Drugs / Macitentan
Macitentan
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic thromboembolic pulmonary hypertension 1 milestone | |||||
| Filed | US (FDA) | OPSUMIT | chronic thromboembolic pulmonary hypertension | 2018-04-30 | “Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)” jnj.com ↗ “A supplemental New Drug Application was submitted to the FDA seeking to expand the indication of OPSUMIT (macitentan)” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 · 1 met primary | ||||||
| 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| Phase 1 | NCT05731492 | Mar → Apr 2024 | pulmonary arterial hypertension | Actelion | Withdrawn | No outcome recorded Stop: Business |
| 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 | Met primary |
| 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 Stop: Enrollment |
| 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 · 2 met primary · 1 missed | ||||||
| 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 | Met primary |
| Phase 2 | NCT02651272 | Jul 2015 → Dec 2019 | pulmonary hypertension, sickle cell disease | Boston University | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Met primary |
| 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 | Missed primary |
| 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 · 2 met primary · 3 missed | ||||||
| Phase 3 | NCT05946811 | May 2024 → Jan 2028 | pulmonary embolism | University of Maryland, Baltimore | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| 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 | Met primary |
| 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 Stop: Business |
| 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 | Missed primary |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 46 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 4 | NCT02310672 | Jun 2015 → Sep 2019 | pulmonary arterial hypertension | Actelion | Completed | Met primary |
| Phase 4 | NCT03236818 | May 2013 → Sep 2017 | pulmonary arterial hypertension | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT03153111 Comparator | Jul 2017 → Mar 2021 | diastolic heart failure | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT05140525 Comparator | Jan 2025 → Mar 2026 | chronic thromboembolic pulmonary hypertension | Dr Sudarshan Rajagopal | Terminated | No outcome recorded |
| Phase 3 | NCT02558231 Background | May 2016 → Aug 2019 | pulmonary arterial hypertension | Actelion | Completed | Missed primary |
| 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 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 |
| — | NCT07844213 Comparator | Aug 2022 → Jul 2025 | congenital heart disease | China National Center for Cardiovascular Diseases | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2024-03-22 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2024-03-22 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-09-06 | Janssen Research & Development, LLC | Results Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced its decision to stop the Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) due to futility. |
| 2023-06-26 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-05-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-05-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.1 |
| 2023-03-06 | Janssen Research & Development, LLC | Results Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2023-03-06 | Janssen Research & Development, LLC | Results Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH) |
| 2022-03-01 | Alembic Pharmaceuticals Ltd. | Regulatory 14th March, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg. |
| 2021-10-15 | Janssen Research & Development, LLC | Regulatory OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2021-10-15 | Janssen Research & Development, LLC | Regulatory OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health CanadaApproved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2021-04-08 | Zydus Lifesciences Limited | Regulatory Zydus Cadila announces final USFDA approval for Macitentan Tablets, 10 mg and gets eligibility for 180-day shared exclusivity zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Macitentan Tablets, 10 mg (US RLD: Opsumit Tablets ). |
| 2020-04-15 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Macitentan Tablets zyduslife.com ↗
Zydus Worldwide DMCC, a wholly owned subsidiary of Cadila Healthcare Limited, has received tentative approval from the USFDA to market Macitentan Tablets (US RLD: Opsumit® Tablets), 10 mg. |
| 2019-11-12 | Janssen Research & Development, LLC | Regulatory Actelion Withdraws Regulatory Filings to Extend the Indication of OPSUMIT® (macitentan 10mg) in CTEPH jnj.com ↗
Actelion has decided to withdraw the ongoing worldwide submissions based on the Phase 2 study of Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension (MERIT-1). |
| 2019-10-21 | Janssen Research & Development, LLC | Results New OPSUMIT® (macitentan) Data Show Initial Combination Therapy with Tadalafil Improved Hemodynamic Clinical and Functional Parameters in Patients with Pulmonary Arterial Hypertension jnj.com ↗
Patients with pulmonary arterial hypertension (PAH, WHO Group 1) taking this combination showed hemodynamic improvement, as well as improvements in functional parameters and risk profiles. |
| 2019-03-15 | Janssen Research & Development, LLC | Results Interim Analysis Showed Treatment with OPSUMIT® (macitentan) Associated with Significant Improvement in Right Ventricular (RV) Function and Pulmonary Vascular Resistance (PVR) in Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
Interim Analysis Showed Treatment with OPSUMIT® (macitentan) Associated with Significant Improvement in Right Ventricular (RV) Function and Pulmonary Vascular Resistance (PVR) in Patients with Pulmonary Arterial Hypertension (PAH) |
| 2018-04-30 | Janssen Research & Development, LLC | Regulatory Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) jnj.com ↗
Actelion Submits Supplemental New Drug Application to US FDA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) |
| 2015-03-26 | Nippon Shinyaku Co., Ltd. | Regulatory 肺動脈性高血圧症治療剤「オプスミット®錠10ｍｇ」の製造販売承認取得のお知らせ nippon-shinyaku.co.jp ↗
日本新薬が、アクテリオン ファーマシューティカルズ ジャパン株式会社（本社：東京都渋谷区、社長：田中論、以下「アクテリオンジャパン」）と共同で国内ＰⅢ試験を実施した肺動脈性肺高血圧症（PAH）治療剤「オプスミット ® 錠10ｍｇ」（開発番号：ACT-064992 一般名：マシテンタン 以下、本剤）が、本日、製造販売承認を取得しましたのでお知らせします。 |
All press releases naming this drug 18 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 67 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 ↗62“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 |