{"id":"bosentan","rwe":[],"_fda":{"id":"33935d05-c8ff-4d9e-91bf-fac9072d25fd","set_id":"02892f47-0d59-4254-9ee7-d524278fdd79","openfda":{"unii":["Q326023R30"],"route":["ORAL"],"rxcui":["349253","656659"],"spl_id":["33935d05-c8ff-4d9e-91bf-fac9072d25fd"],"brand_name":["Bosentan"],"spl_set_id":["02892f47-0d59-4254-9ee7-d524278fdd79"],"package_ndc":["70771-1017-6","70771-1017-1","70771-1017-8","70771-1017-5","70771-1017-2","70771-1017-4","70771-1018-6","70771-1018-1","70771-1018-8","70771-1018-5","70771-1018-2","70771-1018-4"],"product_ndc":["70771-1017","70771-1018"],"generic_name":["BOSENTAN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["BOSENTAN"],"manufacturer_name":["Zydus Lifesciences Limited"],"application_number":["ANDA207760"],"is_original_packager":[true]},"version":"6","spl_medguide":["SPL MEDGUIDE"],"effective_time":"20241125","spl_unclassified_section":[""],"spl_product_data_elements":["Bosentan Bosentan BOSENTAN BOSENTAN ANHYDROUS ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN LIGHT PINK BICONVEX 446 Bosentan Bosentan BOSENTAN BOSENTAN ANHYDROUS ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN LIGHT PINK BICONVEX 447"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1017-6 Bosentan tablets, 62.5 mg 60 tablets Rx only NDC 70771-1018-6 Bosentan tablets, 125 mg 60 tablets Rx only Bosentan tablets Bosentan tablets"]},"tags":[{"label":"Endothelin Receptor Antagonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Endothelin-1 receptor","category":"target"},{"label":"EDNRA","category":"gene"},{"label":"EDNRB","category":"gene"},{"label":"ABCB11","category":"gene"},{"label":"C02KX01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Pulmonary arterial hypertension","category":"indication"},{"label":"Pulmonary hypertension","category":"indication"},{"label":"Systemic sclerosis","category":"indication"},{"label":"Actelion","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Endothelin Receptor Antagonists","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"9300 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"5976 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"2682 reports"},{"date":"","signal":"PULMONARY ARTERIAL HYPERTENSION","source":"FDA FAERS","actionTaken":"2284 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"2231 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2202 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2053 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1967 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"1869 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"1759 reports"}],"drugInteractions":[{"url":"/drug/ciclosporin","drug":"ciclosporin","action":"Avoid combination","effect":"May interact with Cyclosporine","source":"DrugCentral","drugSlug":"ciclosporin"},{"url":"/drug/ethinylestradiol","drug":"ethinylestradiol","action":"Avoid combination","effect":"May interact with Ethinyl Estradiol","source":"DrugCentral","drugSlug":"ethinylestradiol"},{"url":"/drug/fluconazole","drug":"fluconazole","action":"Monitor closely","effect":"May interact with Fluconazole","source":"DrugCentral","drugSlug":"fluconazole"},{"url":"/drug/glibenclamide","drug":"glibenclamide","action":"Avoid combination","effect":"May interact with Glyburide","source":"DrugCentral","drugSlug":"glibenclamide"},{"url":"/drug/itraconazole","drug":"itraconazole","action":"Monitor closely","effect":"May interact with Itraconazole","source":"DrugCentral","drugSlug":"itraconazole"},{"url":"/drug/ketoconazole","drug":"ketoconazole","action":"Monitor closely","effect":"May interact with Ketoconazole","source":"DrugCentral","drugSlug":"ketoconazole"},{"url":"/drug/norethisterone","drug":"norethisterone","action":"Monitor closely","effect":"May interact with Norethindrone","source":"DrugCentral","drugSlug":"norethisterone"},{"url":"/drug/sildenafil","drug":"sildenafil","action":"Monitor closely","effect":"May interact with Sildenafil Citrate","source":"DrugCentral","drugSlug":"sildenafil"},{"url":"/drug/voriconazole","drug":"voriconazole","action":"Monitor closely","effect":"May interact with Voriconazole","source":"DrugCentral","drugSlug":"voriconazole"},{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Abnormal liver function","drugRate":"","severity":"common","organSystem":""},{"effect":"Marked decreases in hemoglobin (>15% decrease from baseline resulting in values <11 g/dL)","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Decline in sperm count of at least 