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Metabolic & endocrine

Terlipressin

A vasopressin analogue approved intravenously for hepatorenal syndrome — with a boxed warning about serious or fatal respiratory failure.

L5Practice-changingApproved — narrow indicationApprovedModerate confidenceLast reviewed 2026-08-23
IV

Also known as: Terlivaz

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
Moderate confidence
Human efficacy
70/100
Human safety
65/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
IV
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved narrow-indication hospital medicine

Overview

Human evidence70/100
Preclinical evidence65/100
Human safety evidence65/100

Clinical maturity: Approved narrow-indication hospital medicine

Routes & formulations

Studied / approved routes

IV

The approved context is intravenous administration in hospital for hepatorenal syndrome.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A prodrug analogue of vasopressin that preferentially constricts the splanchnic (gut) circulation, redirecting blood flow and improving kidney perfusion in advanced cirrhosis.

What people claim

  • Improves kidney function in hepatorenal syndrome

What the evidence actually says

A pivotal randomised, placebo-controlled trial supported US approval for a specific, severe complication of cirrhosis. The same label restricts use because of serious respiratory risk — an example of approval being indication- and patient-specific, not a general endorsement.

Human evidence

  • Pivotal randomised placebo-controlled trial (CONFIRM) in hepatorenal syndrome.
  • Longer European clinical experience with terlipressin in cirrhosis complications.

Preclinical evidence

  • Splanchnic haemodynamic pharmacology of V1 agonism.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • V1-receptor-mediated splanchnic vasoconstriction raises effective arterial volume and renal perfusion.

Safety and unknowns

  • Boxed warning: serious or fatal respiratory failure; the label guides patient selection.
  • Ischaemic effects and other labelled warnings apply; hospital-only use.

Cancer relevance

No concern identified

No established human cancer signal within approved use.

Regulatory status

FDA-approved (Terlivaz) to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. The label carries a boxed warning for serious or fatal respiratory failure.

Evidence grade

L5Practice-changingModerate confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Not applicable at this evidence tier.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.