Dublin, Ireland | May 1, 2026
Keenova Therapeutics has announced new real-world clinical analysis of TERLIVAZ® (terlipressin) for hepatorenal syndrome–acute kidney injury (HRS-AKI), to be presented at Digestive Disease Week (DDW) 2026, highlighting treatment patterns, patient outcomes, and evolving clinical insights in U.S. hospital settings. The data further strengthen the clinical evidence base for TERLIVAZ, the first and only FDA-approved therapy indicated to improve kidney function in adults with HRS-AKI, a life-threatening complication of advanced liver disease.
Real-World Clinical Data Enhances Treatment Understanding
The new analysis is based on preliminary real-world data collected from seven U.S. hospitals, offering critical insights into treatment patterns and patient outcomes associated with terlipressin use in routine clinical practice.
HRS-AKI is a rapidly progressive condition characterized by acute kidney failure in patients with advanced liver disease, associated with high morbidity and mortality, making timely and effective intervention essential. The study aims to bridge the gap between controlled clinical trials and real-world patient management, providing clinicians with valuable evidence to optimize treatment strategies. These findings are expected to inform clinical decision-making and improve patient care pathways in hospital settings.
TERLIVAZ Demonstrates Clinical Utility in HRS-AKI
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TERLIVAZ (terlipressin) is currently the only FDA-approved pharmacologic therapy specifically indicated for improving kidney function in HRS-AKI patients, addressing a significant unmet need in hepatology and critical care.
The drug works by constricting blood vessels and improving renal perfusion, helping to reverse kidney dysfunction associated with severe liver disease. The growing body of evidence supports its role as a cornerstone therapy in managing HRS-AKI, particularly in hospitalized patients requiring urgent intervention. As incidence rates of HRS continue to rise globally, the importance of effective treatment options like TERLIVAZ becomes increasingly critical.
Safety Profile and Risk Management Considerations
While TERLIVAZ provides meaningful clinical benefits, it is associated with important safety considerations, including a boxed warning for serious or fatal respiratory failure.
Patients with hypoxia or advanced liver failure are at increased risk, requiring careful monitoring of oxygen saturation and respiratory status during treatment. Additional risks include ischemic events and fluid overload, emphasizing the need for strict adherence to clinical guidelines and patient monitoring protocols. These safety considerations highlight the importance of balancing therapeutic benefits with risk management in critically ill patient populations.
Expanding Clinical Evidence Through Scientific Collaboration
The presentation at DDW 2026 reflects ongoing efforts to expand the clinical evidence base for TERLIVAZ through real-world data and scientific collaboration, supporting continuous improvement in patient care.By sharing real-world insights with the global medical community, Keenova aims to enhance understanding of HRS-AKI and improve treatment outcomes, particularly in high-risk patient populations. The data also underscore the growing role of post-marketing evidence generation in validating and optimizing the use of approved therapies in real-world settings.
Addressing a Growing Clinical Burden
HRS-AKI represents a significant and increasing healthcare burden, with rising hospitalization rates and associated costs.Effective management of this condition requires early diagnosis, targeted therapy, and comprehensive patient monitoring, all of which are supported by emerging clinical evidence such as this analysis. The continued development and dissemination of real-world data are essential for advancing treatment standards and improving survival outcomes in this high-risk population.
Source: Keenova press release
