Zydus Lifesciences plans Phase III Desidustat trial sickle cell ICMR

Zydus Lifesciences has secured regulatory approval to initiate a Phase III trial of Desidustat for treating anemia in sickle cell disease (SCD) in collaboration with the Indian Council of Medical Research (ICMR), following a successful Phase II proof-of-concept. The 203-day, double-blind, randomized, placebo-controlled study will enroll 164 patients to evaluate Desidustat’s efficacy and safety, building on US FDA Orphan Drug Designation for SCD and beta-thalassemia. Desidustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor that has already been approved in India and China for renal anemia, and is being developed to address anemia in SCD rather than directly modifying the underlying disease. SCD remains a significant public health challenge in India, affecting an estimated 20 million people with about 50,000 children born with the condition each year. The ongoing collaboration with ICMR-INTENT underscores a broader effort to advance novel therapies through public-private partnerships in India. Experts note that while Desidustat targets anemia improvement, the designation could position it as a potential first-in-class option for SCD-related anemia treatment.