Thursday, September 11, 2025
Optimus seeks emergency approval from DCGI for phase 3 clinical trial of Molnupiravir for Covid-19

Optimus seeks emergency approval from DCGI for phase 3 clinical trial of Molnupiravir for Covid-19

Hyderabad, April 27 :Optimus Pharma Chairman and CEO, Dr D.Srinivas Reddy on Tuesday announced that they have filed for seeking emergency approval from the Drugs Controller General of India (DCGI) for Phase 3 Clinical Trial of Molnupiravir for Covid-19 in India.

Once the approval is granted for Phase 3 Clinical Trial, we would be extensively accelerating the manufacturing of our in-house developed generic version of Molnupiravir for making it available in the Indian market as soon as possible, the pharma company said in a release here.

Ensuring immediate relief to all those who have been infected with the highly virulent SARS-CoV-2, it said it will announce the development of oral Molnupiravir on fast lane.

Optimus Pharma , which is becoming a key player in fight against the COVID-19 pandemic in the country, having already achieved very high production levels of Favipiravir one of our flagship drugs for COVID-19 infection.

In a bid to develop and diversify our anti-viral portfolio especially against SARS-CoV-2, we are here with yet another promising drug to compensate for the lack of antiviral drugs in the market further diversifying our antivirals portfolio.

In hindsight of the raging second wave, Molnupiravir has been developed for non-hospitalized mild to moderate infections of SARS-CoV-2, the Pharma Company said it is aggressively pushing for achieving scalability for 800mg dose of the drug.

With our available pre-clinical data on Molnupiravir already demonstrated there were no adverse clinical signs and mortality observed in any of the treatment groups, it claimed.

The drug has been shown to be effective against a variety of viruses that use an RNA-dependent RNA polymerase (RdRp), as is the case with SARS-CoV-2 which is directly responsible for the transcription of Viral m-RNA of the virus in the infected subject.

It has been observed that Molnupiravir is only marginally successful in preventing extreme SARS-CoV-2 infection that is severe cases of the infection, the pharma company added.(UNI)

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