Terlipressin

Also known as: Glypressin · Terlivaz

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application
Randomized controlled trials 140 of 1,263 publications on PubMed
Registered clinical trials 116 15 active
Adverse event reports 376 346 classified as serious
  • Terlipressin is an FDA-approved drug, marketed as Terlivaz (first approval: September 14, 2022).
  • PubMed lists 1,263 publications mentioning it, including 140 randomized controlled trials and 80 animal-only studies.
  • ClinicalTrials.gov lists 116 registered studies testing it (15 active).
  • FDA's adverse event system (FAERS) holds 376 reports mentioning it; 346 classified as serious. Reports do not prove causation.

Research topics

  • Vasoconstrictor Agents 81
  • Hepatorenal Syndrome 51
  • Acute Kidney Injury 40
  • Liver Cirrhosis 37
  • Albumins 16
  • Liver Transplantation 15
  • Esophageal and Gastric Varices 14
  • Gastrointestinal Hemorrhage 14
  • Norepinephrine 12
  • Ascites 8

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA022231 TERLIVAZ Approved, marketed September 14, 2022 MALLINCKRODT IRELAND

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 1,263
  • Human (MeSH) 944
  • Animal only 80
  • Clinical trials 173
  • Randomized controlled trials 140
  • Systematic reviews & meta-analyses 81
  • Case reports 155
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
116
Active
15
With posted results
7

