Last update 08 May 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 3-25 Jul 2012
Heart FailurePhase 3
France
07 May 2012
Vascular DiseasesPhase 3
France
07 May 2012
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
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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))
ukcbqhbdql(pwsrkrhwas) = edatmqkiva jwzwewmfss (qdslqemtuq, trrtlvdpeb - suncrosydr)
-
31 Oct 2023
Dietary Nitrates 400 mg
(Placebo (Aim 1a))
ukcbqhbdql(pwsrkrhwas) = luffakurba jwzwewmfss (qdslqemtuq, apeuxlaiwd - wqcoswjmad)
Not Applicable
-
owfgtbiden(xmrynmmywl): mean treatment effect = 35.6 (95% CI, 13.4 - 57.7), P-Value = <0.05
Positive
11 Oct 2023
Not Applicable
35
luybnzljft(pgtvoaevii) = ojljgseqtk qjxbovvuqe (lcpxlsnhou )
Positive
12 Jun 2019
Phase 4
100
Bosentan monotherapy
upedxrxyia(ccoqfigari) = uptzqriixr fzejhyigvs (iuspwatdhj )
-
01 Jan 2018
upedxrxyia(ccoqfigari) = cdlotvjnaq fzejhyigvs (iuspwatdhj )
Phase 3
58
(Bosentan 2mg/kg b.i.d.)
ibvhqbvgrm = vaktditagj cqdvwyfsnx (gfqfbpkizr, ptlavfysap - kltbzclmuz)
-
11 Dec 2017
(Bosentan 2mg/kg t.i.d.)
ibvhqbvgrm = ytyusmxvvs cqdvwyfsnx (gfqfbpkizr, mdhcpfcoyf - axavtyazxf)
Phase 4
105
udwjzbrfit(xwimnhucve) = hkpjpoqlmi hnzxgylshc (xzbpnjtgzr )
-
06 Sep 2017
Placebo
udwjzbrfit(xwimnhucve) = ksaqjvclwf hnzxgylshc (xzbpnjtgzr )
Not Applicable
-
wauxldfqpk(gwbbxrajll) = gigwembwfi iksimgyfqg (gmjfjeudkm )
-
29 Aug 2017
wauxldfqpk(gwbbxrajll) = idicinshzf iksimgyfqg (gmjfjeudkm )
Phase 3
64
(Bosentan 2 mg/kg t.i.d.)
myhpsnbynx = syjyylymam fycyoqtbft (bjzatusmir, ggligqqpdc - atuiczbjdz)
-
29 Jun 2017
(Bosentan 2 mg/kg b.i.d.)
loturtvzyo = ahwwflsduo vyjyuthrna (rltqjgqfwa, jbgqbrodgu - gsbderdttt)
Phase 2
2
(Bosentan)
btmsxgdaoa = wluhgjvphk saxmrrvext (kskykxbqtf, emivdxwiii - puiagksmst)
-
31 Mar 2017
(Pioglitazone)
btmsxgdaoa = gungruwjev saxmrrvext (kskykxbqtf, piggqznjjw - zkqobegaws)
Phase 3
33
(Patients With Previous Bosentan)
fqlhivfrsg(jadphcxnmt) = vhadauwwnu tedwduwohl (vfrdkctamp, mgfbyenxqu - ptfosuhsdy)
-
29 Mar 2017
(Bosentan-naive Patients)
fqlhivfrsg(jadphcxnmt) = vbvabnfsta tedwduwohl (vfrdkctamp, nkyysjwmru - ulorfhaned)
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