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Terlipressinum
Terlipressinum is a Small molecule drug developed by Shanghai Zhongshan Hospital. It is currently in Phase 2 development.
Terlipressin is used to treat conditions such as variceal bleeding, cirrhosis, and portal hypertension, often in combination with endoscopic treatment. It is compared to other vasoactive substances like somatostatin and octreotide in clinical trials for the control of variceal bleeding.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Terlipressinum |
|---|---|
| Sponsor | Shanghai Zhongshan Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) (NA)
- Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome (NA)
- Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy (PHASE3)
- Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation (NA)
- 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)
- Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics (PHASE1)
- Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis (PHASE3)
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:
- Terlipressinum CI brief — competitive landscape report
- Terlipressinum updates RSS · CI watch RSS
- Shanghai Zhongshan Hospital portfolio CI
Frequently asked questions about Terlipressinum
What is Terlipressinum?
Who makes Terlipressinum?
What development phase is Terlipressinum in?
Related
- Manufacturer: Shanghai Zhongshan Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing