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Drug

Terlipressin

Approved medicine
ClassVasopressin V1 receptor binding agentResearchOngoing clinical research
Also known as Terlivaz, Terlipresina, Terlipressina, Terlipressine+1 more

Terlivaz, Terlipresina, Terlipressina, Terlipressine, Terlipressinum.

RxNorm57048ChEMBLCHEMBL2135460ATCH01BA04UNII7Z5X49W53P
5
Active clinical trials
3
Protein targets
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, A Double-blind Randomized Controlled Trial

Clinical trial2026-07-13Status changed to Active, not recruiting · ClinicalTrials.gov

Label change: TERLIPRESSIN (NDA022231)

Regulatory2026-06-10FDA

A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

Clinical trial2026-04-29Results expected Q1 2027 · ClinicalTrials.gov

ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

Clinical trial2026-03-25Completed · ClinicalTrials.gov

Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

Clinical trial2025-10-30Completed · ClinicalTrials.gov

Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock - A Randomised Controlled Trial

Clinical trial2025-08-31Primary completion · ClinicalTrials.gov

Terlipressin Versus Placebo for Septic Shock Refractory to High Doses Catecholamine Vasopressors: A Randomized-controlled Trial

Clinical trial2025-03-31Primary completion · ClinicalTrials.gov

Drug Safety Update: Terlipressin: new recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome

Regulatory2023-03-23MHRA

Label change: TERLIPRESSIN (NDA022231)

Regulatory2023-01-09FDA

Approval: TERLIPRESSIN (NDA022231)

Regulatory2022-09-14FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Terlipressin
Aliases & brands
TerlivazTerlipresinaTerlipressinaTerlipressineTerlipressinum
RxNorm CUI
57048
ChEMBL ID
CHEMBL2135460
ATC codes
H01BA04
UNII
7Z5X49W53P
Primary mechanism
Vasopressin V1 receptor binding agent
Regulatory jurisdictions
mhrafda

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Vasopressin V1a receptor
AVPR1A · P37288
BINDING AGENTVasopressin V1 receptor binding agent
Vasopressin V1b receptor
AVPR1B · P47901
BINDING AGENTVasopressin V1 receptor binding agent
Vasopressin V2 receptor
AVPR2 · P30518
BINDING AGENTVasopressin V2 receptor binding agent

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-09-14
Latest approval
2022-09-14
Authorities
FDA · MHRA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-06-10Label change
Label change: TERLIPRESSIN (NDA022231)
Evidence ↗
2023-01-09Label change
Label change: TERLIPRESSIN (NDA022231)
Evidence ↗
2022-09-14Approval
Approval: TERLIPRESSIN (NDA022231)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2023-03-23Safety communicationSafety
Drug Safety Update: Terlipressin: new recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

61 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
61
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
3
Recruiting
48
Late-stage (III+)
34
Completed
22
Discontinued
PHASE DISTRIBUTIONn = 61
Phase 1 / 21Phase 212Phase 2 / 32Phase 311Phase 415Phase N / A20

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effect of Intraoperative Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients: a Randomized, Double-blind, Placebo-controlled Study

Unknown statusPH IVBeijing Tsinghua Chang Gung Hospitaln=1042024

Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903): A Multicenter, Single-blind, Randomised Controlled Trial

Unknown statusPH IVNanfang Hospital, Southern Medical Universityn=602022

Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Unknown statusPH IVJuan A. Arnaizn=362022

The Protection of Telipression on Developing of Acute Kidney Injury in Cirrhotic Patients With Upper-gastroentestinal Bleeding

CompletedPH IVChanghai Hospitaln=542020

Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After Endoscopic Variceal Ligation: A Randomised Controlled Clinical Trial

CompletedPH IVPost Graduate Institute of Medical Education and Research, Chandigarhn=742019

Recent completions

Trials that read out recently, adding to the completed evidence base.

ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

CompletedPH IIIAssistance Publique - Hôpitaux de Parisn=3152026

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

CompletedN/ALahore General Hospitaln=602025

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial

CompletedN/AWael Elbanna Clinicn=992024

A Multi-Center, Open Label, Collaborative Research Study to Treat HRS-AKI Patients With Continuous Terlipressin Infusion

CompletedPH IIIUniversity of Pennsylvanian=502023

Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure- A Randomized Open Label Study.

CompletedN/AInstitute of Liver and Biliary Sciences, Indian=702022

Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock

CompletedN/ASoutheast University, Chinan=222020
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.