MedPath

Terlipressin

Generic Name
Terlipressin
Brand Names
Terlivaz
Drug Type
Biotech
CAS Number
14636-12-5
Unique Ingredient Identifier
7Z5X49W53P
Background

Terlipressin is a synthetic analogue of vasopressin, which is an endogenous neurohormone that acts as a vasoconstrictor. It is a prodrug of lypressin, or lysine vasopressin. Compared to endogenous vasopressin, terlipressin has a longer half life and increased selectivity for the V1 receptor. As a potent vasopressor, terlipressin has been investigated in various shock states and conditions with diminished vasomotor tone. It was also studied in hepatorenal syndrome (HRS) and variceal bleeding. The drug was first approved by the FDA in September 2022.

Indication

Terlipressin is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. The US prescribing information states that patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit from terlipressin.

Associated Conditions
Hepato-Renal Syndrome, Hepatorenal Syndrome Type 1, Oesophageal varices haemorrhage, Portal Hypertension

A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

Phase 1
Completed
Conditions
Hepatorenal Syndrome Type 1
Interventions
First Posted Date
2011-06-15
Last Posted Date
2012-02-14
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
8
Registration Number
NCT01373606
Locations
🇯🇵

Investigational site, Kanto, Japan

A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

Phase 3
Completed
Conditions
Hepatorenal Syndrome
Interventions
Drug: Placebo
First Posted Date
2010-06-14
Last Posted Date
2022-11-29
Lead Sponsor
Mallinckrodt
Target Recruit Count
196
Registration Number
NCT01143246
Locations
🇺🇸

Scripps Clinic, La Jolla, California, United States

🇺🇸

University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States

🇺🇸

Iowa City VA Health Care System, Iowa City, Iowa, United States

and more 70 locations

Terlipressin in Septic Shock: Effects on Microcirculation

First Posted Date
2009-10-15
Last Posted Date
2010-02-04
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
60
Registration Number
NCT00995839
Locations
🇮🇹

Departement of Anesthesiology and Intensive Care, Rome, I, Italy

Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin

Phase 3
Completed
Conditions
Cirrhosis
Interventions
Drug: Placebo
First Posted Date
2009-09-30
Last Posted Date
2015-06-15
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
82
Registration Number
NCT00986817
Locations
🇫🇷

CARBONELL Nicolas, Paris, France

Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Phase 4
Completed
Conditions
Variceal Bleeding, Cirrhosis
Interventions
First Posted Date
2009-08-26
Last Posted Date
2018-03-19
Lead Sponsor
Korea University
Target Recruit Count
1034
Registration Number
NCT00966355
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

Prevention of Esophageal Variceal Rebleeding

Phase 4
Conditions
Esophageal Variceal Rebleeding
Interventions
Drug: pantoloc (proton pump inhibitor)
First Posted Date
2009-03-18
Last Posted Date
2009-03-18
Lead Sponsor
National Science Council, Taiwan
Target Recruit Count
120
Registration Number
NCT00863837

Terlipressin Administration in Septic Shock Refractory to Catecholamines

Phase 2
Conditions
Septic Shock
Interventions
First Posted Date
2008-11-19
Last Posted Date
2008-11-19
Lead Sponsor
Assaf-Harofeh Medical Center
Target Recruit Count
30
Registration Number
NCT00793559
Locations
🇮🇱

Asaf Harofeh MC, Zrifin, Israel

Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

First Posted Date
2008-08-28
Last Posted Date
2014-10-15
Lead Sponsor
University of Padova
Target Recruit Count
70
Registration Number
NCT00742690
Locations
🇮🇹

Liver Unit, General Hospital, Padova, Italy

Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome

Phase 2
Terminated
Conditions
Cirrhosis
Hepatorenal Syndrome
Interventions
First Posted Date
2008-08-27
Last Posted Date
2014-10-15
Lead Sponsor
University of Padova
Target Recruit Count
49
Registration Number
NCT00742339
Locations
🇮🇹

Dept. of Clinical and Experimental Medicine, University of Padova, Padova, Italy

Terlipressin in Septic Shock in Cirrhosis

Phase 2
Completed
Conditions
Liver Cirrhosis
Septic Shock
Interventions
Drug: alpha adrenergic drugs
First Posted Date
2008-03-04
Last Posted Date
2016-02-24
Lead Sponsor
Hospital Clinic of Barcelona
Target Recruit Count
72
Registration Number
NCT00628160
Locations
🇪🇸

Hospital Clinic Barcelona, Barcelona, Catalonia, Spain

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