Ethyl pyruvate Clinical Trials

Size	Price	Qty
25ul	USD 97

Clinical Trials

A Phase 4 clinical trial investigates the therapeutic application of a modified salicylate formulation of ethyl pyruvate for treating common cutaneous warts. Sponsored by Michael D. Grossman, D.P.M., in collaboration with Main Line Health, the study focuses on dermatological interventions targeting benign viral skin lesions. Currently, the recruitment status for this late-phase trial is documented as unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01712295	Unknown status	Warts	Grossman Michael D.P.M.\|Main Line Health	2011-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ethyl pyruvate acts as an antioxidant and anti-inflammatory agent that scavenges reactive oxygen species and blocks downstream nuclear factor kappa B activation, thereby suppressing pro-inflammatory cytokine production and cell apoptosis. By mitigating localized tissue inflammation and cellular damage, these biological effects provide a therapeutic rationale for its investigation in dermatological conditions such as warts.

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>).