Overview
Digoxin is one of the oldest cardiovascular medications used today. It is a common agent used to manage atrial fibrillation and the symptoms of heart failure. Digoxin is classified as a cardiac glycoside and was initially approved by the FDA in 1954. This drug originates from the foxglove plant, also known as the Digitalis plant, studied by William Withering, an English physician and botanist in the 1780s. Prior to this, a Welsh family, historically referred to as the Physicians of Myddvai, formulated drugs from this plant. They were one of the first to prescribe cardiac glycosides, according to ancient literature dating as early as the 1250s.
Indication
Digoxin is indicated in the following conditions: 1) For the treatment of mild to moderate heart failure in adult patients. 2) To increase myocardial contraction in children diagnosed with heart failure. 3) To maintain control ventricular rate in adult patients diagnosed with chronic atrial fibrillation. In adults with heart failure, when it is clinically possible, digoxin should be administered in conjunction with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor for optimum effects.
Associated Conditions
- Myocardial contractility
- Ventricular Arrhythmia
- Mild to moderate heart failure
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/13 | Phase 1 | Completed | |||
2020/01/18 | Phase 1 | Completed | |||
2020/01/03 | Phase 2 | Withdrawn | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2019/12/20 | Phase 1 | Completed | |||
2019/10/28 | Phase 2 | Active, not recruiting | |||
2019/09/19 | Phase 1 | Completed | |||
2019/07/05 | Phase 1 | Completed | |||
2019/04/26 | Early Phase 1 | Completed | University Hospital, Basel, Switzerland | ||
2019/04/10 | Phase 1 | Completed | |||
2019/03/26 | Phase 1 | Active, not recruiting | Danae Hamouda, MD |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| DEPT HEALTH CENTRAL PHARMACY | 53808-0165 | ORAL | 125 ug in 1 1 | 11/30/2009 | |
| NuCare Pharmaceuticals, Inc. | 66267-443 | ORAL | 0.125 mg in 1 1 | 1/22/2020 | |
| Carilion Materials Management | 68151-1602 | ORAL | 125 ug in 1 1 | 2/23/2012 | |
| A-S Medication Solutions | 50090-0962 | ORAL | 250 ug in 1 1 | 2/13/2012 | |
| Sandoz Inc | 0781-3059 | INTRAMUSCULAR, INTRAVENOUS, PARENTERAL | 250 ug in 1 mL | 10/9/2018 | |
| Rebel Distributors Corp | 21695-678 | ORAL | 0.125 mg in 1 1 | 10/1/2010 | |
| Carilion Materials Management | 68151-1603 | ORAL | 250 ug in 1 1 | 2/23/2012 | |
| Hikma Pharmaceuticals USA Inc. | 0143-1241 | ORAL | 250 ug in 1 1 | 8/30/2023 | |
| American Health Packaging | 60687-551 | ORAL | 250 ug in 1 1 | 10/4/2023 | |
| VistaPharm, LLC | 66689-327 | ORAL | 0.05 mg in 1 mL | 11/29/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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