NDAORALTABLETPriority Review
Approved
Jun 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
LETAIRIS (ambrisentan) by Gilead Sciences is endothelin receptor antagonists [moa]. First approved in 2007.
Drug data last refreshed 18m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LETAIRIS (ambrisentan) is an oral endothelin receptor antagonist approved in 2007 for pulmonary arterial hypertension (PAH). It selectively blocks endothelin-1 signaling on pulmonary and systemic vasculature to reduce pulmonary vascular resistance and improve exercise capacity. The drug is currently in peak commercial lifecycle under Gilead Sciences sponsorship.
$89MPart D
Peak5.3 years to LOEPeak-stage product with stable Medicare spending of $89M annually supports a mature, focused commercial team structure with emphasis on retention and payer management.
Mechanism of Action
Endothelin Receptor Antagonists
Pharmacologic Class:
Endothelin Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants
Started Sep 2019
29 enrolled
Hypertension, Pulmonary
Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension
Started Oct 2017
0Portopulmonary HypertensionPulmonary HypertensionCirrhosis, Liver
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
0Pulmonary Arterial Hypertension
A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects
Started Mar 2016
112 enrolled
Hypertension, Pulmonary
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study
Started Sep 2015
2 enrolled
Pulmonary Arterial Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.