Hyderabad-based Optimus gets DCGI nod for molnupiravir phase III trials
The drug regulator gave nod for conducting the trial on mild and moderate Covid-19 patients
Hyderabad: Hyderabad-based Optimus Pharma received DCGI nod for conducting phase III clinical trials for orally administered molnupiravir capsules on patients with mild and moderate Covid-19 patients.
Optimus Pharma said, having internally developed the active pharmaceutical ingredient (API) and the formulations for the product, the company had filed for clinical trials with the DCGI. The regulator gave nod for conducting the trial on mild and moderate patients.
As per the clinical trial protocols approved, a total of 2,500 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. The treatment duration is a maximum of five days, and the total study duration will be maximum for 29 days from randomisation, the company said.
“Optimus is all geared to immediately begin clinical trials on molnupiravir on Covid-19 patients in India. The clinical trial will let us know the efficacy of this molecule on Covid-19 patients,” Optimus Pharma CMD Dr D Srinivas Reddy said.
The company stated that molnupiravir demonstrated promising results in reducing viral load to 0.0 per cent in merely five days of treatment duration. Based on completed phase II clinical studies, proposed dosage is 800mg twice daily, which significantly reduces viral culture in infected patients not progressing into ARDS (acute respiratory distress syndrome).
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