Drug firm MSN Laboratories on Tuesday said it is initiating a phase III clinical trial of Molnupiravir capsules for the treatment of COVID-19 in India. The company said it has received its clinical trial approval on May 19, 2021, from the Drug Controller General of India (DCGI) to perform an efficacy and safety study on Molnupiravir capsules on mild to moderate COVID-19 patients.
The company will start its clinical trials in more than 40 sites across the country and the first dosing is expected to begin soon, MSN Laboratories said in a regulatory filing. The clinical trials will be performed on more than 2,400 subjects suffering from mild to moderate COVID-19, it added. Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.
MSN said its R&D team has developed both the API and Formulation and is expecting to launch the drug soon after the successful conclusion of the clinical study followed by regulatory approval.