Mericitabine Clinical Trials

Size	Price	Qty
5mg	USD 279

Clinical Trials

A clinical trial sponsored by Hoffmann-La Roche evaluated mericitabine for the treatment of chronic hepatitis C. Lacking a formal phase assignment, this long-term observational study assessed the durability of sustained virological response and the persistence of drug-resistant mutations following direct-acting antiviral therapy. The trial's recruitment status was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01168856	Terminated	Hepatitis C Chronic	Hoffmann-La Roche	2010-09	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mericitabine acts as a nucleoside inhibitor that selectively targets the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase, incorporating into nascent viral RNA to cause premature chain termination and block transcript elongation during viral replication. By halting viral RNA synthesis and preventing viral progeny production within host cells, this mechanism suppresses viral load to achieve therapeutic clearance in chronic hepatitis C.

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>).