Clinical Trials

Numerous clinical trials evaluate ambrisentan across Phase 1 through Phase 4, primarily focusing on pulmonary arterial hypertension, hypertension, idiopathic pulmonary fibrosis, acute mountain sickness, pediatric single ventricle cardiac conditions, and severe hypoxemic respiratory conditions. Sponsored by academic research centers, healthcare trusts, and major pharmaceutical companies such as GlaxoSmithKline and Gilead Sciences, these studies encompass various recruitment statuses including completed, recruiting, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07245680 RECRUITING
Pulmonary Arterial Hypertension (PAH); Comorbidities; Cardiovascular Disease (CVD)
Assistance Publique - Hôpitaux de Paris
 2026-04-28 PHASE3
NCT06968962 RECRUITING
Pulmonary Arterial Hypertension (PAH)
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-05-14
NCT06987097 NOT_YET_RECRUITING
Pulmonary Arterial Hypertension (PAH)
Nanjing First Hospital, Nanjing Medical University
 2025-05-15
NCT07030894 RECRUITING
IgA Nephropathy; Chronic Kidney Disease; Proteinuria
The First Hospital of Jilin University
 2025-09-01 PHASE4
NCT06256432 ACTIVE_NOT_RECRUITING
Hepatorenal Syndrome; Liver Cirrhosis; Acute Kidney Injury; Ascites Hepatic
Noorik Biopharmaceuticals AG
 2024-04-17 PHASE2
NCT04972656 UNKNOWN
Pulmonary Arterial Hypertension
Nanjing First Hospital, Nanjing Medical University
 2022-09-05
NCT04771000 TERMINATED
Covid19; Hypoxemia
Noorik Biopharmaceuticals AG
 2021-02-08 PHASE2
NCT01342952 COMPLETED
Hypertension, Pulmonary
GlaxoSmithKline
 2011-06-21 PHASE2
NCT04393246 COMPLETED
COVID-19
Cambridge University Hospitals NHS Foundation Trust
 2020-07-03 PHASE2; PHASE3
NCT05437224 COMPLETED
Pulmonary Arterial Hypertension
RenJi Hospital
 2018-12-18 PHASE3
NCT04528056 UNKNOWN
Pulmonary Arterial Hypertension
RenJi Hospital
 2020-08-01 PHASE1; PHASE2
NCT02999906 WITHDRAWN
Pulmonary Arterial Hypertension
United Therapeutics
 2017-10 PHASE3
NCT03809156 UNKNOWN
Pulmonary Hypertension
University of Calgary
 2016-04-26 PHASE4
NCT03827200 TERMINATED
Cirrhosis; Portal Hypertension; Ascites
Noorik Biopharmaceuticals AG
 2019-04-11 PHASE2
NCT04450095 UNKNOWN
Kidney Failure, Acute
Bnai Zion Medical Center
 2018-10-11 PHASE2
NCT04095286 COMPLETED
Hypertension, Pulmonary
GlaxoSmithKline
 2019-09-30 PHASE1
NCT00777920 COMPLETED
Pulmonary Hypertension
Gilead Sciences
 2008-11-17 PHASE3
NCT02712346 COMPLETED
Sickle Cell Anemia
Augusta University
 2015-09 PHASE1
NCT03309592 WITHDRAWN
Portopulmonary Hypertension; Pulmonary Hypertension; Cirrhosis, Liver
Ochsner Health System
 2017-10-12 PHASE4
NCT02253394 TERMINATED
Pulmonary Arterial Hypertension
Brigham and Women's Hospital
 2015-09 PHASE4
NCT02290613 COMPLETED
Systemic Sclerosis; Pulmonary Hypertension
Heidelberg University
 2014-07-01 PHASE2
NCT02688387 COMPLETED
Hypertension, Pulmonary
GlaxoSmithKline
 2016-03-18 PHASE1
NCT02080637 COMPLETED
Hypoplastic Left Heart Syndrome; Hypoplastic Right-sided Heart Complex
Kevin Hill
 2015-07 PHASE2
NCT02885012 TERMINATED
Pulmonary Arterial Hypertension
Medical University of South Carolina
 2016-06 PHASE4
NCT02169752 TERMINATED
Pre-Pulmonary Atrial Hypertension
National Jewish Health
 2012-09
NCT01224210 COMPLETED
Portopulmonary Hypertension
Tufts Medical Center
 2010-03 PHASE3
NCT02958358 WITHDRAWN
Pulmonary Arterial Hypertension
Robert Scott Harris, M.D.
