{"id":"digoxin-0-25mg","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Arrhythmias (including ventricular ectopy and atrial fibrillation)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Visual disturbances"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Digoxin toxicity (at supratherapeutic levels)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Digoxin binds to and inhibits the sodium-potassium pump (Na+/K+-ATPase) on cardiac myocyte membranes, leading to increased intracellular sodium and reduced activity of the Na+/Ca2+ exchanger. This results in increased intracellular calcium availability, which strengthens cardiac muscle contraction (positive inotropic effect). Additionally, digoxin enhances vagal tone and directly slows conduction through the atrioventricular node, reducing heart rate and providing antiarrhythmic effects.","oneSentence":"Digoxin inhibits the Na+/K+-ATPase pump, increasing intracellular calcium and enhancing cardiac contractility while slowing atrioventricular node conduction.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:09:30.123Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Heart failure with reduced ejection fraction"},{"name":"Atrial fibrillation with rapid ventricular response"}]},"trialDetails":[{"nctId":"NCT03016819","phase":"PHASE3","title":"Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)","status":"RECRUITING","sponsor":"Advenchen Laboratories, LLC","startDate":"2017-08-15","conditions":"Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma","enrollment":325},{"nctId":"NCT07362030","phase":"PHASE1","title":"Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin","status":"ACTIVE_NOT_RECRUITING","sponsor":"Guangdong Raynovent Biotech Co., Ltd","startDate":"2025-04-14","conditions":"Obesity","enrollment":32},{"nctId":"NCT07128888","phase":"PHASE1","title":"Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection","status":"RECRUITING","sponsor":"Gan & Lee Pharmaceuticals.","startDate":"2025-11-17","conditions":"Obesity or Overweight","enrollment":60},{"nctId":"NCT05064488","phase":"PHASE1","title":"Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2021-10-04","conditions":"Healthy","enrollment":40},{"nctId":"NCT05391893","phase":"PHASE4","title":"Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation","status":"COMPLETED","sponsor":"Corewell Health South","startDate":"2020-06-19","conditions":"Atrial Fibrillation, Atrial Flutter","enrollment":444},{"nctId":"NCT06597760","phase":"PHASE1","title":"A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-10-07","conditions":"Healthy","enrollment":24},{"nctId":"NCT05357911","phase":"PHASE1","title":"A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin","status":"COMPLETED","sponsor":"Nuvation Bio Inc.","startDate":"2021-07-13","conditions":"Solid Tumor","enrollment":16},{"nctId":"NCT06546215","phase":"PHASE1","title":"Bioequivalence Study of Digoxin Tablet in Healthy Subjects","status":"COMPLETED","sponsor":"Xiangya Hospital of Central South University","startDate":"2020-07-05","conditions":"Heart Failure","enrollment":80},{"nctId":"NCT05789342","phase":"PHASE1","title":"A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers","status":"COMPLETED","sponsor":"Jiangxi Qingfeng Pharmaceutical Co. Ltd.","startDate":"2023-02-15","conditions":"Healthy Volunteers","enrollment":54},{"nctId":"NCT04322552","phase":"PHASE1","title":"A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects","status":"COMPLETED","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2020-03-12","conditions":"Advanced Solid Tumor","enrollment":18},{"nctId":"NCT03718273","phase":"PHASE3","title":"IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).","status":"COMPLETED","sponsor":"Adolfo Fontenla","startDate":"2018-10-19","conditions":"Atrial Fibrillation, Heart Diseases","enrollment":68},{"nctId":"NCT05540600","phase":"PHASE3","title":"Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker","status":"UNKNOWN","sponsor":"University of Monastir","startDate":"2022-09-12","conditions":"Atrial Fibrillation, Left Atrial Rhythm","enrollment":30},{"nctId":"NCT04044001","phase":"PHASE1, PHASE2","title":"BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)","status":"COMPLETED","sponsor":"Michael Hoelscher","startDate":"2019-11-15","conditions":"Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis","enrollment":77},{"nctId":"NCT00911508","phase":"NA","title":"Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2009-11-13","conditions":"Atrial Fibrillation, Arrhythmia","enrollment":2204},{"nctId":"NCT03363815","phase":"PHASE1","title":"A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Celgene","startDate":"2017-12-04","conditions":"Heathy Volunteer","enrollment":56},{"nctId":"NCT01583036","phase":"PHASE1","title":"An Open-label, Single-centre Study Evaluating the Pharmacokinetics of Digoxin Alone and When Administered at Various Doses of Ezogabine/Retigabine in Healthy Adults. The Pharmacokinetics of Ezogabine/Retigabine and the N-acetyl Metabolite of Ezogabine/Retigabine (NAMR) Will Also be Assessed","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-01-16","conditions":"Epilepsy","enrollment":30},{"nctId":"NCT02138292","phase":"PHASE1","title":"A Phase 1B Clinical Trial of Trametinib Plus Digoxin in Patients With Unresectable or Metastatic BRAF Wild-type Melanoma","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2014-07","conditions":"Melanoma","enrollment":27},{"nctId":"NCT01561781","phase":"PHASE1","title":"Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib","status":"COMPLETED","sponsor":"Sanofi","startDate":"2012-03","conditions":"Healthy Volunteers","enrollment":14},{"nctId":"NCT02489786","phase":"PHASE4","title":"A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital","status":"COMPLETED","sponsor":"Cairo University","startDate":"2012-10","conditions":"Atrial Fibrillation","enrollment":71},{"nctId":"NCT01357811","phase":"PHASE1","title":"A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2011-08","conditions":"Healthy Volunteer","enrollment":28},{"nctId":"NCT01355354","phase":"PHASE1","title":"Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-06","conditions":"Healthy Volunteers, Rheumatoid Arthritis","enrollment":21}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"INCORRECT DOSE ADMINISTERED"},{"count":1,"reaction":"ARRHYTHMIA"},{"count":1,"reaction":"ASTHENIA"},{"count":1,"reaction":"BLISTER"},{"count":1,"reaction":"BRADYCARDIA"},{"count":1,"reaction":"CARDIOACTIVE DRUG LEVEL INCREASED"},{"count":1,"reaction":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE"},{"count":1,"reaction":"CONDITION AGGRAVATED"},{"count":1,"reaction":"DEATH"},{"count":1,"reaction":"DISEASE COMPLICATION"}],"_approvalHistory":[],"publicationCount":4,"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_3","status":"active","brandName":"Digoxin (0.25mg)","genericName":"Digoxin (0.25mg)","companyName":"Advenchen Laboratories, LLC","companyId":"advenchen-laboratories-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Digoxin (0.25mg) is a small molecule that inhibits the sodium/potassium-transporting ATPase, a mechanism that is consistent with its classification as an inhibitor. Digoxin is being studied in various clinical trials, including a phase I drug-drug interaction study, but its primary indications are not specified in the provided facts.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}