{"id":"macitentan-group","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Flushing"}]},"_chembl":{"chemblId":"CHEMBL2103873","moleculeType":"Small molecule","molecularWeight":"588.28"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Endothelin is a potent vasoconstrictor involved in the pathophysiology of pulmonary arterial hypertension (PAH). By antagonizing both ETA and ETB receptors on vascular smooth muscle and endothelial cells, macitentan reduces vasoconstriction, inhibits cell proliferation, and promotes vasodilation. This dual antagonism provides more comprehensive blockade compared to selective ETA antagonists, leading to improved hemodynamics and clinical outcomes in PAH patients.","oneSentence":"Macitentan is a dual endothelin receptor antagonist that blocks both ETA and ETB receptors to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:49:39.155Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Pulmonary arterial hypertension (PAH)"}]},"trialDetails":[{"nctId":"NCT04273945","phase":"PHASE3","title":"Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension","status":"ACTIVE_NOT_RECRUITING","sponsor":"Actelion","startDate":"2020-06-30","conditions":"Pulmonary Arterial Hypertension","enrollment":935},{"nctId":"NCT02932410","phase":"PHASE3","title":"A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)","status":"COMPLETED","sponsor":"Actelion","startDate":"2017-10-24","conditions":"Pulmonary Arterial Hypertension","enrollment":165},{"nctId":"NCT07392281","phase":"EARLY_PHASE1","title":"Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina","status":"RECRUITING","sponsor":"China-Japan Friendship Hospital","startDate":"2025-09-01","conditions":"Non-Coronary Obstructive Angina","enrollment":40},{"nctId":"NCT03904693","phase":"PHASE3","title":"Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)","status":"COMPLETED","sponsor":"Actelion","startDate":"2019-07-29","conditions":"Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","enrollment":187},{"nctId":"NCT07147114","phase":"PHASE4","title":"Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan and Dapagliflozin in Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction (HFmrEF and HFpEF) and Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH)","status":"NOT_YET_RECRUITING","sponsor":"Gachon University Gil Medical Center","startDate":"2025-10-31","conditions":"Combined Pre- and Post-capillary Pulmonary Hypertension, CpcPH, HFmrEF","enrollment":64},{"nctId":"NCT05039086","phase":"","title":"Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2021-09-01","conditions":"Pulmonary Arterial Hypertension","enrollment":13021},{"nctId":"NCT04271475","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension","status":"TERMINATED","sponsor":"Actelion","startDate":"2020-07-07","conditions":"Chronic Thromboembolic Pulmonary Hypertension","enrollment":127},{"nctId":"NCT02554903","phase":"PHASE2","title":"Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation","status":"COMPLETED","sponsor":"Actelion","startDate":"2016-03-28","conditions":"Pulmonary Hypertension","enrollment":57},{"nctId":"NCT03153137","phase":"PHASE3","title":"Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects","status":"COMPLETED","sponsor":"Actelion","startDate":"2017-08-14","conditions":"Congenital Heart Disease","enrollment":142},{"nctId":"NCT04235270","phase":"PHASE1","title":"A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2020-01-17","conditions":"Healthy","enrollment":62},{"nctId":"NCT02021292","phase":"PHASE2","title":"Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension","status":"COMPLETED","sponsor":"Actelion","startDate":"2014-08-20","conditions":"Chronic Thromboembolic Pulmonary Hypertension","enrollment":80},{"nctId":"NCT02382016","phase":"PHASE4","title":"PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial","status":"COMPLETED","sponsor":"Actelion","startDate":"2015-06-23","conditions":"Portopulmonary Hypertension","enrollment":85},{"nctId":"NCT03362047","phase":"PHASE2","title":"(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)","status":"COMPLETED","sponsor":"University of Giessen","startDate":"2018-03-01","conditions":"Pulmonary Arterial Hypertension (PAH)","enrollment":7},{"nctId":"NCT06811831","phase":"EARLY_PHASE1","title":"Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC)","status":"RECRUITING","sponsor":"China-Japan Friendship Hospital","startDate":"2024-11-01","conditions":"Coronary Microvascular Angina, Macitentan","enrollment":30},{"nctId":"NCT01474122","phase":"PHASE3","title":"Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients","status":"TERMINATED","sponsor":"Actelion","startDate":"2011-12","conditions":"Digital Ulcers","enrollment":265},{"nctId":"NCT06317805","phase":"PHASE4","title":"Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients","status":"RECRUITING","sponsor":"AOP Orphan Pharmaceuticals AG","startDate":"2023-12-06","conditions":"Pulmonary Arterial Hypertension","enrollment":110},{"nctId":"NCT01824290","phase":"PHASE3","title":"A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2014-02-05","conditions":"Hypertension, Pulmonary","enrollment":35},{"nctId":"NCT02484807","phase":"","title":"Effect of Pharmacologic Interaction Between ERAs and PDE-5 Inhibitors on Medication Serum Levels and Clinical Disease Status in Patients With PAH","status":"COMPLETED","sponsor":"Heidelberg University","startDate":"2015-05","conditions":"Pulmonary Arterial Hypertension","enrollment":125},{"nctId":"NCT02070991","phase":"PHASE2","title":"Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction","status":"COMPLETED","sponsor":"Actelion","startDate":"2014-07-01","conditions":"Pulmonary Hypertension","enrollment":63},{"nctId":"NCT01743001","phase":"PHASE3","title":"Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome","status":"COMPLETED","sponsor":"Actelion","startDate":"2013-05-21","conditions":"Pulmonary Arterial Hypertension","enrollment":226},{"nctId":"NCT03045666","phase":"NA","title":"Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.","status":"UNKNOWN","sponsor":"Soroka University Medical Center","startDate":"2017-04-15","conditions":"Pulmonary Arterial Hypertension","enrollment":48},{"nctId":"NCT01266265","phase":"","title":"Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies","status":"COMPLETED","sponsor":"United Therapeutics","startDate":"2010-12","conditions":"Pulmonary Arterial Hypertension","enrollment":1333},{"nctId":"NCT00660179","phase":"PHASE3","title":"Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension","status":"COMPLETED","sponsor":"Actelion","startDate":"2008-05","conditions":"Pulmonary Arterial Hypertension","enrollment":742},{"nctId":"NCT01474109","phase":"PHASE3","title":"Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients","status":"COMPLETED","sponsor":"Actelion","startDate":"2011-12","conditions":"Systemic Sclerosis, Ulcers","enrollment":289},{"nctId":"NCT00903331","phase":"PHASE2","title":"Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study","status":"COMPLETED","sponsor":"Actelion","startDate":"2009-05","conditions":"Idiopathic Pulmonary Fibrosis","enrollment":178}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["JNJ-67896062"],"phase":"phase_3","status":"active","brandName":"Macitentan Group","genericName":"Macitentan Group","companyName":"University of Giessen","companyId":"university-of-giessen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Macitentan is a dual endothelin receptor antagonist that blocks both ETA and ETB receptors to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension. Used for Pulmonary arterial hypertension (PAH).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}