{"id":"bosentan-group","safety":{"commonSideEffects":[{"rate":"30-40%","effect":"Headache"},{"rate":"20-30%","effect":"Dizziness"},{"rate":"10-20%","effect":"Nausea"},{"rate":"10-20%","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL957","moleculeType":"Small molecule","molecularWeight":"551.63"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By inhibiting endothelin-1, bosentan causes vasodilation and reduces pulmonary artery pressure, which is beneficial for patients with pulmonary arterial hypertension. This mechanism of action is specific to the endothelin receptor, which is overexpressed in the pulmonary arteries of patients with this condition.","oneSentence":"Bosentan is an endothelin receptor antagonist that works by blocking the action of endothelin-1, a potent vasoconstrictor.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:58:36.602Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Pulmonary arterial hypertension"}]},"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":"NCT04039464","phase":"PHASE3","title":"Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2022-08-01","conditions":"Pediatric Pulmonary Hypertension","enrollment":28},{"nctId":"NCT06887062","phase":"PHASE2","title":"Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)","status":"RECRUITING","sponsor":"University of Edinburgh","startDate":"2025-03-21","conditions":"Large Vessel Vasculitis, Giant Cell Arteritis (GCA), Takayasu Arteritis","enrollment":60},{"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":"NCT00391443","phase":"PHASE3","title":"BUILD 3: Bosentan Use in Interstitial Lung Disease","status":"COMPLETED","sponsor":"Actelion","startDate":"2007-02","conditions":"Idiopathic Pulmonary Fibrosis","enrollment":616},{"nctId":"NCT00303459","phase":"PHASE4","title":"Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)","status":"COMPLETED","sponsor":"Actelion","startDate":"2006-05","conditions":"Pulmonary Arterial Hypertension","enrollment":334},{"nctId":"NCT00313196","phase":"PHASE3","title":"Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients Diagnosed With Pulmonary Hypertension (PH)","status":"TERMINATED","sponsor":"Actelion","startDate":"2006-04","conditions":"Pulmonary Hypertension","enrollment":12},{"nctId":"NCT00310830","phase":"PHASE3","title":"Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH)","status":"TERMINATED","sponsor":"Actelion","startDate":"2006-03","conditions":"Pulmonary Hypertension","enrollment":14},{"nctId":"NCT01395732","phase":"PHASE4","title":"Bosentan in Systemic Sclerosis","status":"COMPLETED","sponsor":"Actelion","startDate":"2011-03","conditions":"Systemic Sclerosis, Digital Ulcers","enrollment":18},{"nctId":"NCT00313222","phase":"PHASE3","title":"Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension","status":"COMPLETED","sponsor":"Actelion","startDate":"2005-10","conditions":"Chronic Thromboembolic Pulmonary Hypertension","enrollment":157},{"nctId":"NCT05657613","phase":"PHASE1","title":"Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects","status":"COMPLETED","sponsor":"CTI BioPharma","startDate":"2023-01-03","conditions":"Drug Interactions","enrollment":60},{"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":"NCT02377271","phase":"PHASE3","title":"ENDOTHELION Study Group: Effect of Bosentan in NAION Patients","status":"UNKNOWN","sponsor":"University Hospital, Grenoble","startDate":"2015-08","conditions":"Ischemic Optic Neuropathy","enrollment":86},{"nctId":"NCT00593905","phase":"","title":"Pharmacogenomics in Pulmonary Arterial Hypertension","status":"WITHDRAWN","sponsor":"West Penn Allegheny Health System","startDate":"2005-07","conditions":"Pulmonary Arterial Hypertension, Pulmonary Hypertension, PAH WHO Group I","enrollment":""},{"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":"NCT01392469","phase":"PHASE3","title":"Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-04-20","conditions":"Pulmonary Arterial Hypertension","enrollment":21},{"nctId":"NCT04379180","phase":"","title":"Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN","status":"UNKNOWN","sponsor":"Shandong University","startDate":"2020-04-26","conditions":"Persistent Pulmonary Hypertension of the Newborn","enrollment":500},{"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":"NCT02798055","phase":"","title":"Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis","status":"COMPLETED","sponsor":"Elpen Pharmaceutical Co. Inc.","startDate":"2016-09-30","conditions":"Systematic Sclerosis, Digital Ulcer, Scleroderma","enrollment":148},{"nctId":"NCT00625469","phase":"PHASE4","title":"Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan","status":"WITHDRAWN","sponsor":"Rajan Saggar","startDate":"2007-10","conditions":"Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis","enrollment":""},{"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":"NCT01184404","phase":"NA","title":"Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery","status":"UNKNOWN","sponsor":"Berto J Bouma","startDate":"2011-09","conditions":"Congenital Heart Disease","enrollment":100},{"nctId":"NCT01330108","phase":"PHASE4","title":"Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2011-05","conditions":"Pulmonary Arterial Hypertension","enrollment":32},{"nctId":"NCT01292551","phase":"PHASE2","title":"Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2011-02","conditions":"Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart","enrollment":75},{"nctId":"NCT01662037","phase":"PHASE2","title":"Bosentan Therapy in Children With Functional Single Ventricle","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2010-01","conditions":"Congenital Heart Defects, Functional Single Ventricle","enrollment":34}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":65,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"Bosentan group","genericName":"Bosentan group","companyName":"Elpen Pharmaceutical Co. Inc.","companyId":"elpen-pharmaceutical-co-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Bosentan is a small molecule antagonist that targets the endothelin receptor, specifically ET-A/ET-B. It is used to treat conditions such as pulmonary hypertension, systemic sclerosis, digital ulcer, scleroderma, and persistent pulmonary hypertension of the newborn.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}