{"id":"bidil-xr","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":["Concomitant use with phosphodiesterase inhibitors may cause severe hypotension","Use with other vasodilators or antihypertensives may increase the risk of hypotension"],"commonSideEffects":[{"effect":"Headache","drugRate":"29%","severity":"Moderate"},{"effect":"Dizziness","drugRate":"18%","severity":"Mild to Moderate"},{"effect":"Nausea","drugRate":"14%","severity":"Mild"},{"effect":"Hypotension","drugRate":"12%","severity":"Moderate"},{"effect":"Flushing","drugRate":"10%","severity":"Mild"}],"contraindications":["Hypersensitivity to isosorbide dinitrate or hydralazine"],"specialPopulations":{"Elderly":"Start at lower doses and titrate slowly","Renal Impairment":"Use with caution; monitor for hypotension","Hepatic Impairment":"Use with caution; monitor for adverse effects"}},"trials":[],"_chembl":{"chemblId":"CHEMBL258896","moleculeType":"Small molecule","molecularWeight":"549.67"},"aliases":["BiDil capsules, hydralazine HCl + isosorbide dinitrate"],"patents":[{"number":"US7846445B2","expiration":"2025-12-31"},{"number":"US8273381B2","expiration":"2027-06-30"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-06-19","unitCost":"$4.3842/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$1,600","description":"BIDIL 20 MG-37.5 MG TABLET","retrievedDate":"2026-04-07"}],"offLabel":[],"timeline":[{"date":"2005-06-23","type":"Approval","milestone":"FDA approval for heart failure in self-identified Black patients","regulator":"FDA"},{"date":"2023-01-01","type":"Launch","milestone":"Extended-release formulation launched","regulator":"FDA"}],"_dailymed":null,"aiSummary":"BiDil XR is a small molecule medication used to treat heart failure. It is available in extended-release and immediate-release formulations, with the extended-release formulation being studied in a pharmacodynamic and pharmacokinetic study.","ecosystem":[],"mechanism":{"target":"Vasculature and cardiac function","novelty":"Combination therapy for a specific patient population","modality":"Oral extended-release tablets","drugClass":"Vasodilators","explanation":"Isosorbide dinitrate is a nitrate that dilates blood vessels, reducing the heart's workload, while hydralazine is a direct-acting vasodilator that relaxes vascular smooth muscle, further lowering blood pressure.","oneSentence":"BiDil XR combines isosorbide dinitrate and hydralazine to enhance vasodilation and reduce cardiac workload, specifically benefiting patients with heart failure.","technicalDetail":"The combination of these two agents results in a synergistic effect, improving cardiac output and reducing afterload, which is particularly beneficial in heart failure patients."},"_scrapedAt":"2026-03-27T23:40:28.399Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not disclosed","launchDate":"2005","annualCostUS":"$3,000 - $4,000","currentRevenue":"Not disclosed","patientPopulation":"Patients with heart failure who are self-identified as Black","peakSalesEstimate":"Not disclosed"},"references":[],"biosimilars":[],"competitors":["Entresto (sacubitril/valsartan)","Carvedilol","Enalapril"],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":["Heart failure in patients who are self-identified as Black"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02522208","phase":"PHASE1","title":"Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets","status":"COMPLETED","sponsor":"Arbor Pharmaceuticals, Inc.","startDate":"2015-09","conditions":"Heart Failure","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":["Teva Pharmaceutical Industries Ltd.","Mylan N.V."],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":2,"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"BiDil XR","genericName":"BiDil XR","companyName":"Arbor Pharmaceuticals, Inc.","companyId":"arbor-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"2005","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}