Mallinckrodt to Present Five Clinical Studies on TERLIVAZ for Hepatorenal Syndrome at DDW 2025
Key Insights
Mallinckrodt will present five clinical analyses of TERLIVAZ (terlipressin) for hepatorenal syndrome (search) with rapid reduction in kidney function (HRS-AKI (search)) at Digestive Disease Week 2025 in San Diego.
TERLIVAZ is the first and only FDA-approved treatment for improving kidney function in adults with HRS-AKI (search), a rare and life-threatening condition affecting approximately 42,000 Americans annually.
The presentations will include real-world evidence on treatment outcomes in various patient populations, including those on transplant waitlists and with alcohol-associated liver disease (search).
Mallinckrodt plc announced today that it will present new clinical data on TERLIVAZ® (terlipressin) for injection at the upcoming Digestive Disease Week (DDW) meeting in San Diego from May 3-6, 2025. The company will showcase five presentations—four posters and one oral presentation—focusing on the drug's efficacy in treating hepatorenal syndrome (search) with rapid reduction in kidney function (HRS-AKI (search)).
TERLIVAZ holds a significant position in the treatment landscape as the first and only FDA-approved product indicated to improve kidney function in adults with HRS-AKI (search), a life-threatening condition requiring hospitalization. This rare condition affects more than 42,000 Americans annually—approximately 0.01% of the U.S. population—with hospitalization rates continuing to rise.
"We'll be sharing the results of five clinical data analyses at DDW, as we continue to evaluate TERLIVAZ's impact in real-world situations," said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer at Mallinckrodt. "We look forward to connecting with digestive disease colleagues in San Diego and discussing treatment options like TERLIVAZ for appropriate patients."
Key Presentations on TERLIVAZ at DDW 2025
The presentations will cover multiple aspects of TERLIVAZ's clinical performance and real-world outcomes:
Real-world Evidence in Transplant Waitlist Patients
An oral presentation by Kavish R. Patidar will examine treatment outcomes of terlipressin in hospitalized adults with HRS-AKI (search), specifically analyzing results based on patients' transplant waitlist status. This presentation is scheduled for Monday, May 5, 2025.
Comparative Analysis Between UK and US Outcomes
Stevan A. Gonzalez will present a poster comparing real-world HRS-AKI (search) treatment outcomes between the United Kingdom and United States, utilizing both raw clinical data and propensity score-matched evidence.
Outcomes in Alcohol-Associated Liver Disease (search)
Robert Wong will present findings on real-world treatment and outcomes in hospitalized patients with HRS-AKI (search) specifically in the context of alcohol-associated liver disease.
Win Ratio Analysis vs. Placebo
Another poster by Kavish R. Patidar will present a win ratio analysis comparing terlipressin versus placebo in transforming HRS-AKI (search) treatment.
Benefit-to-Risk Profile According to Prescribing Information
Michael P. Curry will present data on improving the benefit-to-risk profile, examining efficacy outcomes in patients with HRS-AKI (search) when selected according to the terlipressin prescribing information.
Understanding Hepatorenal Syndrome
Hepatorenal syndrome (search) is a life-threatening condition occurring in people with advanced liver disease (search). It is classified into two distinct types: a rapidly progressive form leading to acute renal failure (HRS-AKI (search)) and a more chronic type that progresses over weeks to months (HRS-chronic kidney disease).
The prognosis for untreated HRS-AKI (search) is particularly grim, with a median survival time of less than two weeks and greater than 80% mortality within three months. This underscores the critical importance of effective treatments like TERLIVAZ in this patient population.
Safety Considerations
TERLIVAZ carries a boxed warning for serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure Grade 3 are at increased risk. Healthcare providers must assess oxygenation saturation before initiating treatment and should not start TERLIVAZ in patients experiencing hypoxia until oxygenation levels improve.
Continuous monitoring using pulse oximetry during treatment is required, with instructions to discontinue TERLIVAZ if SpO2 decreases below 90%. The drug is contraindicated in patients experiencing hypoxia, worsening respiratory symptoms, or those with ongoing coronary, peripheral, or mesenteric ischemia.
The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Clinical Significance
These presentations at DDW 2025 will provide valuable insights into the real-world application of TERLIVAZ across different patient populations. The data may help clinicians better identify which patients are most likely to benefit from treatment while minimizing risks.
For a rare condition with such high mortality rates, understanding the nuances of treatment efficacy and safety profiles in various patient subgroups represents an important advancement in the management of HRS-AKI (search).
The Digestive Disease Week meeting, as the largest international gathering of physicians, researchers, and academics in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery, provides an ideal forum for sharing these findings with the medical community most directly involved in treating these patients.