2-DG, DRDO's Anti-COVID Drug, Now Cleared For Emergency Use: All You Need To Know
In a major breakthrough in the fight against COVID-19, the Drugs Controller General of India has approved an anti-COVID oral drug, developed by DRDO, for emergency use as adjunct therapy in moderate to severe coronavirus patients.
The therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy¡¯s Laboratories (DRL), Hyderabad.?
Faster recovery
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.
"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," a statement said.
Powder form
The 2-DG comes in powder form in sachet and is taken orally by dissolving it in water.?
"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," the Defence Ministry said.
According to the ministry, the DRDO had has been working on the anti-COVID therapeutic application since April last year.
The phase-II clinical trial of 2-DG in COVID-19 patients began in May 2020, and went on till October 2020.
In this stage the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery. Phase IIa was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC.
Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID hospitals.
In the ongoing second COVID-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation. The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of COVID-19 patients.
