Optimus granted DCGI nod for restricted emergency use of molnupiravir
Hyderabad: Hyderabad-based Optimus Pharma launched their frontline Covid-19 medication molnupiravir in the Indian market, as they have received permission for the restricted emergency use for Covid-19 drug.
Optimus Pharma is ready with a commercial quantity of the drug. The company has completed its phase 3 clinical trials on 1,218 subjects across 29 geographical study sites all over India.
“We wanted 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 five days of treatment duration,” said Optimus Pharma CMD Dr D Srinivasa Reddy.
Optimus Pharma has developed the bulk drug in-house at its R&D centre in Hyderabad. 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 metabolised 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.
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