LETAIRIS

Peak

ambrisentan

NDAORALTABLETPriority Review
Approved
Jun 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Endothelin Receptor Antagonists

Pharmacologic Class:

Endothelin Receptor Antagonist

Clinical Trials (5)

NCT04095286Phase 1Completed

Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants

Started Sep 2019
29 enrolled
Hypertension, Pulmonary
NCT03309592Phase 4Withdrawn

Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension

Started Oct 2017
0
Portopulmonary HypertensionPulmonary HypertensionCirrhosis, Liver
NCT02999906Phase 3Withdrawn

Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

Started Oct 2017
0
Pulmonary Arterial Hypertension
NCT02688387Phase 1Completed

A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects

Started Mar 2016
112 enrolled
Hypertension, Pulmonary
NCT02253394Phase 4Terminated

The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study

Started Sep 2015
2 enrolled
Pulmonary Arterial Hypertension

Loss of Exclusivity

LOE Date
Oct 14, 2031
68 months away
Patent Expiry
Oct 14, 2031

Patent Records (3)

Patent #ExpiryTypeUse Code
8377933
Dec 11, 2027
U-1754
9474752
Dec 11, 2027
U-1754
9549926
Oct 14, 2031
U-1965