Drugs / Ambrisentan
Ambrisentan
also known as
LETAIRIS · GSK1325760A · Volibris · AMB · Ambrisentan mylan · BSF 208075 · GSK-1325760 · LU-208075 · +2 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 53 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| 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 | No outcome recorded |
| 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| Phase 1/2 | NCT01733095 | Jul 2012 → Apr 2016 | pulmonary hypertension | Medical University of Graz | Withdrawn | No outcome recorded |
| Phase 211 trials | ||||||
| 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 |
| Phase 2 | NCT03827200 | Apr 2019 → Dec 2020 | cirrhosis of liver, portal hypertension | Noorik Biopharmaceuticals AG | Terminated | No outcome recorded |
| Phase 2 | NCT02290613 | Jul 2014 → Nov 2017 | pulmonary hypertension, systemic sclerosis | Heidelberg University | Completed | No outcome recorded |
| 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 | NCT00046319 | Sep 2002 → Jun 2003 | 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT01224210 | Mar 2010 → Oct 2016 | pulmonary arterial hypertension | Tufts Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00879229 | Jul 2009 → Feb 2011 | idiopathic pulmonary fibrosis, pulmonary hypertension | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT00768300 | Dec 2008 → Feb 2011 | idiopathic pulmonary fibrosis | Gilead Sciences | Terminated | No outcome recorded |
| 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 3 | NCT00380068 | Aug 2006 → Jul 2008 | pulmonary hypertension | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00578786 | Feb 2004 → Mar 2010 | pulmonary arterial hypertension | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00091598 | Jan 2004 → Feb 2006 | pulmonary arterial hypertension | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00423202 | Dec 2003 → Oct 2005 | pulmonary arterial hypertension | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00423748 | Dec 2003 → Feb 2006 | pulmonary arterial hypertension | Gilead Sciences | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| 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 |
| Phase 4 | NCT02885012 | Jun 2016 → Jul 2017 | pulmonary arterial hypertension | Medical University of South Carolina | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 4 | NCT01051960 | Mar 2009 → Jun 2010 | pulmonary arterial hypertension, systemic sclerosis | University of California, Los Angeles | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01530464 Comparator | Feb → Apr 2012 | pulmonary hypertension | Thies Schroeder | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| 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 32 trials | ||||||
| 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 |
| Phase 43 trials | ||||||
| Phase 4 | NCT06317805 Background | Dec 2023 → Jun 2027 expected | pulmonary arterial hypertension | AOP Orphan Pharmaceuticals AG | Recruiting | No outcome recorded |
| Phase 4 | NCT02253394 Comparator | Sep 2015 → Feb 2018 | pulmonary arterial hypertension | Brigham and Women's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00840463 Comparator | Jan 2009 → Sep 2013 | diastolic heart failure, pulmonary hypertension | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02169752 Comparator | Sep 2012 → May 2017 | pulmonary arterial hypertension | National Jewish Health | Terminated | No outcome recorded |
| — | NCT01072669 Comparator | Feb → Dec 2010 | ischemic disease | Soumya Chatterjee | Completed | No outcome recorded |
Press releases naming this drug 18 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-05-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of a Generic Version of Letairis® (ambrisentan) Tablets in the United States tevapharm.com ↗ |
| 2015-10-02 | Gilead Sciences | 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 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 ↗ |
| 2014-09-08 | Gilead Sciences | 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 | U.S. FDA Removes Warning about Potential Liver Injury from Boxed Warning of Prescribing Information for Gilead's Letairis gilead.com ↗ |
| 2010-12-22 | Gilead Sciences | Gilead Terminates Phase III Clinical Trial of Ambrisentan in Patients with Idiopathic Pulmonary Fibrosis gilead.com ↗ |
| 2009-05-18 | Gilead Sciences | New Data for Gilead Sciences' Ambrisentan Show Clinical Improvements in a Diverse Pulmonary Hypertension (PH) Population gilead.com ↗ |
| 2008-10-28 | Gilead Sciences | Gilead Announces Two-Year Clinical Data for Letairis(R) (ambrisentan) for the Treatment of Pulmonary Arterial Hypertension (WHO Group 1) gilead.com ↗ |
| 2008-05-29 | Gilead Sciences | Data from Pivotal Phase III Studies of Gilead's Letairis(R) (ambrisentan) for Pulmonary Arterial Hypertension (WHO Group 1) in Patients with WHO Functional Class II or III Symptoms Published in Circulation gilead.com ↗ |
| 2008-05-20 | Gilead Sciences | Gilead Announces New Letairis(R) (Ambrisentan) Data for the Treatment of Patients With Pulmonary Arterial Hypertension (WHO Group 1) With WHO Functional Class II or III Symptoms gilead.com ↗ |
| 2008-05-01 | Gilead Sciences | Gilead Initiates Letairis(R) (ambrisentan) Phase IV Program gilead.com ↗ |
| 2007-10-23 | Gilead Sciences | Gilead Announces New Letairis(TM) (ambrisentan) Data for the Treatment of Patients with Pulmonary Arterial Hypertension (WHO Group 1) gilead.com ↗ |
| 2007-06-15 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead's Letairis(TM) (ambrisentan) 5 mg and 10 mg Tablets for the Once-Daily Treatment of Pulmonary Arterial Hypertension (WHO Group 1) in Patients with WHO Functional Class II or III Symptoms gilead.com ↗ |
| 2007-06-15 | Gilead Sciences | Gilead Sciences to Host Conference Call to Discuss the U.S. Food and Drug Administration Approval of Letairis(TM) gilead.com ↗ |
| 2007-05-21 | Gilead Sciences | Gilead Announces Presentation of Long-Term Data for Ambrisentan, a Potential Treatment for Patients With Pulmonary Arterial Hypertension gilead.com ↗ |
| 2007-03-23 | Gilead Sciences | Marketing Authorisation Application for Ambrisentan Validated by European Medicines Agency gilead.com ↗ |
| 2007-02-16 | Gilead Sciences | Gilead's New Drug Application for Ambrisentan Receives Priority Review Status gilead.com ↗ |
| 2006-12-18 | Gilead Sciences | Gilead Submits New Drug Application To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension gilead.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited 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 ↗58“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 ↗ |
| 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 | BSF 208075 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00046319 ↗ |
| 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 ↗ |
| 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...” NCT01342952 ↗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...” NCT01332331 ↗ “Ambrisentan (Volibris (10mg).” NCT04450095 ↗ |
| Action | Inhibit | “A-selective endothelin receptor antagonist” PMID 18506008 ↗ May 2008 |
| Modality | Small molecule | — CHEMBL1111 ↗ |
| Route | Oral | “10.0 mg po qd” NCT00046319 ↗ |