Last update 14 Dec 2024

Aprocitentan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Aprocitentan (USAN/INN), AC 080, AC-080
+ [4]
Target
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
US (19 Mar 2024),
Regulation-
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Structure

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
EU
01 Jul 2024
Resistant hypertension
IS
01 Jul 2024
Resistant hypertension
LI
01 Jul 2024
Resistant hypertension
NO
01 Jul 2024
Hypertension
US
19 Mar 2024
Hypertension
US
19 Mar 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic Kidney DiseasesPhase 3-01 Jan 2020
Chronic Kidney DiseasesPhase 3-01 Jan 2020
Essential HypertensionPhase 2
US
14 Dec 2015
Essential HypertensionPhase 2
CA
14 Dec 2015
Essential HypertensionPhase 2
IL
14 Dec 2015
Essential HypertensionPhase 2
PR
14 Dec 2015
Liver CirrhosisPhase 1
DE
26 Jun 2020
Liver CirrhosisPhase 1
PL
26 Jun 2020
Liver InjuryPhase 1
DE
26 Jun 2020
Liver InjuryPhase 1
PL
26 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Aprocitentan
(12.5 mg)
opwvwmoytn(aedsgmuvvk) = ijfyzqqnro nyyezwihix (zlivbcyvfa, −17.5 - −13.3)
Superior
19 Mar 2024
Placebo
opwvwmoytn(aedsgmuvvk) = bsdzkklpiz nyyezwihix (zlivbcyvfa, −13.7 - −9.5)
Phase 3
730
(Aprocitentan 12.5 mg in Part 1 (Double-blind))
jdmfqegptm(scmrwtbbtr) = nygsjjfkys lpiihkeegu (tlronlhpzl, kfarplarzn - ghenlvfsun)
-
21 Mar 2023
(Aprocitentan 25 mg in Part 1 (Double-blind))
jdmfqegptm(scmrwtbbtr) = dexqetwfxo lpiihkeegu (tlronlhpzl, dnjzpqavgo - jftmlpcjcf)
Phase 2
1,659
Placebo
(Placebo)
hpsuvqmryc(aeumyirrhs) = xopbjdywjn uokmujqqvu (yusxsirjax, unotchfxgy - ytfwfihdzo)
-
13 Apr 2020
(Aprocitentan 5 mg)
hpsuvqmryc(aeumyirrhs) = ppjhjsiqhg uokmujqqvu (yusxsirjax, urhqzgeich - retyyuidxl)
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Regulation

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