Drugs / Ambrisentan
last change Jun 2026 re-read 8 days ago

Ambrisentan

Small molecule

Developed for
pulmonary arterial hypertension · pulmonary hypertension · systemic sclerosis · cirrhosis of liver · acute mountain sickness · COVID-19 · hypertensive disorder · idiopathic pulmonary fibrosis
+17 more · acute kidney injury · asthma · chronic kidney disease · hepatorenal syndrome · IgA glomerulonephritis · metabolic syndrome X · portal hypertension · proteinuria · sarcoidosis · sickle cell disease · ulcer disease · univentricular heart · vascular disorder · diastolic heart failure · hypoplastic left heart syndrome · hypoplastic right heart syndrome · ischemic disease
Investigated by
Gilead Sciences · GlaxoSmithKline · Noorik Biopharmaceuticals AG · Medical University of South Carolina · Nanjing First Hospital, Nanjing Medical University · National Heart, Lung, and Blood Institute (NHLBI)
+52 more · Ochsner Health System · RenJi Hospital · Shanghai Pulmonary Hospital, Shanghai, China · Stanford University · Affiliated Hospital of Jiaxing University · American Diabetes Association · American Heart Association · Assistance Publique - Hôpitaux de Paris · Augusta University · Bayer · Brigham and Women's Hospital · Cambridge University Hospitals NHS Foundation Trust · Center for Health Sciences, Serbia · Covance Harrogate · Eli Lilly and Company · First Affiliated Hospital of Chongqing Medical University · First Affiliated Hospital of Ningbo University · First Affiliated Hospital of Wenzhou Medical University · Guangdong Provincial People's Hospital · Hammersmith Medicines Research · Heidelberg University · Huzhou Central Hospital · Johns Hopkins University · Medical University of Graz · NHS Greater Glasgow and Clyde · National Institutes of Health (NIH) · Ningbo Medical Center Lihuili Hospital · Ningbo No.2 Hospital · Robert J Noveck, M.D. · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Zhongshan Hospital · Taizhou Hospital · The Affiliated Hospital of Qingdao University · The Cleveland Clinic · The First Affiliated Hospital with Nanjing Medical University · The First Hospital of Jilin University · The Second Affiliated Hospital of Jiaxing University · Tianjin Medical University General Hospital · Tufts Medical Center · United States Department of Defense · United Therapeutics · University of Alabama at Birmingham · University of Calgary · University of California, Los Angeles · University of Glasgow · University of Montana · University of Pennsylvania · University of Texas · University of Wisconsin, Madison · Washington University School of Medicine · Wuhan Asia Heart Hospital · Xinqiao Hospital of Chongqing

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed pulmonary arterial hypertension 5 milestones
Filed EU (EMA) Volibris pulmonary arterial hypertension 2014-12-11

“filed a regulatory submission to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for ambrisentan (Volibris®)” gsk.com ↗

Filed US (FDA) Letairis pulmonary arterial hypertension 2014-12-05

“Gilead submitted the AMBITION data in a Letairis supplemental new drug application (sNDA) to the U.S. Food and Drug Administration ( FDA ) on December 5, 2014.” gilead.com ↗

Filed EU (EMA) — pulmonary arterial hypertension 2007-03-23

“GlaxoSmithKline's Marketing Authorisation Application (MAA) for ambrisentan for the treatment of pulmonary arterial hypertension (PAH) was validated by the European Medicines...” gilead.com ↗

Filed US (FDA) — pulmonary arterial hypertension 2007-02-16

“FDA has accepted for filing and granted a Priority Review for the company's New Drug Application (NDA) for marketing approval of ambrisentan” gilead.com ↗

Filed US (FDA) — pulmonary arterial hypertension 2006-12-18

“submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of ambrisentan” gilead.com ↗

Approved Indication not stated 3 milestones
Label expansions (2) US (FDA) LETAIRIS — 2012-02-15 – 2015-10-02 fda.gov ↗
Approved EU (EMA) Volibris — 2008-04-21 europa.eu ↗
Approved US (FDA) LETAIRIS — 2007-06-15 fda.gov ↗

