Clinical Trials

Terlipressin Acetate has been evaluated in numerous clinical trials investigating its therapeutic utility across diverse vascular and hepatic conditions. Research spanning Phase 1 through Phase 4 studies focuses on indications such as hepatorenal syndrome, portal vein pressure elevation, septic shock, liver cirrhosis, acute kidney injury associated with liver transplantation, and perioperative blood loss during myomectomy. Prominent academic sponsors, including the Hospital Clinic of Barcelona, Shanghai Zhongshan Hospital, and Beijing Tsinghua Chang Gung Hospital, have conducted trials evaluating varied administration protocols. These clinical evaluations, encompassing statuses from completed studies such as NCT00628160 to actively recruiting interventions, assess the efficacy of terlipressin in improving systemic hemodynamics and mitigating serious vascular complications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07252401 NOT_YET_RECRUITING
Liver Cirrhosis
General Hospital of Shenyang Military Region
 2026-09-25
NCT07304466 RECRUITING
Liver Transplantation; Portal Hypertension
Istanbul Medipol University Hospital
 2025-12-29
NCT07746349 NOT_YET_RECRUITING
Uterine Fibroids (Leiomyoma); Uterine Myoma; Leiomyoma
Sevil Cankaya
 2026-08-01
NCT06855758 ACTIVE_NOT_RECRUITING
Kidney Transplant; Delayed Graft Function; Intraoperative Hypotension
Beijing Friendship Hospital
 2025-03-06
NCT06256432 ACTIVE_NOT_RECRUITING
Hepatorenal Syndrome; Liver Cirrhosis; Acute Kidney Injury; Ascites Hepatic
Noorik Biopharmaceuticals AG
 2024-04-17 PHASE2
NCT06815770 NOT_YET_RECRUITING
Acute on Chronic Liver Failure
Institute of Liver and Biliary Sciences, India
 2025-02-10 PHASE2; PHASE3
NCT04961528 COMPLETED
Hemoptysis
Assistance Publique - Hôpitaux de Paris
 2022-03-27 PHASE3
NCT03130127 UNKNOWN
Liver Cirrhosis; Portal Hypertension; Variceal Hemorrhage; Bleeding; Esophageal and Gastric Varices
General Hospital of Shenyang Military Region
 2024-07-01
NCT07460908 COMPLETED
Hepatorenal Syndrome
Lahore General Hospital
 2025-05-01
NCT06556472 UNKNOWN
Acute on Chronic Liver Failure
Institute of Liver and Biliary Sciences, India
 2024-08-15
NCT04339868 UNKNOWN
Septic Shock; Refractory Shock; Norepinephrine Adverse Reaction
Mahidol University
 2020-04-03 PHASE2
NCT02368249 WITHDRAWN
Kidney Failure
University of Zurich
 2020-01 PHASE2
NCT05170230 UNKNOWN
Myoma
Wael Elbanna Clinic
 2022-02-27
NCT05154279 UNKNOWN
Laparoscopic Myomectomy
Wael Elbanna Clinic
 2022-02-27
NCT05875948 UNKNOWN
Hepatorenal Syndrome; Acute Kidney Injury
River 2 Renal Corp.
 2023-06-30 PHASE2
NCT05207280 UNKNOWN
Septic Shock
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2022-10-11 PHASE3
NCT06027970 UNKNOWN
Variceal Hemorrhage
Post Graduate Institute of Medical Education and Research, Chandigarh
 2023-09 PHASE3
NCT05266534 RECRUITING
Myoma
Wael Elbanna Clinic
 2021-12-30
NCT06108362 UNKNOWN
Acute Kidney Injury; Liver Transplant; Complications
Beijing Tsinghua Chang Gung Hospital
 2023-08-18 PHASE4
NCT05699824 UNKNOWN
Liver Cirrhosis
Institute of Liver and Biliary Sciences, India
 2023-07-01
NCT02970175 COMPLETED
Bronchial Endoscopy
University Hospital, Rouen
 2017-06-30 PHASE3
NCT05242783 COMPLETED
Myoma
Wael Elbanna Clinic
 2022-02-01
NCT04460560 COMPLETED
Hepatorenal Syndrome
University of Pennsylvania
 2020-12-11 PHASE3
NCT05315557 UNKNOWN
Septic Shock; Cirrhosis, Liver
Institute of Liver and Biliary Sciences, India
 2022-04-05
NCT05080543 UNKNOWN
Septic Shock
Amany Mousa Salama Muhammed
 2021-10 PHASE1
NCT04416282 COMPLETED
Acute-On-Chronic Liver Failure; Hepatorenal Syndrome; Acute Kidney Injury
Institute of Liver and Biliary Sciences, India
 2020-06-22
NCT04056806 UNKNOWN
