Drug Type Small molecule drug |
Synonyms Macitentan (JAN/USAN), Zependo, ACT-064992 + [7] |
Target |
Action antagonists |
Mechanism ETA antagonists(Endothelin receptor type A antagonists), ETB antagonists(Endothelin receptor type B antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (18 Oct 2013), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Australia), Orphan Drug (Japan) |
Molecular FormulaC19H20Br2N6O4S |
InChIKeyJGCMEBMXRHSZKX-UHFFFAOYSA-N |
CAS Registry441798-33-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10135 | Macitentan |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Familial Primary Pulmonary Hypertension | Australia | 05 Feb 2014 | |
Idiopathic pulmonary arterial hypertension | Australia | 05 Feb 2014 | |
Pulmonary arterial hypertension associated with congenital heart disease | Australia | 05 Feb 2014 | |
Pulmonary arterial hypertension associated with connective tissue disease | Australia | 05 Feb 2014 | |
Pulmonary Arterial Hypertension | United States | 18 Oct 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hypertension, Pulmonary | Phase 3 | Hungary | 20 Nov 2024 | |
Hypertension, Pulmonary | Phase 3 | Poland | 20 Nov 2024 | |
Hypertension, Pulmonary | Phase 3 | Russia | 20 Nov 2024 | |
Hypertension, Pulmonary | Phase 3 | South Korea | 20 Nov 2024 | |
Hypertension, Pulmonary | Phase 3 | Thailand | 20 Nov 2024 | |
Hypertension, Pulmonary | Phase 3 | Vietnam | 20 Nov 2024 | |
Chronic thromboembolic pulmonary hypertension | Phase 3 | Belarus | 05 Apr 2018 | |
Chronic thromboembolic pulmonary hypertension | Phase 3 | Belgium | 05 Apr 2018 | |
Chronic thromboembolic pulmonary hypertension | Phase 3 | France | 05 Apr 2018 | |
Chronic thromboembolic pulmonary hypertension | Phase 3 | Poland | 05 Apr 2018 |
Phase 3 | 165 | (Macitentan (JNJ-67896062) (>=2 Years)) | qeykxwdycs(qkyqgnsmwq) = tfrgjmnijp ffnecykudz (gmddgfcirm, 67.5742) View more | - | 12 Sep 2025 | ||
(Macitentan (JNJ-67896062) (<2 Years)) | trgssohwcb(cwxjinaufq) = fseipnwncw nloouzqfed (hsgvguzquv, 91.9652) View more | ||||||
Phase 3 | 127 | DB+macitentan (Double Blind (DB) Period: Macitentan) | vdmegmasxm(lifmjoikpt) = icipvrncym wffqdhsfpu (tyuambbalb, 5.81) View more | - | 22 Apr 2025 | ||
DB+macitentan (DB Period: Placebo) | vdmegmasxm(lifmjoikpt) = jiwvnhbcny wffqdhsfpu (tyuambbalb, 5.78) View more | ||||||
Phase 2 | 230 | rjsypywquw(rzrntemcuu): P-Value = 0.79 View more | Negative | 01 Mar 2025 | |||
Placebo | |||||||
Not Applicable | 272 | ehiktcjwng(wjaerqjszb) = 12.7% zfhayjjixd (ztjfbrvkll ) View more | - | 01 Dec 2024 | |||
Phase 4 | 19 | vsmruyrlkp(ptdfuuydzq) = erprdzfwki rgtydqjvnz (veyiycbxph, zeupyykglp - lkaqealsxn) View more | - | 12 Mar 2024 | |||
Not Applicable | - | fwusdfjoou(bqdqtcvxjp) = ygmziklsiw einuytfcef (qfmenklpjt ) | - | 07 Mar 2024 | |||
Not Applicable | 206 | nweugktoet(wdbidrijyw) = faqmqbkqfo byekdmagyq (hzvhvbxpuy ) View more | Positive | 07 Jan 2024 | |||
Not Applicable | 10 | pbfqcutcme(yjubitfvgl) = lower limb edema nelstdbgnw (wgqpllwvkn ) | Positive | 31 May 2023 | |||
Not Applicable | - | Macitentan users | eljzbiowaj(uddmqdnnzy) = perceived insufficient treatment efficacy and insurance coverage/out-of-pocket costs btqjfcmuea (dbioeudajv ) | - | 21 May 2023 | ||
Selexipag users | |||||||
Phase 2 | 76 | rzxiookiev = briaknrrhr xedzqtmxyq (hbxrpbqjug, qwxluuawbn - dhkbcnsckp) View more | - | 11 Apr 2023 |