Defense Research and Development Organization (DRDO) has issued guidelines for the use of DRDO 2-DG Medicine anti-Covid drug 2–deoxy-D-glucose (2-DG), approved by DCGI for emergency use, for COVID-19 patients. To reduce viral synthesis as well as energy production of SARS-CoV-2 or coronavirus. The drug was developed in the DRDO lab at the Institute of Nuclear Medicine and Allied Sciences (INMAS), New Delhi in collaboration with Hyderabad-based pharma company Dr. Reddy’s Laboratories (DRL).
The much-awaited 2-DG coronavirus drug is not yet available in the market and is expected to be launched by mid-June. Ahead of its release, DRDO listed a set of guidelines to be followed while administering the drug to COVID-19 patients under the supervision and prescription of doctors.
The Defense Research and Development Organization (DRDO) on Tuesday shared guidelines for the use of its 2-DG (2-deoxy-D-glucose) drug in coronavirus patients, saying the drug should be given under the supervision and prescription of doctors. can.
The approval of the 2-DG drug, which has been developed by the Institute of Nuclear Medicine and Allied Sciences, a laboratory of DRDO, comes at a time when India is battling a record-breaking wave of the coronavirus pandemic that has spread across the country’s health. Service infrastructure to its limit.
The drug is a result of laboratory experiments started in April 2020 which found that this molecule was effective against the SARS-CoV-2 virus and inhibits viral growth. The ministry said the drug comes in powder form in sachets and is to be taken orally by dissolving in water. In the trend of efficacy, the ministry said, patients treated with 2-DG showed faster symptomatic cures than the standard of care (SOC) at various endpoints.
The approval obtained by 2-DG allows its use in moderate to severe cases. It is intended to be used as an adjuvant therapy, which means it may complement the primary line of treatment for such patients.
How does 2-DG, DRDO’s new oral drug for COVID work?
DRDO 2-DG Medicines: The Drugs Controller General of India (DCGI) on May 1 had approved the formulation for emergency use as adjuvant therapy in moderate to severe COVID-19 patients.
Defense Minister Rajnath Singh and Health Minister Dr. Harsh Vardhan on Monday (May 17) released the first batch of the indigenously developed anti-Covid-19 drug, 2-deoxy-D-glucose or ‘2-DG’.
The National drug regulator, the Drugs Controller General of India (DCGI), had on May 1 approved the formulation for emergency use as adjuvant therapy in moderate to severe COVID-19 patients.
How to use 2-DG Medicine?
As per the approval of the Director-General of India, DRDO issued guidelines for doctors prescribing medicine to COVID-19 patients.
To whom to give 2-DG Medicine
The 2-DG drug is an adjunct therapy to go along with the standard treatment of COVID-19 patients in a hospital setting.
It should be used only on prescription of doctors
Ideally, 2DG should be prescribed by doctors at the earliest to prevent the worsening of moderate to severe COVID19 infection.
2DG should be prescribed for a maximum duration of 10 days.
Who should not give 2-DG Medicine
2DG should not be given to patients with uncontrolled diabetes, severe heart problems, ARDS, severe hepatic and renal impairment as there are not enough studies to support this. Caution should be exercised.
2DG should not be given to pregnant and lactating women.
Should not be administered with 2DG to COVID-19 patients under 18 years of age.
DRDO also asked the patients and attendants in need of 2-DG medicine to request to contact Dr. Reddy’s Lab, Hyderabad for emergency medicine supply from the hospital.
“Patients/attendants are advised to request their hospital for the supply of medicine from Dr. Reddy’s Lab, Hyderabad on email: 2DG@drreddys.com,” the notice read.
How it works
According to a government release, data from clinical trials shows that the molecule helps in faster recovery of hospitalized patients with COVID-19, and reduces their dependence on supplemental oxygen.
The drug accumulates in virus-infected cells, and inhibits virus growth by inhibiting viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique, the release said.
During the first wave of the pandemic in April 2020, laboratory experiments were conducted by scientists from INMAS-DRDO in collaboration with the Center for Cellular and Molecular Biology (CCMB), Hyderabad found that this molecule was effective against SARS-CoV-2. Works. The coronavirus causes the disease Covid-19 and inhibits viral growth.
In May 2020, DCGI’s Central Drugs Standard Control Organization (CDSCO) allowed Phase 2 clinical trials of 2-DG in Covid-19 patients.
The government said DRDO and its industry partner, DRL, conducted the Phase 2 trial on 110 patients between May and October last year. Phase 2A was conducted in six hospitals, and Phase 2B (dose range) was conducted in 11 hospitals across the country.
Based on data from successful Phase 2 clinical trials, DCGI permitted Phase 3 clinical trials in November 2020. Between December 2020 and March 2021, late-phase trials were conducted on 220 patients admitted to 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal. , Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka, and Tamil Nadu, the government said.
Phase 2 clinical trials were conducted to test the safety and efficacy of the drug in COVID-19 patients. The government release said 2-DG was found to be safe in Covid-19 patients, and there was a significant improvement in their recovery.
In the trend of efficacy, “patients treated with 2-DG showed a faster symptomatic cure than standard care (SOC) at various endpoints,” the release said.
“A significant favorable trend (a difference of 2.5 days) was observed in terms of the meantime to achieve normalization of specific vital sign parameters compared to SoC.”
Data from a phase 3 clinical trial showed that in the 2-dG arm, “a higher proportion of patients improved symptomatically and were free of supplemental oxygen dependence (42% vs 31%) by the third day compared with SOC , which indicates early oxygen therapy/relief from dependence”, the government said.
According to the government, 2-DG being a common molecule and an analog of glucose, it can be easily produced and made available in large quantities.
The drug is available as a powder in a sachet, and can be taken orally after dissolving in water.