Drugs / Bosentan
Bosentan
also known as
Tracleer · Bosentan = Tracleer · Anhydrous bosentan · Bosentan (as monohydrate) · Bosentan anhydrous · Bosentan hydrate · Bosentan monohydrate · BOSENTAN SODIUM · +2 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | TRACLEER | — | 2003-10-06 – 2012-10-04 | fda.gov ↗ |
| Approved | EU (EMA) | Tracleer | — | 2002-05-14 | europa.eu ↗ |
| Approved | US (FDA) | TRACLEER | — | 2001-11-20 | fda.gov ↗ |
Trials 84 · started per year
today
US approved 2001
EU approved 2002
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05518422 | Feb 2024 | dysautonomia, obesity disorder | University of Missouri-Columbia | Withdrawn | No outcome recorded |
| Phase 0 | NCT05146089 | Dec 2016 → Sep 2018 | sleep apnea syndrome | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 0 | NCT01100736 | Jan → Sep 2009 | isoproterenol-mediated vasodilatation, pulmonary arterial hypertension | University of Edinburgh | Completed | No outcome recorded |
| Phase 114 trials | ||||||
| Phase 1 | NCT07649941 | Jun → Aug 2026 overdue | — | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 1 | NCT07081932 | Aug → Sep 2025 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05723874 | Mar → May 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT05657613 | Jan → Jun 2023 | — | CTI BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT04158635 | Sep 2021 → Mar 2027 | malignant pancreatic neoplasm | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 1 | NCT04068272 | Sep 2019 → May 2022 | diabetes mellitus | Retinset SL | Completed | No outcome recorded |
| Phase 1 | NCT04991207 | Feb → May 2018 | pulmonary arterial hypertension | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02667704 | Feb → Mar 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01929213 | Aug → Nov 2013 | — | Dong-A Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT01864863 | Apr → May 2013 | pulmonary arterial hypertension | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00701597 | Apr → Sep 2007 | glaucoma | Medical University of Vienna | Completed | No outcome recorded |
| Phase 1 | NCT00432978 | Jul 2006 → Feb 2007 | altitude sickness, pulmonary hypertension | VA Loma Linda Health Care System | Completed | No outcome recorded |
| Phase 1 | NCT00260819 | Jan 2006 → Apr 2008 | pulmonary hypertension owing to lung disease and/or hypoxia | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 1 | NCT00223717 | Jan 2001 → Jan 2017 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01270750 | Dec 2010 → Jun 2011 | congestive heart failure, mitral valve stenosis, pulmonary hypertension, rheumatic fever | General Hospital of Chalkida | Unknown | No outcome recorded |
| Phase 1/2 | NCT00226889 | Jan 2005 → Jan 2009 | systemic sclerosis | Rikshospitalet University Hospital | Terminated | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT06957002 | Jun 2026 → Jun 2029 expected | temporal arteritis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06887062 | Mar 2025 → Jul 2027 expected | Takayasu arteritis, temporal arteritis | University of Edinburgh | Recruiting | No outcome recorded |
| Phase 2 | NCT04388124 | Oct 2021 → Aug 2026 overdue | resistant hypertension | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 2 | NCT02317679 | Apr → Sep 2014 | — | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 2 | NCT02093195 | Dec 2013 → Dec 2015 | chronic obstructive pulmonary disease | Air Force Military Medical University, China | Unknown | No outcome recorded |
| Phase 2 | NCT01617746 | Nov 2012 → May 2014 | asthma | University of Glasgow | Unknown | No outcome recorded |
| Phase 2 | NCT01241383 | Dec 2010 → Oct 2015 | scleroderma | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01662037 | Jan 2010 → Sep 2011 | congenital heart defects, multiple types, univentricular heart | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00926627 | Apr 2009 → Mar 2010 | pulmonary hypertension, sarcoidosis | Daniel Doberer | Terminated | No outcome recorded |
| Phase 2 | NCT00815347 | Dec 2008 → Sep 2010 | asthma | UConn Health | Terminated | No outcome recorded |
| Phase 2 | NCT00777985 | Dec 2007 → Jan 2012 | hypertensive disorder, obstructive sleep apnea syndrome | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 2 | NCT01357109 | Nov 2007 → Apr 2010 | type 2 diabetes mellitus | Karolinska Institutet | Completed | No outcome recorded |
| Phase 2 | NCT00377455 | Sep 2006 → Sep 2009 | pulmonary hypertension, systemic sclerosis | Georgetown University | Terminated | No outcome recorded |
| Phase 2 | NCT00318175 | Jun 2006 → May 2007 | cutaneous sclerosis, systemic sclerosis | Heinrich-Heine University, Duesseldorf | Completed | No outcome recorded |
| Phase 2 | NCT01009177 | Sep 2005 → Feb 2008 | melanoma | Actelion | Completed | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT06432452 | Nov 2024 → Jun 2026 overdue | coronary vasospasm | Radboud University Medical Center | Enrolling by invitation | 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 | NCT00319033 | Jul 2004 → Feb 2006 | interstitial lung disease, systemic sclerosis | Actelion | Completed | No outcome recorded |
| Phase 2/3 | NCT00071461 | Aug 2003 → Sep 2005 | idiopathic pulmonary fibrosis | Actelion | Completed | No outcome recorded |
| Phase 2/3 | NCT00070590 | Jul 2003 → Sep 2005 | pulmonary fibrosis, systemic sclerosis | Actelion | Completed | No outcome recorded |
| Phase 322 trials | ||||||
| Phase 3 | NCT03841734 | Feb 2020 → Jul 2023 | arteritis, blindness (disorder) | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 3 | NCT02377271 | Aug 2015 → Dec 2023 | non-arteritic anterior ischemic optic neuropathy | University Hospital, Grenoble | Unknown | No outcome recorded |
| Phase 3 | NCT01712997 | Sep 2012 → Sep 2014 | pulmonary arterial hypertension | Air Force Military Medical University, China | Unknown | No outcome recorded |
| Phase 3 | NCT01389856 | Dec 2011 → Dec 2013 | pulmonary hypertension, neonatal | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT01392469 | Apr 2011 → Oct 2012 | pulmonary arterial hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01338415 | Mar 2011 → Aug 2014 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01223352 | Mar 2011 → Apr 2013 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00864201 | Apr 2009 → Apr 2010 | connective tissue disorder, pulmonary hypertension | Hamilton Health Sciences Corporation | Unknown | No outcome recorded |
| Phase 3 | NCT00638131 | Jan 2009 → Mar 2010 | type 2 diabetes mellitus | University of Montreal Hospital Centre (CHUM) | Terminated | No outcome recorded |
| Phase 3 | NCT00631475 | Apr 2008 → Apr 2010 | idiopathic pulmonary fibrosis | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00391443 | Feb 2007 → Feb 2010 | idiopathic pulmonary fibrosis | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00313196 | Apr 2006 → Aug 2007 | pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT00360087 | Mar 2006 → Aug 2007 | pulmonary hypertension, sickle cell disease | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT00310830 | Mar 2006 → Aug 2007 | pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT00303004 | Mar 2006 → Jan 2008 | Eisenmenger syndrome | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 3 | NCT00319111 | Jan 2006 → Feb 2009 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00313222 | Oct 2005 → Feb 2007 | chronic thromboembolic pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00319020 | Aug 2005 → Oct 2011 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00319267 | May 2005 → Dec 2006 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00319696 | Jul 2004 → Jan 2009 | — | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00091715 | Apr 2004 → Nov 2006 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00077584 | Oct 2003 → Mar 2005 | systemic sclerosis | Actelion | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT03229694 | Aug 2017 → Apr 2018 | hypertensive disorder | Xuzhou Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT02480335 | Jun 2015 → Jul 2018 | systemic sclerosis | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 4 | NCT03236818 | May 2013 → Sep 2017 | pulmonary arterial hypertension | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 4 | NCT01779596 | May 2011 → Dec 2013 | type 2 diabetes mellitus | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01395732 | Mar 2011 → Nov 2012 | systemic sclerosis | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT01779609 | Apr 2010 → Dec 2013 | type 2 diabetes mellitus | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00679068 | May 2008 → Dec 2012 | pulmonary hypertension | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Terminated | No outcome recorded |
| Phase 4 | NCT00625469 | Oct 2007 → Jun 2009 | idiopathic pulmonary fibrosis, pulmonary arterial hypertension | Rajan Saggar | Withdrawn | No outcome recorded |
| Phase 4 | NCT00433329 | Mar 2007 → May 2010 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00595049 | May 2006 → Dec 2008 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00303459 | May 2006 → Dec 2013 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00266162 | Aug 2004 → Feb 2008 | Eisenmenger syndrome | Competence Network for Congenital Heart Defects | Completed | No outcome recorded |
| Phase 4 | NCT00367770 | Jan 2004 → Dec 2005 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00317486 | Sep 2003 → Apr 2005 | Eisenmenger syndrome | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00082186 | Jul 2003 → Feb 2007 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07670091 | Jul 2023 → Jul 2025 overdue | coronary microvascular disorder, nonobstructive coronary artery disease | Liverpool University Hospitals NHS Foundation Trust | Active not recruiting | No outcome recorded |
| — | NCT02116335 | Jun 2015 → Dec 2025 overdue | hypertensive disorder | Augusta University | Active not recruiting | No outcome recorded |
| — | NCT01184404 | Sep 2011 → Jul 2016 | congenital heart disease | Berto J Bouma | Unknown | No outcome recorded |
| — | NCT01548950 | Sep 2011 → Jan 2014 | congenital heart disease, pulmonary arterial hypertension | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| — | NCT00989911 | May 2010 → Mar 2013 | congenital heart disease | University of California, Los Angeles | Completed | No outcome recorded |
| — | NCT01738542 | Apr 2009 → Nov 2010 | peripheral arterial disease | Hospital Universitario Getafe | Completed | No outcome recorded |
| — | NCT00909337 | Jan 2008 → Jun 2010 | pulmonary hypertension, systemic sclerosis | Medical University of Graz | Completed | No outcome recorded |
| — | NCT01721564 | Apr 2006 → May 2009 | pulmonary arterial hypertension | Prof David S Celermajer | Completed | No outcome recorded |
Also used as a comparator or background therapy in 18 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04770155 Comparator | May → Sep 2021 | vascular insufficiency disorder | University of Mississippi Medical Center | Terminated | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05072106 Comparator | Jan 2021 → Jan 2022 | neoplasm | PharmaMar | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01827059 Comparator | Oct 2013 → Feb 2018 | congenital heart disease, pulmonary arterial hypertension | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| Phase 2 | NCT01518595 Comparator | Oct 2011 → Apr 2014 | cirrhosis of liver, hepatopulmonary syndrome | Medical University of Vienna | Terminated | No outcome recorded |
| Phase 2 | NCT01292551 Comparator | Feb 2011 → Mar 2013 | hypoplastic left heart syndrome, tricuspid atresia | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT00825266 Comparator | Sep 2008 → May 2010 | pulmonary arterial hypertension | Stanford University | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00581607 Comparator | Apr 2008 → Oct 2012 | pulmonary arterial hypertension, sarcoidosis | University of Cincinnati | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT04039464 Comparator | Aug 2022 → Dec 2025 | pulmonary arterial hypertension | Johns Hopkins University | 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 | NCT01218607 Comparator | Oct 2010 → Mar 2014 | atrial septal defect, ostium secundum type | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 3 | NCT00820352 Comparator | Jan 2009 → Jun 2014 | diastolic heart failure, pulmonary hypertension | University Teaching Hospital Hall in Tirol | Completed | No outcome recorded |
| Phase 3 | NCT00302211 Background | Feb 2006 → Dec 2007 | pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06317805 Background | Dec 2023 → Jun 2027 expected | pulmonary arterial hypertension | AOP Orphan Pharmaceuticals AG | Recruiting | No outcome recorded |
| Phase 4 | NCT03053739 Comparator | Dec 2016 → Dec 2017 | pulmonary arterial hypertension | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT01449253 Comparator | Aug 2011 → Jul 2013 | pulmonary hypertension owing to lung disease and/or hypoxia | All India Institute of Medical Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT00637065 Comparator | Apr 2008 → Apr 2010 | idiopathic pulmonary fibrosis, non-specific interstitial pneumonia, pulmonary hypertension | Royal Brompton & Harefield NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 4 | NCT00323297 Background | Sep 2006 → Aug 2013 | pulmonary arterial hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01378845 Comparator | Jul 2011 → Jun 2015 | Raynaud disease | Christoph Hehrlein | Unknown | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-06-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of a Generic Version of Tracleer® (bosentan) Tablets in the United States tevapharm.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bosentan | “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 ↗100“endothelin receptor antagonist, Tracleer (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension” NCT03229694 ↗ “All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).” NCT01824290 ↗ “Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology” NCT00367770 ↗ “Bosentan 62.5 mg twice daily Uptitrated to 125mg twice daily if tolerated after 4 weeks Total 10 weeks” NCT06432452 ↗ “8 patients will be treat with bosentan at 145 mg per day during 14 days” NCT03841734 ↗ “Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.)” NCT05072106 ↗ “Participants will be given PO Bosentan 125 mg BD for 4 weeks.” NCT07670091 ↗ “One Bosentan 125 mg tablet” NCT01864863 ↗ “Oral Bosentan” NCT05518422 ↗ |
| Known as | Anhydrous bosentan | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | Bosentan (as monohydrate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | Bosentan = Tracleer | “Bosentan = Tracleer” NCT01218607 ↗1“Bosentan: Tracleer” NCT01292551 ↗ |
| Known as | Bosentan anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | Bosentan hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | Bosentan monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | BOSENTAN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | RO 47-0203/029 | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | Stayveer | ChEMBL registry synonym — accepted as the source's own label CHEMBL957 ↗ |
| Known as | Tracleer | “Bosentan (Tracleer®) is a non-selective endothelin receptor antagonist with dual binding (ETA and ETB) and complete blocking of endothelin-1.” NCT00266162 ↗4“Bosentan (Tracleer 125mg Tabletts), peroral, dose: 500mg for 8 days” NCT00701597 ↗ “Bosentan (Tracleer)” NCT00318175 ↗ |
| Action | Inhibit | “Bosentan (an oral dual ET-1 receptor antagonist)” NCT00071461 ↗ |
| Modality | Other / unclassified | “the endothelin receptor antagonist bosentan” NCT01712997 ↗ |
| Route | Oral | “oral bosentan” NCT00070590 ↗ |