Drugs / Bosentan
last change Aug 2026 re-read 9 days ago

Bosentan

Other / unclassified

Developed for
pulmonary arterial hypertension · pulmonary hypertension · systemic sclerosis · hypertensive disorder · idiopathic pulmonary fibrosis · type 2 diabetes mellitus · congenital heart disease · Eisenmenger syndrome
+37 more · asthma · temporal arteritis · altitude sickness · arteritis · blindness (disorder) · chronic obstructive pulmonary disease · chronic thromboembolic pulmonary hypertension · congenital heart defects, multiple types · connective tissue disorder · coronary microvascular disorder · coronary vasospasm · cutaneous sclerosis · diabetes mellitus · glaucoma · interstitial lung disease · malignant pancreatic neoplasm · melanoma · non-arteritic anterior ischemic optic neuropathy · nonobstructive coronary artery disease · obstructive sleep apnea syndrome · peripheral arterial disease · pulmonary fibrosis · pulmonary hypertension owing to lung disease and/or hypoxia · pulmonary hypertension, neonatal · resistant hypertension · sarcoidosis · scleroderma · sickle cell disease · univentricular heart · atrial septal defect, ostium secundum type · diastolic heart failure · hepatopulmonary syndrome · hypoplastic left heart syndrome · non-specific interstitial pneumonia · Raynaud disease · tricuspid atresia · vasculitis
Investigated by
Actelion · Boehringer Ingelheim · Assistance Publique - Hôpitaux de Paris · National Heart, Lung, and Blood Institute (NHLBI) · Radboud University Medical Center · Air Force Military Medical University, China
+60 more · Centre Hospitalier Universitaire de Nice · URC-CIC Paris Descartes Necker Cochin · University Hospital, Grenoble · University of Edinburgh · University of Missouri-Columbia · Amsterdam UMC, location VUmc · Augusta University · Berto J Bouma · Bial - Portela C S.A. · CTI BioPharma · Catharina Ziekenhuis Eindhoven · Center for Health Sciences, Serbia · City of Hope Medical Center · Competence Network for Congenital Heart Defects · Daniel Doberer · Dong-A Pharmaceutical Co., Ltd. · Dong-A ST Co., Ltd. · Encysive Pharmaceuticals · French National Institute of Health and Medical Research · General Hospital of Chalkida · Georgetown University · German Federal Ministry of Education and Research · Hamilton Health Sciences Corporation · Hanmi Pharmaceutical Company Limited · Heinrich-Heine University, Duesseldorf · Hospital Universitario Getafe · IRCCS Azienda Ospedaliero-Universitaria di Bologna · Institute of Applied Ophthalmobiology - IOBA · Instituto do Coracao · Karolinska Institutet · Liverpool University Hospitals NHS Foundation Trust · Maasstad Hospital · Mayo Clinic · Medical University of Graz · Medical University of Vienna · NHS Greater Glasgow and Clyde · National Cancer Institute (NCI) · Novartis Pharmaceuticals · PPD Development, LP · Prof David S Celermajer · Rajan Saggar · Retinset SL · Rigshospitalet, Denmark · Rikshospitalet University Hospital · Shanghai Jiao Tong University School of Medicine · Swedish Heart Lung Foundation · São Paulo Research Foundation · Terns, Inc. · The Swedish Research Council · UConn Health · UMC Utrecht · University Hospital, Rouen · University Medical Center Groningen · University of California, Los Angeles · University of Glasgow · University of Montreal Hospital Centre (CHUM) · University of Sao Paulo General Hospital · VA Loma Linda Health Care System · Vanderbilt University · Xuzhou Medical University

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed pulmonary arterial hypertension 1 milestone
Filed US (FDA) — pulmonary arterial hypertension 2019-06-04

“submission of an Abbreviated New Drug Application (ANDA) with Para IV certification with U.S. Food and Drug Administration (FDA) for the generic version of Bosentan” natcopharma.co.in ↗

