Bosentan Hydrate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Numerous clinical trials evaluate bosentan across Phase 1 through Phase 4 interventions, investigating primary therapeutic efficacy and drug interactions for conditions including pulmonary arterial hypertension, resistant arterial hypertension, congenital heart defects, ischemic optic neuropathy, and advanced solid tumors. Sponsored by pharmaceutical companies such as PharmaMar and Bial alongside academic institutions like Shanghai Jiao Tong University School of Medicine and University Hospital Rouen, these registered studies encompass active, completed, and withdrawn or terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06957002	NOT_YET_RECRUITING	Giant Cell Arteritis (GCA)	Assistance Publique - Hôpitaux de Paris	2026-06	PHASE2
NCT06887062	RECRUITING	Large Vessel Vasculitis; Giant Cell Arteritis (GCA); Takayasu Arteritis	University of Edinburgh	2025-03-21	PHASE2
NCT04158635	SUSPENDED	Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma	City of Hope Medical Center	2021-09-01	PHASE1
NCT04388124	RECRUITING	Resistant Hypertension	University Hospital, Rouen	2021-10-20	PHASE2
NCT07649941	COMPLETED	Healthy	Boehringer Ingelheim	2026-06-22	PHASE1
NCT04039464	COMPLETED	Pediatric Pulmonary Hypertension	Johns Hopkins University	2022-08-01	PHASE3
NCT02116335	ACTIVE_NOT_RECRUITING	Hypertension	Augusta University	2015-06
NCT07081932	COMPLETED	Healthy	Boehringer Ingelheim	2025-08-26	PHASE1
NCT06484673	COMPLETED	Pulmonary Arterial Hypertension	Humanis Saglık Anonim Sirketi	2024-04-21	PHASE1
NCT02377271	UNKNOWN	Ischemic Optic Neuropathy	University Hospital, Grenoble	2015-08	PHASE3
NCT03841734	COMPLETED	Arteritis, Giant Cell; Blindness and Low Vision	Centre Hospitalier Universitaire de Nice	2020-02-04	PHASE3
NCT05657613	COMPLETED	Drug Interactions	CTI BioPharma	2023-01-03	PHASE1
NCT05723874	COMPLETED	Healthy	Boehringer Ingelheim	2023-03-06	PHASE1
NCT04068272	COMPLETED	Diabetes Mellitus	Retinset SL	2019-09-07	PHASE1
NCT05072106	COMPLETED	Advanced Solid Tumor	PharmaMar	2021-01-14	PHASE1
NCT04770155	TERMINATED	Vascular Function; Racial Disparity	University of Mississippi Medical Center	2021-05-27	EARLY_PHASE1
NCT05072106	Unknown status	Advanced Solid Tumor	PharmaMar	2021-01-14	Phase 1
NCT05146089	COMPLETED	Sleep Apnea; Healthy; Vasoconstriction; Vasodilation	University of Missouri-Columbia	2016-12-20	EARLY_PHASE1
NCT02480335	COMPLETED	Scleroderma, Systemic	University Medical Center Groningen	2015-06-26	PHASE4
NCT04101370	COMPLETED	Bioequivalence	Geropharm	2018-05-24	PHASE1
NCT04991207	COMPLETED	Pulmonary Arterial Hypertension	Bial - Portela C S.A.	2018-02-06	PHASE1
NCT04991207	Completed	Pulmonary Arterial Hypertension	Bial - Portela C S.A.	2018-02-06	Phase 1
NCT01827059	UNKNOWN	Pulmonary Arterial Hypertension; Congenital Heart Disease	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	2013-10	PHASE2
NCT03053739	UNKNOWN	Associated Pulmonary Arterial Hypertension	Post Graduate Institute of Medical Education and Research, Chandigarh	2016-12	PHASE4
NCT03236818	UNKNOWN	Pulmonary Arterial Hypertension	Amsterdam UMC, location VUmc	2013-05	PHASE4
NCT02885012	TERMINATED	Pulmonary Arterial Hypertension	Medical University of South Carolina	2016-06	PHASE4
NCT00223717	COMPLETED	Hypertension	Vanderbilt University	2001-01	PHASE1
NCT01184404	UNKNOWN	Congenital Heart Disease	Berto J Bouma	2011-09
NCT02667704	COMPLETED	Healthy	Boehringer Ingelheim	2016-02	PHASE1
NCT02093195	UNKNOWN	Chronic Obstructive Pulmonary Disease (COPD)	Air Force Military Medical University, China	2013-12	PHASE2
NCT01241383	COMPLETED	Scleroderma Renal Crisis	Assistance Publique - Hôpitaux de Paris	2010-12-06	PHASE2
NCT02389426	COMPLETED	Multiple Sclerosis	Universitair Ziekenhuis Brussel	2014-12
NCT02317679	COMPLETED	Port-wine Stains	Centre Hospitalier Universitaire de Nice	2014-04	PHASE2
