An In-Depth Analysis of Xagrotin: An Investigational Herbal Medicine for COVID-19

1. Executive Summary

Xagrotin is an investigational herbal medicine, developed by the originator organization Biomad AS, currently under clinical evaluation primarily for the treatment of COVID-19.[1] Composed of a combination of six distinct plants, Xagrotin has been studied for its potential therapeutic effects against SARS-CoV-2, the virus responsible for COVID-19.[2] Preclinical research, encompassing in-silico modeling, in-vitro cell studies, and in-vivo animal testing, has suggested a potential mechanism of action involving the binding of its constituent ligands to the spike receptor-binding domain and main protease of the coronavirus, thereby potentially interfering with viral entry and replication.[2] These preliminary studies also indicated no significant toxicity in normal human cell lines (HFF-2) and in animal models, paving the way for human trials.[2]

The clinical development program for Xagrotin has included a completed Phase 1/2 trial (NCT05017493) and an ongoing/pending Phase 3 trial (NCT05222425), both focused on COVID-19.[1] The Phase 1/2 trial, which investigated Xagrotin in patients with early-stage COVID-19, was notably stopped early due to observed significant therapeutic benefits.[5] Published results from this trial indicated substantial reductions in mortality rates, disease duration, and the rate and duration of hospitalization in patients receiving Xagrotin compared to a control group.[2] The subsequent Phase 3 trial aims to further evaluate Xagrotin extract (2 grams administered three times daily) in a larger population of non-severe SARS-CoV-2 outpatients, with a planned enrollment of 3000 participants across treatment, placebo (green tea), and standard of care arms.[4]