Approved Indication not stated 3 milestones
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 85 · started per year

today
US approved 2001
EU approved 2002
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT05518422 Feb 2024 dysautonomia, obesity disorder University of Missouri-Columbia Withdrawn No outcome recorded Stop: Enrollment
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 115 trials
Phase 1 NCT07649941 Jun → Jul 2026 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT07081932 Aug → Sep 2025 — Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT07838987 Dec 2023 → Jun 2026 — Terns, Inc. 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 Stop: Enrollment
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 1/22 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 Stop: Enrollment
Phase 215 trials · 1 met primary · 2 missed
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 Stop: Enrollment
Phase 2/35 trials · 2 missed
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 Missed primary
Phase 2/3 NCT00070590 Jul 2003 → Sep 2005 pulmonary fibrosis, systemic sclerosis Actelion Completed Missed primary
Phase 322 trials · 1 met primary · 3 missed
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 Met primary
Phase 3 NCT01389856 Dec 2011 → Dec 2013 pulmonary hypertension, neonatal Actelion Terminated Missed primary
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 Stop: Enrollment
Phase 3 NCT00631475 Apr 2008 → Apr 2010 idiopathic pulmonary fibrosis Actelion Completed No outcome recorded
Phase 415 trials · 1 missed
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 Stop: Enrollment
Phase 4 NCT00625469 Oct 2007 → Jun 2009 idiopathic pulmonary fibrosis, pulmonary arterial hypertension Rajan Saggar Withdrawn No outcome recorded Stop: Enrollment
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 not applicable8 trials · 2 met primary
— 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 Met primary
— NCT00909337 Jan 2008 → Jun 2010 pulmonary hypertension, systemic sclerosis Medical University of Graz Completed Met primary
— NCT01721564 Apr 2006 → May 2009 pulmonary arterial hypertension Prof David S Celermajer Completed No outcome recorded
Comparator or background therapy18 trials
Phase 0 NCT04770155 Comparator May → Sep 2021 vascular insufficiency disorder University of Mississippi Medical Center Terminated No outcome recorded
Phase 1 NCT05072106 Comparator Jan 2021 → Jan 2022 neoplasm PharmaMar Completed No outcome recorded
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 Stop: Enrollment
Phase 2 NCT01292551 Comparator Feb 2011 → Mar 2013 hypoplastic left heart syndrome, tricuspid atresia Rigshospitalet, Denmark Completed No outcome recorded

News releases announcing trial results or a regulatory action · 9

DateIssuerRelease
2026-02-18 Zydus Lifesciences Limited Regulatory Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets, oral suspension, 32 mg (USRLD: Tracleer® Tablets for Oral Suspension, 32 mg).
2025-02-10 NATCO Pharma Ltd. Regulatory NATCO and its alliance partner Lupin announces approval of its Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension (generic of Tracleer®) natcopharma.co.in ↗
NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") today announces final approval of its ANDA for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer® by Actelion Pharmaceuticals US Inc.
2025-02-10 Lupin Limited Regulatory Lupin and Natco Receive Approval from U.S. FDA for Bosentan Tablets for Oral Suspension lupin.com ↗
they have received an approval from the United States Food and Drug Administration (U.S. FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg
2023-02-15 Zydus Lifesciences Limited Regulatory Zydus receives tentative approval from the USFDA for Bosentan Tablets for Oral Suspension zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Bosentan Tablets for Oral Suspension, 32 mg (USRLD: Tracleer® Tablets for Oral Suspension).
2020-01-01 Alembic Pharmaceuticals Ltd. Regulatory Press Release USFDA Approval Bosentan Tablets, 62.5 mg and 125 mg. alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals announces USFDA Final Approval for Bosentan Tablets, 62.5 mg and 125 mg.
2019-06-04 NATCO Pharma Ltd. Regulatory Natco files ANDA for Bosentan 32mg Tablets for the USA market natcopharma.co.in ↗
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) with Para IV certification with U.S. Food and Drug Administration (FDA) for the generic version of Bosentan 32mg tablets for oral suspension.
2019-05-02 NATCO Pharma Ltd. Regulatory Natco & its alliance partner Lupin receive FDA approval for generic Bosentan Tablets natcopharma.co.in ↗
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Bosentan tablets in the strengths of 62.5 mg and 125 mg.
2019-04-30 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Bosentan Tablets & Trientine Hydrochloride Capsules zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Bosentan Tablets USP (US RLD – Tracleer® Tablets), 62.5 mg and 125 mg and Trientine Hydrochloride Capsules USP (US RLD - Syprine® Capsules), 250 mg.
2019-04-30 Lupin Limited Regulatory Lupin in alliance with Natco receives FDA approval for Bosentan Tablets lupin.com ↗
announced that it has received approval for Bosentan Tablets, 62.5 mg and 125 mg, from the United States Food and Drug Administration (FDA)

All press releases naming this drug 12 releases

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 104 sources stand behind the page.

FieldValueCited 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 ↗
101

“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 ↗

NCT01929213 ↗

Show 91 more sources

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 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 Bosentan: Tracleer “Bosentan = Tracleer” NCT01218607 ↗
1

“Bosentan: Tracleer” NCT01292551 ↗

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 ↗

NCT00367770 ↗

NCT01378845 ↗

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 ↗