New Delhi: Generic drugmaker Dr Reddy’s Laboratories, which has developed the drug 2DG as a potential game-changer in the fight against COVID-19, has warned the public against the spurious and illegal products in the name of 2DG. Clinical trial registry data suggest that phase-3 trials for the medicine at over two dozen government and private hospitals and involving 220 patients may continue till August.
The third-phase trials began in January, while the phase-2 trials were conducted over a three-month period between June and September last year and involved 110 patients.
The pharmaceutical company that is all set to produce the drug for hospitals and the markets on Thursday (May 20), released a statement on Twitter regarding the 2DG medicine. It read:
“IMPORTANT INFORMATION REGARDING 2DG Emergency use approval has been granted in India for anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2DG) developed by INMAS, a lab of the DRDO, in collaboration with Dr Reddy’s Laboratories. 2DG is an oral anti-viral drug that can be administered only upon prescription to hospitalised moderate to severe COVID-19 patients as adjunct (add on) therapy along with existing standard care. 2DG has not yet been launched into the market. The price per sachet has not yet been announced. Commercial launch and supply of 2DG to major Government and private hospitals is expected to commence in mid-June. Price is being determined with a view to making it accessible and affordable to as many patients as possible and will be announced soon. Please beware of agents selling spurious or illegal products in the name of 2DG. Please beware of unverified messages relating to 2DG circulating on social media and on WhatsApp. For all queries, please write to 2DG@drreddys.com“
— Dr. Reddy’s (@drreddys) May 19, 2021
While 2-DG has been studied in more than 200 clinical trials for the treatment of various cancers globally, trials to use it as a COVID-19 drug are apparently being done in India only and incidentally, a strong case for its therapeutic use against the novel coronavirus was made in a study paper last year.
The Drugs Controller General India (DCGI) had granted permission in May last year to Dr Reddy’s Laboratories to conduct a clinical trial of 2-DG for ‘acute treatment of moderate to severe COVID-19 patients’.
Interestingly, Dr Reddy’s became the secondary sponsor after phase-2 trials and the DRDO’s Institute of Nuclear Medicine and Allied Sciences became the primary sponsor and main source for material or monetary support during the phase-3 trial.
The phase II clinical trials were conducted at 12 sites across India, including at private and government hospitals. The trials were conducted over a three-month period between June-September 2020, for which a total of 110 COVID-19 patients aged 18-65 years were enrolled.
Those with COVID-19 symptoms like fever, cough, difficulty in breathing, fatigue, body ache, headache, diarrhoea, nasal congestion took part in phase-2 clinical trials. The drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery.