Optimus Pharma seeks nod for phase-3 trials of generic Molnupiravir

Our Bureau Hyderabad | Updated on April 26, 2021

For checking efficacy across demographics

Optimus Pharma has applied for emergency approval for Phase 3 clinical trial of its generic version of Molnupiravir from the Drugs Controller General of India.

“Phase 2a clinical trial study on enrolled 202 non-hospitalised adults is already made available. Virological analysis was characterized by marked decrease in positive viral culture in subjects who received Molnupiravir (all doses) relative to placebo - at day 5: 0% (0/47) for Molnupiravir and 24 pc (6/25) for placebo,’’ the Hyderabad-based company said in a release.

Furthermore, secondary objective for faster decrease in infectious virus among people with early Covid-19 who were treated with Molnupiravir are encouraging and phase-3 clinical trials were warranted for checking the efficacy of the molecule across demographics, particularly as the SARS-CoV-2 virus, it added.

Published on April 26, 2021

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