Optimus Pharma gets nod for Molnupiravir Phase III trials

Hyderabad: Hyderabad-based Optimus Pharma has received approval from the Indian drug regulator, Drugs Controller General of India (DCGI), for conducting Phase III clinical trials of oral anti-viral drug Molnupiravir on patients with mild to moderate Covid-19 disease.

The company said that the trials will be conducted on as many as 2500 Covid-19 patients suffering from mild and moderate symptoms. The drug will be administered for a period of five days to the volunteers.

“As per the clinical trial protocols approved, total of 2500 subjects in both mild and moderate Covid-19 will be randomised in the study in a 1:1 ratio for Molnupiravir with standard supportive care or standalone standard supportive care. The treatment duration is a maximum of 5 days and the total study duration will be maximum for 29 days from randomisation,” the company said.

Molnupiravir is an experimental anti-viral drug developed for influenza and is now being repurposed for Covid-19.