Trials 52

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials · 1 met primary
Phase 1 NCT04095286 Sep → Dec 2019 pulmonary hypertension GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02936687 Jan 2017 → Jul 2021 metabolic syndrome X University of Wisconsin, Madison Completed No outcome recorded
Phase 1 NCT02688387 Mar 2016 → Aug 2017 pulmonary hypertension GlaxoSmithKline Completed Met primary
Phase 1 NCT02712346 Sep 2015 → May 2019 sickle cell disease Augusta University Completed No outcome recorded
Phase 1 NCT01794078 Sep 2013 → Sep 2014 acute mountain sickness Robert J Noveck, M.D. Completed No outcome recorded
Phase 1 NCT00424034 Jan → Feb 2007 — GlaxoSmithKline Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT04528056 Aug 2020 → Dec 2021 pulmonary arterial hypertension RenJi Hospital Unknown No outcome recorded
Phase 1/2 NCT01733095 Jul 2012 → Apr 2016 pulmonary hypertension Medical University of Graz Withdrawn No outcome recorded Stop: Enrollment
Phase 210 trials · 1 missed
Phase 2 NCT06256432 Apr 2024 → May 2026 overdue acute kidney injury, cirrhosis of liver, hepatorenal syndrome Noorik Biopharmaceuticals AG Active not recruiting No outcome recorded
Phase 2 NCT04771000 Feb 2021 → Feb 2023 COVID-19 Noorik Biopharmaceuticals AG Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03827200 Apr 2019 → Dec 2020 cirrhosis of liver, portal hypertension Noorik Biopharmaceuticals AG Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02290613 Jul 2014 → Nov 2017 pulmonary hypertension, systemic sclerosis Heidelberg University Completed Missed primary
Phase 2 NCT01617746 Nov 2012 → May 2014 asthma University of Glasgow Unknown No outcome recorded
Phase 2 NCT01342952 Jun 2011 → Jun 2022 pulmonary arterial hypertension GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01332331 Jan 2011 → Nov 2013 pulmonary arterial hypertension GlaxoSmithKline Terminated No outcome recorded
Phase 2 NCT00540436 Aug 2007 → Jan 2009 pulmonary arterial hypertension GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00423592 May 2005 → Jan 2006 pulmonary hypertension Gilead Sciences Completed No outcome recorded
Phase 2 NCT00424021 Apr 2003 → Dec 2009 pulmonary hypertension Gilead Sciences Completed No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT04393246 Jul 2020 → Jun 2022 COVID-19 Cambridge University Hospitals NHS Foundation Trust Completed No outcome recorded
Phase 2/3 NCT01902758 Aug 2013 acute mountain sickness University of Montana Completed No outcome recorded
Phase 2/3 NCT01352065 Jan 2011 → Dec 2012 pulmonary hypertension Center for Health Sciences, Serbia Completed No outcome recorded
Phase 2/3 NCT00851929 Nov 2008 → Apr 2011 pulmonary hypertension, sarcoidosis Medical University of South Carolina Completed No outcome recorded
Phase 315 trials · 3 met primary · 2 missed
Phase 3 NCT07245680 Apr 2026 → Feb 2029 expected pulmonary arterial hypertension Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT05437224 Dec 2018 → Jan 2022 pulmonary arterial hypertension RenJi Hospital Completed No outcome recorded
Phase 3 NCT01894022 Jan 2014 → Nov 2015 hypertensive disorder GlaxoSmithKline Terminated No outcome recorded
Phase 3 NCT01884675 Sep 2013 → Mar 2015 hypertensive disorder GlaxoSmithKline Terminated No outcome recorded
Phase 3 NCT01808313 Dec 2012 → Aug 2014 vascular disorder GlaxoSmithKline Completed Met primary
Phase 3 NCT01224210 Mar 2010 → Oct 2016 pulmonary arterial hypertension Tufts Medical Center Completed Mixed
Phase 3 NCT00879229 Jul 2009 → Feb 2011 idiopathic pulmonary fibrosis, pulmonary hypertension Gilead Sciences Terminated Missed primary
Phase 3 NCT00768300 Dec 2008 → Feb 2011 idiopathic pulmonary fibrosis Gilead Sciences Terminated Missed primary
Phase 3 NCT00777920 Nov 2008 → Sep 2019 pulmonary hypertension Gilead Sciences Completed No outcome recorded
Phase 3 NCT00554619 Feb 2008 → Jan 2011 pulmonary arterial hypertension GlaxoSmithKline Completed No outcome recorded
Phase 410 trials · 3 met primary
Phase 4 NCT07030894 Sep 2025 → Dec 2026 expected IgA glomerulonephritis, chronic kidney disease, proteinuria The First Hospital of Jilin University Recruiting No outcome recorded
Phase 4 NCT03309592 Oct 2017 → Nov 2018 cirrhosis of liver, pulmonary hypertension Ochsner Health System Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT02885012 Jun 2016 → Jul 2017 pulmonary arterial hypertension Medical University of South Carolina Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT03809156 Apr 2016 → Dec 2020 pulmonary hypertension University of Calgary Unknown No outcome recorded
Phase 4 NCT01971580 Aug 2012 → May 2015 univentricular heart Washington University School of Medicine Completed No outcome recorded
Phase 4 NCT01330108 May 2011 → Jun 2012 pulmonary arterial hypertension University of Alabama at Birmingham Completed No outcome recorded
Phase 4 NCT01042158 Jan 2010 → Nov 2014 pulmonary arterial hypertension, systemic sclerosis Johns Hopkins University Completed Met primary
Phase 4 NCT01051960 Mar 2009 → Jun 2010 pulmonary arterial hypertension, systemic sclerosis University of California, Los Angeles Completed Met primary
Phase 4 NCT01338636 Sep 2008 → Feb 2016 pulmonary arterial hypertension Brigham and Women's Hospital Completed No outcome recorded
Phase 4 NCT00617305 Apr 2008 → Feb 2011 pulmonary arterial hypertension Gilead Sciences Completed Met primary
Phase not applicable5 trials
— NCT06987097 May 2025 → Feb 2028 expected pulmonary arterial hypertension Nanjing First Hospital, Nanjing Medical University Not yet recruiting No outcome recorded
— NCT06968962 May 2025 → May 2028 expected pulmonary arterial hypertension Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
— NCT04972656 Sep 2022 → Dec 2025 pulmonary arterial hypertension Nanjing First Hospital, Nanjing Medical University Unknown No outcome recorded
— NCT01093885 Feb 2010 → Jul 2016 systemic sclerosis University of Pennsylvania Completed No outcome recorded
— NCT00725361 Jun 2008 → Dec 2010 systemic sclerosis, ulcer disease Stanford University Completed No outcome recorded
Comparator or background therapy11 trials
Phase 1 NCT01530464 Comparator Feb → Apr 2012 pulmonary hypertension Thies Schroeder Completed No outcome recorded
Phase 2 NCT04450095 Comparator Oct 2018 → Feb 2020 acute kidney injury Bnai Zion Medical Center Unknown No outcome recorded
Phase 2 NCT02080637 Comparator Jul 2015 → Jul 2017 hypoplastic left heart syndrome, hypoplastic right heart syndrome Kevin Hill Completed No outcome recorded
Phase 3 NCT01824290 Background Feb 2014 → Mar 2019 pulmonary arterial hypertension Eli Lilly and Company Completed No outcome recorded
Phase 3 NCT01178073 Comparator Oct 2010 → Jul 2014 pulmonary arterial hypertension GlaxoSmithKline Completed No outcome recorded

