Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection at the 2025 Digestive Disease Week (DDW) Annual Meeting
Mallinckrodt has announced the presentation of five clinical studies on TERLIVAZ® (terlipressin) at the 2025 Digestive Disease Week (DDW) in San Diego. The research focuses on treating hepatorenal syndrome (HRS) with rapid reduction in kidney function, also known as HRS-AKI.
TERLIVAZ is the first FDA-approved treatment for this rare condition, which affects over 42,000 Americans annually (0.01% of U.S. population). The presentations include one oral presentation and four posters, covering topics such as real-world treatment outcomes, comparative analysis between UK and US patients, and efficacy in patients with alcohol-associated liver disease.
The presentations will take place from May 3-6, 2025, featuring research on transplant waitlist status, treatment comparisons, and benefit-to-risk profiles. Important safety information indicates that TERLIVAZ may cause serious respiratory failure, particularly in patients with volume overload or acute-on-chronic liver failure Grade 3.
Mallinckrodt ha annunciato la presentazione di cinque studi clinici su TERLIVAZ® (terlipressina) durante la Digestive Disease Week (DDW) 2025 a San Diego. La ricerca si concentra sul trattamento della sindrome epatorenale (HRS) con rapido deterioramento della funzione renale, nota anche come HRS-AKI.
TERLIVAZ è il primo trattamento approvato dalla FDA per questa rara condizione, che colpisce oltre 42.000 americani ogni anno (0,01% della popolazione statunitense). Le presentazioni includono un intervento orale e quattro poster, affrontando temi come i risultati del trattamento nella pratica clinica, l’analisi comparativa tra pazienti del Regno Unito e degli Stati Uniti, e l’efficacia nei pazienti con malattia epatica associata all’alcol.
Le presentazioni si terranno dal 3 al 6 maggio 2025 e riguarderanno lo stato delle liste d’attesa per il trapianto, confronti tra trattamenti e profili di beneficio-rischio. Informazioni importanti sulla sicurezza segnalano che TERLIVAZ può causare gravi insufficienze respiratorie, in particolare nei pazienti con sovraccarico di volume o insufficienza epatica acuta su cronica di grado 3.
Mallinckrodt ha anunciado la presentación de cinco estudios clínicos sobre TERLIVAZ® (terlipresina) en la Digestive Disease Week (DDW) 2025 en San Diego. La investigación se centra en el tratamiento del síndrome hepatorrenal (SHR) con rápida disminución de la función renal, también conocido como SHR-AKI.
TERLIVAZ es el primer tratamiento aprobado por la FDA para esta condición rara, que afecta a más de 42,000 estadounidenses cada año (0.01% de la población de EE.UU.). Las presentaciones incluyen una ponencia oral y cuatro pósteres, cubriendo temas como resultados del tratamiento en el mundo real, análisis comparativo entre pacientes del Reino Unido y EE.UU., y eficacia en pacientes con enfermedad hepática asociada al alcohol.
Las presentaciones se realizarán del 3 al 6 de mayo de 2025, con investigaciones sobre el estado en la lista de espera para trasplante, comparaciones de tratamientos y perfiles de beneficio-riesgo. Información importante de seguridad indica que TERLIVAZ puede causar insuficiencia respiratoria grave, especialmente en pacientes con sobrecarga de volumen o insuficiencia hepática aguda sobre crónica grado 3.
Mallinckrodt는 2025년 샌디에이고에서 열리는 소화기 질환 주간(DDW)에서 TERLIVAZ®(테를리프레신)에 관한 다섯 편의 임상 연구를 발표할 예정입니다. 연구는 신장 기능이 급격히 저하되는 간신증후군(HRS), 특히 HRS-AKI 치료에 중점을 두고 있습니다.
TERLIVAZ는 이 희귀 질환에 대해 FDA 승인을 받은 최초의 치료제로, 미국에서 매년 42,000명 이상(미국 인구의 0.01%)이 이 질환에 영향을 받습니다. 발표는 구두 발표 1건과 포스터 4건으로 구성되며, 실제 치료 결과, 영국과 미국 환자 간 비교 분석, 알코올 관련 간질환 환자에서의 효능 등을 다룹니다.
