Themis gets Drug Controller’s nod to launch Inosine Pranobex a novel medicine to treat Covid19, A Viral Infection

In a landmark development for the treatment of COVID-19, Themis Medicare Ltd. (Themis), a Pharmaceutical company headquartered in Mumbai with a legacy of over 50 years of making new treatment options available, announced the approval of its antiviral drug VIRALEX® by 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 COVID-19 patients.

Viralex^® has been found to be effective and well tolerated in mild to moderate COVID-19, in two Randomized 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^® (Generic name: Inosine 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® group as compared to that in the placebo group on day 6 of treatment. There was early improvement and cure 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.

Randomized, Double-Blind, Placebo-controlled, Multicentre Trial is considered as the clinical research methodology of the highest global standard for evaluating drugs against diseases. Themis is one of the few companies to submit data from a higher number of patients from RCTs for approval in management of COVID- 19.

After detailed deliberation, the drug regulatory authority granted permission to manufacture and market this new drug for restricted emergency use of the drug as an add on therapy for treatment of mild and moderate COVID-19.

VIRALEX^® would be available on the prescription.

Based on the promising study results, the drug appears to offer immense clinical benefit to the patients in the early stages of COVID-19, thus reducing the load on the health care system.

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. In an in vitro study initiated by Themis, it showed dose-dependent inhibition of viral replication against SARS- CoV-2 (COVID-19).

According to Themis, VIRALEX® will be manufactured at an EU-GMP-certified facility with the highest safety standards and stringent manufacturing protocols in place, and the medication will be available in the form of a 500 mg tablet at a much affordable price.

Speaking at the release, Dr. Sachin Patel, Managing Director& CEO of Themis Medicare Ltd. said, “Our endeavor has always been to develop medicines that benefit patients and make healthcare far, far more effective. Given the current scenario of grave health concerns and economic challenges surrounding COVID- 19 in India, this is our effort to contribute to the wellbeing of people of India”.