Last Updated on October 17, 2024 by The Health Master
HYDERABAD: The Hyderabad-based Hetero Drugs announced interim results from Phase III clinical trials of Molnupiravir in treatment of mild C-19 patients on Friday, July 9, 2021, seeking emergency use authorisation for the drug from the Drug Controller General of India (DCGI).
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 C-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.
DCGI denied approval for final trial of Sputnik Light to Dr Reddy’s Labs
DCGI allows Cipla to import Moderna vaccine in India
DCGI allows to conduct phase-III clinical trials on C-19 drug
Lupin gets CDSCO committee nod for marketing Ranibizumab
CDSCO asks Philips India to discontinue these Ventilators
IPCA Lab gets CDSCO nod to conduct Phase-III study of HCQ
All Legislation of India (for Pharma and Health professionals)
Latest Notifications: General (Pharmaceuticals)
Webinar held on Investigational skills for Drug regulators of India
CDSCO to API units: To file online applications on Sugam Portal
Delhi High Court set up IPD for Pharma Industry
Fake Favipiravir racket busted: FIR lodged
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
