{"id":"macitentan-tablets","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Peripheral edema"},{"rate":null,"effect":"Flushing"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Endothelin is a potent vasoconstrictor that plays a key role 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 smooth muscle proliferation, and decreases inflammation in the pulmonary vasculature. This leads 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":"2026-03-28T01:20:01.148Z","_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":"NCT05179876","phase":"PHASE3","title":"A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option","status":"RECRUITING","sponsor":"Actelion","startDate":"2022-05-04","conditions":"Hypertension, Pulmonary","enrollment":280},{"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":"NCT05167825","phase":"PHASE3","title":"A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2022-11-14","conditions":"Pulmonary Arterial Hypertension","enrollment":7},{"nctId":"NCT05140525","phase":"PHASE3","title":"Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH","status":"RECRUITING","sponsor":"Dr Sudarshan Rajagopal","startDate":"2025-01-27","conditions":"CTEPH","enrollment":15},{"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":"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":"NCT01346930","phase":"PHASE2","title":"Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis","status":"WITHDRAWN","sponsor":"Actelion","startDate":"2011-07-31","conditions":"Idiopathic Pulmonary Fibrosis","enrollment":""},{"nctId":"NCT03215966","phase":"PHASE1","title":"A Study to Compare the Macitentan-tadalafil Fixed Dose 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Hypertension","status":"COMPLETED","sponsor":"Actelion","startDate":"2016-05-01","conditions":"Pulmonary Arterial Hypertension","enrollment":247},{"nctId":"NCT02126943","phase":"","title":"OPsumit USers Registry","status":"COMPLETED","sponsor":"Actelion","startDate":"2014-04-30","conditions":"Pulmonary Arterial Hypertension","enrollment":2686},{"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":"NCT02060721","phase":"PHASE2","title":"Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension","status":"COMPLETED","sponsor":"Actelion","startDate":"2015-02-03","conditions":"Chronic Thromboembolic 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mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants","status":"COMPLETED","sponsor":"Actelion","startDate":"2022-02-04","conditions":"Healthy","enrollment":40},{"nctId":"NCT03153111","phase":"PHASE2","title":"A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease","status":"COMPLETED","sponsor":"Actelion","startDate":"2017-07-11","conditions":"Heart Failure With Preserved Ejection Fraction","enrollment":143},{"nctId":"NCT04211272","phase":"PHASE1","title":"A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants","status":"COMPLETED","sponsor":"Actelion","startDate":"2020-01-14","conditions":"Healthy","enrollment":47},{"nctId":"NCT03726398","phase":"PHASE2, PHASE3","title":"CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH","status":"WITHDRAWN","sponsor":"Franz Rischard, DO","startDate":"2018-09-01","conditions":"Interstitial Lung Disease, Scleroderma, Pulmonary Hypertension","enrollment":""},{"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":"NCT03714815","phase":"PHASE2","title":"A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease","status":"TERMINATED","sponsor":"Actelion","startDate":"2018-12-07","conditions":"Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease","enrollment":91},{"nctId":"NCT01474122","phase":"PHASE3","title":"Macitentan for the Treatment of Digital Ulcers in 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Fibrosis","enrollment":178}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["OPSUMIT"],"phase":"phase_3","status":"active","brandName":"Macitentan Tablets","genericName":"Macitentan Tablets","companyName":"Dr Sudarshan Rajagopal","companyId":"dr-sudarshan-rajagopal","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":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}