발표는 2025년 5월 3일부터 6일까지 진행되며, 이식 대기자 명단 상태, 치료 비교, 이익과 위험 프로필에 관한 연구가 포함됩니다. 중요한 안전 정보로는 TERLIVAZ가 체액 과부하 또는 급성-만성 간부전 3등급 환자에서 심각한 호흡 부전을 유발할 수 있다는 점이 있습니다.
Mallinckrodt a annoncé la présentation de cinq études cliniques sur TERLIVAZ® (terlipressine) lors de la Digestive Disease Week (DDW) 2025 à San Diego. La recherche porte sur le traitement du syndrome hépatorénal (SHR) avec une réduction rapide de la fonction rénale, également appelé SHR-AKI.
TERLIVAZ est le premier traitement approuvé par la FDA pour cette maladie rare, qui touche plus de 42 000 Américains chaque année (0,01 % de la population américaine). Les présentations comprennent une communication orale et quatre affiches, abordant des sujets tels que les résultats du traitement en conditions réelles, une analyse comparative entre patients britanniques et américains, ainsi que l’efficacité chez les patients atteints de maladie hépatique liée à l’alcool.
Les présentations auront lieu du 3 au 6 mai 2025, avec des recherches sur le statut en liste d’attente de transplantation, les comparaisons de traitements et les profils bénéfice-risque. Des informations importantes sur la sécurité indiquent que TERLIVAZ peut provoquer une insuffisance respiratoire grave, en particulier chez les patients présentant une surcharge volumique ou une insuffisance hépatique aiguë sur chronique de grade 3.
Mallinckrodt hat die Präsentation von fünf klinischen Studien zu TERLIVAZ® (Terlipressin) auf der Digestive Disease Week (DDW) 2025 in San Diego angekündigt. Die Forschung konzentriert sich auf die Behandlung des hepatorenalen Syndroms (HRS) mit raschem Nierenfunktionsverlust, auch bekannt als HRS-AKI.
TERLIVAZ ist die erste von der FDA zugelassene Behandlung für diese seltene Erkrankung, die jährlich über 42.000 Amerikaner betrifft (0,01 % der US-Bevölkerung). Die Präsentationen umfassen einen mündlichen Vortrag und vier Poster, die Themen wie Behandlungsergebnisse aus der Praxis, vergleichende Analysen zwischen britischen und US-amerikanischen Patienten sowie Wirksamkeit bei Patienten mit alkoholbedingter Lebererkrankung behandeln.
Die Präsentationen finden vom 3. bis 6. Mai 2025 statt und beinhalten Forschungen zum Status auf der Transplantations-Warteliste, Behandlungsvergleiche und Nutzen-Risiko-Profile. Wichtige Sicherheitsinformationen weisen darauf hin, dass TERLIVAZ schwere Ateminsuffizienz verursachen kann, insbesondere bei Patienten mit Volumenüberladung oder akut-chronischem Leberversagen Grad 3.
- None.
- None.
– Five presentations highlight TERLIVAZ research in adults with HRS with rapid reduction in kidney function,1 also known as HRS-AKI2 –
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 also known as HRS-AKI,2 an acute and life-threatening condition requiring hospitalization.3 HRS-AKI is estimated to affect more than 42,000 Americans annually, approximately
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
"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 (
Abstract #4243460: Treatment and Outcomes of Terlipressin in Hospitalized Adults with Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI): Real-world Evidence in Patients by Transplant Waitlist Status6
- Embargoed Until: Monday, May 5, 2025; 12:01 a.m. PDT
- Presenter: Kavish R. Patidar
- Session Type: Oral Presentation
- Session Title: SOA - Cirrhosis in the Obese Patient
- Session Date and Time: Monday, May 5, 2025; 4:45 – 5:00 p.m. PDT
Abstract #4253811: A Comparative Analysis of Real-World HRS-AKI Treatment and Outcomes in the
- Embargoed Until: Tuesday, May 6, 2025; 12:01 a.m. PDT
- Presenter: Stevan A. Gonzalez
- Session Type: Poster Session
- Session Title: Portal Hypertension and Non Bleeding Complications of Cirrhosis: Encephalopathy, Ascites, and HRS
- Session Date and Time: Tuesday, May 6, 2025; 12:30 – 1:30 p.m. PDT
Abstract #4253534: Real-World Treatment and Outcomes in Hospitalized Patients with Hepatorenal Syndrome-Acute Kidney Injury and Alcohol-Associated Liver Disease8
- Embargoed Until: Tuesday, May 6, 2025; 12:01 a.m. PDT
- Presenter: Robert Wong
- Session Type: Poster Session
- Session Title: Portal Hypertension and Non Bleeding Complications of Cirrhosis: Encephalopathy, Ascites, and HRS
- Session Date and Time: Tuesday, May 6, 2025; 12:30 – 1:30 p.m. PDT
Abstract #4230360: Transforming Hepatorenal Syndrome-Acute Kidney Injury Treatment: A Win Ratio Analysis of Terlipressin Versus Placebo9
