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Non-clinical GLP genotoxicity and rodent oral toxicity studies of 6′-hydroxy justicidin B for anti-COVID-19 agent development

Year: 2025

Type: article

Abstract: Despite the development of Coronavirus Disease 2019 (COVID-19) vaccines, the search for a definitive cure continues. 6′-Hydroxy justicidin B (6′-HJB), found in Justicia procumbens and used in Chinese medicine for its antiviral properties, shows promise as a therapeutic candidate against COVID-19. Nevertheless, it is crucial to establish its safety profile before clinical trials. This study evaluated its safety through non-clinical Good Laboratory Practice genotoxicity and rodent toxicity studies. The results indicated that 6′-HJB is not genotoxic, supporting its safety for future clinical use. The compound exhibited a low risk of DNA damage, a critical concern in drug development. Extensive toxicity studies, including single and repeated oral doses in Sprague Dawley rats, showed that the lethal dose of 6′-HJB exceeded 2000 mg/kg, with no observed adverse effects at this level. Safety data from genotoxicity and rodent toxicity studies strongly support further investigation of 6′-HJB as a novel treatment for COVID-19. 6′-HJB is expected to serve as a promising therapeutic option for overcoming future emerging viral infectious diseases. • GLP-compliant genotoxicity and toxicity tests established 6′-HJB safety. • 6′-HJB showed no genotoxic effects in regulatory-standard safety assays. • Oral doses up to 2000 mg/kg caused no mortality or adverse findings. • Sprague–Dawley rat studies confirmed non-lethal and non-toxic outcomes. • Results support 6′-HJB as a safe candidate for future clinical development.

Source: Biomedicine & Pharmacotherapy

DOI: 10.1016/j.biopha.2025.118708