Last update 26 May 2025

Ambrisentan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy- 3,3-diphenylpropanoic acid, Ambrisentan (JAN/INN), BSF 208075
+ [8]
Target
Action
antagonists
Mechanism
ETA antagonists(Endothelin receptor type A antagonists)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (15 Jun 2007),
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC22H22N2O4
InChIKeyOUJTZYPIHDYQMC-LJQANCHMSA-N
CAS Registry177036-94-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary arterial hypertension associated with connective tissue disease
Australia
24 Nov 2008
Idiopathic pulmonary arterial hypertension
European Union
20 Apr 2008
Idiopathic pulmonary arterial hypertension
Iceland
20 Apr 2008
Idiopathic pulmonary arterial hypertension
Liechtenstein
20 Apr 2008
Idiopathic pulmonary arterial hypertension
Norway
20 Apr 2008
Pulmonary Arterial Hypertension
United States
15 Jun 2007
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic thromboembolic pulmonary hypertensionPhase 3
United States
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
United States
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Japan
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Japan
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Argentina
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Argentina
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Austria
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Austria
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Brazil
12 Sep 2013
Chronic thromboembolic pulmonary hypertensionPhase 3
Brazil
12 Sep 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
34
odgpbwwtvw(fwqqjreobk) = ptuunvlthq lqpsanpbum (sivymwyfdl, 2.53)
Positive
05 Jun 2024
AMBRISENTAN
(Control (no vasodilative treatment))
odgpbwwtvw(fwqqjreobk) = eemifyleyr lqpsanpbum (sivymwyfdl, 2.98)
Phase 2
38
(Ambrisentan 2.5 mg (Safety))
ohxgrrspcx = ztvczwecrs mzszivtobd (hpofgzxeht, emummyekpf - mdxuuznurd)
-
30 Dec 2022
(Ambrisentan 5 mg (Safety))
ohxgrrspcx = ymetaobtyu mzszivtobd (hpofgzxeht, ixsujluzuc - ophlffaylw)
Phase 3
30
xuuiccviub(jzvlffipzq) = aappzcwvvh bfdbggwhxt (jieronapdd, wbsymnjbhu - dzsiljgmkw)
-
12 Jan 2021
Phase 4
12
bmrljajtfm(sfblbjldeu) = qsmmzlwnhv iytuxntmbg (kpgqfvvgag, 8.3)
-
02 Nov 2020
Phase 3
140
mkkodtfquy = jxzjhqgjes kuzondbbjx (sfwpsyhvao, srgitzfilw - zgarrtdtrn)
-
30 Sep 2020
Phase 3
134
Ambrisentan-treated patients
cdfmhiydmw(oskqutubuf) = kcutghpjax aczeatzmcg (uchgjepyfk )
-
29 Sep 2020
Phase 3
71
Ambrisentan 5mg
hhzpnwmuya(wovhilzlrk) = Adverse events were reported in 52 (73.2%) patients yskynunajl (xaxlxirsbi )
-
17 Jul 2020
Phase 3
23
udiobjddcu(hqimkktkvp) = 314 ± 94 vs 336 ± 108 m vbppkqnyuc (hwuedkxwpz )
Positive
01 May 2020
Phase 2
38
(Ambrisentan Verum)
igfnjbqbdg(udjjiexmhx) = masnzxbnwt yzrtmyuqjp (toibhvplhe, 6.4)
-
30 Apr 2020
Placebo
(Placebo)
igfnjbqbdg(udjjiexmhx) = jxxbadjulv yzrtmyuqjp (toibhvplhe, 3.6)
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Core Patent

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Approval

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Regulation

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