Pleconaril Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

A clinical trial evaluated the therapeutic utility of pleconaril for enterovirus infection in neonates presenting with enteroviral sepsis syndrome. Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), this Phase 2, double-blind, placebo-controlled study has completed recruitment while investigating whether capsid inhibition reduces viral burden and severe morbidity. Overall, the investigation highlights the targeted clinical development of pleconaril for severe enteroviral diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00031512	Completed	Enterovirus Infection	National Institute of Allergy and Infectious Diseases (NIAID)	2001-06-27	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pleconaril selectively binds to the hydrophobic pocket of the enteroviral capsid protein, thereby preventing the conformational changes necessary for viral uncoating and host cell entry. By halting viral genomic release and inhibiting viral replication, this mechanism blocks viral propagation to provide targeted therapeutic efficacy against enterovirus infection.

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>).