The Drugs Controller General of India (DCGI) has approved an anti-Covid-19 oral drug, developed by India’s Defence Research and Development Organisation (DRDO), for emergency use in patients with moderate to severe Covid-19 infection.
The drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in partnership with Hyderabad-based Dr Reddy’s Laboratories (DRL).
According to the government, the clinical trial results have shown that the molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
It said that a higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid-19 patients.
The drug, which comes in form of powder in a sachet, is taken orally by dissolving it in water.
It accumulates in the virus-infected cells and prevents the growth of the virus by stopping viral synthesis and energy production, making it a unique drug available for the Covid-19 treatment.
DRDO took the initiative of developing an anti-Covid therapeutic application of 2-DG after Prime Minister Narendra Modi’s call for preparedness against the pandemic.
In April last year, INMAS-DRDO scientists have carried out experiments with the support from Centre for Cellular and Molecular Biology (CCMB), based in Hyderabad.
They found that the molecule works effectively against the SARS-CoV-2 virus and inhibits the growth of the virus.
Based on the results, Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices, has permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May last year.
The Phase-II trials were conducted from May to October 2020 on 110 patients and the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery.
The patients treated with the 2-DG oral drug showed faster symptomatic cure than the standard of care (SoC) on several endpoints.
Based on successful results, DCGI has given a nod for the Phase-III clinical trials in November last year. The Phase-III clinical trial was conducted from December 2020 to March this year on 220 patients.
“On May 01, 2021, 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 of Defence said.