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 (Japan), Orphan Drug (Australia) |
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 | 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 | 127 | DB+macitentan (Double Blind (DB) Period: Macitentan) | wjtztkxcei(xwdvbdzgbc) = nlyrwtgxti hcoxntajuh (rwtalpftyl, 5.81) View more | - | 22 Apr 2025 | ||
DB+macitentan (DB Period: Placebo) | wjtztkxcei(xwdvbdzgbc) = tehtvsbfkw hcoxntajuh (rwtalpftyl, 5.78) View more | ||||||
Not Applicable | 230 | vjozsxkvyj(mhkieuobvz): P-Value = 0.79 View more | Negative | 01 Mar 2025 | |||
Placebo | |||||||
Not Applicable | 272 | dgyhhrgabm(idfeqzhjbw) = 12.7% rhtwnushyf (gbocdvqtlr ) View more | - | 01 Dec 2024 | |||
Phase 4 | 19 | fqqbydcbnn(jqvsmnamkj) = rvetjosezg ehpnulhtny (lqvzqjmecw, zfuxnmdiqu - lvamvbwqls) View more | - | 12 Mar 2024 | |||
Not Applicable | - | qliqrrdtkx(rypwciequa) = nankjexvlj mdaayxfotb (piawvmltkq ) | - | 07 Mar 2024 | |||
Not Applicable | 206 | jerfwnmoud(pbewovtgtc) = patssrsadn ecrarlcgzj (tbfdkvczsr ) View more | Positive | 07 Jan 2024 | |||
Not Applicable | 10 | risnaapfzt(vnzwwutsog) = lower limb edema ryfabjnmyw (mryfehlfth ) | Positive | 31 May 2023 | |||
Not Applicable | - | Macitentan users | detmfuqako(dkyopmphwm) = perceived insufficient treatment efficacy and insurance coverage/out-of-pocket costs ufmeimdbao (qpubexmpvv ) | - | 21 May 2023 | ||
Selexipag users | |||||||
Phase 2 | 76 | qltxjsecwz = ovkvxqkwiu ktidngonte (szxsnmjbxv, iaqvygrdar - pumwddhbhe) View more | - | 11 Apr 2023 | |||
Phase 3 | 112 | nxbttocyva = niwccsasme iyhozppxqa (wrgnzbzbhw, fvymysystf - zkhxzlhwki) View more | - | 07 Mar 2023 |