How is terlipressin different from vasopressin?

It is a synthetic vasopressin analogue with a longer duration of action and more selective splanchnic V1 vasoconstriction, allowing intermittent dosing rather than a continuous ICU infusion.

Why does the FDA label warn about breathing problems?

In trials, terlipressin was linked to serious and sometimes fatal respiratory failure, so the label advises careful patient selection and avoiding it in people who are hypoxic or whose breathing is worsening.

Is terlipressin FDA-approved for variceal bleeding?

No. In the US the approval is specifically for hepatorenal syndrome; variceal-bleeding use is established in Europe and in clinical guidelines rather than by FDA labeling.

Can terlipressin be used outside a hospital?

No. It is a specialist intravenous drug for hospitalized cirrhosis patients, requiring monitoring for ischaemia, respiratory failure and fluid or sodium disturbances.

EMA-approvedaka Glypressin, Terlivaz

Terlipressin — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Terlipressin (also known as Glypressin) is a peptide catalogued under Sexual Health (Vasopressin analog). It is described as: V1 receptor agonist. Documented context: Hepatorenal syndrome; esophageal varices. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Terlipressin?

Terlipressin is a synthetic long-acting vasopressin analogue (a prodrug slowly cleaved to lysine-vasopressin) used as a splanchnic vasoconstrictor. It has long-standing European approval for hepatorenal syndrome and for bleeding oesophageal varices, and was approved by the FDA in 2022 (Terlivaz) to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

The evidence base is human randomized controlled trials and meta-analyses in patients with cirrhosis.

It is a hospital-administered drug, not a consumer or wellness product.

How does Terlipressin work?

Terlipressin activates vascular V1 (V1a) receptors, causing splanchnic (mesenteric) vasoconstriction that reduces portal blood inflow and portal pressure.

In hepatorenal syndrome this shifts blood back toward the systemic and renal circulation, improving effective arterial volume and kidney perfusion.

What does the research say about Terlipressin?

In hepatorenal syndrome type 1, terlipressin plus albumin significantly improved reversal of the syndrome compared with placebo plus albumin in the pivotal CONFIRM trial. ^[1]
Terlipressin plus albumin improved renal function versus placebo in an earlier randomized, double-blind, placebo-controlled trial of type 1 hepatorenal syndrome (OT-0401). ^[2]
For acute oesophageal variceal bleeding, terlipressin reduced all-cause mortality compared with placebo in a Cochrane systematic review of randomized trials. ^[4]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome — Wong F et al., New England Journal of Medicine 2021. (Randomized controlled trial (CONFIRM))
[2] A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome — Sanyal AJ et al., Gastroenterology 2008. (Randomized controlled trial (OT-0401))
[3] Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomised clinical studies — Sanyal AJ et al., Alimentary Pharmacology and Therapeutics 2017. (Pooled analysis of two randomized trials)
[4] Terlipressin for acute esophageal variceal hemorrhage — Ioannou G et al., Cochrane Database of Systematic Reviews 2003. (Cochrane systematic review of randomized trials)
[5] Terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of hepatorenal syndrome: A randomized trial — Cavallin M et al., Hepatology 2015. (Randomized controlled trial)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Terlipressin is given intravenously (by bolus or continuous infusion in different protocols) in hospitalized cirrhosis patients, alongside albumin for hepatorenal syndrome, with close monitoring of oxygen saturation, fluid balance and signs of ischaemia.

This is context only: dose, duration and eligibility are decided by hepatology or critical-care specialists, and treatment is stopped for lack of response or for respiratory or ischaemic complications.

Side effects & safety profile

As a potent vasoconstrictor, terlipressin can cause ischaemic complications, including peripheral, cardiac and intestinal ischaemia, arrhythmias, fluid overload and hyponatraemia.

The FDA label carries a warning about serious or fatal respiratory failure and advises against use in patients with hypoxia or worsening respiratory symptoms and careful patient selection; in the CONFIRM trial, respiratory failure and adverse events were more frequent with terlipressin.

It is generally avoided in patients with advanced acute-on-chronic liver failure or high baseline serum creatinine, and must be used only in a monitored hospital setting with attention to oxygenation and volume status.

Stacking & combinations

In hepatorenal syndrome it is deliberately paired with intravenous albumin under specialist care, and is not intended for combination with off-label peptides or supplements.

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Frequently asked questions

It has long-standing EU approval for hepatorenal syndrome and bleeding oesophageal varices, and since 2022 FDA approval (Terlivaz) to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

References

[1] Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome — Wong F et al., New England Journal of Medicine 2021. PMID: 33657294. View sourceStudy: Randomized controlled trial (CONFIRM)Terlipressin plus albumin more often achieved verified reversal of type 1 hepatorenal syndrome than placebo, but with more respiratory-failure adverse events.
[2] A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome — Sanyal AJ et al., Gastroenterology 2008. PMID: 18471513. View sourceStudy: Randomized controlled trial (OT-0401)Terlipressin improved renal function versus placebo in type 1 hepatorenal syndrome, supporting its vasoconstrictor mechanism.
[3] Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the OT-0401 and REVERSE randomised clinical studies — Sanyal AJ et al., Alimentary Pharmacology and Therapeutics 2017. PMID: 28370090. View sourceStudy: Pooled analysis of two randomized trialsPooled data showed higher rates of HRS-1 reversal with terlipressin plus albumin than with placebo plus albumin.
[4] Terlipressin for acute esophageal variceal hemorrhage — Ioannou G et al., Cochrane Database of Systematic Reviews 2003. PMID: 12535432. View sourceStudy: Cochrane systematic review of randomized trialsTerlipressin was associated with reduced all-cause mortality versus placebo in acute oesophageal variceal bleeding.
[5] Terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of hepatorenal syndrome: A randomized trial — Cavallin M et al., Hepatology 2015. PMID: 25644760. View sourceStudy: Randomized controlled trialTerlipressin plus albumin achieved higher rates of hepatorenal-syndrome reversal than midodrine plus octreotide plus albumin.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.