Zydus Lifesciences Gets Nod for Phase III Sickle Cell Trial

Zydus Lifesciences Ltd. has received approval to conduct a Phase III clinical trial for its drug Desidustat in patients with Sickle Cell Disease (SCD). The trial, conducted in collaboration with the Indian Council of Medical Research (ICMR), will evaluate the efficacy and safety of Desidustat oral tablets in treating anemia associated with SCD. This follows the successful completion of a Phase II Proof-of-Concept trial which met its primary endpoint. The US FDA has previously granted Orphan Drug Designation to Desidustat for both SCD and beta-thalassemia. The Phase III trial will enroll 164 patients and aims to address a significant unmet medical need, particularly in India where SCD is prevalent.