Optimus Pharma announced that they have received permission from the Drugs Controller General of India (DCGI), to manufacture and market molnupiravir in the Indian market. This is for restricted use only.

Optimus Pharma successfully completed the Phase 3 Clinical Trial on 1218 subjects across 29 geographical study sites all over India. “We want to cover maximum demographic diversity into our trial in order to obtain data across the different geographical regions of the country and conclusive evidence that molnupiravir is able to bring about viral load reduction over 5 days of treatment duration” said Chairman and Managing Director of Optimus Pharma, Dr D Srinivasa Reddy.

Optimus Pharma has developed the API in house at its R&D center in Hyderabad. Optimus Pharma has revealed highly promising results of the drug in its ability to reduce viral load and bring out significant symptomatic improvement in patient’s health.

Molnupiravir is administered as an 800 mg dose by orally consuming four capsules of 200mg twice a day. Upon oral administration, molnupiravir, being a prodrug, is metabolized into its active form and converted into its triphosphate (TP) form. The TP form of molnupiravir is incorporated into RNA and inhibits the action of viral RNA-dependent RNA polymerase. This results in the termination of RNA transcription thereby significantly reducing viral replication.