Summary
Terlipressin is an FDA approved intravenous vasopressin analog, a lab-made relative of a hormone that tightens blood vessels (Terlivaz, approved September 2022), used in hospital, with albumin (a blood protein given by drip), to improve kidney function in adults with hepatorenal syndrome (kidney failure caused by advanced liver disease) and rapidly worsening kidney function. In the CONFIRM trial of 300 patients it achieved verified reversal of hepatorenal syndrome in 32% of patients versus 17% with placebo, but it carries a boxed warning, FDA's most serious label warning, for serious or fatal respiratory failure and did not improve 90 day survival. It is strictly an inpatient drug, not something dispensed or compounded for outpatient use.
What is Terlipressin?
Terlipressin is a synthetic vasopressin analog prodrug (12 amino acid peptide, converted to lysine vasopressin), V1 receptor agonist. It is also known as Terlivaz, Glypressin, triglycyl lysine vasopressin, tGLVP.
How does it work?
Terlipressin is a prodrug that is slowly cleaved by tissue peptidases to release lysine vasopressin. The active hormone constricts splanchnic arterioles through V1 receptors, which reduces the portal hypertension driven splanchnic vasodilation that underlies hepatorenal syndrome. Redirecting blood volume to the systemic circulation raises mean arterial pressure and renal perfusion, so glomerular filtration improves. It also has weak V2 activity, which can cause fluid retention.
| Cluster | Other peptides |
|---|---|
| Routes | Intravenous bolus every 6 hours (US label); Continuous intravenous infusion (studied outside the US) |
| Conditions studied | None recorded |
| Record | v3, draft, verified Sep 23, 2026 |
FDA-approved uses of Terlipressin
Yes, since September 14, 2022. The Terlivaz label covers improving kidney function in adults with hepatorenal syndrome (kidney failure caused by advanced liver disease) with rapid reduction in kidney function; patients with serum creatinine, a blood marker that rises as kidneys fail, above 5 mg/dL are unlikely to benefit. It had been used in Europe, Asia, and Australia for many years before the US approval, which followed the CONFIRM trial. [1] [4] [5]
What does the evidence say about Terlipressin?
Three randomized placebo controlled trials in type 1 hepatorenal syndrome, all with albumin in both arms. CONFIRM (n = 300) showed verified HRS reversal in 32% versus 17%. REVERSE (n = 196) showed confirmed HRS reversal in 19.6% versus 13.1%, not statistically significant, though creatinine fell more with terlipressin. The 2008 trial (n = 112) showed HRS reversal in 34% versus 13%. None showed a survival benefit, and respiratory failure was more common with terlipressin in CONFIRM (10% versus 3%).
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 3 | 608 |
| Human observational studies | 0 | n/a |
| Animal studies | 0 | n/a |
| All indexed studies | 3 | 608 |
Human evidence
CONFIRM 2021 (n = 300, 2:1 randomization): verified reversal of hepatorenal syndrome (two consecutive serum creatinine values of 1.5 mg per dL or less at least 2 hours apart, alive without renal replacement therapy for at least 10 days) in 32% with terlipressin versus 17% with placebo (p = 0.006); death by day 90 was 51% versus 45%; respiratory failure occurred in 10% versus 3%. REVERSE 2016 (n = 196): confirmed HRS reversal 19.6% versus 13.1% (p = 0.22), with greater improvement in creatinine in the terlipressin group. Sanyal 2008 (n = 112): treatment success 25% versus 12.5% and HRS reversal 34% versus 13%.
Animal evidence
Animal pharmacology established V1 mediated splanchnic vasoconstriction, reduced portal pressure, and slow release of lysine vasopressin from the prodrug. Efficacy in hepatorenal syndrome was established in human trials rather than animal disease models.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome (CONFIRM)2021 PMID 33657294 | Randomized, double blind, placebo controlled phase 3 trial, 2:1 allocation, up to 14 days of treatmentn = 300 Adults with cirrhosis, ascites, and type 1 hepatorenal syndrome (creatinine doubling to at least 2.25 mg per dL) | Verified HRS reversal 32% versus 17% (p = 0.006); 90 day mortality 51% versus 45%; respiratory failure 10% versus 3% | Evidence: Human RCT evidence |
| Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1 (REVERSE)2016 PMID 26896734 | Randomized, double blind, placebo controlled phase 3 trialn = 196 Adults with cirrhosis and type 1 hepatorenal syndrome | Confirmed HRS reversal 19.6% versus 13.1% (not significant); greater decrease in serum creatinine with terlipressin | Evidence: Human RCT evidence |
| A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome2008 PMID 18471513 | Randomized, double blind, placebo controlled trial, up to 14 daysn = 112 Adults with type 1 hepatorenal syndrome in North America | Treatment success 25% versus 12.5%; HRS reversal 34% versus 13% (p = 0.008); no difference in overall survival | Evidence: Human RCT evidence |
Is Terlipressin legal in the United States?
FDA and compounding status
FDA approved prescription drug (Terlivaz, approved September 14, 2022 for hepatorenal syndrome with rapid reduction in kidney function), administered intravenously in hospital. Widely used in Europe for decades before US approval. Commercially available, so not eligible for routine compounding and not on any 503A bulks list. Not a research chemical.
WADA status
Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.
Regulatory timeline
- FDA
FDA approves Terlivaz (terlipressin) for hepatorenal syndrome
FDA approved terlipressin injection (Terlivaz), a vasopressin analog, to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
Regulatory: FDA approvedSource: Drugs@FDA: Terlivaz (terlipressin) NDA 022231
Terlipressin dose on the FDA label
Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.
