Zydus Lifesciences Limited, in collaboration with the Indian Council of Medical Research (ICMR), has announced the successful completion of Phase II Proof-of-Concept trials and approval to initiate Phase III trials for Desidustat oral tablets in patients with Sickle Cell Disease (SCD).
The completed Phase II study met its primary endpoints, demonstrating positive efficacy and safety outcomes in treating SCD. The upcoming Phase III trial will be a double-blind, randomized, placebo-controlled, parallel, multicenter study designed to evaluate the safety and efficacy of Desidustat oral tablets specifically for managing anemia in sickle cell disease patients.
Highlighting its therapeutic promise for rare blood disorders, the US FDA has already granted Orphan Drug Designation (ODD) to Desidustat for both Sickle Cell Disease and beta-thalassemia. This joint initiative aims to deliver an effective, accessible oral therapeutic option to address a critical unmet medical need affecting millions globally.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