 2014-09
NCT01093885 COMPLETED
Systemic Sclerosis; Scleroderma
University of Pennsylvania
 2010-02
NCT01733095 WITHDRAWN
Portopulmonary Hypertension
Medical University of Graz
 2012-07 PHASE1; PHASE2
NCT01338636 COMPLETED
Exercise-induced Pulmonary Arterial Hypertension
Brigham and Women's Hospital
 2008-09 PHASE4
NCT01894022 TERMINATED
Hypertension
GlaxoSmithKline
 2014-01-23 PHASE3
NCT02712346 Completed
Sickle Cell Anemia
Augusta University|Gilead Sciences|National Heart Lung and Blood Institute (NHLBI)
 2015-09 Phase 1
NCT02080637 Completed
Hypoplastic Left Heart Syndrome|Hypoplastic Right-sided Heart Complex
Kevin Hill|Duke University
 2015-07 Phase 2
NCT01971580 COMPLETED
Single Ventricle Fontan Palliation
Washington University School of Medicine
 2012-08 PHASE4
NCT01884675 TERMINATED
Hypertension
GlaxoSmithKline
 2013-09 PHASE3
NCT01042158 COMPLETED
Pulmonary Arterial Hypertension; Systemic Sclerosis; Scleroderma Spectrum of Diseases; Connective Tissue Disease; Pulmonary Hypertension
Johns Hopkins University
 2010-01 PHASE4
NCT01794078 COMPLETED
Acute Mountain Sickness and Fatigue
Robert J Noveck, M.D.
 2013-09 PHASE1
NCT01808313 COMPLETED
Vascular Disease
GlaxoSmithKline
 2012-12-01 PHASE3
NCT01178073 COMPLETED
Hypertension, Pulmonary
GlaxoSmithKline
 2010-10-01 PHASE3
NCT01617746 UNKNOWN
Asthma
University of Glasgow
 2012-11 PHASE2
NCT01894022 Terminated
Hypertension
GlaxoSmithKline
 2014-01-23 Phase 3
NCT01332331 TERMINATED
Hypertension, Pulmonary
GlaxoSmithKline
 2011-01-04 PHASE2
NCT00840463 TERMINATED
Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction
University of Texas Southwestern Medical Center
 2009-01 PHASE4
NCT01902758 COMPLETED
Acute Mountain Sickness
University of Montana
 2013-08 PHASE2; PHASE3
NCT01352065 COMPLETED
Pulmonary Hypertension
Center for Health Sciences, Serbia
 2011-01 PHASE2; PHASE3
NCT01330108 COMPLETED
Pulmonary Arterial Hypertension
University of Alabama at Birmingham
 2011-05 PHASE4
NCT01530464 COMPLETED
High Altitude Pulmonary Hypertension
Thies Schroeder
 2012-02 PHASE1
NCT00851929 COMPLETED
Sarcoidosis; Pulmonary Hypertension
Medical University of South Carolina
 2008-11 PHASE2; PHASE3
NCT00879229 TERMINATED
Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension
Gilead Sciences
 2009-07 PHASE3
NCT00768300 TERMINATED
Idiopathic Pulmonary Fibrosis
Gilead Sciences
 2008-12 PHASE3
NCT00617305 COMPLETED
Pulmonary Arterial Hypertension
Gilead Sciences
 2008-04 PHASE4
NCT01072669 COMPLETED
Ischemia
Soumya Chatterjee
 2010-02
NCT00725361 COMPLETED
n Ulcer; Scleroderma, Systemic
Stanford University
 2008-06
NCT01051960 COMPLETED
Systemic Sclerosis; Shortness of Breath; Pulmonary Hypertension
University of California, Los Angeles
 2009-03 PHASE4
NCT00578786 COMPLETED
Pulmonary Arterial Hypertension
Gilead Sciences
 2004-02 PHASE3
NCT00424021 COMPLETED
Pulmonary Hypertension
Gilead Sciences
 2003-04 PHASE2
NCT00380068 COMPLETED
Pulmonary Hypertension
Gilead Sciences
 2006-08 PHASE3
NCT00424034 COMPLETED
Healthy Subjects
GlaxoSmithKline
 2007-01 PHASE1
NCT00091598 COMPLETED
Pulmonary Hypertension
Gilead Sciences
 2004-01 PHASE3
NCT00423592 COMPLETED
Pulmonary Hypertension
Gilead Sciences
 2005-05 PHASE2
NCT00423202 COMPLETED
Pulmonary Arterial Hypertension
Gilead Sciences
 2003-12 PHASE3
NCT00423748 COMPLETED
Pulmonary Arterial Hypertension
Gilead Sciences
 2003-12 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-13)

Check the Ambrisentan product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ambrisentan selectively binds to and inhibits the endothelin-1 type A receptor, thereby blocking endothelin-1-mediated intracellular calcium influx and downstream vasoconstrictive signaling cascades in vascular smooth muscle cells. This inhibition promotes vasodilation and prevents pathological vascular remodeling, directly addressing elevated vascular resistance in conditions such as pulmonary arterial hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.