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Letairis

(Ambrisentan)

ApprovedSmall molecule

Ambrisentan is used to treat pulmonary arterial hypertension, a condition where blood pressure in the lungs becomes dangerously high, making it hard for the heart to pump blood through the lungs.[2] Letairis is currently approved and in use across 15 indications[4].[1]

Letairis is one of 290 small molecule programs targeting Pulmonary arterial hypertension associated with portal hypertension. It is currently in Approved.

15

Indications

49

Total Trials

5

Active Trials

289

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Pulmonary Arterial Hypertension Associated With Portal HypertensionApproved

HypertensionActive, not recruiting

IschemiaActive, not recruiting

Vascular DiseaseApproved

Acute Kidney InjuryApproved

Hypoplastic Left Heart SyndromeApproved

Altitude SicknessApproved

Systemic SclerosisActive, not recruiting

SclerodermaActive, not recruiting

Diastolic Heart FailureActive, not recruiting

Pulmonary Arterial Hypertension Associated With Portal HypertensionApproved

Approved

HypertensionApproved

Active, not recruiting

IschemiaPreclinical

Active, not recruiting

Vascular DiseaseApproved

Approved

Acute Kidney InjuryApproved

Approved

Hypoplastic Left Heart SyndromeApproved

Approved

Altitude SicknessApproved

Approved

Systemic SclerosisPreclinical

Active, not recruiting

SclerodermaPreclinical

Active, not recruiting

Diastolic Heart FailureApproved

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

157 competitors in Hypertension

#DrugCompanyPhaseTrials

Letairis

Foundayo

Nitrostat

VViatris Specialty LLC

Alka-Seltzer

Minocycline /d

UUniversity of Florida

SGLT2

PProf. Dr. med. Ingo Eitel

Avastin

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Combination Therapy

NCT06968962

Q1 2029

Phase 3Not yet recruiting

Cardiovascular

NCT07245680

N/ANot yet recruiting

Pulmonary Arterial Hypertension

NCT06987097

Clinical

Trials by Indication[1]

Pulmonary Arterial Hypertension17 trials

An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH)

Completed·—·Phase 4·NCT01338636·30 enrolled

Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension

Completed· Gilead logo

Gilead·Phase 2·NCT00423592·36 enrolled

Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension

Terminated·NNational Jewish Health·N/A·NCT02169752·7 enrolled

Show 14 more trials

Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

Completed· GSK logo

GSK··NCT01406327·900 enrolled

Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

Completed· Gilead logo

Gilead·Phase 2·NCT00424021·54 enrolled

ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)

Completed· Gilead logo

Gilead·Phase 3·NCT00091598·372 enrolled

Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

Completed· Gilead logo

Gilead·Phase 3·NCT00423748·186 enrolled

Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension

Unknown status·RRenJi Hospital·Phase 1/2·NCT04528056·80 enrolled

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)

Completed· Gilead logo

Gilead·Phase 4·NCT00617305·38 enrolled

A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

Completed· Gilead logo

Gilead·Phase 3·NCT00578786·383 enrolled

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

Completed· Gilead logo

Gilead·Phase 3·NCT00423202·186 enrolled

Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)

Completed· GSK logo

GSK·Phase 3·NCT01808313·134 enrolled

Ambrisentan for Early Low-Risk Pulmonary Arterial Hypertension

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·N/A·NCT06987097·410 enrolled

Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)

Completed·HHeidelberg University·Phase 2·NCT02290613·38 enrolled

Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension

Recruiting·NNanjing First Hospital, Nanjing Medical University·N/A·NCT04972656·420 enrolled

Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

Completed·RRenJi Hospital·Phase 3·NCT05437224·80 enrolled

A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

Completed· GSK logo

GSK·Phase 3·NCT01178073·610 enrolled

Pulmonary Hypertension7 trials

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

Completed·TTufts Medical Center·Phase 3·NCT01224210·30 enrolled

Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

Completed· Gilead logo

Gilead·Phase 3·NCT00380068·224 enrolled

Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan

Completed·UUniversity of California, Los Angeles·Phase 4·NCT01051960·12 enrolled

Show 4 more trials

Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension

Completed·MMedical University of South Carolina·Phase 2/3·NCT00851929·16 enrolled

Study of Ambrisentan in Participants With Pulmonary Hypertension

Completed· Gilead logo

Gilead·Phase 3·NCT00777920·140 enrolled

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT01330108·32 enrolled

Ambrisentan for Treatment of Portopulmonary Hypertension

Withdrawn·MMedical University of Graz·Phase 1/2·NCT01733095

Chronic Thromboembolic Pulmonary Hypertension2 trials

Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.

