“As per the results of a double-blind randomized controlled trials (RCT), the drug helps in early relief of the clinical symptoms in mild to moderate COVID-19 patients”, the drug company said in an exchange filing.

The approval for VIRALEX is based on the results of the robust phase 2 and phase 3 RCTs conducted in India, and the well-established safety profile of the drug. As per the results of the Phase 3 Randomized, Double-blind, Placebo-controlled Trial, 80.17% of patients treated with VIRALEX showed clinical improvement on day 6, which is significantly higher from that in the controlled group.

VIRALEX is an immunomodulatory agent with broad-spectrum antiviral properties. It enhances both innate & adaptive immunity and strengthens the body's defence response to viral infections. Themis said that the drug will be manufactured at an EU-GMP-certified facility and the medication will be available in the form of a 500 mg tablet.

Themis Medicare is a pharmaceutical company, engaged in manufacturing pharmaceuticals and medicinal chemicals. On a consolidated basis, the company reported a 6% rise in net profit to Rs 12.46 crore on a 44.9% jump in net sales to Rs 94.92 crore in Q3 FY22 over Q3 FY21.

Shares of Themis Medicare closed 2.14% lower at Rs 1,007.25 on Thursday.