NCT01712997	UNKNOWN	Pulmonary Arterial Hypertension	Air Force Military Medical University, China	2012-09	PHASE3
NCT01338415	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2011-03-08	PHASE3
NCT00820352	COMPLETED	Heart Failure, Diastolic; Hypertension, Pulmonary	University Teaching Hospital Hall in Tirol	2009-01	PHASE3
NCT01617746	UNKNOWN	Asthma	University of Glasgow	2012-11	PHASE2
NCT01518595	TERMINATED	Hepatopulmonary Syndrome; Liver Cirrhosis	Medical University of Vienna	2011-10	PHASE2
NCT01218607	COMPLETED	Heart Septal Defects, Atrial	Universitaire Ziekenhuizen KU Leuven	2010-10	PHASE3
NCT01508780	WITHDRAWN	Pulmonary Arterial Hypertension	Massachusetts General Hospital	2012-05	PHASE4
NCT01548950	COMPLETED	Congenital Heart Disease; Pulmonary Arterial Hypertension	University of Sao Paulo General Hospital	2011-09
NCT01779596	COMPLETED	Type 2 Diabetes Mellitus	Radboud University Medical Center	2011-05	PHASE4
NCT01389856	TERMINATED	Persistent Pulmonary Hypertension of the Newborn	Actelion	2011-12	PHASE3
NCT01779609	COMPLETED	Type 2 Diabetes Mellitus	Radboud University Medical Center	2010-04	PHASE4
NCT00303459	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2006-05	PHASE4
NCT01929213	UNKNOWN	Healthy Volunteers	Dong-A Pharmaceutical Co., Ltd.	2013-08	PHASE1
NCT01929213	Unknown status	Healthy Volunteers	Dong-A Pharmaceutical Co. Ltd.\|Dong-A ST Co. Ltd.	2013-08	Phase 1
NCT00323297	COMPLETED	Pulmonary Arterial Hypertension	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	2006-09	PHASE4
NCT01449253	UNKNOWN	Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia	All India Institute of Medical Sciences	2011-08	PHASE4
NCT01223352	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2011-03-08	PHASE3
NCT01292551	COMPLETED	Hypoplastic Left Heart Syndrome; Tricuspid Atresia; Other Specified Congenital Anomalies of Heart	Rigshospitalet, Denmark	2011-02	PHASE2
NCT00989911	COMPLETED	Congenital Heart Disease	University of California, Los Angeles	2010-05
NCT01352065	COMPLETED	Pulmonary Hypertension	Center for Health Sciences, Serbia	2011-01	PHASE2; PHASE3
NCT00679068	TERMINATED	Pulmonary Hypertension	IRCCS Azienda Ospedaliero-Universitaria di Bologna	2008-05	PHASE4
NCT01395732	COMPLETED	Systemic Sclerosis; Digital Ulcers	Actelion	2011-03-31	PHASE4
NCT01392469	COMPLETED	Pulmonary Arterial Hypertension	Novartis Pharmaceuticals	2011-04-20	PHASE3
NCT00581607	COMPLETED	Sarcoidosis; Pulmonary Arterial Hypertension	University of Cincinnati	2008-04	PHASE2; PHASE3
NCT01330108	COMPLETED	Pulmonary Arterial Hypertension	University of Alabama at Birmingham	2011-05	PHASE4
NCT00777985	COMPLETED	Obstructive Sleep Apnea; Hypertension	University Hospital, Grenoble	2007-12	PHASE2
NCT00319020	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2005-08-23	PHASE3
NCT01662037	COMPLETED	Congenital Heart Defects; Functional Single Ventricle	Shanghai Jiao Tong University School of Medicine	2010-01	PHASE2
NCT01270750	UNKNOWN	SECONDARY PULMONARY HYPERTENSION; MITRAL STENOSIS; CHILDHOOD RHEUMATOID FEVER; CONGESTIVE HEART FAILURE	General Hospital of Chalkida	2010-12	PHASE1; PHASE2
NCT01738542	COMPLETED	Peripheral Arterial Disease	Hospital Universitario Getafe	2009-04
NCT00815347	TERMINATED	Asthma	UConn Health	2008-12	PHASE2
NCT00909337	COMPLETED	Pulmonary Hypertension; Systemic Sclerosis	Medical University of Graz	2008-01
NCT00825266	TERMINATED	Hypertension, Pulmonary	Stanford University	2008-09	PHASE2
NCT00433329	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2007-03	PHASE4
NCT00637065	UNKNOWN	Pulmonary Hypertension; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Nonspecific Interstitial Pneumonia	Royal Brompton & Harefield NHS Foundation Trust	2008-04	PHASE4
NCT01357109	COMPLETED	Type 2 Diabetes Mellitus	Karolinska Institutet	2007-11	PHASE2
