RNS: The Drugs Controller General of India (DCGI) has given approval for emergency use to an oral drug, developed by the Defence Research and Development Organisation (DRDO), for the treatment of moderate to severe coronavirus patients.
The drug 2-deoxy-D-glucose comes in powder form, needs to be taken orally by dissolving it in water the defence ministry said on Saturday.
“It accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique,” it said.
Clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence, it said.
The drug has been developed by one of the DRDO lab, Institute of Nuclear Medicine and Allied Sciences, INMAS in collaboration with Dr. Reddy’s Laboratories. Results of clinical trials have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in the country.
DRDO took the initiative of developing anti-Covid therapeutic application following the Prime Minister Narendra Modi’s call for preparedness against the pandemic.
In April last year, scientists of the INMAS conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, the Central Drugs Standard Control Organization permitted Phase-II clinical trial of 2-deoxy-D-glucose in COVID patients.
In Phase-II clinical trial, the drug was found to be safe in Covid patients and showed significant improvement in their recovery. The phase-II trial was conducted on 110 patients between the months of May to October last year.
Based on successful results, DCGI further permitted the Phase-III clinical trials in November last year.
The phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 Covid hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-III clinical trials was submitted to DCGI.
“On May 01, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country,” the ministry said in a statement.
The drug comes in powder form in a sachet and is taken orally by dissolving it in water. This drug will be of immense benefit to the people suffering from COVID-19, ministry said.
