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July 6, 2020

India’s Zydus gets Mexican approval to trial Desidustat for Covid-19

India-based pharmaceutical company Zydus has received approval from the Mexican regulatory authority, COFEPRIS, to assess Desidustat as a potential Covid-19 treatment.

India-based pharmaceutical company Zydus has received approval from the Mexican regulatory authority, COFEPRIS, to assess Desidustat as a potential Covid-19 treatment.

Mexico-based contract research organisation (CRO) Avant Santé Research Center will be responsible for the clinical and regulatory development of the drug in the country.

Zydus will perform a multi-centre, open-label, randomised, comparator-controlled Phase IIb trial to assess the safety and efficacy of Desidustat Tablet for the management of the disease.

During the study, 100mg tablets of the drug will be given for 14 days, along with recommended standard care.

Zydus Cadila chairman Pankaj Patel said: “At Zydus, we have been stepping up our efforts to fight the Covid-19 pandemic through therapeutic drugs, diagnostics and vaccines. With Desidustat, we will study a novel approach for the management of Covid-19.”

Patients with Covid-19 are known to experience signs of ‘hypoxia’, which can cause organ failure and death, even after the use of antivirals, anti-inflammatory drugs, or ventilators.

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The disease is said to decrease the amount of haemoglobin that can carry oxygen and carbon dioxide, leading to intense poisoning and inflammation in lung cells.

Desidustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.

At higher altitudes, the body responds to lower availability of oxygen by stabilising hypoxia-inducible factor, causing increased red blood cell production and improved oxygen delivery to tissues.

The drug is currently being studied in Phase III trials for treating chronic kidney disease patients.

Last week, Zydus secured regulatory approval from the Drug Controller General of India (DCGI) to conduct Phase I/II human trials of its Covid-19 vaccine candidate, named ZyCoV-D.

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