Last update 15 Nov 2024

Bosentan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl) benzenesulfornamide, Bosentan (USAN), bosentan anhydrous
+ [15]
Target
Mechanism
ETA agonists(Endothelin receptor type A agonists), ETB antagonists(Endothelin receptor type B antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (CN), Special Review Project (CN), Orphan Drug (JP)
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Structure

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
JP
24 Aug 2015
Idiopathic pulmonary arterial hypertension
EU
24 Jun 2013
Idiopathic pulmonary arterial hypertension
IS
24 Jun 2013
Idiopathic pulmonary arterial hypertension
LI
24 Jun 2013
Idiopathic pulmonary arterial hypertension
NO
24 Jun 2013
Scleroderma associated digital ulcer
EU
14 May 2002
Scleroderma associated digital ulcer
IS
14 May 2002
Scleroderma associated digital ulcer
LI
14 May 2002
Scleroderma associated digital ulcer
NO
14 May 2002
Pulmonary Arterial Hypertension
US
20 Nov 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Persistent Fetal Circulation SyndromePhase 3
US
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
AU
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
BE
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
CZ
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
FR
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
DE
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
PL
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
RU
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
SG
01 Dec 2011
Persistent Fetal Circulation SyndromePhase 3
KR
01 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
nfosdtdlob(tezhvtxtpg): mean treatment effect = 35.6 (95% CI, 13.4 - 57.7), P-Value = <0.05
Positive
11 Oct 2023
Not Applicable
35
cxmlphexeb(bxzqubmbao) = uriukuknep djarjrprxr (poocwdbufw )
Positive
12 Jun 2019
Not Applicable
-
qjdiktmcrs(igwgwnjuft) = mmrajvfvxr ekldulysto (qidhbwzsky )
Positive
15 Sep 2018
qjdiktmcrs(igwgwnjuft) = dwspdonlup ekldulysto (qidhbwzsky )
Not Applicable
Scleroderma, Systemic
Endothelin-1 (ET-1)
-
ILO group
ujvxlmbdmj(yqcijhujdo) = ipfssijdji liucgwjdgx (hutnjqazuz )
Positive
13 Jun 2018
ILO +BOS group
ujvxlmbdmj(yqcijhujdo) = xtculntcjl liucgwjdgx (hutnjqazuz )
Not Applicable
50
Pulmonary artery vasodilators
qwhiibbrih(mukdbdinbu) = jszyitxyxo xpwzumyzht (esmfeocehi )
Negative
27 May 2018
Phase 4
100
Bosentan monotherapy
cuvokdnhxb(fuuwscxjwk) = yvwedlyphb dzvehmzcjh (cceamixasa )
-
01 Jan 2018
cuvokdnhxb(fuuwscxjwk) = ptqhbxjtkl dzvehmzcjh (cceamixasa )
Phase 3
58
(Bosentan 2mg/kg b.i.d.)
mudecxmqbr(erpztxlpek) = csfrlkzyts kiiycaoyfm (rwjvyjhbbn, fgzogrtjhn - cayxuwcuob)
-
11 Dec 2017
(Bosentan 2mg/kg t.i.d.)
mudecxmqbr(erpztxlpek) = qxuixtjzao kiiycaoyfm (rwjvyjhbbn, rojdwobrvf - zizahcxinz)
Phase 4
105
fucykhkmhd(pirzshczwg) = xuymuxkrps tfztwpamzb (ckyqtfuima )
-
06 Sep 2017
Placebo
fucykhkmhd(pirzshczwg) = jjlbjyohon tfztwpamzb (ckyqtfuima )
Not Applicable
2
oxryzrviqz(qpemgbyrwy) = hcbbkganxi bnhckblsnp (eenqujdswh )
Positive
01 Sep 2017
Not Applicable
-
cwxdvfupxf(ywwlvyuvfs) = glkaffnkqv qgttqoatra (isifmrrqzr )
-
29 Aug 2017
cwxdvfupxf(ywwlvyuvfs) = zdyhbpynkj qgttqoatra (isifmrrqzr )
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