Letairis, Volibris(ambrisentan)
Letairis, Volibris (ambrisentan) is a small molecule pharmaceutical. Ambrisentan was first approved as Letairis on 2007-06-15. It is used to treat pulmonary hypertension in the USA. It has been approved in Europe to treat pulmonary hypertension. The pharmaceutical is active against endothelin-1 receptor. In addition, it is known to target endothelin receptor type B.
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Commercial
Trade Name
FDA
EMA
Letairis (generic drugs available since 2019-03-28)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ambrisentan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LETAIRIS | Gilead Sciences | N-022081 RX | 2007-06-15 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ambrisentan | ANDA | 2023-03-16 |
| letairis | New Drug Application | 2020-12-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary hypertension | EFO_0001361 | D006976 | I27.20 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 3 | 10 | 9 | 4 | 3 | 26 |
| Pulmonary arterial hypertension | D000081029 | 1 | 1 | 5 | 5 | 3 | 14 | ||
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | 2 | 2 | 5 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | 1 | — | 2 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | 1 | — | 1 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | — | 1 | — | 1 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | — | — | 1 | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 2 | 1 | — | — | 2 | |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 2 | — | — | 2 |
| Altitude sickness | D000532 | EFO_1000782 | T70.29 | 1 | 1 | 1 | — | — | 2 |
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | — | — | 2 | — | — | 2 | |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypoxia | D000860 | R09.02 | — | 1 | — | — | — | 1 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | — | — | — | 1 |
| Ascites | D001201 | HP_0001541 | R18 | — | 1 | — | — | — | 1 |
| Hypoplastic left heart syndrome | D018636 | Q23.4 | — | 1 | — | — | — | 1 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | 1 | 1 | |
| Ulcer | D014456 | MPATH_579 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AMBRISENTAN |
| INN | ambrisentan |
| Description | Ambrisentan is a diarylmethane. |
| Classification | Small molecule |
| Drug class | endothelin receptor antagonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 177036-94-1 |
| RxCUI | 358274 |
| ChEMBL ID | CHEMBL1111 |
| ChEBI ID | — |
| PubChem CID | 6918493 |
| DrugBank | DB06403 |
| UNII ID | HW6NV07QEC (ChemIDplus, GSRS) |
Target
Agency Approved
EDNRA
EDNRA
Organism
Homo sapiens
Gene name
EDNRA
Gene synonyms
ETA, ETRA
NCBI Gene ID
Protein name
endothelin-1 receptor
Protein synonyms
endothelin receptor subtype A, Endothelin receptor type A, endothelin-1-specific receptor, ET-A, ETA-R, G protein-coupled receptor, hET-AR
Uniprot ID
Mouse ortholog
Ednra (13617)
endothelin-1 receptor (Q91VV2)
Alternate
EDNRB
EDNRB
Variants
Clinical Variant
No data
Financial
Letairis - Gilead Sciences
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,126 documents
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Safety
Black-box Warning
Black-box warning for: Ambrisentan, Letairis
Adverse Events
Top Adverse Reactions
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1,535 adverse events reported
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