- Embargoed Until: Tuesday, May 6, 2025; 12:01 a.m. PDT
- Presenter: Kavish R. Patidar
- Session Type: Poster Session
- Session Title: Portal Hypertension and Non Bleeding Complications of Cirrhosis: Encephalopathy, Ascites, and HRS
- Session Date and Time: Tuesday, May 6, 2025; 12:30 – 1:30 p.m. PDT
Abstract #4253824: Improving the Benefit-to-risk Profile: Efficacy Outcomes in Patients with Hepatorenal Syndrome-Acute Kidney Injury When Selected According to the Terlipressin Prescribing Information10
- Embargoed Until: Tuesday, May 6, 2025; 12:01 a.m. PDT
- Presenter: Michael P. Curry
- Session Type: Poster Session
- Session Title: Portal Hypertension and Non Bleeding Complications of Cirrhosis: Encephalopathy, Ascites, and HRS
- Session Date and Time: Tuesday, May 6, 2025; 12:30 – 1:30 p.m. PDT
These analyses were sponsored by Mallinckrodt Pharmaceuticals.
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
- 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 below90% .
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 DIGESTIVE DISEASE WEEK® (DDW)
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
ABOUT HEPATORENAL SYNDROME (HRS)
Hepatorenal syndrome (HRS) is a life-threatening condition that occurs in people with advanced liver disease.3 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care (HRS-acute kidney injury (AKI)) and a more chronic type that progresses over weeks to months (HRS-chronic kidney disease (CKD)).3 HRS-AKI is estimated to affect more than 42,000 Americans annually, approximately
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology and ophthalmology; neonatal respiratory critical care therapies; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CAUTIONARY STATEMENTS RELATED TO 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: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; 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 Mallinckrodt's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt 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.
CONTACT
Media Inquiries
Green Room Communications
908-577-4531
mediainquiries@grcomms.com
Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
Mallinckrodt, the "M" brand mark, TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
©2025 Mallinckrodt. US-2500183 04/25
References
1 TERLIVAZ® (terlipressin) for injection. [Prescribing Information]. Mallinckrodt Hospital Products Inc. 2023.
2 Flamm S.L., Brown K., Wadei H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
3 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at:https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed March 2025.
4 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed March 2025.
5 Singh J., Dahiya D.S., Kichloo A., et al. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890.
6 Patidar K.R., Barritt A.S. IV, Wong R., et al. Treatment and Outcomes of Terlipressin in Hospitalized Adults with Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI): Real-world Evidence in Patients by Transplant Waitlist Status. Abstract to be presented in an oral presentation at the Digestive Disease Week Meeting. May 2025.
7 Gonzalez S.A., Allegretti A.S., Chirikov V.V., et al. A Comparative Analysis of Real-World HRS-AKI Treatment and Outcomes in the
8 Wong R., Patidar K.R., Barritt A.S. IV, et al. Real-World Treatment and Outcomes in Hospitalized Patients with Hepatorenal Syndrome-Acute Kidney Injury and Alcohol-Associated Liver Disease. Abstract to be presented in a poster presentation at the Digestive Disease Week Meeting. May 2025.
9 Patidar K.R., Hernaez R., Cullaro G., et al. Transforming Hepatorenal Syndrome-Acute Kidney Injury Treatment: A Win Ratio Analysis of Terlipressin Versus Placebo. Abstract to be presented in a poster presentation at the Digestive Disease Week Meeting. May 2025.
10 Curry M.P., Pappas S.C., Marden M., et al. Improving the Benefit-to-risk Profile: Efficacy Outcomes in Patients with Hepatorenal Syndrome-Acute Kidney Injury When Selected According to the Terlipressin Prescribing Information. Abstract to be presented in a poster presentation at the Digestive Disease Week Meeting. May 2025.
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SOURCE Mallinckrodt plc
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