{"id":"riociguat-oral-product","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL2107834","moleculeType":"Small molecule","molecularWeight":"422.42"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Riociguat directly activates soluble guanylate cyclase (sGC) in vascular smooth muscle cells, leading to increased production of cyclic GMP (cGMP). This elevation in cGMP causes smooth muscle relaxation and vasodilation, reducing pulmonary vascular resistance and improving hemodynamics in pulmonary hypertension. The drug works independently of nitric oxide availability, making it effective even in patients with impaired endothelial function.","oneSentence":"Riociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP levels to promote vasodilation and reduce pulmonary vascular resistance.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:05:10.717Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Pulmonary arterial hypertension (PAH)"},{"name":"Chronic thromboembolic pulmonary hypertension (CTEPH)"}]},"trialDetails":[{"nctId":"NCT03409588","phase":"PHASE2","title":"Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2018-06-13","conditions":"Chronic Thromboembolic Disease (CTED), Exercise Intolerance Post PEA Surgery","enrollment":10},{"nctId":"NCT05762146","phase":"PHASE2","title":"Networked Drug REpurposing for Mechanism-based neuroPrOtection in Acute Ischaemic STROKE","status":"UNKNOWN","sponsor":"Maastricht University","startDate":"2022-09-05","conditions":"Ischemic Stroke, Acute","enrollment":28},{"nctId":"NCT04600492","phase":"PHASE2","title":"THERAPY-HYBRID-BPA Trial","status":"UNKNOWN","sponsor":"National Hospital Organization Okayama Medical Center","startDate":"2020-10-16","conditions":"Hypertension, Pulmonary","enrollment":72},{"nctId":"NCT04366622","phase":"PHASE1","title":"Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-04-14","conditions":"Clinical Pharmacology","enrollment":32},{"nctId":"NCT04364464","phase":"PHASE1","title":"Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-02-19","conditions":"Clinical Pharmacology","enrollment":40},{"nctId":"NCT03809156","phase":"PHASE4","title":"Upfront Combination Pulmonary Arterial Hypertension Therapy","status":"UNKNOWN","sponsor":"University of Calgary","startDate":"2016-04-26","conditions":"Pulmonary Hypertension","enrollment":20},{"nctId":"NCT02556268","phase":"PHASE1","title":"Interaction With HIV Antiretroviral Agents","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-02-23","conditions":"HIV-DDI","enrollment":40},{"nctId":"NCT02024386","phase":"PHASE4","title":"Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude","status":"COMPLETED","sponsor":"Richard Moon","startDate":"2014-01","conditions":"Hypertension, Pulmonary, Altitude Sickness","enrollment":28},{"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":"NCT02625558","phase":"PHASE4","title":"Riociguat for Sarcoidosis Associated Pulmonary Hypertension","status":"UNKNOWN","sponsor":"University of Cincinnati","startDate":"2015-04","conditions":"Sarcoidosis","enrollment":60},{"nctId":"NCT02159326","phase":"PHASE1","title":"Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women","status":"COMPLETED","sponsor":"Bayer","startDate":"2014-06","conditions":"Drug Interactions","enrollment":31}],"_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":["Ambrisentan Oral Product"],"phase":"marketed","status":"active","brandName":"Riociguat Oral Product","genericName":"Riociguat Oral Product","companyName":"University of Calgary","companyId":"university-of-calgary","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Riociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP levels to promote vasodilation and reduce pulmonary vascular resistance. Used for Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTEPH).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}