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Hyderabad-based Hetero Drugs seeks emergency use authorisation for Molnupiravir

Phase III clinical trials were conducted at different sites across the country and involved 741 mild Covid-19 patients, and early clinical improvement was observed among the patients on Molnupiravir.

Published: 10th July 2021 09:02 AM  |   Last Updated: 10th July 2021 09:02 AM   |  A+A-

All adverse events reported in the Molnupiravir group were of non-serious nature, mild in severity and none led to drug discontinuation.

All adverse events reported in the Molnupiravir group were of non-serious nature, mild in severity and none led to drug discontinuation. (File photo | K K Sundar, Express)

By Express News Service

HYDERABAD: The Hyderabad-based Hetero Drugs announced interim results from Phase III clinical trials of Molnupiravir in treatment of mild Covid-19 patients on Friday, July 9, 2021, seeking emergency use authorisation for the drug from the Drug Controller General of India. 

In a press statement, the company informed that the Phase III clinical trials were conducted at different sites across the country and involved 741 mild Covid-19 patients. It said that early clinical improvement was observed among the patients on Molnupiravir as compared to the control group. The median time to clinical improvement was eight days in Molnupiravir group as compared to 12 days in the control group. 
Hospitalisations were fewer in the Molnupiravir group (1.89%) as compared to the control group (6.22%), and earlier RT-PCR negativity was also observed in the Molnupiravir group, it said. 

All adverse events reported in the Molnupiravir group were of non-serious nature, mild in severity and none led to drug discontinuation. The most common adverse events reported were nausea, diarrhoea and headache which were resolved completely, it added.



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