Ambrisentan
GET
/api/v1/drug/ambrisentanMechanism of action
Sourced from openFDAMechanism-of-action class: Endothelin Receptor Antagonists.
Endothelin Receptor
Approval history
Sourced from openFDA- Jun 15, 2007NDANDA022081Gilead
- Mar 28, 2019ANDAANDA208252Watson Labs Inc
- Mar 28, 2019ANDAANDA210058Zydus Pharms
- Mar 28, 2019ANDAANDA210784Sun Pharm
- Mar 28, 2019ANDAANDA208441Mylan
- Apr 10, 2019ANDAANDA208354Sigmapharm Labs Llc
- Apr 26, 2019ANDAANDA210715Cipla
- May 19, 2022ANDAANDA210701Apotex
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
123,381 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Dyspnoea19,05115%
- 2Death11,3219.2%
- 3Headache10,6818.7%
- 4Pneumonia7,2295.9%
- 5Diarrhoea7,0385.7%
- 6Fatigue6,5405.3%
- 7Dizziness6,4945.3%
- 8Nausea6,4765.2%
- 9Fluid Retention5,4504.4%
- 10Malaise5,3044.3%
- 11Cough4,5763.7%
- 12Oedema Peripheral4,1783.4%
- 13Peripheral Swelling4,0083.2%
- 14Chest Pain3,8233.1%
- 15Nasal Congestion3,7903.1%
Clinical trials
The 10 most recently updated of 77 ClinicalTrials.gov registrations naming Ambrisentan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial HypertensionActive not recruiting · Phase 3 · Interventional · 935 enrolled · ActelionNCT04273945updated 2026-06-05
- COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular ComorbiditiesRecruiting · Phase 3 · Interventional · 186 enrolled · Assistance Publique - Hôpitaux de ParisNCT07245680updated 2026-05-13
- Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal SyndromeActive not recruiting · Phase 2 · Interventional · 54 enrolled · Noorik Biopharmaceuticals AGNCT06256432updated 2026-04-13
- The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial HypertensionRecruiting · Observational · 121 enrolled · University of Sao Paulo General HospitalNCT07013149updated 2025-10-01
- Nefecon and Ambrisentan in IgA NephropathyRecruiting · Phase 4 · Interventional · 129 enrolled · The First Hospital of Jilin UniversityNCT07030894updated 2025-09-15
- COMPERA / COMPERA-KIDSRecruiting · Observational · 14,000 enrolled · Technische Universität DresdenNCT01347216updated 2025-08-24
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5Completed · Observational · 13,021 enrolled · Brigham and Women's HospitalNCT05039086updated 2025-08-06
- Comparison of Sequential to Initial Combination Therapy in PAHRecruiting · Interventional · 376 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT06968962updated 2025-07-29
- Ambrisentan for Early Low-Risk Pulmonary Arterial HypertensionNot yet recruiting · Interventional · 410 enrolled · Nanjing First Hospital, Nanjing Medical UniversityNCT06987097updated 2025-05-23
- Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I PatientsRecruiting · Phase 4 · Interventional · 110 enrolled · AOP Orphan Pharmaceuticals AGNCT06317805updated 2024-03-19
Frequently asked questions
- How does Ambrisentan work?
- Mechanism-of-action class: Endothelin Receptor Antagonists.
- What class of drug is Ambrisentan?
- Ambrisentan is classified as Antihypertensives for pulmonary arterial hypertension, Endothelin Receptor Antagonist, Endothelin Receptor Antagonists, Decreased Blood Pressure, Pulmonary Arterial Vasodilation.
- What are the brand names for Ambrisentan?
- Ambrisentan is marketed under brand names including Letairis.
Note. Data for
ambrisentan is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.