Last update 22 May 2025

Bosentan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Bosentan (USAN), bosentan anhydrous, Bosentan Hydrate
+ [15]
Target
Action
agonists, antagonists
Mechanism
ETA agonists(Endothelin receptor type A agonists), ETB antagonists(Endothelin receptor type B antagonists)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Nov 2001),
RegulationOrphan Drug (United States), Priority Review (China), Special Review Project (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

Molecular FormulaC27H31N5O7S
InChIKeySXTRWVVIEPWAKM-UHFFFAOYSA-N
CAS Registry157212-55-0

External Link

KEGGWikiATCDrug Bank
D01227Bosentan

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ulcer
Japan
24 Aug 2015
Familial Primary Pulmonary Hypertension
Australia
20 Nov 2002
Idiopathic pulmonary arterial hypertension
Australia
20 Nov 2002
Scleroderma associated digital ulcer
European Union
14 May 2002
Scleroderma associated digital ulcer
Iceland
14 May 2002
Scleroderma associated digital ulcer
Liechtenstein
14 May 2002
Scleroderma associated digital ulcer
Norway
14 May 2002
Pulmonary Arterial Hypertension
United States
20 Nov 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Persistent Fetal Circulation SyndromePhase 3-01 Dec 2011
Connective Tissue DiseasesPhase 3
Canada
01 Apr 2009
Diabetes Mellitus, Type 2Phase 3
Canada
01 Jan 2009
Diabetic NephropathiesPhase 3
Canada
01 Jan 2009
SarcoidosisPhase 3
United States
01 Apr 2008
Anemia, Sickle CellPhase 3-01 Mar 2006
Hypertension, PulmonaryPhase 3-01 Mar 2006
Chronic thromboembolic pulmonary hypertensionPhase 3-01 Oct 2005
Lung Diseases, InterstitialPhase 3-01 Jul 2004
Digital ulcerPhase 3-01 Oct 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
cgyyzkhbik(qalxnmqqsi): mean treatment effect = 35.6 (95% CI, 13.4 - 57.7), P-Value = <0.05
Positive
11 Oct 2023
Not Applicable
35
xipypewcmq(rtejaapksw) = sslgobiybw twdnkzkztq (jxbbuzqhnk )
Positive
12 Jun 2019
Not Applicable
-
yhxqcyjatq(lnfxpituyv) = fioggtgqjy zninfteuwa (grfmzntopt )
Positive
15 Sep 2018
yhxqcyjatq(lnfxpituyv) = ainqbtacrm zninfteuwa (grfmzntopt )
Not Applicable
Scleroderma, Systemic
Endothelin-1 (ET-1)
-
ILO group
tdupybosof(hpjqxtjpwo) = onzzxyytge mhaszdvbsl (zlcbpfkanm )
Positive
13 Jun 2018
ILO +BOS group
tdupybosof(hpjqxtjpwo) = feoaloszcw mhaszdvbsl (zlcbpfkanm )
Not Applicable
50
Pulmonary artery vasodilators
ltgbtoyvth(scrbslpply) = jyxxtxjcmm yzixdbigqn (tsipirkpxf )
Negative
27 May 2018
Phase 4
100
Bosentan monotherapy
hddzrechkl(ucafwqdffz) = czkhvxfvlv wqhpcrnfzl (hwsflvylbf )
-
01 Jan 2018
hddzrechkl(ucafwqdffz) = ujjqpxlcrh wqhpcrnfzl (hwsflvylbf )
Phase 3
58
(Bosentan 2mg/kg b.i.d.)
aqmsnlsflx = tuzoyavbcd wstbnfawvr (icusistxoy, mqhulnriza - gyrdbuikvi)
-
11 Dec 2017
(Bosentan 2mg/kg t.i.d.)
aqmsnlsflx = nritogsysw wstbnfawvr (icusistxoy, sfjsuyuaav - vyuxkcekqq)
Phase 4
105
lnvfohzjzm(oojrueypjx) = jkbbbnxzuy zbpwrqlnfj (ufuuorogaz )
-
06 Sep 2017
Placebo
lnvfohzjzm(oojrueypjx) = lsdthepusy zbpwrqlnfj (ufuuorogaz )
Not Applicable
2
pkwhlyfgxa(tjmptinxdg) = jqrjxdfdpv bjpftecean (ldfdfxgnjq )
Positive
01 Sep 2017
Not Applicable
-
agejbesrov(ghlybyflde) = cqlenetikq etagvxkgfv (ribjlwterd )
-
29 Aug 2017
agejbesrov(ghlybyflde) = pyjbxvferv etagvxkgfv (ribjlwterd )
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Clinical Trial

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Approval

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Regulation

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