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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/18 | Phase 1 | Not yet recruiting | |||
2025/03/27 | Phase 1 | Recruiting | |||
2025/02/07 | Phase 1 | Recruiting | |||
2025/01/27 | Phase 1 | Completed | |||
2024/12/09 | Phase 1 | Completed | |||
2024/11/22 | Phase 2 | Recruiting | |||
2024/11/07 | Phase 1 | Completed | |||
2024/10/03 | Phase 1 | Completed | |||
2024/09/19 | Phase 1 | Completed | |||
2024/09/19 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Concordia Pharmaceuticals Inc. | 59212-245 | ORAL | 0.1875 mg in 1 1 | 8/19/2020 | |
| Concordia Pharmaceuticals Inc. | 59212-249 | ORAL | 0.25 mg in 1 1 | 8/19/2020 | |
| Major Pharmaceuticals | 0904-5922 | ORAL | 250 ug in 1 1 | 12/10/2022 | |
| A-S Medication Solutions | 50090-5276 | ORAL | 125 ug in 1 1 | 5/15/2019 | |
| Atlantic Biologicals Corps | 17856-0057 | ORAL | 0.05 mg in 1 mL | 9/1/2009 | |
| Novitium Pharma LLC | 70954-201 | ORAL | 0.125 mg in 1 1 | 8/27/2022 | |
| Amneal Pharmaceuticals NY LLC | 69238-1991 | ORAL | 125 ug in 1 1 | 12/29/2023 | |
| Oliva Therapeutics, LLC | 82685-202 | ORAL | 250 ug in 1 1 | 6/26/2023 | |
| Marlex Pharmaceuticals, Inc. | 10135-748 | ORAL | 0.25 mg in 1 1 | 2/28/2023 | |
| A-S Medication Solutions | 50090-4432 | ORAL | 125 ug in 1 1 | 4/3/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LANOXIN PAEDIATRIC/GERIATRIC ELIXIR 0.05 mg/ml | SIN00544P | ELIXIR | 0.05 mg/ml | 4/29/1988 | |
| LANOXIN INJECTION 0.5 mg/2 ml | SIN00547P | INJECTION | 0.5 mg/2 ml | 4/29/1988 | |
| LANOXIN TABLET 0.25 mg | SIN01198P | TABLET | 0.25 mg | 5/13/1988 | |
| LANOXIN-PG PAEDIATRIC/GERIATRIC TABLET 0.0625 mg | SIN01203P | TABLET | 0.0625 mg | 5/13/1988 | |
| DIGOKERN TABLETS 0.25MG | SIN17078P | TABLET | 0.25mg | 9/10/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Digoxin Oral Solution | 国药准字H20050664 | 化学药品 | 口服溶液剂 | 7/21/2020 | |
| Digoxin Oral Solution | 国药准字H10970389 | 化学药品 | 口服溶液剂 | 12/4/2020 | |
| Digoxin Tablets | 国药准字H41022833 | 化学药品 | 片剂 | 5/18/2020 | |
| Digoxin Tablets | 国药准字H23020316 | 化学药品 | 片剂(素片) | 6/19/2020 | |
| Digoxin Tablets | 国药准字H50020121 | 化学药品 | 片剂 | 7/12/2020 | |
| Digoxin Tablets | 国药准字H51022119 | 化学药品 | 片剂 | 8/5/2020 | |
| Digoxin Tablets | 国药准字H20227049 | 化学药品 | 片剂 | 4/12/2022 | |
| Digoxin Tablets | 国药准字H11020053 | 化学药品 | 片剂 | 11/26/2020 | |
| Digoxin Tablets | 国药准字H37020332 | 化学药品 | 片剂 | 3/11/2020 | |
| Digoxin Tablets | 国药准字H31020678 | 化学药品 | 片剂 | 7/24/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LANOXIN digoxin 250 microgram tablet blister pack | 15333 | Medicine | A | 9/5/1991 | |
| SIGMAXIN digoxin 250microgram tablet blister pack | 90116 | Medicine | A | 7/29/2002 | |
| SIGMAXIN PG digoxin 62.5microgram tablet bottle | 90114 | Medicine | A | 7/29/2002 | |
| Lanoxin Adult 500mcg/2mL injection ampoule | 11106 | Medicine | A | 8/2/1991 | |
| LANOXIN PG digoxin 62.5microgram tablet bottle | 11108 | Medicine | A | 8/2/1991 | |
| LANOXIN digoxin 250 micrograms tablet bottle | 11109 | Medicine | A | 8/2/1991 | |
| LANOXIN PG digoxin 62.5 microgram tablet blister pack | 40661 | Medicine | A | 7/30/1992 | |
| Lanoxin Infants 50mcg/2mL injection ampoule | 11105 | Medicine | A | 8/2/1991 | |
| LANOXIN PAEDIATRIC Elixir | 42757 | Medicine | A | 12/22/1992 | |
| Lanoxin-PG (HK) | 337630 | Medicine | A | 6/10/2020 |