Digestive & weight Vasopressin analog
Terlipressin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Terlipressin (sold as Terlivaz) is a long-acting vasopressin analog used to improve kidney function in adults with hepatorenal syndrome, a dangerous form of kidney failure that develops in advanced liver disease. It constricts the splanchnic circulation to redirect blood flow toward the kidneys. It has been FDA-approved in the U.S. since 2022, after long use abroad, and carries a boxed warning about serious respiratory failure.
At a glance
- What it is
- A long-acting vasopressin analog and prodrug, a V1 receptor agonist
- Approved for
- Improving kidney function in adults with hepatorenal syndrome and rapid decline in kidney function
- Key fact
- In the CONFIRM trial it reversed hepatorenal syndrome in about 32 percent of patients versus 17 percent on placebo
- Route
- Intravenous
- Evidence strength
- FDA approved
Summary
Terlipressin (Terlivaz) is an FDA-approved vasopressin analog that improves kidney function in hepatorenal syndrome. Learn how it works and its boxed warning.
What is terlipressin?
Terlipressin, sold under the brand Terlivaz, is a synthetic vasopressin analog that the body slowly converts into its active form, giving a longer and steadier effect than vasopressin itself. It is used for hepatorenal syndrome, a type of acute kidney failure that occurs in people with advanced liver disease and carries a poor prognosis. It was used in Europe and elsewhere for years before being approved in the United States in 2022.
How does terlipressin work?
Terlipressin is a prodrug: after injection, enzymes slowly cleave it to release lysine-vasopressin, which acts mainly at V1a receptors. In hepatorenal syndrome, the arteries supplying the gut (the splanchnic circulation) are abnormally dilated, which lowers the effective blood volume reaching the kidneys and shuts down kidney function. By constricting those splanchnic vessels, terlipressin reduces the pooling of blood in the gut circulation and redistributes it toward the systemic and kidney circulation, raising kidney perfusion.
The goal is to reverse the kidney failure while the underlying liver disease is addressed, often as a bridge to liver transplantation. The CONFIRM trial compared terlipressin with placebo:
| Outcome | Terlipressin | Placebo |
|---|---|---|
| Hepatorenal syndrome reversed | About 32% of patients | 17% of patients |
| Respiratory complications | More patients affected | Fewer patients affected |
Is it FDA-approved?
Editor’s note
Status: Yes. Terlipressin (Terlivaz) was approved by the FDA in 2022 to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. It carries a boxed warning for serious or fatal respiratory failure and is avoided in patients who are already hypoxic.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Terlipressin (Terlivaz) was approved by the FDA in 2022 to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. It carries a boxed warning for serious or fatal respiratory failure and is avoided in patients who are already hypoxic.
What is terlipressin prescribed for?
Terlipressin is prescribed for adults with hepatorenal syndrome (the type with rapidly worsening kidney function) to improve kidney function. It is used in a hospital setting with careful monitoring, including of oxygen levels, and the labeling advises against use in those with high baseline risk of respiratory or ischemic complications.
What are the side effects?
According to the prescribing information, common side effects include:
- Abdominal pain
- Nausea and diarrhea
- Shortness of breath
More serious considerations include:
- A boxed warning for serious or fatal respiratory failure, with higher risk in patients with fluid overload, so oxygenation is monitored and it is avoided in hypoxic patients
- Reduced blood flow causing ischemia in the heart, brain, gut, fingers, or skin
- Respiratory failure or ischemia that can make a patient ineligible for a liver transplant
Sources: FDA prescribing information for Terlivaz; the CONFIRM trial (Wong et al., The New England Journal of Medicine, 2021, DOI: 10.1056/NEJMoa2008290), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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