- In April 2025, Averoa announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for XOANACYL, an oral treatment for chronic kidney disease (CKD). This marks a significant milestone, bringing the therapy one step closer to potential approval in the European Union
- In March 2025, Kye Pharmaceuticals, Inc. announced the nationwide availability of ACCRUFeR (ferric maltol) in Canada. Approved as a prescription medication, ACCRUFeR is indicated for adult patients with iron deficiency anemia (IDA) who are either unresponsive to or unable to tolerate other oral iron therapies. Notably, ACCRUFeR is currently the only prescription-only oral treatment specifically approved for IDA in Canada
- In February 2023, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral therapy for treating anemia resulting from chronic kidney disease in adults who have been undergoing dialysis for a minimum of four months
- In December 2022, Shield Therapeutics plc announced the signing of an exclusive multi-year agreement with Viatris Inc. to co-commercialize Accrufer. As the only FDA-approved oral iron therapy for treating iron deficiency—with or without anemia—Accrufer stands out in the market. This strategic partnership aims to broaden Accrufer’s commercial reach and strengthen its market presence, supporting its ambition to become the preferred oral iron treatment in the U.S.
- In March 2022, Zydus Lifesciences Ltd. announced that it had received approval from the Drug Controller General of India for its New Drug Application (NDA) for Oxemia (Desidustat). Oxemia is the first oral treatment of its kind in India for managing anemia associated with chronic kidney disease (CKD). It is an oral, small-molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor designed to address anemia in CKD patients
