Letairis, Volibris(ambrisentan)
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.
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YTD
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Ambrisentan, Letairis (discontinued: Ambrisentan)
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 | 2025-09-23 |
| letairis | New Drug Application | 2025-08-22 |
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
76 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 2 | 4 | 4 | — | 2 | 12 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 4 | 5 | — | 1 | 11 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | 4 | 3 | — | 1 | 8 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | — |
| 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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Letairis – Gilead Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,877 documents
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Safety
Black-box Warning
Black-box warning for: Ambrisentan, Letairis
Adverse Events
Top Adverse Reactions
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111,107 adverse events reported
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