As of September 2026, terlipressin is an approved medicine in the US for hepatorenal syndrome with rapidly declining kidney function. It has long been approved in Europe too. It is used only in hospital and carries a boxed warning for serious or fatal respiratory failure. If a vial of terlipressin reached you outside a hospital, no trial here tested it, and you cannot tell from the outside what it holds.
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What is terlipressin?
Terlipressin is a lab-made relative of vasopressin that the body slowly converts into a form that constricts blood vessels in the gut and kidneys. It has been used in Europe since the 1980s for bleeding esophageal varices and hepatorenal syndrome, a severe kidney failure in advanced liver disease. The FDA approved it in 2022, based largely on the CONFIRM trial.
Does terlipressin work?
The FDA reviewed the trials and approved it for hepatorenal syndrome with rapidly worsening kidney function. The approval rested largely on CONFIRM, where terlipressin with albumin improved reversal of the syndrome compared with placebo.
What we found. 3 completed randomized trials counted on the record. The study list names two trials, CONFIRM and OT-0401. Its third row is decades of use in Europe, which is not a trial.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| CONFIRM trial (Wong and colleagues, NEJM 2021) | People | Completed. The main trial for the FDA approval | Terlipressin plus albumin improved reversal of hepatorenal syndrome compared with placebo, with more respiratory adverse events |
| OT-0401 trial, an earlier US Phase 3 trial | People | Completed | It added supporting efficacy and safety data before the resubmission based on CONFIRM |
| Use in Europe after approval, over decades | People | Ongoing or completed. Not a trial | The record says long clinical experience in Europe informed the established safety profile |
Is terlipressin safe?
In the CONFIRM trial, people given terlipressin with albumin had more respiratory adverse events than people given placebo. The record's main safety concern is reduced blood flow to tissues, and it reports a boxed warning for serious or fatal respiratory failure. US real-world outcome data and long-term safety data are limited, given the 2022 approval. This picture comes from hospital use under close monitoring. A vial that never passed through a hospital pharmacy is taken up below.
Is terlipressin legal?
- United States
- Approved by the FDA in 2022 as Terlivaz, for hepatorenal syndrome with rapidly declining kidney function.
- European Union
- Long approved in Europe for variceal bleeding and hepatorenal syndrome, the record says. It names no regulator and no date.
- Sport
- Not named on WADA's list. That is not clearance.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as terlipressin?
The record says terlipressin is used only in hospital patients under close monitoring. It holds no sign that the compound is sold anywhere else. If a vial reached you another way, neither trial above tested it, and the checklist lists what to ask the seller.
What don't we know?
- What US real-world outcomes and long-term safety look like. Those data are limited, given the 2022 approval.
- What patient selection best limits respiratory and blood-flow (ischemic) complications. Data here are especially limited.
- What is in any vial that did not come from a hospital pharmacy.
The other side
Terlipressin reaches patients only in hospital, under close monitoring. The record says Europe has used it since the 1980s, and that this long experience informed its safety profile. The limits on this page reflect how new the US experience is.
What would change this record?
- Published real-world data on groups of US patients treated since approval.
- Longer follow-up on ischemic and respiratory adverse events. The record says both would firm up the current picture.
Three questions to ask next
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- How do you read a certificate of analysis?
Ask better questions.
More questions about terlipressin
Is terlipressin the same as Terlivaz?
- Terlivaz is the brand name the FDA approved in 2022.
What is terlipressin approved for?
- In the US, hepatorenal syndrome with rapidly declining kidney function. The record says it has long been approved in Europe for that syndrome and for variceal bleeding.
Has terlipressin been tested in people?
- Yes. The record lists two completed trials, CONFIRM and an earlier US Phase 3 trial called OT-0401. It also cites decades of clinical use in Europe.
Is terlipressin used outside hospitals?
- No, according to the record. It says terlipressin is used only in hospital patients under close monitoring.
Is terlipressin the same as desmopressin?
- No. Both are lab-made relatives of vasopressin. Terlipressin is converted in the body into a form that constricts blood vessels. Desmopressin was engineered to lose vasopressin's blood-pressure-raising effect.
Record checked on . Each source shows the date it was checked.
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