In a major development, India’s prestigious Defence Research and Development Organisation (DRDO) has developed an anti-Covid oral drug for emergency use. This oral drug is developed by DRDO’s biomedical lab – The Institute of Nuclear Medicine and Allied Sciences (INMAS) – in association with Dr Reddy’s Laboratories in Hyderabad. The Drugs Controller General of India (DCGI) has approved the medicine which has to be taken after dissolving it in water.
“Named 2-deoxy-D-glucose (2-DG), the drug was developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a laboratory of the DRDO in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad,” announced Defence Ministry said in New Delhi on Saturday.
Announcing the oral drug, the DRDO tweeted:
An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by INMAS, a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad. The drug will help in faster recovery of Covid-19 patients. https://t.co/HBKdAnZCCP pic.twitter.com/8D6TDdcoI7
— DRDO (@DRDO_India) May 8, 2021
Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A 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. The 2-DG comes in powder form in the sachet and is taken orally by dissolving it in water.
“On May 01, DCGI granted permission for emergency use of this drug as an 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,” said the Defence Ministry of India.
“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 Ministry said.
According to DRDO officials, in April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against the SARS-CoV-2 virus and inhibits the viral growth. Based on these results, the DCGI’s Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020.
The DRDO, in collaboration with Dr Reddy’s Laboratories in Hyderabad, started clinical trials to test the safety and efficacy of the drug in COVID-19 patients. In Phase-II trials (including dose-ranging) conducted from May to October 2020, the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery. Phase II-a was conducted in six hospitals and Phase II-b (dose-ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
In the 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, the 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 Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of the Phase-III clinical trial was presented to DCGI. In the 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day-3 in comparison to SoC, indicating an early relief from oxygen therapy or dependence, said DRDO’s scientists.
On May 01, 2021, DCGI granted permission for the Emergency Use of this drug as an 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 drug comes in powder form in the sachet, which 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,” said DRDO.
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