Conditions studied

  • Hepatorenal Syndrome 17
  • Septic Shock 14
  • Liver Cirrhosis 10
  • Cirrhosis 10
  • Acute Kidney Injury 9
  • Portal Hypertension 8
  • Acute-On-Chronic Liver Failure 6
  • Cirrhosis, Liver 6
  • Ascites Hepatic 5
  • Acute on Chronic Liver Failure 4
  • Myoma 4
  • Liver Transplantation 3
Study Status Phase Start
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial
NCT07075315 Institute of Liver and Biliary Sciences, India
Not yet recruiting Phase 3 Jan 2028
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem Cell Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patient- Phase-II Trial
NCT07131306 Institute of Liver and Biliary Sciences, India
Not yet recruiting Phase 2 Jan 2027
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
NCT07252401 General Hospital of Shenyang Military Region
Not yet recruiting N/A September 25, 2026
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
NCT07746349 Sevil Cankaya
Not yet recruiting N/A August 1, 2026
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
NCT07178366 Institute of Liver and Biliary Sciences, India
Not yet recruiting N/A May 10, 2026
Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
NCT07304466 Istanbul Medipol University Hospital
Recruiting N/A December 29, 2025
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
NCT06855758 Beijing Friendship Hospital
Active, not recruiting N/A March 6, 2025
Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed
NCT06815770 Institute of Liver and Biliary Sciences, India
Not yet recruiting Phase 2, Phase 3 February 10, 2025
Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome
NCT06256432 Noorik Biopharmaceuticals AG
Active, not recruiting Phase 2 April 17, 2024
Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis
NCT06122753 West China Hospital
Not yet recruiting N/A Jan 2024
Show 40 more studies
Study Status Phase Start
Preemptive TIPS for Gastric Variceal Bleeding in Patients With Cirrhosis
NCT06122792 West China Hospital
Not yet recruiting N/A Jan 2024
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
NCT05346393 Jena University Hospital
Recruiting N/A November 29, 2022
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
NCT05490888 PharmaIN
Recruiting Phase 1 January 3, 2022
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets
NCT05266534 Wael Elbanna Clinic
Recruiting N/A December 30, 2021
Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial
NCT02473341 Dayanand Medical College and Hospital
Active, not recruiting Phase 3 November 14, 2017
Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome
NCT07460908 Lahore General Hospital
Completed N/A May 1, 2025
Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock
NCT06556472 Institute of Liver and Biliary Sciences, India
Unknown status N/A August 15, 2024
Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis
NCT03130127 General Hospital of Shenyang Military Region
Unknown status N/A July 1, 2024
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
NCT07719933 First Affiliated Hospital, Sun Yat-Sen University
Completed — April 1, 2024
Terlipressin in Combined Hepatorenal Syndrome in Patients With Signs of Chronic Renal Disease
NCT06161766 University Hospital Freiburg
Completed — March 3, 2024
Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients
NCT06108362 Beijing Tsinghua Chang Gung Hospital
Completed Phase 4 October 25, 2023
Efficacy of Continuous Terlipressin Therapy After Endoscopic Variceal Ligation
NCT06027970 Post Graduate Institute of Medical Education and Research, Chandigarh
Unknown status Phase 3 Sep 2023
To Study the Hemodynamic Response of Early Addition of Carvedilol to Terlipressin in Acute Variceal Bleed in Child's B and C Cirrhosis
NCT05699824 Institute of Liver and Biliary Sciences, India
Unknown status N/A July 1, 2023
Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome
NCT05875948 River 2 Renal Corp.
Unknown status Phase 2 June 30, 2023
Methods Decreasing Bleeding in Open Myomectomy
NCT05806307 Cairo University
Unknown status Phase 4 March 15, 2023
Noradrenaline Versus Glypressin for Prevention of Hypotension After Deflation of Tourniquet in Knee Arthroplasty
NCT05774067 Tanta University
Completed N/A December 1, 2022
Clinical Trial Comparing Noradrenaline (NA) Plus Placebo Versus Noradrenaline Plus Terlipressin (TP) in Septic Shock
NCT05207280 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Unknown status Phase 3 October 11, 2022
Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial
NCT05315557 Institute of Liver and Biliary Sciences, India
Unknown status N/A April 5, 2022
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
NCT04961528 Assistance Publique - Hôpitaux de Paris
Completed Phase 3 March 27, 2022
The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations
NCT05154279 Wael Elbanna Clinic
Unknown status N/A February 27, 2022
The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations
NCT05170230 Wael Elbanna Clinic
Unknown status N/A February 27, 2022
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
NCT05242783 Wael Elbanna Clinic
Completed N/A February 1, 2022
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
NCT05434286 Post Graduate Institute of Medical Education and Research, Chandigarh
Unknown status — December 15, 2021
Microcirculation Recruitment Using Albumin 20% and Terlipressin in Septic Patients
NCT05080543 Amany Mousa Salama Muhammed
Unknown status Phase 1 Oct 2021
Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.
NCT04819568 Institute of Liver and Biliary Sciences, India
Unknown status N/A June 25, 2021
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
NCT04112199 BioVie Inc.
Terminated Phase 2 June 17, 2021
Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy
NCT05331768 Instituto Mexicano del Seguro Social
Completed N/A January 1, 2021
Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
NCT04460560 University of Pennsylvania Results posted
Completed Phase 3 December 11, 2020
Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure.
NCT04416282 Institute of Liver and Biliary Sciences, India
Completed N/A June 22, 2020
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
NCT04353193 Juan A. Arnaiz
Unknown status Phase 4 Jun 2020
Terlipressin for Refractory Septic Shock
NCT04339868 Mahidol University
Unknown status Phase 2 April 3, 2020
Does Terlipressin Improve Renal Outcome After Liver Surgery
NCT02368249 University of Zurich
Withdrawn Phase 2 Jan 2020
The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
NCT04221672 Shanghai Zhongshan Hospital
Unknown status Phase 3 November 7, 2019
Thermal Imaging in Liver Disease.
NCT03279419 University of Edinburgh
Completed — September 1, 2019
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
NCT04948372 Southeast University, China
Completed N/A September 1, 2019
2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Control Acute Gastroesophageal Variceal Hemorrhage
NCT04056806 E-DA Hospital
Unknown status Phase 4 Aug 2019
Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903)
NCT04028323 Nanfang Hospital, Southern Medical University
Unknown status Phase 4 July 16, 2019
Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
NCT04013113 Institute of Liver and Biliary Sciences, India
Unknown status N/A July 9, 2019
Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage
NCT03846180 General Hospital of Shenyang Military Region
Completed — March 1, 2019
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
NCT04110418 Ain Shams University
Unknown status Phase 2 February 19, 2019

All 116 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
376
Serious
346
With death outcome
121

Most reported reactions

  • Drug ineffective 46
  • Ascites 23
  • Electrocardiogram qt prolonged 23
  • Renal impairment 22
  • Off label use 21
  • Diarrhoea 20
  • Multiple organ dysfunction syndrome 20
  • Hepatic encephalopathy 19
  • Acute kidney injury 17
  • Product use in unapproved indication 17
  • Respiratory failure 17
  • Hepatic failure 16

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.