Triazavirin (TZV) Clinical Trials

Size	Price	Qty
1mg	USD 129
5mg	USD 457

Clinical Trials

A clinical trial evaluated the efficacy of Triazavirin (TZV) in patients with mild-to-moderate COVID-19 caused by SARS-CoV-2. Jointly sponsored by academic and commercial entities, including the Wits Health Consortium, PharmaCentrix, and the Perinatal HIV Research Unit, this pragmatic, double-blind, placebo-controlled Phase 2/Phase 3 study represents the documented evaluation landscape for the antiviral agent. However, recruitment for the study was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04581915	Terminated	Covid19	Wits Health Consortium (Pty) Ltd\|PharmaCentrix (Pty) Ltd\|Perinatal HIV Research Unit of the University of the Witswatersrand	2020-09-08	Phase 2\|Phase 3

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

Check the Triazavirin (TZV) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a synthetic nucleoside analogue, Triazavirin incorporates into nascent nucleic acid chains to inhibit viral RNA and DNA synthesis, thereby suppressing the replication of viral genomic fragments within host cells. This targeted block in viral nucleic acid synthesis prevents viral progeny assembly and cellular viral propagation, providing the mechanistic rationale for evaluating its therapeutic utility against viral respiratory infections such as COVID-19.

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>).