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 | 2022-09-19 |
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
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HCPCS
No data
Clinical
Clinical Trials
78 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 | — | 5 | 5 | 5 | 6 | 17 |
Septic shock | D012772 | A48.3 | 1 | 5 | 5 | 1 | 6 | 16 | |
Hepatorenal syndrome | D006530 | K76.7 | 1 | 3 | 6 | 3 | 3 | 13 | |
Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | 3 | 4 | 7 |
Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | — | 2 | 1 | 4 |
Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | 2 | 2 | 4 |
Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | 1 | 1 | 2 | 4 |
Liver transplantation | D016031 | EFO_0010682 | — | 1 | — | 1 | — | 2 | |
Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 1 | |
Fibrosis | D005355 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Drug-related side effects and adverse reactions | D064420 | T88.7 | — | 2 | 2 | — | — | 4 | |
Ascites | D001201 | HP_0001541 | R18 | — | 2 | 2 | — | — | 3 |
Shock | D012769 | R57.1 | — | 1 | 1 | — | — | 2 | |
Liver failure | D017093 | HP_0001399 | K72.9 | — | 1 | 1 | — | — | 2 |
Sepsis | D018805 | A41.9 | — | 1 | 1 | — | — | 1 | |
Hemoptysis | D006469 | HP_0002105 | R04.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
Portal pressure | D017082 | — | 1 | — | — | — | 1 |
Indications Phases 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 | 57048 |
ChEMBL ID | CHEMBL2135460 |
ChEBI ID | — |
PubChem CID | 72081 |
DrugBank | DB02638 |
UNII ID | 7Z5X49W53P (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,923 documents
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Safety
Black-box Warning
Black-box warning for: Terlivaz
Adverse Events
Top Adverse Reactions
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55 adverse events reported
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