Zydus Lifesciences Limited announced that the U.S. Food and Drug Administration (USFDA) has granted Orphan Drug Designation (ODD) to its novel oral HIF-PHI, Desidustat, for the treatment of Sickle Cell Disease (SCD). The USFDA's Office of Orphan Drug Products grants this designation to support the development of medicines for rare diseases affecting fewer than 200,000 people in the United States. This designation for Desidustat highlights the urgent medical need for a therapy for sickle cell disease, and Zydus believes Desidustat can address this unmet need. Currently, therapeutic options for sickle cell disease are limited. While hydroxyurea can reduce painful crises, it is not universally effective and carries side effects. Blood transfusions are costly, not always accessible, and carry risks. Zydus has completed a Phase II study evaluating the efficacy and safety of Desidustat for SCD, with data slated for publication in a medical journal. The Orphan Drug Designation by the USFDA provides Desidustat with eligibility for certain development incentives. These include tax credits for qualified clinical testing, exemptions from prescription drug user fees, and a potential seven-year marketing exclusivity upon USFDA approval.