DCGI nod to Optimus Pharma Molnupiravir Phase 3 trials on COVID patients
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Hyderabad: Drugs Manufacturer from Hyderabad, Optimus Pharma on Wednesday said it has received Drugs Controller General of India (DCGI) nod for conducting Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild and Moderate Covid-19.
With severe shortage of antiviral drugs in the market against the SARS-CoV-2 infection, it is imperative that more drugs with potent antiviral activity against SARS-CoV-2 be introduced, the Pharmaceutical company said in a release here.
Optimus pharma said having internally developed the Active Pharmaceutical Ingredient (API) and the formulations for the product, it had filed for clinical trials with the DCGI.
The DCGI gave nod for conducting the trial on mild and moderate patients.
As per the clinical trial protocols approved, a total of 2500 subjects in both mild and moderate COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with standard supportive care or standalone standard supportive care.
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