{"id":"dronedarone-hydrochloride-tablets","safety":{"boxedWarning":"Dronedarone is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with recent decompensation requiring hospitalization because it doubles the risk of death.","commonSideEffects":["Diarrhea","Nausea","Abdominal pain","Vomiting","Asthenia"],"contraindications":["NYHA Class IV heart failure or decompensated heart failure","Permanent atrial fibrillation","Severe hepatic impairment","Concomitant use of strong CYP3A inhibitors or drugs that prolong QT interval"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"Multiple cardiac ion channels (potassium, sodium, calcium channels)","explanation":"Dronedarone is a multichannel blocker that inhibits potassium currents (IKr, IKs, IKur, IKAch), sodium channels, L-type calcium channels, and has non-competitive beta-adrenergic blocking properties. These actions prolong cardiac action potential duration and refractory period, helping to maintain normal sinus rhythm.","oneSentence":"Dronedarone blocks multiple cardiac ion channels including potassium, sodium, and calcium channels, and has antiadrenergic properties."},"_scrapedAt":"2026-03-28T04:36:24.219Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123440,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"Amiodarone","brand":"Cordarone","company":null,"rationale":"Class III antiarrhythmic for atrial fibrillation maintenance"},{"name":"Sotalol","brand":"Betapace","company":null,"rationale":"Beta-blocker with Class III antiarrhythmic properties"},{"name":"Flecainide","brand":"Tambocor","company":null,"rationale":"Class IC antiarrhythmic for rhythm control in atrial fibrillation"}],"description":"Dronedarone hydrochloride is an antiarrhythmic medication used to maintain normal heart rhythm in patients with atrial fibrillation or atrial flutter. It is a benzofuran derivative that blocks multiple ion channels in cardiac tissue. This formulation is being developed by Shandong New Time Pharmaceutical Co., LTD.","indications":{"approved":[{"status":"investigational","condition":"Atrial fibrillation","patientPopulation":"Adult patients to reduce cardiovascular hospitalization"},{"status":"investigational","condition":"Atrial flutter","patientPopulation":"Adult patients with paroxysmal or persistent arrhythmia"}]},"trialDetails":[{"nctId":"NCT07396506","phase":"NA","title":"Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions","status":"COMPLETED","sponsor":"Shandong New Time Pharmaceutical Co., LTD","startDate":"2023-06-05","conditions":"Atrial Fibrillation (AF)","enrollment":51},{"nctId":"NCT07396519","phase":"NA","title":"Bioequivalence Study of Dronedarone Hydrochloride Tablets","status":"COMPLETED","sponsor":"Shandong New Time Pharmaceutical Co., LTD","startDate":"2022-11-14","conditions":"Atrial Fibrillation (AF)","enrollment":48}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_1","status":"active","brandName":"Dronedarone Hydrochloride Tablets","genericName":"Dronedarone Hydrochloride Tablets","companyName":"Shandong New Time Pharmaceutical Co., LTD","companyId":"shandong-new-time-pharmaceutical-co-ltd","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}