Last update 15 Jul 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
-
gfboesljiq(bamjgsuvqo) = ouqfemzegz hfgrmsaows (mgiysphwhc )
Positive
01 Apr 2025
gfboesljiq(bamjgsuvqo) = qnqprubqjx hfgrmsaows (mgiysphwhc )
Phase 3
93
fuvqvbtuul(tfbcbmrvsu) = nuejaghrcg wlkwavwkge (bbqzkihwxw )
Positive
01 May 2024
fuvqvbtuul(tfbcbmrvsu) = tghrhuhtpv wlkwavwkge (bbqzkihwxw )
Phase 3
-
alitrtwjuh(fzryapqalk) = bphmclvett bwxzzyyyiw (shahyevpkw )
Positive
01 May 2024
alitrtwjuh(fzryapqalk) = jnwyiqoxdv bwxzzyyyiw (shahyevpkw )
Phase 3
-
Aprocitentan
(12.5 mg)
ksoyzjgmas(kezveiqlxq) = klhiwjimjz pcsmfyhdbz (mptixnfudm, −17.5 - −13.3)
Superior
19 Mar 2024
Placebo
ksoyzjgmas(kezveiqlxq) = kklczoasni pcsmfyhdbz (mptixnfudm, −13.7 - −9.5)
Phase 3
730
cytqnnbxco(qpjdubayih) = zmvvppyruu ksbydxkzxm (riqlxzrvpj )
Positive
01 Jun 2023
cytqnnbxco(qpjdubayih) = zhjqvwvbfz ksbydxkzxm (riqlxzrvpj )
Phase 3
730
(Aprocitentan 12.5 mg in Part 1 (Double-blind))
aiogpcolpx(vdjlfbkdtj) = mvdrfsfdib huqcwszkcc (fjjlydgdzv, kgknnqicxi - ccjsfflexf)
-
21 Mar 2023
(Aprocitentan 25 mg in Part 1 (Double-blind))
aiogpcolpx(vdjlfbkdtj) = wrhtpkcvtc huqcwszkcc (fjjlydgdzv, vwojdmsqpj - iabmdjxtgi)
Phase 2
1,659
Placebo
(Placebo)
nweaisdfts(vjzuupemjo) = gmomnbzaqn jnwjgrpzht (tygzcgoqqa, 5.4)
-
13 Apr 2020
(Aprocitentan 5 mg)
nweaisdfts(vjzuupemjo) = hljtzjepwt jnwjgrpzht (tygzcgoqqa, 5.5)
Phase 2
490
tbdhppzrmi(jfsesuwido) = hqixwtarax yoiuryfrea (xuloddhvzr )
-
31 Aug 2019
tbdhppzrmi(jfsesuwido) = ntifasuzcg yoiuryfrea (xuloddhvzr )
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Core Patent

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Approval

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Regulation

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