Summary
AKI continues to be associated with substantial morbidity and mortality, particularly in hospitalized and ICU-based settings where patients often present with severe underlying illness.
TERLIVAZ (terlipressin) is the only approved pharmacologic therapy in the broader AKI space, receiving US FDA approval in September 2022 for HRS-AKI, a high-mortality but relatively narrow AKI segment.
Drug development in AKI has faced numerous interconnected obstacles. Recent clinical setbacks, including the discontinuation of investigational candidates such as RMZ-035, ANG-3777, AP214, and GDC-8265, further highlight the complexity of these challenges.
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