Drug-maker Optimus Pharma on Wednesday said it received approval of the Drugs Controller General of India (DCGI) to conduct Phase III clinical trials for Molnupiravir capsule on mild and moderate COVID-19 patients.
As per the clinical trial protocols approved, a total of 2,500 subjects in both mild and moderate COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with standard supportive care or standalone standard supportive care. The treatment duration is a maximum of five days and the total study duration will be a maximum of 29 days from randomisation, the release said.
A release from Optimus Pharma said the company had internally developed the active pharmaceutical ingredient (API) and the formulations for the product. “Optimus is all geared to immediately begin clinical trials on Molnupiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule on COVID-19 patients,” CMD D. Srinivas Reddy said.
