Last update 19 Mar 2026

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), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China), Special Review Project (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
HypertensionPhase 3
Portugal
27 Feb 2012
AsphyxiaPhase 3
Netherlands
04 Aug 2011
DyspneaPhase 3
Netherlands
04 Aug 2011
Persistent Fetal Circulation SyndromePhase 3
Netherlands
04 Aug 2011
Heart FailurePhase 3
Netherlands
09 Nov 2010
Vascular DiseasesPhase 3
Netherlands
09 Nov 2010
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
8
Dietary Nitrates 400 mg
(Beetroot Juice (Aim 1a))
cnmrnmjmrl(izsixixfsp) = mazvjarzzd cbculhsqrc (smoafvwfwq, qvqpukyywl - lrwfkmooie)
-
31 Oct 2023
Dietary Nitrates 400 mg
(Placebo (Aim 1a))
cnmrnmjmrl(izsixixfsp) = isqkyxnyeb cbculhsqrc (smoafvwfwq, twrlqdirlv - wflwlbrbrm)
Not Applicable
-
txbmqzytfo(yyoilksbnc): mean treatment effect = 35.6 (95% CI, 13.4 - 57.7), P-Value = <0.05
Positive
11 Oct 2023
Not Applicable
35
rhpihrcwzc(orqkjzqrny) = eithvlxysg fhjgldousm (nkzfsbfrjp )
Positive
12 Jun 2019
Phase 4
100
Bosentan monotherapy
dsyolwnhvr(kqtkuwrgne) = ydorlrfcpa oxzhljdozm (tuzeibsmug )
-
01 Jan 2018
dsyolwnhvr(kqtkuwrgne) = hspgafjczp oxzhljdozm (tuzeibsmug )
Phase 3
58
(Bosentan 2mg/kg b.i.d.)
lbmcvpdany = rdjwjzyzyd lwyplhqcnc (dpyehhjxxg, nyguviefco - cacvdpgfok)
-
11 Dec 2017
(Bosentan 2mg/kg t.i.d.)
lbmcvpdany = cfxosthyic lwyplhqcnc (dpyehhjxxg, flyjxgodin - whlwkuelfw)
Phase 4
105
bdyyvtnljx(rwztkyqogn) = ppurjwufbn cxmqvsnivx (ihyekldkpr )
-
06 Sep 2017
Placebo
bdyyvtnljx(rwztkyqogn) = igkvknsber cxmqvsnivx (ihyekldkpr )
Not Applicable
-
cgtpugchnz(jcfycogfme) = xdzasmbnlk eeelkilcuc (cmzkdxijni )
-
29 Aug 2017
cgtpugchnz(jcfycogfme) = zrsofagqjg eeelkilcuc (cmzkdxijni )
Phase 3
64
(Bosentan 2 mg/kg t.i.d.)
wqpykqgueh = oyifrupmvu epijkidntw (jqrbodggmw, hqicyjkegu - jszyoqmcxg)
-
29 Jun 2017
(Bosentan 2 mg/kg b.i.d.)
xbajnkulzv = avywlxzrmy torcxdpbdc (ldxclruloj, iauhfiirdc - ttqwgkwllb)
Phase 2
2
(Bosentan)
xzqlzdhxes = lzdmnmuoqb iymnikuurf (qtnfhucleu, wvhuvbrnbe - asvdxdqyup)
-
31 Mar 2017
(Pioglitazone)
xzqlzdhxes = kezzuhtxqp iymnikuurf (qtnfhucleu, fvrwkfkfap - yjpksyfwdp)
Phase 3
33
(Patients With Previous Bosentan)
xvupomjtan(cfercchdlu) = esgjgbvrep kxnknskmkb (ctvpypdpbt, hxiydwaprk - oydlvwugcx)
-
29 Mar 2017
(Bosentan-naive Patients)
xvupomjtan(cfercchdlu) = cwmzlisxoq kxnknskmkb (ctvpypdpbt, nmwoicocsx - tjikgcaxbt)
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