Terlipressin
Terlivaz (terlipressin) is a protein pharmaceutical. Terlipressin was first approved as Terlivaz on 2022-09-14.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Terlivaz
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Terlipressin acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TERLIVAZ | Mallinckrodt | N-022231 RX | 2022-09-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| terlivaz | New Drug Application | 2024-04-15 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TERLIPRESSIN ACETATE, TERLIVAZ, MALLINCKRODT IRELAND | |||
| 2029-09-14 | ODE-406 | ||
| 2027-09-14 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Terlipressin Acetate, Terlivaz, Mallinckrodt Ireland | |||
| 10335452 | 2037-04-05 | U-3711 | |
HCPCS
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Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 8 | 5 | 5 | 16 | 31 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 2 | 9 | 14 | 27 |
| Fibrosis | D005355 | — | — | 1 | 7 | 5 | 5 | 11 | 25 |
| Hepatorenal syndrome | D006530 | — | K76.7 | 1 | 5 | 9 | 3 | 9 | 24 |
| Syndrome | D013577 | — | — | 1 | 5 | 7 | 3 | 6 | 19 |
| Septic shock | D012772 | — | A48.3 | 1 | 7 | 6 | 1 | 6 | 18 |
| Shock | D012769 | — | R57.1 | — | 7 | 5 | 1 | 5 | 15 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 2 | 1 | 3 | 7 | 13 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | 1 | 4 | 7 | 12 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | — | 3 | 5 | 9 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ascites | D001201 | HP_0001541 | R18 | 1 | 4 | 3 | — | 2 | 9 |
| Liver failure | D017093 | HP_0001399 | K72.9 | — | 1 | 1 | — | 7 | 9 |
| Hepatic insufficiency | D048550 | — | — | — | — | 1 | — | 6 | 7 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | 2 | 2 | — | — | 4 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | 1 | — | 2 | 3 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | 1 | 2 | — | — | 2 |
| Hemoptysis | D006469 | HP_0002105 | R04.2 | — | — | 1 | — | 1 | 2 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | 1 | 1 | — | — | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 1 | 1 | — | — | 1 |
| Retinopathy of prematurity | D012178 | EFO_1001158 | H35.1 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neonatal sepsis | D000071074 | HP_0040187 | — | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | — | 1 |
| Portal pressure | D017082 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 7 | 7 |
| Acute-on-chronic liver failure | D065290 | — | — | — | — | — | — | 7 | 7 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 2 | 2 |
| Surgical portasystemic shunt | D011170 | — | — | — | — | — | — | 2 | 2 |
| Varicose veins | D014648 | HP_0002619 | I83.90 | — | — | — | — | 1 | 1 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Uterine myomectomy | D063186 | — | — | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | — | — | — | 1 | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Terlipressin |
| INN | terlipressin |
| Description | Terlipressin is a polypeptide. |
| Classification | Protein |
| Drug class | vasoconstrictors (vasopressin derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSC[C@H](NC(=O)CNC(=O)CNC(=O)CN)C(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 14636-12-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2135460 |
| ChEBI ID | — |
| PubChem CID | 72081 |
| DrugBank | DB02638 |
| UNII ID | 7Z5X49W53P (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 2,348 documents
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Safety
Black-box Warning
Black-box warning for: Terlivaz
Adverse Events
Top Adverse Reactions
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109 adverse events reported
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