Overview
Terlipressin is a synthetic analogue of vasopressin, which is an endogenous neurohormone that acts as a vasoconstrictor. It is a prodrug of lypressin, or lysine vasopressin. Compared to endogenous vasopressin, terlipressin has a longer half life and increased selectivity for the V1 receptor. As a potent vasopressor, terlipressin has been investigated in various shock states and conditions with diminished vasomotor tone. It was also studied in hepatorenal syndrome (HRS) and variceal bleeding. The drug was first approved by the FDA in September 2022.
Background
Terlipressin is a synthetic analogue of vasopressin, which is an endogenous neurohormone that acts as a vasoconstrictor. It is a prodrug of lypressin, or lysine vasopressin. Compared to endogenous vasopressin, terlipressin has a longer half life and increased selectivity for the V1 receptor. As a potent vasopressor, terlipressin has been investigated in various shock states and conditions with diminished vasomotor tone. It was also studied in hepatorenal syndrome (HRS) and variceal bleeding. The drug was first approved by the FDA in September 2022.
Indication
Terlipressin is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. The US prescribing information states that patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit from terlipressin.
Associated Conditions
- Hepato-Renal Syndrome
- Hepatorenal Syndrome Type 1
- Oesophageal varices haemorrhage
- Portal Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/04 | Not Applicable | Recruiting | |||
2025/02/07 | Phase 2 | Not yet recruiting | |||
2024/08/16 | Not Applicable | Not yet recruiting | |||
2024/02/13 | Phase 2 | Recruiting | |||
2023/12/08 | N/A | Completed | University Hospital Freiburg | ||
2023/10/31 | Phase 4 | Recruiting | |||
2023/09/07 | Phase 3 | Not yet recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2023/05/25 | Phase 2 | Recruiting | |||
2022/04/07 | Not Applicable | UNKNOWN | |||
2022/03/04 | Not Applicable | Recruiting | Wael Elbanna Clinic |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mallinckrodt Hospital Products Inc. | 43825-200 | INTRAVENOUS | 0.85 mg in 5 mL | 4/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GLYPRESSIN solution for injection, 1 mg/8.5 ml | SIN14244P | INJECTION, SOLUTION | 1 mg/8.5 ml | 10/4/2012 | |
| TERLIPRESSIN-AFT SOLUTION FOR INJECTION 0.85MG/8.5ML | SIN17190P | INJECTION, SOLUTION | 0.85mg/8.5ml | 2/28/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Terlipressin Injection | 国药准字H20233111 | 化学药品 | 注射剂 | 5/26/2023 | |
| Terlipressin Injection | 国药准字H20234546 | 化学药品 | 注射剂 | 11/28/2023 | |
| Terlipressin Injection | 国药准字H20223879 | 化学药品 | 注射剂 | 11/22/2022 | |
| Terlipressin Injection | 国药准字H20223621 | 化学药品 | 注射剂 | 8/30/2022 | |
| Terlipressin for Injection | 国药准字H20223270 | 化学药品 | 注射剂 | 4/29/2022 | |
| Terlipressin for Injection | 国药准字H20233814 | 化学药品 | 注射剂 | 6/27/2023 | |
| Terlipressin for Injection | 国药准字H20233232 | 化学药品 | 注射剂 | 2/28/2023 | |
| Terlipressin for Injection | 国药准字H20233606 | 化学药品 | 注射剂 | 5/26/2023 | |
| Terlipressin for Injection | 国药准字HJ20140690 | 化学药品 | 注射剂 | 4/25/2024 | |
| Terlipressin for Injection | 国药准字H20233156 | 化学药品 | 注射剂 | 8/4/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TERLIPRESSIN HMH terlipressin (as acetate) 0.85 mg/8.5mL solution for injection vial | 394191 | Medicine | A | 9/30/2024 | |
| GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule | 177708 | Medicine | A | 5/14/2012 | |
| TERLIPRESSIN EVER PHARMA terlipressin 0.85 mg/5 mL solution for injection vial | 288142 | Medicine | A | 8/16/2018 | |
| TERLIPRESSIN EVER PHARMA terlipressin 1.7 mg/10 mL solution for injection vial | 288156 | Medicine | A | 8/16/2018 | |
| TERLIPRESSIN SXP terlipressin (as acetate) 0.85 mg/8.5mL solution for injection vial | 394190 | Medicine | A | 9/30/2024 | |
| TERLIPRESSIN ANS terlipressin (as acetate) 0.85 mg/8.5mL solution for injection vial | 394192 | Medicine | A | 9/30/2024 |