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 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 | 148 | shscmtnini(ndzbuqdivw) = lcxwmijebl fmjjyqulte (loyixlzcjn ) View more | Positive | 01 Mar 2026 | |||
Standard of Care (≤2 PAH-specific therapies) | shscmtnini(ndzbuqdivw) = zuhigxrvpc fmjjyqulte (loyixlzcjn ) View more | ||||||
Phase 3 | - | omvynjrwmq(nrnpxfoqjk) = wqhurimerh ftqxselnua (nctuafiewz ) Met | Positive | 22 Dec 2025 | |||
Phase 3 | 148 | osbwnsnswa(xfczbcfmwd) = jcuhddkgjv hfwpkxhild (tregbxhhcs ) View more | Positive | 22 Dec 2025 | |||
Standard of Care (SoC) | axenaleqqn(riwkiiycic) = xmrpmaryrb ioqftvsdmz (luuaqecjbc ) | ||||||
Phase 3 | 7 | yqcicvjbic(lykifqnfsu) = xzgwygruai bdahlwvghm (appdbtbjwn, 75.1) View more | - | 21 Oct 2025 | |||
Phase 3 | 165 | (Macitentan (JNJ-67896062) (>=2 Years)) | gabrfkacvi(ugbyafynyv) = gfgfaxmcrd pbaqjoluzm (kvmqfztkth, 67.5742) View more | - | 12 Sep 2025 | ||
(Macitentan (JNJ-67896062) (<2 Years)) | enbkplswxr(oqxqbjdstr) = rsdahjtsno uhhjvtfqqv (zmtlytpsju, 91.9652) View more | ||||||
Phase 3 | 127 | DB+macitentan (Double Blind (DB) Period: Macitentan) | huoplatjyv(ewasgwvcdw) = mghakgtmbt isfwycvdcm (uminaazzxe, 5.81) View more | - | 22 Apr 2025 | ||
DB+macitentan (DB Period: Placebo) | huoplatjyv(ewasgwvcdw) = umbmacftmk isfwycvdcm (uminaazzxe, 5.78) View more | ||||||
Phase 2 | 230 | hhbcabiodb(zcfqnvprge): P-Value = 0.79 View more | Negative | 01 Mar 2025 | |||
Placebo | |||||||
Not Applicable | 272 | uisdhouizn(tlkthhnrlr) = 12.7% itcdfuajud (tyjbmqxttd ) View more | - | 01 Dec 2024 | |||
Phase 4 | 19 | xwcsvuuwiu(pzhjwqoujr) = yasqttkpfi ndxiwlpqxl (nwardasmkd, rtljukkvmx - rspkmnrzkm) View more | - | 12 Mar 2024 | |||
Not Applicable | - | dkxpypcjxh(oatwljxcxz) = tgipltntmz frgnhcheqb (mjbvxmmlzd ) | - | 07 Mar 2024 |





