Terlipressin (Terlivaz)

Peptide

Terlipressin is a synthetic vasopressin analog with preferential V1 receptor activity used for hepatorenal syndrome and variceal bleeding. FDA-approved September 2022 as the first and only drug for HRS-AKI in the US. CONFIRM trial (n=300): HRS reversal 32% vs 17% placebo (P=0.012). Also highly effective for acute variceal bleeding - Cochrane meta-analysis showed 34% relative reduction in mortality vs placebo. SAFETY CONCERN: Black box warning for respiratory failure risk - avoid if oxygen saturation <90%.

Quick Answer

What it is

Terlipressin is a synthetic vasopressin analog with preferential V1 receptor activity used for hepatorenal syndrome and variceal bleeding. FDA-approved September 2022 as the first and only drug for HRS-AKI in the US.

Key findings

  • Grade A: HRS Reversal (CONFIRM Trial) (Hepatorenal Syndrome)
  • Grade A: HRS Reversal (Pooled Analysis) (Hepatorenal Syndrome)
  • Grade A: Serum Creatinine Improvement (Hepatorenal Syndrome)

Safety

  • SAFETY CONCERN: Black box warning for respiratory failure risk - avoid if oxygen saturation <90%.
  • 34% relative risk reduction.
  • SAFETY CONCERN: CONFIRM trial showed increased serious respiratory adverse events with terlipressin.
⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Terlipressin (Terlivaz)

Quick Facts: Terlipressin (Terlivaz)

  • Best Evidence:Grade A
  • Conditions Studied:2
  • Research Outcomes:11
  • Grade A Findings:6
  • Grade B Findings:3
  • Key Effect:Hepatorenal Syndrome
A6
B3
C2
D0
2 conditions · 11 outcomes

Detailed Outcomes

|
A
HRS Reversal (CONFIRM Trial)
CONFIRM Phase 3 trial (n=300): Verified HRS reversal achieved in 32% terlipressin vs 17% placebo (P=0.012). Led to FDA approval. Mean serum creatinine improvement significantly greater with terlipressin. Effects maintained through study duration.
large↑Improves
A
HRS Reversal (Pooled Analysis)
Pooled OT-0401 + REVERSE trials (n=308): HRS reversal 27% terlipressin vs 14% placebo (P=0.004). Mean serum creatinine difference -53.0 umol/L favoring terlipressin (P<0.0001). Consistent effect across both trials.
large↑Improves
A
Serum Creatinine Improvement
CONFIRM trial: Significant improvement in renal function with terlipressin vs placebo. 29% achieved kidney function improvement vs 16% placebo. Early treatment (<48h from diagnosis) associated with better outcomes.
moderate↑Improves
A
Respiratory Failure Risk
SAFETY CONCERN: CONFIRM trial showed increased serious respiratory adverse events with terlipressin. Black box warning: Risk of respiratory failure. Avoid use if oxygen saturation <90%. Higher risk in ACLF grade 3 patients. Patients with SCr >5 mg/dL unlikely to benefit.
moderate↑Worsens
A
Mortality Reduction (Variceal Bleeding)
Cochrane meta-analysis (7 RCTs, 443 patients): Terlipressin reduced all-cause mortality vs placebo (RR 0.66, 95% CI 0.49-0.88). 34% relative risk reduction. The only vasoactive agent proven to reduce mortality in acute variceal hemorrhage.
large↓Improves
A
Bleeding Control (Variceal)
2018 meta-analysis (30 RCTs, 3344 patients): Terlipressin significantly improved bleeding control within 48h vs no vasoactive drug (OR 2.94, P=0.0008). Reduced need for emergency procedures (RR 0.72 vs placebo).
large↑Improves
B
Liver Protection
49 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderate↑Improves
B
Kidney Function
39 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderate↑Improves
B
Sepsis Outcomes
5 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
small↓Improves
C
Pulmonary Function
3 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
small↑Improves
C
Safety/Tolerability
3 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
small↑Improves

Research Citations (37)

Multisystem hemodynamic effects of terlipressin in cirrhosis: A scoping review.
(2025)
PMID: 39955856
Terlipressin for the treatment of hepatorenal syndrome: a meta-analysis of randomized controlled trials.
(2025)
PMID: 40207491
Terlipressin Administration Strategies in Hepatorenal Syndrome-Acute Kidney Injury: A Narrative Review of Continuous Infusion and Intermittent Bolus Approaches.
(2025)
PMID: 41314419
Terlipressin use in HRS-AKI and respiratory failure.
(2024)
PMID: 39073583
Safety and efficacy of continuous terlipressin infusion in HRS-AKI in a transplant population.
(2024)
PMID: 38771635
Incidence and type of adverse events in patients with cirrhosis receiving terlipressin: A systematic review and meta-analysis.
(2024)
PMID: 39298544
Comparative efficacy of terlipressin and norepinephrine for treatment of hepatorenal syndrome-acute kidney injury: A systematic review and meta-analysis.
(2024)
PMID: 38285703
Early treatment with terlipressin in patients with hepatorenal syndrome yields improved clinical outcomes in North American studies
(2023)
PMID: 36633470
Terlipressin and the Treatment of Hepatorenal Syndrome: How the CONFIRM Trial Moves the Story Forward
(2022)
PMID: 34606933
Respiratory events with terlipressin and albumin in hepatorenal syndrome: A review and clinical guidance.
(2022)
PMID: 35838488