Keenova Presents a New TERLIVAZ® (terlipressin) Clinical Analysis at Digestive Disease Week

DUBLIN, May 1, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that a new presentation on hepatorenal syndrome-acute kidney injury (HRS‑AKI) and TERLIVAZ^® (terlipressin) will be shared at Digestive Disease Week (DDW), taking place May 2-5, 2026.

"We are pleased to share these findings with the medical community, as they expand the clinical evidence and advance our understanding of this challenging and rapidly progressive condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "These data improve understanding of characteristics, treatment patterns, and outcomes associated with terlipressin use in U.S. practice, helping inform efforts to support care for patients with HRS-AKI."

TERLIVAZ is the first and only FDA‑approved therapy indicated to improve kidney function in adults with HRS‑AKI.

Presentation Details

• Title: Real-world terlipressin treatment patterns and outcomes in hepatorenal syndrome-acute kidney injury (HRS-AKI): Preliminary data from seven US hospitals
• Authors: Stevan A. Gonzalez, MD; Aanchal Kapoor, MD; A. Sidney Barritt IV, MD, MSCR; Xingyue Huang, PhD; Sneha S. Kelkar, MSc, MPH; Rishi P. Verma, MPH; Malinda Tan, PharmD; Jordana K. Schmier, MA; Mary Panaccio, PhD; R. Todd Frederick, MD; Christopher White, MD, MSPH

About Hepatorenal Syndrome-Acute Kidney Injury
Hepatorenal syndrome–acute kidney injury (HRS-AKI) is a life-threatening condition in adults with advanced liver disease that is marked by a rapid decline in kidney function¹ and is associated with high morbidity and mortality.² It is an acute medical emergency that requires hospitalization.³ A U.S. study based on national data revealed that the projected annual number of inpatients diagnosed with HRS has increased between 2018 and 2023, from 42,930 to 63,381.⁴

INDICATION 
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

LIMITATION OF USE

• Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

• TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO₂) before initiating TERLIVAZ. 
   
• Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO₂ <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO₂ decreases below 90%.

Contraindications
TERLIVAZ is contraindicated:

• In patients experiencing hypoxia or worsening respiratory symptoms.
• In patients with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

• Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms.
   
  Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
   
• Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
   
• Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
   
• Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Adverse Reactions

• The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

Please click here to see full Prescribing Information, including BOXED WARNING.

About Keenova 
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.

Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com.

Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Keenova's most recent Annual Report on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available on the SEC's website (www.SEC.gov) and Keenova's website (www.keenova.com). The forward-looking statements made herein speak only as of the date hereof and Keenova does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

References

1. Wong RJ, Balasubramanian J, Panaccio M, Huang X. Acute kidney injury and hepatorenal syndrome among hospitalized patients with chronic liver disease. JAMA Netw Open. 2025;8(5):e2511816.
2. Loftus M, Brown RS Jr, El-Farra NS, Owen EJ, Reau N, Wadei HM, Bernstein D. Improving the management of hepatorenal syndrome–acute kidney injury using an updated guidance and a new treatment paradigm. Gastroenterol Hepatol (N Y). 2023;19(9):527-536.
3. National Organization for Rare Disorders. Hepatorenal syndrome. Available at https://rarediseases.org/rare-diseases/hepatorenal-syndrome. Accessed March 17, 2026.
4. Goyes M, et al. Increasing incidence, cost, and mortality of AKI and HRS in hospitalized patients with cirrhosis. JAMA Netw Open. 2025;8(5):e2511822.

SOURCE Keenova Therapeutics