Variceal Rebleeding Rate and Infections
E-DA Hospital
 2019-08 PHASE4
NCT04819568 UNKNOWN
Liver Cirrhosis
Institute of Liver and Biliary Sciences, India
 2021-06-25
NCT04353193 UNKNOWN
Liver Cirrhosis Portal
Juan A. Arnaiz
 2020-06 PHASE4
NCT05331768 COMPLETED
Esophageal and Gastric Varices
Instituto Mexicano del Seguro Social
 2021-01-01
NCT04221672 UNKNOWN
Terlipressin Adverse Reaction; Ascites Hepatic; Liver Failure; Acute Kidney Injury
Shanghai Zhongshan Hospital
 2019-11-07 PHASE3
NCT04028323 UNKNOWN
Renal Function Disorder; Acute Variceal Bleeding
Nanfang Hospital, Southern Medical University
 2019-07-16 PHASE4
NCT03608514 UNKNOWN
Resolution of Septic Shock With Terlipressin
National Hepatology & Tropical Medicine Research Institute
 2018-07-01 PHASE2; PHASE3
NCT04948372 COMPLETED
Septic Shock
Southeast University, China
 2019-09-01
NCT04028505 UNKNOWN
Terlipressin Adverse Reaction
Aga Khan University
 2018-10-25 PHASE3
NCT03822091 COMPLETED
Type 1 HEPATO RENAL SYNDROME(HRS)
Post Graduate Institute of Medical Education and Research, Chandigarh
 2019-01-28 PHASE3
NCT04358016 COMPLETED
Cirrhosis, Liver; Upper Gastrointestinal Bleeding
Changhai Hospital
 2018-01-01 PHASE4
NCT03584087 COMPLETED
Acute Variceal Haemorrhage
Post Graduate Institute of Medical Education and Research, Chandigarh
 2018-05-07 PHASE4
NCT02770716 COMPLETED
Hepatorenal Syndrome
Mallinckrodt
 2016-07-13 PHASE3
NCT03107091 COMPLETED
Cirrhosis; Ascites Hepatic
BioVie Inc.
 2017-07-15 PHASE2
NCT03336814 UNKNOWN
Septic Shock
Assistance Publique Hopitaux De Marseille
 2018-07-27 PHASE4
NCT03038503 UNKNOWN
Septic Shock; Refractory Shock
Ramathibodi Hospital
 2016-12 PHASE3
NCT03395574 COMPLETED
Terlipressin Adverse Reaction; Liver Transplantation
Kasr El Aini Hospital
 2018-01-25 PHASE2
NCT03352349 UNKNOWN
Portal Vein Pressure
Shanghai Zhongshan Hospital
 2017-12-01 PHASE2
NCT03144713 COMPLETED
Cirrhosis
Institute of Liver and Biliary Sciences, India
 2017-05-28
NCT01921985 TERMINATED
Liver Resection; Liver Failure
Insel Gruppe AG, University Hospital Bern
 2013-11 PHASE2
NCT02726620 COMPLETED
Hypotension
Vanderbilt University Medical Center
 2017-01-05
NCT02695862 COMPLETED
Acute Variceal Bleeding
Institute of Liver and Biliary Sciences, India
 2016-05-05
NCT02788240 TERMINATED
Acute on Chronic Liver Failure
Institute of Liver and Biliary Sciences, India
 2016-05-01
NCT03572088 COMPLETED
Terlipressin; Blood Loss
Assiut University
 2016-05 PHASE2
NCT02718599 COMPLETED
Hemodynamics, Liver, Terlipressin
Assiut University
 2016-04 PHASE2
NCT02489864 UNKNOWN
Hepatorenal Syndrome
Sun Yat-sen University
 2015-07 PHASE4
NCT02468063 COMPLETED
Cirrhosis With Septic Shock
Institute of Liver and Biliary Sciences, India
 2015-05-01
NCT02573727 COMPLETED
Acute on Chronic Liver Failure
Institute of Liver and Biliary Sciences, India
 2015-10
NCT02059460 COMPLETED
Acute Kidney Injury; Liver Transplantation; Terlipressin; NGAL
National Liver Institute, Egypt
 2013-05 PHASE4
NCT01530711 UNKNOWN
Cirrhosis; Hepatorenal Syndrome Type I
Pere Gines
 2012-04 PHASE4
NCT02119884 COMPLETED
Gastric and Esophageal Varices
Shanghai Zhongshan Hospital
 2014-02 PHASE4
NCT02588716 COMPLETED
Hepatectomy, Surgical Blood Loss, Terlipressin
Assiut University
 2015-09 PHASE2
NCT01697410 UNKNOWN
Septic Shock
First Affiliated Hospital, Sun Yat-Sen University
 2013-01
NCT02306239 UNKNOWN
Terlipressin; Septic Shock
Liu ZiMeng
 2014-12
NCT01649037 WITHDRAWN
Hepatorenal Syndrome
Institute of Liver and Biliary Sciences, India
 2012-08
NCT00986817 COMPLETED
Cirrhosis
Assistance Publique - Hôpitaux de Paris
 2009-11 PHASE3
NCT02757703 COMPLETED
Vasoconstrictor Choice on Acute Variceal Bleeding
Kaohsiung Veterans General Hospital.
