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.
Background
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 |
|---|---|---|---|---|---|
2017/12/06 | Phase 1 | Completed | |||
2017/10/11 | Phase 1 | Completed | |||
2017/08/25 | Early Phase 1 | Completed | |||
2017/06/23 | Phase 1 | Completed | Theracos | ||
2017/05/02 | Phase 4 | Completed | |||
2017/05/02 | Phase 1 | Completed | |||
2017/04/27 | Phase 1 | Completed | |||
2017/04/13 | Phase 1 | Terminated | |||
2017/02/03 | Phase 1 | Completed | |||
2016/09/27 | Phase 1 | Withdrawn |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Northwind Pharmaceuticals | 51655-000 | oral | 0.25 mg in 30 1 | 5/20/2014 | |
| American Health Packaging | 60687-540 | ORAL | 125 ug in 1 1 | 10/4/2023 | |
| Major Pharmaceuticals | 0904-5921 | ORAL | 125 ug in 1 1 | 12/10/2022 | |
| Bryant Ranch Prepack | 71335-9610 | ORAL | 125 ug in 1 1 | 1/3/2023 | |
| Amneal Pharmaceuticals of New York LLC | 0115-9822 | ORAL | 250 ug in 1 1 | 6/1/2019 | |
| Covis Pharma US, Inc | 70515-262 | INTRAMUSCULAR, INTRAVENOUS | 100 ug in 1 mL | 10/17/2019 |
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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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||