By: IPP Bureau
Last updated : July 23, 2026 11:16 am
203-day study with ICMR to evaluate the efficacy and safety of the oral therapy in 164 patients with sickle cell disease
Zydus Lifesciences Limited has received regulatory permission to initiate a Phase III clinical trial of Desidustat for the treatment of anaemia in patients with Sickle Cell Disease (SCD), marking a significant milestone in the development of a potential new therapy for the condition.
The 203-day multicentre study, to be conducted in collaboration with the Indian Council of Medical Research (ICMR), will evaluate the efficacy and safety of Desidustat oral tablets in 164 patients diagnosed with sickle cell disease.
Sickle Cell Disease remains a major public health challenge in India, particularly among tribal populations where the prevalence is significantly higher.
According to the National Health Mission, nearly 20 million people in the country are living with the condition, and approximately 50,000 children are born with sickle cell anaemia each year.
While treatment options such as hydroxyurea and blood transfusions are available, limited access, variable effectiveness and associated complications continue to leave a substantial unmet medical need.
Desidustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor discovered and developed by Zydus. The therapy is already approved in India for the treatment of anaemia associated with chronic kidney disease.
Dr. Rajiv Bahl, Secretary, Department of Health Research and Director General, ICMR, said, "We have successfully completed the Phase II study of Desidustat in Sickle Cell Disease in collaboration with Zydus Lifesciences. This truly marks a significant leap forward for patients who have limited options beyond hydroxyurea.”
“As we move towards Phase III trials, we see huge potential for this Indian innovation in addressing a severe health challenge. This collaboration reflects our commitment to clinical research through strong public-private partnerships," added Dr. Bahl.
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, “Sickle cell disease severely impacts the lives of millions of people and represents a high unmet medical need. We are happy to collaborate with ICMR to develop new and effective therapeutic options for patients living with Sickle Cell Disease.”
“Desidustat, discovered and developed at the Zydus Research Centre, reflects our commitment to advancing novel innovations and improving the quality of life for patients," added Patel.