Dublin, Ireland, October 12, 2026
Keenova Therapeutics plc has announced a new exploratory analysis of TERLIVAZ® (terlipressin) in adults with hepatorenal syndrome–acute kidney injury (HRS-AKI) who are ineligible for liver transplantation. The analysis of data from the pivotal CONFIRM clinical trial was presented at the American College of Gastroenterology (ACG) Annual Meeting, held from October 9–14, 2026. The presentation examines the efficacy and safety of terlipressin in a particularly vulnerable patient population affected by advanced liver disease and rapidly declining kidney function. HRS-AKI is a serious complication of cirrhosis that can progress quickly and requires urgent hospital-based medical care. By examining outcomes among patients who cannot undergo liver transplantation, the analysis aims to provide additional clinical evidence to support treatment decisions in this challenging setting. TERLIVAZ is approved by the U.S. Food and Drug Administration (FDA) to improve kidney function in adults with HRS-AKI, making the findings relevant to clinicians managing this life-threatening condition.
CONFIRM Trial Analysis Focuses on Transplant-Ineligible Patients
The presentation, titled Efficacy and Safety of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Ineligible for Liver Transplant: An Exploratory Analysis of the CONFIRM Trial, was presented on October 12. It explores the clinical experience of patients who are not eligible for liver transplantation, a group for whom treatment decisions can be especially complex. The analysis was presented by Nancy Reau, MD, Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center. The work involved a multidisciplinary group of clinical and research contributors with expertise in hepatology, transplantation, pharmacy and clinical outcomes. The findings expand the available analysis of terlipressin in HRS-AKI and are intended to help healthcare professionals better understand the medicine’s potential role in this patient population. As an exploratory analysis, the results should be interpreted in the context of the original clinical trial design and the limitations associated with subgroup assessments. The announcement does not establish a new indication or demonstrate that terlipressin is appropriate for every transplant-ineligible patient. Treatment decisions require individualized assessment of expected benefits, clinical status and safety risks.
TERLIVAZ and Kidney Function in Advanced Liver Disease
Hepatorenal syndrome–acute kidney injury is characterized by a rapid deterioration in kidney function in people with advanced liver disease. It is associated with substantial morbidity and mortality and often requires hospitalization, close monitoring and coordinated specialist care. U.S. national data cited by Keenova indicate that the estimated annual number of hospital inpatients diagnosed with hepatorenal syndrome increased from 42,930 in 2018 to 63,381 in 2023, underscoring the growing clinical burden. Terlipressin is a vasopressin analogue that acts on blood vessels to improve circulatory function in appropriate patients with HRS-AKI. TERLIVAZ is administered intravenously and is intended to improve kidney function in adults with this condition. However, the medicine carries an important boxed warning for serious or fatal respiratory failure. Patients with fluid overload or acute-on-chronic liver failure Grade 3 may face increased risk, and oxygenation must be assessed before treatment and monitored during therapy. The product is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms and in those with ongoing coronary, peripheral or mesenteric ischemia. These considerations are especially important in advanced liver disease, where patients may have complex medical needs and limited treatment options.
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Keenova Advances Evidence for HRS-AKI Treatment
The latest presentation forms part of Keenova’s ongoing efforts to expand the clinical evidence surrounding TERLIVAZ and improve understanding of treatment outcomes in patients with serious liver-related complications. The company develops and commercializes branded therapeutics across several specialty areas, including nephrology, hepatology-related conditions and other diseases with unmet medical needs. The exploratory analysis presented at the ACG Annual Meeting may help clinicians assess the available evidence when considering treatment for patients who cannot receive a liver transplant. Further interpretation of the findings requires access to the detailed study results, including the relevant patient characteristics, efficacy measures and safety outcomes. The company announcement identifies the analysis and its clinical focus but does not provide numerical outcome data sufficient to establish a specific treatment benefit in transplant-ineligible patients. The findings therefore add to the ongoing clinical discussion rather than establish a new standard of care. Continued research, careful safety monitoring and individualized treatment decisions remain essential for managing HRS-AKI. For healthcare professionals, the analysis highlights the importance of evaluating both kidney-function outcomes and potentially serious adverse events when selecting treatment for patients with advanced liver disease.
Source: Keenova Therapeutics press release
