Hyderabad (Telangana) [India], May 25 (ANI/PRNewswire): Optimus Pharma on the 19th of May 2021 received DCGI nod for conducting Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild to Moderate Covid-19 patients.
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.
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 regulator gave nod for conducting the trial on mild to moderate patients.
Drugs manufacturer from Hyderabad on overdrive ANI | Updated: May 19, 2021 13:15 IST
Hyderabad (Telangana) [India], May 19 (ANI/PNN): Optimus Pharma on Tuesday received DCGI nod for conducting Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild and Moderate Covid-19 symptoms.
With a 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.
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 regulator gave a nod for conducting the trial on mild and moderate patients on May 18 2021.
May 19, 2021
The orally administered drug is being tested for treating mild and moderate infection
Optimus Pharma has received the approval of the Drug Controller General of India (DCGI) to conduct Phase III clinical trials of orally administered Molnupiravir capsules on patients with mild and moderate Covid-19 infection.
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.
Treatment modes
The treatment duration is a maximum of five days and the total study duration will be maximum for 29 days from randomisation, the Hyderabad-based company said in a release on Wednesday.
Optimus Pharma gets nod for phase 3 trials of Molnupiravir capsule
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Drug-maker Optimus Pharma on Wednesday said it received approval of the Drugs Controller General of India (DCGI) to conduct Phase III clinical trials for Molnupiravir capsule on mild and moderate COVID-19 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 a maximum of 29 days from randomisation, the release said.