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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/12 | Not Applicable | Not yet recruiting | Karuna Therapeutics | ||
2025/07/02 | Not Applicable | Recruiting | |||
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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PMS-DIGOXIN | 02335700 | Tablet - Oral | 0.0625 MG | 12/23/2009 | |
| AURO-DIGOXIN | auro pharma inc | 02554399 | Tablet - Oral | 0.0625 MG | N/A |
| PEDIATRIC DIGOXIN INJECTION C.S.D. | 02048272 | Liquid - Intravenous
,
Intramuscular | 0.05 MG / 1 ML | 12/31/1994 | |
| LANOXIN ELX 0.05MG/ML PEDIATRIC | glaxo wellcome inc. | 00242713 | Liquid - Oral | .05 MG / ML | 12/31/1956 |
| PMS-DIGOXIN | 02518414 | Tablet - Oral | 0.125 MG | N/A | |
| LANOXIN TAB 0.125MG | glaxo wellcome inc. | 00035319 | Tablet - Oral | .125 MG | 12/31/1971 |
| LANOXIN TAB 0.0625MG | glaxo wellcome inc. | 00731269 | Tablet - Oral | .0625 MG | 12/31/1987 |
| APO-DIGOXIN | 02281236 | Tablet - Oral | 0.0625 MG | 6/22/2006 | |
| DIGOXIN INJECTION C.S.D. | 02048264 | Liquid - Intramuscular
,
Intravenous | 0.5 MG / 2 ML | 12/31/1994 | |
| PMS-DIGOXIN | 02518392 | Solution - Oral | 0.05 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| DIGOXINA KERN PHARMA 0,25 mg COMPRIMIDOS | 34566 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| DIGOXINA KERN PHARMA 0,25 mg/ml SOLUCION INYECTABLE | 34753 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LANACORDIN PEDIATRICO | 34755 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| DIGOXINA TEOFARMA 0,25 mg COMPRIMIDOS | Teofarma S.R.L. | 23850 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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