Terlipressin
Vasopressin analog
Also Terlivaz, Glypressin, Terlipressin acetate, Triglycyl-lysine vasopressin, Remestyp, Lucassin
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Intravenous
- Studies cited
- 1 human0 animal or cell
A hospital drug for kidney failure caused by liver disease. In a 300-patient trial it restored kidney function more often than a dummy drip, but it did not help people live longer.
Sold for
Terlipressin is the hospital drug that can pull the kidneys back in people with cirrhosis whose kidneys are shutting down.
Studies say
A 300-patient randomized trial showed more reversals of hepatorenal syndrome than placebo, at the cost of more respiratory failure and no survival gain, which supports an A grade for the narrow approved use.
Why grade A. The CONFIRM trial randomized 300 patients with hepatorenal syndrome type 1 to terlipressin or placebo, both with albumin, and showed roughly double the rate of verified reversal of kidney failure. The label's efficacy section rests on CONFIRM, a double-blind randomized trial, so the approved use grades A, with the caveat that reversal of kidney injury did not translate into better 90-day survival. 12
FDA. Terlipressin is approved by the FDA as Terlivaz (September 2022) 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. 2
Written from 2 cited sources. Fact-checked 2026-10-27: 18 claims checked, 8 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Restoring kidney function in severe liver disease.
- Can a US doctor prescribe it?
- Yes, FDA approved for kidney failure from liver disease (hepatorenal syndrome).
- Properly tested in people?
- Yes, in large controlled trials: a 300-patient trial.
Evidence checklist
- Randomised controlled trial CONFIRM, placebo-controlled with albuminyes
- Human study over 100 people CONFIRM 300 patientsyes
- More than one research group North American trial plus earlier onesno information
- Clinical outcomes, not surrogate markers Kidney reversal; 90-day survival not improvedno
- Human safety data beyond case reports Boxed warning: respiratory failureyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Terlipressin is a lab-made version of vasopressin, the body's antidiuretic hormone. It has 12 amino acids. Three extra glycine amino acids are attached to one end. This makes it a prodrug. Enzymes in the body slowly clip them off. This frees the active vasopressin-like molecule over hours instead of minutes. It is given by vein in hospital. 12
Hepatorenal syndrome is kidney failure in advanced cirrhosis. It happens without any structural kidney disease. Blood vessels in the belly widen. Blood pressure to the kidneys falls, and they stop filtering. Before terlipressin, the only US options were off-label mixes of other vasoconstrictors, or a liver transplant. Europe had used terlipressin for decades before the FDA approved it. 12
How it works
The active form of terlipressin stimulates V1 receptors on smooth muscle in the splanchnic (belly) blood vessels. This squeezes them. Blood volume moves back into the central circulation. Arterial pressure rises, and blood flow to the kidneys returns. It is given with albumin by vein to expand blood volume. The same squeezing of vessels in other parts of the body explains its main danger. So does fluid shifting into the lungs. 12
What human research shows
CONFIRM was published in the New England Journal of Medicine in 2021. It randomized 300 patients with cirrhosis and hepatorenal syndrome type 1 at North American centers. They were assigned 2:1 to terlipressin (199) or placebo (101) for up to 14 days. Both arms also got albumin. Verified reversal of hepatorenal syndrome meant two creatinine readings in a row at or below the threshold. The patient also had to be alive and off dialysis for 10 days. This occurred in 32 percent of the terlipressin group and 17 percent of the placebo group. By day 30, reversal without dialysis or other kidney replacement therapy was also more common (34 versus 17 percent). Verified reversal without a relapse by day 30 (26 versus 17 percent) did not reach statistical significance. 1
Death by day 90 was 51 percent on terlipressin and 45 percent on placebo. This difference was not statistically significant. Serious or fatal respiratory failure occurred in 14 percent of terlipressin patients and 5 percent of placebo patients. Deaths from lung disorders within 90 days were 11 percent versus 2 percent. 12
| Study | Model | Finding |
|---|---|---|
| CONFIRM (Wong 2021) | Humans, n=300 with hepatorenal syndrome type 1, randomized 2:1 double-blind placebo-controlled, albumin in both arms | Verified reversal of hepatorenal syndrome in 32 percent on terlipressin versus 17 percent on placebo; no significant difference in 90-day mortality; respiratory failure 14 percent versus 5 percent. 1 |
| Terlivaz prescribing information | FDA label | Approved indication, boxed warning for respiratory failure, and contraindication in patients with ongoing hypoxia. 2 |
Safety
The boxed warning covers serious or fatal respiratory failure. The highest risk is in patients with fluid overload or grade 3 acute-on-chronic liver failure. The drug must not be used in patients who are already hypoxic or have worsening breathing symptoms. Belly pain, nausea, diarrhea and shortness of breath were the most common side effects in trials. 12
Terlipressin constricts blood vessels. So it can cause ischemia of the heart, gut, skin or limbs. It must not be used in people with ongoing coronary, peripheral or mesenteric ischemia. The label also warns of side effects such as respiratory failure or ischemia. These may make a patient on the transplant list ineligible for a liver transplant. 2
Questions for your clinician
- Is my oxygen level safe for starting terlipressin?
- How will breathing and fluid be monitored?
- If kidney reversal did not improve survival, what is the goal?
Questions people ask
Is terlipressin FDA-approved?
Yes. Terlivaz was approved in September 2022. Its approved use is to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Europe and other places had used it for many years before that. 2
Does terlipressin save lives?
In CONFIRM it reversed kidney failure in about twice as many patients as placebo. But 90-day mortality was not lower (51 percent versus 45 percent). More terlipressin patients reached day 30 with reversal and without dialysis (34 versus 17 percent). Its benefit is kidney recovery, not proven survival. 1
What is the boxed warning about?
Serious or fatal respiratory failure. In the phase 3 trial 14 percent of terlipressin patients developed it versus 5 percent on placebo. Risk is highest in people who are already low on oxygen or overloaded with fluid. The label says not to start it in hypoxic patients. 12
How does terlipressin differ from vasopressin?
Terlipressin is a prodrug. It releases its active vasopressin-like piece slowly. So it can be given as doses by vein now and then, with no need for a nonstop infusion. It acts mostly on blood vessels (V1 receptors) rather than the kidney's water-holding V2 receptors. 12