The Drugs Controller General of India (DCGI) approved the antiviral drug VIRALEX, manufactured by Themis Medicare Ltd. (Themis), for the treatment of COVID-19. 

Inosine pranobex (VIRALEX) isan immunomodulatory agent exhibiting broad-spectrum antiviral properties and enhances both innate and adaptive immunity while boosting the body’s defense against any viral infection. The drug showed dose-dependent inhibition of viral replication against SARS- CoV-2 in an in vitro study started by Themis.

The approval is based on the findings from phase 2 and phase 3 double-blind randomized controlled clinical trials done in India. In the two RCTs conducted with 499 Indian patients, the drug was found to be effective and well-tolerated in patients with mild to moderate COVID-19 infection. The safety profile of the drug was also well-established. The drug provided early relief of the clinical symptoms in mild to moderate COVID-19 patients. 

The data from the phase 3 trial showed that 80.17% of the patients who were given VIRALEX showed that both clinical improvement and clinical cure were greater compared to the control group among the mild to moderate non-hospitalized COVID-19 patients on day 6. No serious side effects were reported.

After scrutinizing the data, the drug regulatory authority granted permission to manufacture and market the drugfor restricted emergency use of the drug as an add on therapy for the treatment of mild and moderate COVID-19. (ET Healthworld, March 12, 2022)