The DCGI approval comes at a time when India is grappling with oxygen shortage.
2-DG is developed by the Defence Research and Development Organisation’s (DRDO) lab, the Institute of Nuclear Medicine and Allied Sciences (INMAS), in partnership with Dr Reddy’s Laboratories in the Telangana state of India.
Indicated for oral administration, 2-DG is available in powder form and can be dissolved in water. It works by building up selectively in the virus-infected cells and inhibits virus growth by hindering viral synthesis and energy production.
A Ministry of Defence press statement said: “Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
“Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients. The drug will be of immense benefit to the people suffering from Covid-19.”
In April last year, INMAS-DRDO researchers carried out laboratory experiments in collaboration with the Centre for Cellular and Molecular Biology (CCMB), Hyderabad and observed that 2-DG molecule works against SARS-CoV-2 and hinders viral growth.
The results from Phase II trials of 2-DG, which enrolled 110 Covid-19 patients, showed that the drug was safe and demonstrated substantial progress in their recovery.
Subjects who received the treatment had quicker symptomatic cure as compared to standard of care (SoC) on various efficacy endpoints.
Data showed that the difference in median time to reaching normalisation of certain vital signs parameters in those receiving treatment versus SoC was 2.5 days.
The Phase III trials, which commenced in November last year, enrolled 220 subjects at 27 Covid hospitals in various Indian states.
According to the results, an increased proportion of subjects in the 2-DG arm showed symptomatic improvement and were free of supplemental oxygen by day three versus SoC. This signifies that the treatment can provide quick relief from oxygen therapy or dependence.
In patients aged above 65 years, a similar development was seen.
The DCGI permitted the emergency use of 2-DG as an adjunct treatment for moderate to severe Covid-19 patients.
In a separate development, German company OntoChem has allocated its drug discovery technologies and assets, including its drug discovery partnership with Anixa Biosciences to a new company, MolGenie.
Anixa and OntoChem were planning to develop an oral, metabolically stable, non-toxic anti-viral Covid-19 therapy.