FDA label (Terlivaz, DailyMed; intravenous, in hospital): 0.85 mg (1 vial) every 6 hours on days 1 to 3. On day 4, if serum creatinine has fallen at least 30% from baseline, continue 0.85 mg every 6 hours; if it has fallen less than 30%, the dose may be increased to 1.7 mg (2 vials) every 6 hours; if it is at or above baseline, stop. Treatment continues until 24 hours after two consecutive creatinine values of 1.5 mg/dL or less at least 2 hours apart, or a maximum of 14 days. Oxygen saturation is checked before starting and monitored throughout because of a boxed warning for serious or fatal respiratory failure.
Routes reported
| # | Route |
|---|---|
| 1 | Intravenous bolus every 6 hours (US label) |
| 2 | Continuous intravenous infusion (studied outside the US) |
What are the side effects and interactions of Terlipressin?
Side effects
| # | Reported side effect |
|---|---|
| 1 | Boxed warning: serious or fatal respiratory failure (10% versus 3% in CONFIRM), highest risk in patients with volume overload or grade 3 acute-on-chronic liver failure |
| 2 | Abdominal pain, nausea, and diarrhea |
| 3 | Ischemic events including myocardial, mesenteric, peripheral, and skin ischemia |
| 4 | Bradycardia and hypertension |
| 5 | Fluid overload and hyponatremia (weak V2 activity) |
| 6 | Dyspnea and pleural effusion |
Interactions
| # | Interaction |
|---|---|
| 1 | Other vasoconstrictors or drugs that cause bradycardia (beta blockers): additive cardiovascular effects; the label advises caution |
| 2 | Albumin: used together by design; excessive albumin volume increases the risk of respiratory failure |
| 3 | QT prolonging drugs: terlipressin may prolong the QT interval |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Hypoxia (oxygen saturation under 90%) or worsening respiratory symptoms |
| 2 | Ongoing coronary, peripheral, or mesenteric ischemia |
| 3 | Not recommended when serum creatinine is 5 mg per dL or higher, because benefit is unlikely |
| 4 | Pregnancy (uterine contraction and ischemia in animal studies) |
How do people access Terlipressin legally?
Typical cost: Unknown at the per patient level; it is a hospital administered drug billed as part of an inpatient admission for cirrhosis and kidney failure. List price per vial is in the low thousands of USD and a course runs several days.
Verified access options
Step 1
Hospital administration under a hepatologist or intensivist for a confirmed diagnosis of hepatorenal syndrome.
Step 2
Not available through retail pharmacies, compounding pharmacies, or telehealth.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Frequently asked questions
Does terlipressin work for hepatorenal syndrome?
It improves kidney function in a minority of patients. In CONFIRM (n = 300), 32% of patients on terlipressin plus albumin had verified reversal of hepatorenal syndrome versus 17% on placebo plus albumin. An earlier trial (n = 112) found reversal in 34% versus 13%. However, 90 day survival was not improved (51% versus 45% mortality in CONFIRM), so the drug is a bridge to recovery or transplant rather than a cure. [1] [3]
What are the side effects of terlipressin?
The most serious is respiratory failure, which occurred in 10% of terlipressin patients versus 3% on placebo in CONFIRM and is the subject of a boxed warning, especially in patients with fluid overload or severe acute-on-chronic liver failure. Ischemic events (heart, gut, limbs, skin), abdominal pain, nausea, diarrhea, bradycardia, and fluid retention also occur. Patients are monitored in hospital for oxygen saturation and volume status. [1] [5]
What is the terlipressin (Terlivaz) dose on the FDA label?
0.85 mg by intravenous bolus every 6 hours for days 1 to 3. On day 4 the dose stays the same if creatinine has fallen at least 30%, may rise to 1.7 mg every 6 hours if it has fallen less, and is stopped if creatinine is at or above baseline. It continues until 24 hours after two creatinine values of 1.5 mg/dL or less, for at most 14 days, with oxygen levels monitored because of the respiratory failure warning. [5]
How much does terlipressin cost?
It is an inpatient hospital drug, so patients rarely see a direct price; the cost is folded into the hospital admission and billed to insurance or Medicaid. Per vial list pricing is in the low thousands of USD and a typical course lasts several days. There is no cash pay or outpatient channel. [5]
Is terlipressin banned by WADA?
No. Terlipressin is not on the WADA Prohibited List and has no performance enhancing use. Vasopressin analogs in general are not prohibited. [6]
Terlipressin vs vasopressin or octreotide plus midodrine for hepatorenal syndrome?
Terlipressin is the only agent with randomized placebo controlled evidence of reversing hepatorenal syndrome. Before its US approval, US hospitals typically used octreotide plus midodrine with albumin, or norepinephrine in intensive care, largely on the basis of small studies. International guidelines list terlipressin plus albumin as first line; norepinephrine is an alternative where terlipressin is unavailable or in intensive care settings. [1] [2]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Wong F et al. Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome. N Engl J Med 2021 (CONFIRM)PubMed 33657294, 2021
- [2]Boyer TD et al. Terlipressin plus albumin is more effective than albumin alone in improving renal function in patients with cirrhosis and hepatorenal syndrome type 1. Gastroenterology 2016 (REVERSE)PubMed 26896734, 2016
- [3]Sanyal AJ et al. A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome. Gastroenterology 2008PubMed 18471513, 2008
- [4]Drugs@FDA: Terlivaz (terlipressin) NDA 022231FDA, 2022
- [5]FDA prescribing information for Terlivaz (terlipressin) for injection, via DailyMedFDA, 2026
- [6]WADA Prohibited ListWADA, 2026
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