Riamilovir Clinical Trials

Size	Price	Qty
25mg	USD 567

Clinical Trials

A clinical trial was designed as a Phase 2/Phase 3 study to evaluate the safety and efficacy of the broad-spectrum antiviral candidate Riamilovir in patients with mild-to-moderate COVID-19. Jointly supported by academic and commercial entities—including the Wits Health Consortium, PharmaCentrix, and the Perinatal HIV Research Unit of the University of the Witwatersrand—the study's recruitment status was ultimately recorded as terminated. Consequently, clinical evidence regarding Riamilovir’s therapeutic efficacy against SARS-CoV-2 remains limited.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Riamilovir acts as a synthetic purine analogue that targets viral RNA-dependent RNA polymerase, thereby disrupting viral nucleic acid synthesis and downstream genomic replication within host cells. By halting intracellular viral assembly and suppressing viral propagation, this mechanism underpins its therapeutic evaluation for inhibiting SARS-CoV-2 replication in patients with Covid19.

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>).