Gregorio Marañón, is investigating the median effective dose of intrathecal hyperbaric prilocaine in patients undergoing transperineal magnetic resonance imaging-transrectal ultrasound fusion-guided prostate biopsy. Overall, this research emphasizes establishing optimized local anesthesia protocols to achieve effective analgesia during targeted prostate biopsies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05649020	Recruiting	Evaluate Requirements of 2% Prilocaine in MR-UF Prostate Biopsy	Hospital General Universitario Gregorio Marañon	2022-11-24	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Prilocaine is an amino amide local anesthetic that selectively binds to voltage-gated sodium channels on the neuronal cell membrane, inhibiting sodium ion influx and blocking membrane depolarization. This inhibition prevents the generation and conduction of nerve impulses along neuronal pathways, providing localized analgesia essential for procedural pain control during interventions such as prostate biopsies.

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>).