NCT00864201	UNKNOWN	Hypertension, Pulmonary; Connective Tissue Disease	Hamilton Health Sciences Corporation	2009-04	PHASE3
NCT00631475	COMPLETED	Idiopathic Pulmonary Fibrosis	Actelion	2008-04	PHASE3
NCT00926627	TERMINATED	Sarcoidosis; Pulmonary Hypertension	Daniel Doberer	2009-04	PHASE2
NCT00638131	TERMINATED	Type 2 Diabetes	Centre hospitalier de l'Université de Montréal (CHUM)	2009-01	PHASE3
NCT00391443	COMPLETED	Idiopathic Pulmonary Fibrosis	Actelion	2007-02	PHASE3
NCT01100736	COMPLETED	Pulmonary Arterial Hypertension; Vasodilation; Vasoconstriction	University of Edinburgh	2009-01	EARLY_PHASE1
NCT00377455	TERMINATED	Systemic Scleroderma; Pulmonary Hypertension	Georgetown University	2006-09	PHASE2
NCT00625469	WITHDRAWN	Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis	Rajan Saggar	2007-10	PHASE4
NCT01721564	COMPLETED	Pulmonary Arterial Hypertension	Prof David S Celermajer	2006-04
NCT00319111	COMPLETED	Pulmonary Hypertension	Actelion	2006-01	PHASE3
NCT00319696	COMPLETED	Digital Ulcers	Actelion	2004-07-08	PHASE3
NCT00226889	TERMINATED	Systemic Sclerosis (Scleroderma)	Rikshospitalet University Hospital	2005-01	PHASE1; PHASE2
NCT00595049	COMPLETED	Hypertension, Pulmonary	Actelion	2006-05-31	PHASE4
NCT00260819	COMPLETED	Hypoxia-Induced Pulmonary Artery Hypertension	Assistance Publique - Hôpitaux de Paris	2006-01	PHASE1
NCT01009177	COMPLETED	Melanoma	Actelion	2005-09-30	PHASE2
NCT00266162	COMPLETED	Eisenmenger Syndrome	Competence Network for Congenital Heart Defects	2004-08	PHASE4
NCT00303004	COMPLETED	Eisenmenger Syndrome	Rigshospitalet, Denmark	2006-03	PHASE3
NCT00302211	TERMINATED	Pulmonary Hypertension	Actelion	2006-02-01	PHASE3
NCT00701597	COMPLETED	Glaucoma; Blood Flow Velocity	Medical University of Vienna	2007-04	PHASE1
NCT00310830	TERMINATED	Pulmonary Hypertension	Actelion	2006-03	PHASE3
NCT00313196	TERMINATED	Pulmonary Hypertension	Actelion	2006-04	PHASE3
NCT00360087	TERMINATED	Pulmonary Hypertension; Sickle Cell Anemia	Actelion	2006-03	PHASE3
NCT00082186	COMPLETED	Hypertension, Pulmonary	Actelion	2003-07	PHASE4
NCT00313222	COMPLETED	Chronic Thromboembolic Pulmonary Hypertension	Actelion	2005-10	PHASE3
NCT00319267	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2005-05	PHASE3
NCT00091715	COMPLETED	Pulmonary Hypertension	Actelion	2004-04	PHASE3
NCT00120380	TERMINATED	Hypertension	Hannover Medical School	2004-09	PHASE4
NCT00319033	COMPLETED	Interstitial Lung Disease; Scleroderma	Actelion	2004-07	PHASE2; PHASE3
NCT00086463	COMPLETED	Pulmonary Arterial Hypertension; Ayerza Syndrome; Pulmonary Hypertension	Actelion	2004-06	PHASE2
NCT00367770	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2004-01	PHASE4
NCT00070590	COMPLETED	Pulmonary Fibrosis; Scleroderma, Systemic	Actelion	2003-07	PHASE2; PHASE3
NCT00071461	COMPLETED	Idiopathic Pulmonary Fibrosis	Actelion	2003-08	PHASE2; PHASE3
NCT00317486	COMPLETED	Pulmonary Arterial Hypertension Related to Eisenmenger Physiology	Actelion	2003-09	PHASE4
NCT00077584	COMPLETED	Digital Ulcers; Systemic Sclerosis	Actelion	2003-10	PHASE3
NCT00318175	COMPLETED	Systemic Scleroderma; Skin Fibrosis; Hand Functionality	Heinrich-Heine University, Duesseldorf	2006-06	PHASE2
NCT00432978	COMPLETED	Altitude; Pulmonary Hypertension	VA Loma Linda Health Care System	2006-07	PHASE1
NCT00780728	WITHDRAWN	Hypertension, Pulmonary	University Health Network, Toronto		PHASE3
NCT00080457	COMPLETED	Pulmonary Hypertension	Encysive Pharmaceuticals	2003-05	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bosentan competitively binds to endothelin receptors ET-A and ET-B, blocking endothelin-1-mediated intracellular calcium influx and downstream vasoconstrictive signaling cascades. This receptor blockade promotes vascular smooth muscle relaxation and inhibits pathological remodeling, thereby reducing pulmonary 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>).