50%","drugRate":"25%","severity":"common","organSystem":""}],"contraindications":["Anemia","Breastfeeding (mother)","Decompensated cardiac failure","Disease of liver","Drug-induced hepatitis","Edema","Hepatic failure","Hyperbilirubinemia","Liver function tests abnormal","Pregnancy, function","Pulmonary edema","Pulmonary veno-occlusive disease","Thrombocytopenic disorder"],"specialPopulations":{"Pregnancy":"Bosentan may cause fetal harm, including birth defects and fetal death, when administered to pregnant female and is contraindicated during pregnancy. There are limited data on bosentan use in pregnant women. In animal reproduction studies, oral administration of bosentan to pregnant rats at 2-times the maximum recommended human dose (MRHD) on mg/m2 basis caused teratogenic effects in rats, including malformations of the head, mouth, face, and large blood vessels. Advise pregnant women of the potential risk to fetus.","Geriatric use":"Clinical studies of bosentan tablets did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.","Paediatric use":"The efficacy of bosentan tablets in patients <18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with bosentan tablets. In this study, cardiopulmonary hemodynamic improvements were similar to those seen in adults treated with bosentan tablets. Safety in pediatric patients is supported by data from 100 pediatric patients treated with bosentan tablets for median of 17 months."},"seriousAdverseEvents":[{"effect":"Hepatotoxicity/Abnormal liver function (treatment discontinuation)","drugRate":"","severity":"serious"},{"effect":"Marked oligospermia","drugRate":"4.3%","severity":"serious"}]},"trials":[],"aliases":[],"company":"AstraZeneca","patents":[{"type":"Formulation","number":"8309126","applicant":"ACTELION PHARMACEUTICALS US INC","territory":"US","tradeName":"TRACLEER","expiryDate":"2026-05-15"},{"type":"Formulation","number":"7959945","applicant":"ACTELION PHARMACEUTICALS US INC","territory":"US","tradeName":"TRACLEER","expiryDate":"2027-12-28"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BOSENTAN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:42:51.160903+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:42:51.160504+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bosentan","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:42:58.601931+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:42:57.205461+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:42:51.182842+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:42:49.796465+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BOSENTAN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:42:57.982050+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:47.607076+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:47.607125+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:42:59.545930+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Endothelin receptor, ET-A/ET-B antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:58.601553+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL957/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:42:58.490676+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA207760","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:47.607135+00:00"}},"allNames":"tracleer","offLabel":[],"synonyms":["bosentan hydrate","bosentan monohydrate","stayveer","bosentan","actelion","tracleer","bosentan anhydrous"],"timeline":[{"date":"2001-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ACTELION PHARMS LTD to Actelion"},{"date":"2001-11-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Actelion Pharms Ltd)"},{"date":"2002-05-14","type":"positive","source":"DrugCentral","milestone":"EMA approval (Janssen-Cilag International N.V.)"},{"date":"2017-09-05","type":"positive","source":"FDA Orange Book","milestone":"Tracleer approved — 32MG"},{"date":"2019-04-26","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 8 manufacturers approved"}],"aiSummary":"Tracleer (bosentan) is a small molecule endothelin receptor antagonist developed by Actelion, targeting the endothelin-1 receptor to treat pulmonary arterial hypertension, pulmonary hypertension, and systemic sclerosis. It was FDA-approved in 2001 and is now off-patent with multiple generic manufacturers. Tracleer works by blocking the action of endothelin-1, a potent vasoconstrictor, to improve blood flow and reduce pressure in the lungs. As an off-patent medication, Tracleer is widely available in generic forms. Key safety