Terminated· GSK logo

GSK·Phase 3·NCT01884675·33 enrolled

A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Terminated· GSK logo

GSK·Phase 3·NCT01894022·19 enrolled

Systemic Sclerosis2 trials

Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis

Completed·UUniversity of Pennsylvania·N/A·NCT01093885·15 enrolled

A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).

Completed·SStanford University·N/A·NCT00725361·20 enrolled

Hepatorenal Syndrome1 trial

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

Recruiting·NNoorik Biopharmaceuticals AG·Phase 2·NCT06256432·54 enrolled

20 more indications

Kidney Injury1 trial

Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery

Unknown status·—·Phase 2·NCT04450095·30 enrolled

Altitude1 trial

A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude

Completed·RRobert J Noveck, M.D.·Phase 1·NCT01794078·92 enrolled

Idiopathic Pulmonary Fibrosis1 trial

ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

Terminated· Gilead logo

Gilead·Phase 3·NCT00879229·40 enrolled

Effectiveness1 trial

(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

Terminated· Gilead logo

Gilead·Phase 3·NCT00768300·494 enrolled

Asthma1 trial

Examination of the Bronchoprotective Effect of Endothelin Receptor Blockade in Asthma

Unknown status·UUniversity of Glasgow·Phase 2·NCT01617746·18 enrolled

Cardiovascular1 trial

COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT07245680·186 enrolled

Pediatric Patients1 trial

Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529

Completed· GSK logo

GSK·Phase 2·NCT01342952·38 enrolled

Oral1 trial

The Safety Evaluation of Aminophylline and Ambrisentan When Administered Orally Alone and in Combination to Healthy Volunteers

Completed·TThies Schroeder·Phase 1·NCT01530464·18 enrolled

COVID-191 trial

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

Completed·—·Phase 2/3·NCT04393246·454 enrolled

Observational Study1 trial

An Observational Study For Ambrisentan

Completed· GSK logo

GSK··NCT00679224·800 enrolled

Combination Therapy1 trial

Comparison of Sequential to Initial Combination Therapy in PAH

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT06968962·376 enrolled

Single ventricle1 trial

Ambrisentan in Single Ventricle

Completed·KKevin Hill·Phase 2·NCT02080637·16 enrolled

Prolonged1 trial

Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration

Completed·CCenter for Health Sciences, Serbia·Phase 2/3·NCT01352065·30 enrolled

BOS1 trial

Crossover Study From Macitentan or Bosentan Over to Ambrisentan

Terminated·MMedical University of South Carolina·Phase 4·NCT02885012·3 enrolled

Diastolic Heart Failure1 trial

Safety and Efficacy Trial to Treat Diastolic Heart Failure Using Ambrisentan

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00840463·4 enrolled

Exercise1 trial

The Effects of Ambrisentan on Exercise Capacity in Fontan Patients

Completed·WWashington University School of Medicine·Phase 4·NCT01971580·28 enrolled

Sickle Cell Disease1 trial

The Role of Endothelin-1 in Sickle Cell Disease

Completed·—·Phase 1·NCT02712346·26 enrolled

Cirrhosis1 trial

A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis

Terminated·NNoorik Biopharmaceuticals AG·Phase 2·NCT03827200·19 enrolled

Respiratory insufficiency1 trial

A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19

Terminated·NNoorik Biopharmaceuticals AG·Phase 2·NCT04771000·88 enrolled

Scleroderma1 trial

Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet

Completed·SSoumya Chatterjee·N/A·NCT01072669·20 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 15, 2007

LETAIRIS

NDA NDA022081

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Ambrisentan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Letairis drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ambrisentan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ambrisentan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022081). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Letairis. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Endothelin Receptor, ET-A/ET-B Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Patent Landscape[6]

Patent Cliff

Dec 11, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9474752Dec 11, 2027

8377933Dec 11, 2027

9549926Oct 14, 2031

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