Themis Medicare gets DCGI nod for antiviral drug ‘Viralex’

Themis Medicare Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 530199 | NSE: THEMISMED

21 Mar 2022 Evaluate

Themis Medicare has received approval for its antiviral drug ‘Viralex’ from the Drug Controller General of India (DCGI). 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 COV1D- 19 patients.

In line with the DCGI's current approach for approval of medicines for the management of the ongoing pandemic, approval for Viralex (Generic name: lnosine pranobex) 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 (p<0.001) from that in the controlled group (52.38%) among the mild to moderate non-hospitalized COVID-19 patients. Clinical Cure (complete relief from symptoms) was also seen in significantly higher number of patients in the Viralex group as compared to that in the placebo group on day 6 of treatment. There was early improvement and complete relief from symptoms in patients who received Viralex. This drug was well tolerated by the patients without any serious side effects. The study was conducted during the Delta wave of the pandemic.

Themis Medicare is a research-based pharmaceutical company specializing in manufacture of a wide range of products for application areas like Pain Management, Critical Care and Anti-Infectives.