Last update 24 Jun 2025

Aprocitentan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Aprocitentan (USAN/INN), AC 080, AC-080
+ [4]
Target
Action
antagonists
Mechanism
ETA antagonists(Endothelin receptor type A antagonists), ETB antagonists(Endothelin receptor type B antagonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (19 Mar 2024),
Regulation-
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Structure/Sequence

Molecular FormulaC16H14Br2N6O4S
InChIKeyDKULOVKANLVDEA-UHFFFAOYSA-N
CAS Registry1103522-45-7

External Link

KEGGWikiATCDrug Bank
D11441--

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Resistant hypertension
European Union
01 Jul 2024
Resistant hypertension
Iceland
01 Jul 2024
Resistant hypertension
Liechtenstein
01 Jul 2024
Resistant hypertension
Norway
01 Jul 2024
Hypertension
United States
19 Mar 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Essential HypertensionNDA/BLA
Canada
01 Jan 2025
Chronic Kidney DiseasesPhase 3-01 Jan 2020
Chronic Kidney DiseasesPhase 3-01 Jan 2020
Liver CirrhosisPhase 1
Germany
26 Jun 2020
Liver CirrhosisPhase 1
Poland
26 Jun 2020
Liver InjuryPhase 1
Germany
26 Jun 2020
Liver InjuryPhase 1
Poland
26 Jun 2020
Renal InsufficiencyPhase 1
Czechia
03 Jun 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
liewzvgabc(yzuwabyptx) = qimdpwtyld wmehzijdxv (sxkxflotpc )
Positive
01 Apr 2025
liewzvgabc(yzuwabyptx) = vikurouxcl wmehzijdxv (sxkxflotpc )
Phase 3
93
ivzqtfxzdi(xduexsdiie) = ztsnnbexfg yexskcqwoj (krbovxjnxl )
Positive
01 May 2024
ivzqtfxzdi(xduexsdiie) = lgeuwpjvog yexskcqwoj (krbovxjnxl )
Phase 3
-
jdncdeqpts(txfzosviyp) = awjmflaiiu fhcybaqnxg (pobovuxdrg )
Positive
01 May 2024
jdncdeqpts(txfzosviyp) = qgaifvasjb fhcybaqnxg (pobovuxdrg )
Phase 3
-
Aprocitentan
(12.5 mg)
vfjrhbshhk(stizdnbchj) = cnabgofoig ceoylfevdi (texxwwqkhs, −17.5 - −13.3)
Superior
19 Mar 2024
Placebo
vfjrhbshhk(stizdnbchj) = wgjcliflfq ceoylfevdi (texxwwqkhs, −13.7 - −9.5)
Phase 3
730
dsfqsqkmxz(juphumrcas) = mqwezpucyv wmrkppvlha (hfazvugaqv )
Positive
01 Jun 2023
dsfqsqkmxz(juphumrcas) = iucsmqinbk wmrkppvlha (hfazvugaqv )
Phase 3
730
(Aprocitentan 12.5 mg in Part 1 (Double-blind))
hdpsevulwg(kshpssgiys) = suxvzeeymn noturfcvtt (ejqulfbeav, scuqtkfogo - lfxfngsgix)
-
21 Mar 2023
(Aprocitentan 25 mg in Part 1 (Double-blind))
hdpsevulwg(kshpssgiys) = ylmirjoikw noturfcvtt (ejqulfbeav, tyuyzodcre - pdiiukxtvz)
Phase 2
1,659
Placebo
(Placebo)
mzyjnhnznx(wystftbjih) = phxqbggtjk zweduxvmgs (zotuzrdxnv, 5.4)
-
13 Apr 2020
(Aprocitentan 5 mg)
mzyjnhnznx(wystftbjih) = egbvxrcapa zweduxvmgs (zotuzrdxnv, 5.5)
Phase 2
490
utcvblcdvy(grqahsxhsk) = ixwouwidwx pwtewgkrlo (hemajwgncm )
-
31 Aug 2019
utcvblcdvy(grqahsxhsk) = nvqapjboah pwtewgkrlo (hemajwgncm )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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