 2010-05 PHASE4
NCT00742690 UNKNOWN
Cirrhosis; Type 1 Hepatorenal Syndrome
University of Padova
 2005-05 PHASE2; PHASE3
NCT01640964 COMPLETED
Compensated Cirrhosis and Portal Hypertension
Novartis Pharmaceuticals
 2013-04 PHASE2
NCT01836224 COMPLETED
Cirrhosis With Septic Shock
Institute of Liver and Biliary Sciences, India
 2012-10
NCT01271114 TERMINATED
Septic Shock; Sepsis-associated Hypotension
Hospital General de Ciudad Real
 2012-06 PHASE3
NCT00742339 TERMINATED
Cirrhosis; Hepatorenal Syndrome
University of Padova
 2005-05 PHASE2; PHASE3
NCT01932151 COMPLETED
Hepatorenal Syndrome
Hospital Clinic of Barcelona
 2012-12
NCT01143246 COMPLETED
Hepatorenal Syndrome
Mallinckrodt
 2010-10-11 PHASE3
NCT00628160 COMPLETED
Liver Cirrhosis; Septic Shock
Hospital Clinic of Barcelona
 2006-10 PHASE2; PHASE3
NCT01637454 COMPLETED
Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS
Post Graduate Institute of Medical Education and Research, Chandigarh
 2009-01 PHASE3
NCT00966355 COMPLETED
Variceal Bleeding, Cirrhosis
Korea University
 2006-09 PHASE4
NCT01112852 COMPLETED
Esophageal Varices; Bleeding
National Science and Technology Council, Taiwan
 2006-12 PHASE4
NCT00995839 COMPLETED
Septic Shock; Sepsis
University of Roma La Sapienza
 2008-11 PHASE2; PHASE3
NCT00863837 UNKNOWN
Esophageal Variceal Rebleeding
National Science and Technology Council, Taiwan
 2006-12 PHASE4
NCT00793559 UNKNOWN
Septic Shock
Assaf-Harofeh Medical Center
 2008-11 PHASE2
NCT01373606 COMPLETED
Hepatorenal Syndrome Type 1
Ferring Pharmaceuticals
 2007-11 PHASE1; PHASE2
NCT00369694 COMPLETED
Hemorrhage; Esophageal Varices; Portal Hypertension
Aga Khan University
 2006-08 PHASE4
NCT00481572 COMPLETED
Septic Shock
University of Roma La Sapienza
 2007-01 PHASE2
NCT00370253 COMPLETED
Hepatorenal Syndrome
University of Turin, Italy
 2006-09 PHASE3
NCT00089570 COMPLETED
Hepatorenal Syndrome
Mallinckrodt
 2004-06 PHASE3
NCT00287664 SUSPENDED
Cirrhosis; Hepatorenal Syndrome
Hospital Clinic of Barcelona
 2002-02 PHASE4
NCT00115947 COMPLETED
Cirrhosis; Ascites
Hvidovre University Hospital
 2004-12 PHASE2; PHASE3
NCT00534677 COMPLETED
Portal Hypertension; Cirrhosis; Hematemesis; Melena
Aga Khan University
 2004-05 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the Terlipressin Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Terlipressin Acetate acts as a prodrug that is cleaved to release lysine vasopressin, which selectively binds to and activates vascular smooth muscle vasopressin V1 receptors. This receptor activation stimulates intracellular signal transduction pathways to induce potent splanchnic vasoconstriction, thereby reducing elevated portal vein pressure and restoring systemic blood pressure in clinical conditions such as hepatorenal syndrome and septic shock.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.