News releases announcing trial results or a regulatory action · 20

DateIssuerRelease
2019-03-29 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Ambrisentan Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Ambrisentan Tablets USP (US RLD – Letairis Tablets), 5 mg and 10 mg.
2015-11-24 GlaxoSmithKline Regulatory GSK receives European marketing authorisation to expand indication for Volibris® in treatment of pulmonary arterial hypertension gsk.com ↗
GSK today announced that the European Commission has approved a variation to expand the current therapeutic indication for Volibris® (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH).
2015-10-23 GlaxoSmithKline Regulatory GSK receives CHMP positive opinion to expand indication for Volibris® in pulmonary arterial hypertension gsk.com ↗
The positive opinion is a formal recommendation by the CHMP to expand the existing marketing authorisation for ambrisentan to include combination treatment.
2015-10-02 Gilead Sciences Regulatory U.S. Food and Drug Administration Approves New Treatment Combination of Gilead’s Letairis® with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1) gilead.com ↗
2015-08-26 Gilead Sciences Results Results From the AMBITION Study of First-Line Treatment With Letairis and Tadalafil in Pulmonary Arterial Hypertension Published in The New England Journal of Medicine gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the AMBITION study (a randomized, double-blind, multicenter study of first-line combination therapy with AMB r I sentan and T adalafil in patients with pulmonary arterial hypertens ION ).
2014-12-11 GlaxoSmithKline Regulatory GSK announces EU regulatory submission seeking extended indication for ambrisentan (Volibris®) in pulmonary arterial hypertension gsk.com ↗
GSK today announced that it has filed a regulatory submission to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for ambrisentan (Volibris®), to extend the current therapeutic indication to include its use in initial combination therapy for patients with pulmonary arterial hypertension (PAH).
2014-09-08 GlaxoSmithKline Results GSK announces first-line combination of ambrisentan and tadalafil reduces risk of clinical failure compared to monotherapy in pulmonary arterial hypertension outcomes study gsk.com ↗
The length of time before patients experienced clinical failure was significantly prolonged for those receiving first-line combination compared to monotherapy.
2014-09-08 Gilead Sciences Results First-Line Combination of Ambrisentan and Tadalafil Reduces Risk of Clinical Failure Compared to Monotherapy in Pulmonary Arterial Hypertension Outcomes Study gilead.com ↗
2011-03-04 Gilead Sciences Regulatory U.S. FDA Removes Warning about Potential Liver Injury from Boxed Warning of Prescribing Information for Gilead's Letairis gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved a change to the prescribing information for Letairis (R) (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.
2010-12-22 Gilead Sciences Results Gilead Terminates Phase III Clinical Trial of Ambrisentan in Patients with Idiopathic Pulmonary Fibrosis gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is stopping ARTEMIS-IPF, the company's ongoing Phase III clinical trial of ambrisentan in patients with idiopathic pulmonary fibrosis (IPF), due to lack of efficacy.
2009-05-18 Gilead Sciences Results New Data for Gilead Sciences' Ambrisentan Show Clinical Improvements in a Diverse Pulmonary Hypertension (PH) Population gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from ARIES-3, an open-label, single-arm, Phase III study evaluating the efficacy and safety of ambrisentan in patients with pulmonary hypertension (PH), which showed a mean 21-meter improvement from baseline in six-minute walk distance (6MWD) at 24 weeks.
2008-10-28 Gilead Sciences Results Gilead Announces Two-Year Clinical Data for Letairis(R) (ambrisentan) for the Treatment of Pulmonary Arterial Hypertension (WHO Group 1) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results of a two-year (104-week), open-label, uncontrolled, extension study (ARIES-E) of Letairis(R) in patients with pulmonary arterial hypertension (PAH) (WHO Group 1).