considerations include potential liver enzyme elevations and teratogenic effects.","brandName":"Tracleer","ecosystem":[{"indication":"Pulmonary arterial hypertension","otherDrugs":[{"name":"ambrisentan","slug":"ambrisentan","company":"Gilead"},{"name":"epoprostenol","slug":"epoprostenol","company":"Glaxosmithkline Llc"},{"name":"iloprost","slug":"iloprost","company":"Actelion Pharms Ltd"},{"name":"macitentan","slug":"macitentan","company":"Actelion Pharms Ltd"}],"globalPrevalence":1280000000},{"indication":"Pulmonary hypertension","otherDrugs":[{"name":"epoprostenol","slug":"epoprostenol","company":"Glaxosmithkline Llc"},{"name":"nitric oxide","slug":"nitric-oxide","company":"Ino"},{"name":"tadalafil","slug":"tadalafil","company":"Lilly"}],"globalPrevalence":1280000000},{"indication":"Systemic sclerosis","otherDrugs":[{"name":"benzoic acid","slug":"benzoic-acid","company":""},{"name":"rituximab","slug":"rituximab","company":"Genentech"}],"globalPrevalence":136000000}],"mechanism":{"target":"Endothelin-1 receptor","novelty":"Follow-on","targets":[{"gene":"EDNRA","source":"DrugCentral","target":"Endothelin-1 receptor","protein":"Endothelin-1 receptor"},{"gene":"EDNRB","source":"DrugCentral","target":"Endothelin B receptor","protein":"Endothelin B receptor"},{"gene":"ABCB11","source":"DrugCentral","target":"Bile salt export pump","protein":"Bile salt export pump"},{"gene":"NR1I2","source":"DrugCentral","target":"Nuclear receptor subfamily 1 group I member 2","protein":"Nuclear receptor subfamily 1 group I member 2"}],"moaClass":"Cytochrome P450 2C9 Inducers","modality":"Small Molecule","drugClass":"Endothelin Receptor Antagonist","explanation":"","oneSentence":"","technicalDetail":"Tracleer (bosentan) is a non-selective endothelin receptor antagonist that binds to both ETA and ETB receptors, preventing the action of endothelin-1 and leading to vasodilation and reduced pulmonary vascular resistance."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Bosentan","title":"Bosentan","extract":"Bosentan, sold under the brand name Tracleer among others, is a dual endothelin receptor antagonist medication used in the treatment of pulmonary artery hypertension (PAH).","wiki_history":"==History==\nBosentan was studied in heart failure in a trial called REACH-1 that was terminated early in 1997, due to toxicity at the dose that was being studied.\n\nIt was approved for pulmonary artery hypertension in the US in November 2001, and in the European Union in May 2002.","wiki_society_and_culture":"== Society and culture ==\n=== Economics ===\nBy 2013, worldwide sales of bosentan were $1.57 billion. The patents on bosentan started expiring in 2015."},"commercial":{"launchDate":"2001","_launchSource":"DrugCentral (FDA 2001-11-20, ACTELION PHARMS LTD)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/392","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BOSENTAN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BOSENTAN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Bosentan","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T09:05:32.587478","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:43:00.462968+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ambrisentan","drugSlug":"ambrisentan","fdaApproval":"2007-06-15","patentExpiry":"Oct 14, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"macitentan","drugSlug":"macitentan","fdaApproval":"2013-10-18","patentExpiry":"Sep 11, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"riociguat","drugSlug":"riociguat","fdaApproval":"2013-10-08","patentExpiry":"Feb 18, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tadalafil","drugSlug":"tadalafil","fdaApproval":"2003-11-21","patentExpiry":"Dec 24, 2038","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"bosentan","indications":{"approved":[{"name":"Pulmonary arterial hypertension","source":"DrugCentral","snomedId":11399002,"regulator":"FDA","usPrevalence":119900000,"globalPrevalence":1280000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Pulmonary hypertension","source":"DrugCentral","snomedId":70995007,"regulator":"FDA","usPrevalence":119900000,"globalPrevalence":1280000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Systemic sclerosis","source":"DrugCentral","snomedId":89155008,"regulator":"FDA","usPrevalence":null,"globalPrevalence":136000000,"prevalenceMethod":"curated","prevalenceSource":"Rheumatology (Oxford), 2021 (PMID:33630060)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Actelion","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ambrisentan","brandName":"ambrisentan","genericName":"ambrisentan","approvalYear":"2007","relationship":"same-class"},{"drugId":"macitentan","brandName":"macitentan","genericName":"macitentan","approvalYear":"2013","relationship":"same-class"},{"drugId":"riociguat","brandName":"riociguat","genericName":"riociguat","approvalYear":"2013","relationship":"same-class"},{"drugId":"tadalafil","brandName":"tadalafil","genericName":"tadalafil","approvalYear":"2003","relationship":"same-class"}],"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,"completionDate":"2029-02-20"},{"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,"completionDate":"2025-12-31"},{"nctId":"NCT04388124","phase":"PHASE2","title":"Endothelin-1 Receptor Blockade in Resistant Hypertension","status":"RECRUITING","sponsor":"University Hospital, Rouen","startDate":"2021-10-20","conditions":["Resistant Hypertension"],"enrollment":24,"completionDate":"2026-08"},{"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,"completionDate":"2027-07-01"},{"nctId":"NCT03481881","phase":"","title":"Pharmacokinetics of Drugs Administered to Children","status":"RECRUITING","sponsor":"Duke University","startDate":"2013-08-14","conditions":["Pediatric ALL"],"enrollment":200,"completionDate":"2033-08-14"},{"nctId":"NCT00777985","phase":"PHASE2","title":"Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea","status":"COMPLETED","sponsor":"University Hospital, Grenoble","startDate":"2007-12","conditions":["Obstructive Sleep Apnea","Hypertension"],"enrollment":19,"completionDate":"2012-01"},{"nctId":"NCT05723874","phase":"PHASE1","title":"A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2023-03-06","conditions":["Healthy"],"enrollment":14,"completionDate":"2023-05-26"},{"nctId":"NCT07081932","phase":"PHASE1","title":"A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2025-08-26","conditions":["Healthy"],"enrollment":16,"completionDate":"2025-10-08"},{"nctId":"NCT07013149","phase":"","title":"The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension","status":"RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2025-08-20","conditions":["Pulmonary Arterial Hypertension","Pulmonary Arterial Hypertension (PAH)","Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)"],"enrollment":121,"completionDate":"2026-12-01"},{"nctId":"NCT05072106","phase":"PHASE1","title":"Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"PharmaMar","startDate":"2021-01-14","conditions":["Advanced Solid Tumor"],"enrollment":11,"completionDate":"2022-01-18"},{"nctId":"NCT01347216","phase":"","title":"COMPERA / COMPERA-KIDS","status":"RECRUITING","sponsor":"Technische Universität Dresden","startDate":"2007-07-01","conditions":["Pulmonary Arterial Hypertension (PAH)","Pulmonary Hypertension (PH)"],"enrollment":14000,"completionDate":"2026-12-31"},{"nctId":"NCT04158635","phase":"PHASE1","title":"Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2021-09-01","conditions":["Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Pancreatic Carcinoma"],"enrollment":21,"completionDate":"2026-01-27"},{"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,"completionDate":"2022-10-04"},{"nctId":"NCT06957002","phase":"PHASE2","title":"Bosentan in the Treatment of Giant Cell Arteritis","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2025-09","conditions":["Giant Cell Arteritis (GCA)"],"enrollment":40,"completionDate":"2029-09"},{"nctId":"NCT01338415","phase":"PHASE3","title":"FUTURE 3 Study Extension","status":"COMPLETED","sponsor":"Actelion","startDate":"2011-03-08","conditions":["Pulmonary Arterial Hypertension"],"enrollment":58,"completionDate":"2020-05-29"},{"nctId":"NCT04278404","phase":"","title":"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","status":"RECRUITING","sponsor":"Duke University","startDate":"2020-03-05","conditions":["Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome"],"enrollment":5000,"completionDate":"2027-09"},{"nctId":"NCT00319020","phase":"PHASE3","title":"Bosentan in Children With Pulmonary Arterial Hypertension Extension Study","status":"COMPLETED","sponsor":"Actelion","startDate":"2005-08-23","conditions":["Pulmonary Arterial Hypertension"],"enrollment":33,"completionDate":"2011-10-28"},{"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,"completionDate":"2010-07"},{"nctId":"NCT00631475","phase":"PHASE3","title":"Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who 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