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TERLIPRESSIN
TERLIPRESSIN is a Vasopressin Receptor Agonist [EPC] drug. It is currently FDA-approved (first approved 2022).
Terlipressin is a binding agent that targets the vasopressin V1 receptor. It is used to treat conditions such as liver cirrhosis, esophageal and gastric varices, hemorrhage, and hepatorenal syndrome, among others.
At a glance
| Generic name | TERLIPRESSIN |
|---|---|
| Drug class | Vasopressin Receptor Agonist [EPC] |
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 2022 |
Approved indications
Boxed warnings
- WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.1) ]. WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with ACLF Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% ( 2.1 , 4 , 5.1 ).
Common side effects
- Abdominal pain
- Nausea
- Respiratory failure
- Diarrhea
- Dyspnea
- Fluid overload
- Pleural effusion
- Sepsis
- Bradycardia
- Ischemia-related events
- Headache
- Hyponatremia
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TERLIPRESSIN CI brief — competitive landscape report
- TERLIPRESSIN updates RSS · CI watch RSS
Frequently asked questions about TERLIPRESSIN
What is TERLIPRESSIN?
TERLIPRESSIN is a Vasopressin Receptor Agonist [EPC] drug.
What drug class is TERLIPRESSIN in?
TERLIPRESSIN belongs to the Vasopressin Receptor Agonist [EPC] class. See all Vasopressin Receptor Agonist [EPC] drugs at /class/vasopressin-receptor-agonist-epc.
When was TERLIPRESSIN approved?
TERLIPRESSIN was first approved on 2022.
What development phase is TERLIPRESSIN in?
TERLIPRESSIN is FDA-approved (marketed).
What are the side effects of TERLIPRESSIN?
Common side effects of TERLIPRESSIN include Abdominal pain, Nausea, Respiratory failure, Diarrhea, Dyspnea, Fluid overload.
Related
- Drug class: All Vasopressin Receptor Agonist [EPC] drugs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing