HY-094

HY-094 is an innovative intravenous (IV) injectable iron therapy being developed as a new chemical entity (NCE) for the treatment of iron deficiency and iron deficiency anemia. Co-developed by Hyloris Pharmaceuticals and AFT Pharmaceuticals, HY-094 is designed to address significant safety concerns associated with existing IV iron products, such as iron-induced hypophosphatemia. Clinical data suggests that HY-094 does not cause clinically relevant decreases in blood serum phosphate concentrations and maintains lower concentrations of free iron in the blood and urine, potentially offering a superior toxicity profile compared to current standards of care. The drug is currently entering Phase 3 clinical development, with a pivotal study expected to support global regulatory filings through 2028.