All press releases naming this drug 24 releases

DateIssuerRelease

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 65 sources stand behind the page.

FieldValueCited text
Known as Ambrisentan “All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one...” NCT06317805 ↗
59

“The aim of this study is to provide clinically relevant information on the pharmacokinetic (PK) and safety profile of a new lower dose formulation ambrisentan (AMB) tablet,...” NCT04095286 ↗

“All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).” NCT01824290 ↗

“Riociguat Oral Product and Ambrisentan Oral Product to be given in combination to de novo (untreated) patients.” NCT03809156 ↗

“ET-1 inhibition: Ambrisentan is an antagonist of the ETA receptor.” NCT02936687 ↗

NCT02169752 ↗

NCT01894022 ↗

NCT00879229 ↗

NCT00423202 ↗

NCT03827200 ↗

NCT00423748 ↗

Show 49 more sources

Known as AMB “The aim of this study is to provide clinically relevant information on the pharmacokinetic (PK) and safety profile of a new lower dose formulation ambrisentan (AMB) tablet,...” NCT04095286 ↗
Known as Ambrisentan mylan ChEMBL registry synonym — accepted as the source's own label CHEMBL1111 ↗
Known as GSK-1325760 ChEMBL registry synonym — accepted as the source's own label CHEMBL1111 ↗
Known as GSK1325760A ClinicalTrials.gov intervention name — accepted as the source's own label NCT00554619 ↗
2

NCT00424034 ↗

NCT00540436 ↗

Known as LETAIRIS “Ambrisentan (VOLIBRIS™ tablets) is an endothelin receptor antagonist (ERA) marketed in the European Union (EU) and some other countries by GlaxoSmithKline (GSK) and in the...” NCT01332331 ↗
3

“Ambrisentan (VOLIBRIS™ tablets) is an endothelin receptor antagonist (ERA) marketed in the European Union (EU) and some other countries by GlaxoSmithKline (GSK) and in the...” NCT01342952 ↗

“This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.” NCT00725361 ↗

“Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis” NCT00851929 ↗

Known as LU-208075 ChEMBL registry synonym — accepted as the source's own label CHEMBL1111 ↗
Known as N-003 (ambrisentan solution) “N-003 (ambrisentan solution)” NCT04771000 ↗
Known as Pu Nuo An “The domestic Ambrisentan tablet is produced by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. under the trade name of "Pu Nuo An".” NCT05437224 ↗
Known as Volibris “Ambrisentan (VOLIBRIS™ tablets) is an endothelin receptor antagonist (ERA) marketed in the European Union (EU) and some other countries by GlaxoSmithKline (GSK) and in the...” NCT01332331 ↗
2

“Ambrisentan (VOLIBRIS™ tablets) is an endothelin receptor antagonist (ERA) marketed in the European Union (EU) and some other countries by GlaxoSmithKline (GSK) and in the...” NCT01342952 ↗

“Ambrisentan (Volibris (10mg).” NCT04450095 ↗

Action Inhibit “A-selective endothelin receptor antagonist” PMID 18506008 ↗ May 2008
Modality Small molecule — CHEMBL1111 ↗
Route Oral “orally once daily” PMID 18506008 ↗ May 2008