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Letairis (AMBRISENTAN)
Letairis (Ambrisentan) is a small molecule endothelin receptor antagonist developed by Gilead, targeting the endothelin-1 receptor to treat pulmonary arterial hypertension. It was FDA-approved in 2007 and remains a branded product, with multiple generic manufacturers available. As an endothelin receptor antagonist, Letairis works by blocking the action of endothelin-1, a potent vasoconstrictor, to reduce pulmonary artery pressure. Key safety considerations include potential liver enzyme elevations and teratogenic effects. Letairis is a commercially available product with a complex pharmacokinetic profile.
At a glance
| Generic name | AMBRISENTAN |
|---|---|
| Sponsor | Gilead Sciences |
| Drug class | Endothelin Receptor Antagonist [EPC] |
| Target | Endothelin-1 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2007 |
Approved indications
- Pulmonary arterial hypertension
Common side effects
- Peripheral edema
- Headache
- Nasal congestion
- Cough
- Anemia
- Dyspepsia
- Bronchitis
Serious adverse events
- Hepatic injury
Key clinical trials
- Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (PHASE3)
- COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities (PHASE3)
- The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension
- Nefecon and Ambrisentan in IgA Nephropathy (PHASE4)
- COMPERA / COMPERA-KIDS
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5
- Comparison of Sequential to Initial Combination Therapy in PAH (NA)
- Ambrisentan for Early Low-Risk Pulmonary Arterial Hypertension (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Letairis CI brief — competitive landscape report
- Letairis updates RSS · CI watch RSS
- Gilead Sciences portfolio CI