Drugs / Macitentan
Macitentan
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OPSUMIT | — | 2025-02-28 | fda.gov ↗ |
| Approved | EU (EMA) | Opsumit | — | 2013-12-20 | europa.eu ↗ |
| Approved | US (FDA) | OPSUMIT | — | 2013-10-18 | fda.gov ↗ |
Trials 55 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07392281 | Sep 2025 → Aug 2027 expected | nonobstructive coronary artery disease | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT06811831 | Nov 2024 → Oct 2026 expected | coronary microvascular disorder | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| Phase 117 trials | ||||||
| Phase 1 | NCT06553924 | May 2024 | pulmonary arterial hypertension | Humanis | Completed | No outcome recorded |
| Phase 1 | NCT05731492 | Mar → Apr 2024 | pulmonary arterial hypertension | Actelion | Withdrawn | No outcome recorded |
| Phase 1 | NCT05433675 | Jun → Aug 2022 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT05392530 | May → Aug 2022 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT05236231 | Feb → May 2022 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT04963439 | Jul → Sep 2021 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT04540744 | Apr → Aug 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04500808 | Jul → Dec 2020 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT04235270 | Jan → Jul 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04211272 | Jan 2020 → Apr 2021 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT03389321 | Jan → Feb 2018 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT03359291 | Nov → Dec 2017 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT03215966 | Aug → Sep 2017 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02476864 | Aug → Dec 2015 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02254954 | Jan 2015 → Sep 2016 | glioblastoma | Actelion | Terminated | No outcome recorded |
| Phase 1 | NCT01499251 | Jan 2012 → Jan 2016 | glioblastoma | Actelion | Terminated | No outcome recorded |
| Phase 1 | NCT02050802 | Aug → Nov 2011 | — | Actelion | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT03714815 | Dec 2018 → Oct 2021 | pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 2 | NCT03362047 | Mar 2018 → Jul 2024 | pulmonary arterial hypertension | University of Giessen | Completed | No outcome recorded |
| Phase 2 | NCT02554903 | Mar 2016 → Mar 2020 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 2 | NCT02651272 | Jul 2015 → Dec 2019 | pulmonary hypertension, sickle cell disease | Boston University | Terminated | No outcome recorded |
| Phase 2 | NCT02060721 | Feb 2015 → Mar 2022 | chronic thromboembolic pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 2 | NCT02021292 | Aug 2014 → Sep 2016 | chronic thromboembolic pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 2 | NCT02070991 | Jul 2014 → Nov 2015 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 2 | NCT01346930 | Jul 2011 → Aug 2016 | idiopathic pulmonary fibrosis | Actelion | Withdrawn | No outcome recorded |
| Phase 2 | NCT00903331 | May 2009 → Jun 2011 | idiopathic pulmonary fibrosis | Actelion | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04780932 | Jun 2021 → Jul 2025 | chronic thromboembolic pulmonary hypertension | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2/3 | NCT03726398 | Sep 2018 → Aug 2020 | interstitial lung disease, pulmonary hypertension, scleroderma | Franz Rischard, DO | Withdrawn | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT05946811 | May 2024 → Jan 2028 | pulmonary embolism | University of Maryland, Baltimore | Withdrawn | No outcome recorded |
| Phase 3 | NCT05167825 | Nov 2022 → Aug 2024 | pulmonary arterial hypertension | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT05179876 | May 2022 → Jan 2027 expected | pulmonary hypertension | Actelion | Recruiting | No outcome recorded |
| Phase 3 | NCT04271475 | Jul 2020 → Dec 2023 | chronic thromboembolic pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT04273945 | Jun 2020 → Oct 2025 overdue | pulmonary arterial hypertension | Actelion | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03904693 | Jul 2019 → Aug 2022 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT03775421 | Apr 2019 → Jan 2022 | congenital anomaly of cardiovascular system | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT03809650 | Jan 2019 → Jun 2020 | chronic thromboembolic pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT03422328 | Apr 2018 → Dec 2023 | chronic thromboembolic pulmonary hypertension, pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT02932410 | Oct 2017 → Aug 2024 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT03153137 | Aug 2017 → Jun 2021 | congenital heart disease | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT02112487 | Jun 2014 → Sep 2018 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT02081690 | Mar 2014 → Oct 2015 | pulmonary arterial hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT01739400 | Sep 2013 → Jan 2018 | pulmonary arterial hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT01847014 | Sep 2013 → Oct 2015 | pulmonary arterial hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT01743001 | May 2013 → Dec 2016 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01841762 | Apr 2013 → Nov 2015 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00667823 | Oct 2008 → Dec 2020 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT00660179 | May 2008 → Mar 2012 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07147114 | Nov 2025 → Sep 2027 expected | mild heart failure, pulmonary hypertension | Gachon University Gil Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05373108 | May 2022 → Feb 2023 | — | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT02968901 | Sep 2015 → Sep 2018 | pulmonary arterial hypertension | Actelion | Terminated | No outcome recorded |
| Phase 4 | NCT02382016 | Jun 2015 → Oct 2017 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT02310672 | Jun 2015 → Sep 2019 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT03236818 | May 2013 → Sep 2017 | pulmonary arterial hypertension | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03153111 Comparator | Jul 2017 → Mar 2021 | diastolic heart failure | Actelion | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT05140525 Comparator | Jan 2025 → Dec 2026 expected | chronic thromboembolic pulmonary hypertension | Dr Sudarshan Rajagopal | Recruiting | No outcome recorded |
| Phase 3 | NCT02558231 Background | May 2016 → Aug 2019 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01824290 Background | Feb 2014 → Mar 2019 | pulmonary arterial hypertension | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01474109 Comparator | Dec 2011 → Nov 2013 | systemic sclerosis, ulcer disease | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01474122 Comparator | Dec 2011 → Feb 2014 | — | Actelion | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06317805 Background | Dec 2023 → Jun 2027 expected | pulmonary arterial hypertension | AOP Orphan Pharmaceuticals AG | Recruiting | No outcome recorded |
| Phase 4 | NCT02893176 Comparator | Sep 2016 → Sep 2019 | transplant rejection | University of California, Los Angeles | Withdrawn | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Macitentan | “All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one...” NCT06317805 ↗61“This clinical trial will evaluate whether combination therapy with Dapagliflozin + Macitentan improves outcomes compared to Dapagliflozin + placebo in patients with combined...” NCT07147114 ↗ “Macitentan 30, 60, 90 mg or higher in 30 mg dose increments, given orally, up to 150 mg, then 225 mg, 300 mg and 375 mg, unless otherwise decided by the Safety Monitoring Committee.” NCT01499251 ↗ “All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).” NCT01824290 ↗ “one film-coated tablet containing 10 mg of macitentan as active substance” NCT02476864 ↗ “Macitentan” NCT01739400 ↗ |
| Known as | ACT-064992 | “macitentan (ACT-064992)” NCT00660179 ↗ |
| Known as | Macitentan / ACT-064992 | “Macitentan / ACT-064992” NCT01841762 ↗ |
| Known as | Macitentan component of opsynvi | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103873 ↗ |
| Known as | Opsumit | “Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15” NCT03389321 ↗ |
| Action | Inhibit | “macitentan, a new dual endothelin-receptor antagonist” PMID 23984728 ↗ Aug 2013 |
| Modality | Other / unclassified | “endothelin receptor antagonist” NCT01474122 ↗ |
| Route | Oral | “macitentan, an oral endothelin receptor antagonist” PMID 29280064 ↗ Feb 2018 |