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Drug

Ambrisentan

Approved · EMA
Emerging researchLate-stage development

Also known as Letairis.

RxNorm358274ChEMBLCHEMBL1111UNIIHW6NV07QEC
1
Research papers
4
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Comparison of Initial Dual Oral COMbination Therapy to MOnotherapy in Pulmonary Arterial Hypertension With Cardiovascular comorbiDITIES

Clinical trial2026-05-13Results expected Q1 2029 · ClinicalTrials.gov

A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled Study

Clinical trial2025-12-30Primary completion · ClinicalTrials.gov

A Multicenter, Randomized, Controlled, Double-blind, and Non-inferiority Clinical Trial to Compare the Efficacy of Sequential to Initial Combination Therapy in Patients With Pulmonary Arterial Hypertension

Clinical trial2025-07-29Results expected Q2 2028 · ClinicalTrials.gov

Ambrisentan for the Treatment of Early-Stage Low-Risk Pulmonary Arterial Hypertension: A Multicenter, Randomized, Double-Blind, Placebo-Controlled ALEPH Trial

Clinical trial2025-05-23Results expected Q1 2028 · ClinicalTrials.gov

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Ambrisentan in Patients With Severe COVID-19

Clinical trial2023-02-27Terminated · ClinicalTrials.gov

An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired

Clinical trial2022-12-30Results posted · ClinicalTrials.gov

mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E)

Clinical trial2022-06-08Completed · ClinicalTrials.gov

A Multicenter Open Label Study to Evaluate Efficacy and Safety of China Made Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

Clinical trial2022-02-06Completed · ClinicalTrials.gov

Approval: Ambrisentan Viatris (previously Ambrisentan Mylan) (EMA)

Regulatory2019-06-20EMA

Brief report: effect of ambrisentan treatment on exercise-induced pulmonary hypertension in systemic sclerosis: a prospective single-center, open-label pilot study.

Research2012-12-01Arthritis and rheumatism

Approval: Volibris (EMA)

Regulatory2008-04-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ambrisentan
Aliases & brands
Letairis
RxNorm CUI
358274
ChEMBL ID
CHEMBL1111
UNII
HW6NV07QEC
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2008-04-21
Latest approval
2019-06-20
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2019-06-20Approval
Approval: Ambrisentan Viatris (previously Ambrisentan Mylan) (EMA)
Indication: Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination… Show full indication

Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

Evidence ↗
2008-04-21Approval
Approval: Volibris (EMA)
Indication: Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see… Show full indication

Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).  Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

48 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
48
registered trials across all phases
LATEST COMPLETION 2022
4
Active studies
3
Recruiting
32
Late-stage (III+)
29
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 48
Phase 13Phase 1 / 22Phase 211Phase 2 / 33Phase 315Phase 47Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)

TerminatedPH IVMedical University of South Carolinan=32017

An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension

CompletedPH IVBrigham and Women's Hospitaln=302016

The Effects of Ambrisentan on Exercise Capacity in Fontan Patients

CompletedPH IVWashington University School of Medicinen=282015

Safety and Efficacy Trial Using Ambrisentan for Pulmonary Hypertension Associated With Congestive Heart Failure With Preserved Left Ventricular Ejection Fraction

TerminatedPH IVUniversity of Texas Southwestern Medical Centern=42014

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

CompletedPH IVUniversity of Alabama at Birminghamn=322012

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired

CompletedPH IIGlaxoSmithKlinen=382022

mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E)

CompletedPH II/IIICambridge University Hospitals NHS Foundation Trustn=4542022

A Multicenter Open Label Study to Evaluate Efficacy and Safety of China Made Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

CompletedPH IIIRenJi Hospitaln=802022

Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial

CompletedPH IIITufts Medical Centern=302020

The Role of Endothelin-1 in Sickle Cell Disease

CompletedPH IAugusta Universityn=262019

ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension

CompletedPH IIIGilead Sciencesn=1402019

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Arthritis and rheumatism1
Leading researchers
  • Abtin F1
  • Belperio J1
  • Clements P1
  • Dua S1
  • Furst DE1
  • Khanna D1
  • Maranian P1
  • Saggar R1
Leading institutions
free-text, unnormalised
  • Heart-Lung Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.