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Terlipressin administration
Terlipressin administration is a Vasopressin analog Small molecule drug developed by University Hospital, Rouen. It is currently in Phase 3 development for Acute variceal bleeding in patients with portal hypertension, Hepatorenal syndrome (HRS) in cirrhotic patients.
Terlipressin is a vasopressin analog that selectively activates V1 receptors on vascular smooth muscle to cause vasoconstriction and reduce portal pressure.
Terlipressin is a vasopressin analog that selectively activates V1 receptors on vascular smooth muscle to cause vasoconstriction and reduce portal pressure. Used for Acute variceal bleeding in patients with portal hypertension, Hepatorenal syndrome (HRS) in cirrhotic patients.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Terlipressin administration |
|---|---|
| Sponsor | University Hospital, Rouen |
| Drug class | Vasopressin analog |
| Target | Vasopressin V1 receptor |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Hepatology |
| Phase | Phase 3 |
Mechanism of action
Terlipressin binds to vasopressin V1 receptors on splanchnic and systemic blood vessels, causing vasoconstriction that decreases portal venous inflow and reduces portal hypertension. This mechanism makes it effective in acute variceal bleeding and hepatorenal syndrome by improving renal perfusion and reducing bleeding from esophageal varices in cirrhotic patients.
Approved indications
- Acute variceal bleeding in patients with portal hypertension
- Hepatorenal syndrome (HRS) in cirrhotic patients
Common side effects
- Abdominal pain
- Diarrhea
- Hypertension
- Headache
- Ischemic complications (rare)
Key clinical trials
- Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome (NA)
- Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy (PHASE3)
- Terlipressin in Combined Hepatorenal Syndrome in Patients With Signs of Chronic Renal Disease
- Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury (NA)
- National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem Cell Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patient- Phase-II Trial (PHASE2)
- National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial (PHASE3)
- Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation (NA)
- Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Terlipressin administration CI brief — competitive landscape report
- Terlipressin administration updates RSS · CI watch RSS
- University Hospital, Rouen portfolio CI
Frequently asked questions about Terlipressin administration
What is Terlipressin administration?
How does Terlipressin administration work?
What is Terlipressin administration used for?
Who makes Terlipressin administration?
What drug class is Terlipressin administration in?
What development phase is Terlipressin administration in?
What are the side effects of Terlipressin administration?
What does Terlipressin administration target?
Related
- Drug class: All Vasopressin analog drugs
- Target: All drugs targeting Vasopressin V1 receptor
- Manufacturer: University Hospital, Rouen — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Hepatology
- Indication: Drugs for Acute variceal bleeding in patients with portal hypertension
- Indication: Drugs for Hepatorenal syndrome (HRS) in cirrhotic patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing