Zydus Lifesciences Limited and the Indian Council of Medical Research (ICMR) have commenced a Phase 2 proof-of-concept clinical trial for Desidustat in patients with Sickle Cell Disease (SCD). This trial, co-funded by the Indian National Clinical Trial and Education Network (INTENT), aims to evaluate the safety and efficacy of Desidustat in improving hemoglobin levels in SCD patients.
The double-blind, randomized, placebo-controlled trial will measure hemoglobin response as the primary endpoint, with secondary outcomes including the need for blood transfusions and incidence of vaso-occlusive crises. The study is being conducted across multiple centers in India and is registered under CTRI/2024/06/068363.
Dr. Rajiv Bahl, Director General of ICMR, emphasized the importance of this collaboration, stating that this effort underscores India’s focus on developing innovative healthcare solutions. Zydus Chairman Pankaj Patel highlighted the potential of the trial to contribute toward the goals of the National Sickle Cell Anemia Elimination Mission.
Sickle Cell Disease affects approximately 20 million people in India, with limited treatment options currently available. Desidustat, which is already approved for treating anemia in chronic kidney disease patients, offers hope for a novel therapy for managing this condition.