07 March 2022 | News
The drug helps in early relief of the clinical symptoms in mild to moderate COVID-19 patients
Mumbai-based Themis Medicare has announced the approval of its antiviral drug VIRALEX by the Drug Controller General of India (DCGI).
As per the results of double-blind randomized controlled trials (RCT), the drug helps in early relief of the clinical symptoms in mild to moderate COVID-19 patients.
Viralex is effective and well-tolerated in mild to moderate COVID-19, in two randomised controlled clinical trials conducted on 499 Indian patients.
In line with the DCGI’s current approach for approval of medicines for the management of the ongoing pandemic, approval for VIRALEX is based on the results of the robust phase 2 and phase 3RCTs conducted in India, and the well-established safety profile of the drug.
The drug was well tolerated by the patients without any serious side effects. The study was conducted during the Delta wave of the pandemic.