Data updated: May 26, 2026
LANOXIN PEDIATRIC (digoxin)
Cardiovascular
Approved 1954-11-16
LANOXIN PEDIATRIC is indicated for the treatment of Heart Failure; Atrial Fibrillation.
Source: FDA Label • AZURITY
1
Indication
--
Phase 3 Trials
1
Priority Reviews
71
Years on Market
Details
- Status
- Prescription
- First Approved
- 1954-11-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LANOXIN PEDIATRIC Approval History
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Original
New Indication
New Form
Label Update
18 FDA actions from 1954 to 2025
Jul 1998 SUPPL
Label
Jun 1996 SUPPL
Label
Aug 1995 SUPPL
Label
Aug 1993 SUPPL
Mfg
May 1992 SUPPL
Label
Sep 1991 SUPPL
Mfg
Nov 1954 ORIGINAL Priority
New Drug
What LANOXIN PEDIATRIC Treats
2 indicationsLANOXIN PEDIATRIC is approved for 2 conditions since its original approval in 1954. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heart Failure
- Atrial Fibrillation
Source: FDA Label
LANOXIN PEDIATRIC Competitive Set
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What's emerging in LANOXIN PEDIATRIC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LANOXIN PEDIATRIC treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
127 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07570082 | CRN04894-131 | Ph 1 | recruiting | Drug-Drug Interaction Study of Atumelnant in Healthy Participants |
| NCT07567781 | M25-744 | Ph 1 | recruiting | A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. |
| NCT03783429 DECISION | DECISION trial | Ph 4 | completed | Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands |
| NCT02783040 results posted | 1346.22 2015-001371-41 | Ph 1 | completed | Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin |
| NCT07502001 | HDM1005-104 | Ph 1 | not yet recruiting | Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin |
| NCT07223671 | CA127-1088 | Ph 1 | completed | Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants |
| NCT06899061 | D9723C00002 2024-513692-41-00 | Ph 1 | active not recruiting | Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib |
| NCT07066722 | 219890 | Ph 1 | completed | A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults |
| NCT07118215 | CN012-0013 | Ph 1 | recruiting | A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin |
| NCT06701812 | MCC-23221 | Ph 2 | recruiting | Digoxin Medulloblastoma Study |
| NCT06575933 | 1084-009 CA43815, MK-1084-009 | Ph 1 | completed | A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) |
| NCT07321509 DIG-DICA | 16824 | Ph 4 | recruiting | Digoxin After Acute Heart Failure |
| NCT07215260 | 1509-0014 2025-520656-29-00, U1111-1317-7517 | Ph 1 | completed | A Study in Healthy People to Test Whether BI 3000202 Affects How 2 Other Medicines (Rosuvastatin and Digoxin) Are Taken up in the Body |
| NCT05444556 results posted | 18413 J2J-MC-JZLI | Ph 1 | completed | A Study of Imlunestrant (LY3484356) in Female Healthy Participants |
| NCT06588699 CODIN | 2000038275 1R01DK134624-01A1 | Ph 2 | recruiting | Digoxin In NASH (CODIN) |
| NCT07047209 ACACIA | 2025P001103 | Ph 2 | active not recruiting | Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS) |
| NCT03889795 | C3 | Ph 1 | active not recruiting | Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors |
| NCT06813924 | NN7535-7976 U1111-1309-3456 | Ph 1 | completed | A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants |
| NCT04141995 | 0668-19-FB 1P50CA127297-01A2 | Ph 2 | terminated | FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer |
| NCT07025850 | Dynamic | Ph 1, Ph 2 | not yet recruiting | Efficacy Study of Digoxin Combined With Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer |
| NCT04972396 | ALT-801-103 Pemvidutide, ALT-801 | Ph 1 | completed | Pemvidutide (ALT-801) DDI Study in Healthy Volunteers |
| NCT06723691 | HRS9531-107 | Ph 1 | completed | Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects |
| NCT01598363 | 402-C-1104 | Ph 1 | completed | An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Volunteers |
| NCT06335134 | SCW0502-1016 | Ph 1 | completed | A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin |
| NCT01162135 results posted | 10G.87 2009-43, JT 1532 | Ph 2 | completed | Digoxin for Recurrent Prostate Cancer |
| NCT06793943 | TAK-279-1011 | Ph 1 | completed | A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults |
| NCT05598281 | 20190315 | Ph 1 | completed | Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants |
| NCT05828303 | CA127-1027 | Ph 1 | withdrawn | A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors |
| NCT04206488 | CR108712 70033093THR1001, 2019-003783-46 | Ph 1 | completed | A Study of JNJ-70033093 and Digoxin in Healthy Participants |
| NCT06194214 results posted | LOXO-BTK-20021 J2N-OX-JZNT | Ph 1 | completed | A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants |
| NCT06416800 | INCB54707-110 | Ph 1 | completed | A Study to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants |
| NCT02888327 | AL-794-802 | Ph 1 | completed | A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872 |
| NCT06503679 | 27110 J5C-MC-FOAF, DC-853104 | Ph 1 | completed | A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants |
| NCT06677957 | GP45712 | Ph 1 | completed | A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants |
| NCT06597760 | 0616-031 MK-0616-031, CA41814 | Ph 1 | completed | A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) |
| NCT04094519 | 9785-CL-0018 | Ph 1 | completed | A Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer |
| NCT05738291 | 1490-0002 2022-003161-38 | Ph 1 | completed | A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood |
| NCT06111521 | LOXO-RAS-23007 J3M-OX-JZQJ | Ph 1 | completed | A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants |
| NCT05526911 results posted | TBAJ-876-CL002 | Ph 1 | completed | A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults |
| NCT06625827 | 1026-012 MK-1026-012 | Ph 1 | completed | A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012) |
| NCT06601517 | HDM1002-106 | Ph 1 | not yet recruiting | A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects. |
| NCT03433833 | 2019-0064 | Ph 1 | withdrawn | Digoxin for Congenital Erythrocytosis Due to Up-Regulated Hypoxia Sensing |
| NCT06546215 | BTINT024-BE-01 | Ph 1 | completed | Bioequivalence Study of Digoxin Tablet in Healthy Subjects |
| NCT05694221 | YN011-D01 | Ph 1 | completed | Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin |
| NCT06293742 | EC0007 | Ph 1 | completed | ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants |
| NCT06186622 | 18631 J2A-MC-GZPG | Ph 1 | completed | A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants |
| NCT03559868 results posted | 2000025289 1U01AA026962-01 | Ph 1 | completed | Inhibition of Sterile Inflammation by Digoxin |
| NCT04887194 | 516-010 | Ph 1 | completed | PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates |
| NCT05541471 | VX21-548-010 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin |
| NCT05954624 | ZSP1273-23-13 | Ph 1 | completed | Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid |
Showing 50 of 127 trials
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LANOXIN PEDIATRIC FDA Label Details
Indications & Usage
FDA Label (PDF)LANOXIN PEDIATRIC is indicated for the treatment of Heart Failure; Atrial Fibrillation.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.