{"id":"bay60-4552-plus-vardenafil","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Flushing"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Hypotension"}]},"_chembl":{"chemblId":"CHEMBL5715931","moleculeType":null,"molecularWeight":"579.12"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"BAY60-4552 is a soluble guanylate cyclase activator that directly stimulates the enzyme to produce cyclic GMP (cGMP), a key signaling molecule in vascular smooth muscle relaxation. Vardenafil is a phosphodiesterase-5 (PDE-5) inhibitor that prevents the breakdown of cGMP. Together, this combination provides dual pathway enhancement of cGMP signaling, potentially offering greater efficacy than either agent alone in conditions characterized by impaired nitric oxide-cGMP signaling.","oneSentence":"BAY60-4552 activates soluble guanylate cyclase to increase cGMP levels, while vardenafil inhibits phosphodiesterase-5 to prevent cGMP degradation, synergistically enhancing vasodilation and improving erectile function.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:57:51.360Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Erectile dysfunction"},{"name":"Pulmonary hypertension"}]},"trialDetails":[{"nctId":"NCT01168817","phase":"PHASE2","title":"Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-08","conditions":"Erectile Dysfunction","enrollment":140},{"nctId":"NCT01110590","phase":"PHASE1","title":"Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-01","conditions":"Erectile Dysfunction","enrollment":37}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"BAY60-4552 plus Vardenafil","genericName":"BAY60-4552 plus Vardenafil","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BAY60-4552 activates soluble guanylate cyclase to increase cGMP levels, while vardenafil inhibits phosphodiesterase-5 to prevent cGMP degradation, synergistically enhancing vasodilation and improving erectile function. Used for Erectile dysfunction, Pulmonary hypertension.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}