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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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 | 2025-11-18 |
| 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
77 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 10 | 17 | 10 | 10 | 48 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | 7 | 12 | 8 | 13 | 40 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 4 | 10 | 12 | 6 | 6 | 35 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | — | 6 | 5 | 7 | 18 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | 2 | 2 | 5 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | 2 | 2 | 5 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | — | 1 | — | 3 |
| Sclerosis | D012598 | — | — | — | 1 | — | 2 | — | 3 |
| Univentricular heart | D000080039 | — | Q20.4 | — | 1 | — | 1 | — | 2 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | — | 1 | 2 | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | 1 | — | — | 2 |
| Altitude sickness | D000532 | EFO_1000782 | T70.29 | 1 | 1 | 1 | — | — | 2 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 1 | 1 | — | 1 | 2 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | — | 2 | — | — | 2 |
| Pulmonary fibrosis | D011658 | — | J84.10 | — | — | 2 | — | — | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Morbidity | D009017 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute kidney injury | D058186 | — | N17 | — | 2 | — | — | — | 2 |
| Ascites | D001201 | — | R18 | — | 2 | — | — | — | 2 |
| Hypoxia | D000860 | — | R09.02 | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | — | 1 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | — | — | — | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | — | 1 | — | — | — | 1 |
| Hypoplastic left heart syndrome | D018636 | — | Q23.4 | — | 1 | — | — | — | 1 |
| Dextrocardia | D003914 | — | Q24.0 | — | 1 | — | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
| Hepatorenal syndrome | D006530 | — | K76.7 | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | — | — | — | — | 1 |
| Aneurysm | D000783 | — | I72.9 | 1 | — | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| Fatigue | D005221 | — | R53.83 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| 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 | — |
| 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
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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 2,906 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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