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Drug

Digoxin

Established medicine
ClassSodium/potassium-transporting ATPase inhibitorResearchOngoing clinical research
Also known as Cardoxin, Digitek, Digossina, Lanoxicaps+5 more

Cardoxin, Digitek, Digossina, Lanoxicaps, Lanoxin, Digox, Digoxina, Digoxine, Digoxinum.

RxNorm3407ChEMBLCHEMBL1751ATCC01AA05UNII73K4184T59
2
Research papers
12
Active clinical trials
8
Protein targets
8
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in Healthy Participants

Clinical trial2026-08-19Status changed to Completed · ClinicalTrials.gov

Label change: DIGOXIN (ANDA040481)

Regulatory2026-08-10FDA

A Phase 2a Biomarker-Driven Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS) - The Acacia Trial, an ALS MyMatch Trial

Clinical trial2026-07-30Status changed to Completed · ClinicalTrials.gov

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

Clinical trial2026-07-22Status changed to Completed · ClinicalTrials.gov

A Phase 1 Study to Evaluate the Effect of Multiple Doses of ABBV-722 on the Pharmacokinetics of Cocktail Probe Substrates of CYP3A and Select Transporters in Healthy Adult Subjects

Clinical trial2026-07-20Status changed to Active, not recruiting · ClinicalTrials.gov

Evaluation of Digoxin for Relapsed Non-WNT, Non-SHH Medulloblastoma

Clinical trial2026-07-07Results expected Q1 2027 · ClinicalTrials.gov

Evaluation of Digoxin Therapy in Patients With Heart Failure After Acute Decompensation

Clinical trial2026-06-02Results expected Q4 2027 · ClinicalTrials.gov

Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review.

Research2024-01-25Drug safety

Label change: DIGOXIN (ANDA040481)

Regulatory2020-07-16FDA

Label change: DIGOXIN (ANDA040481)

Regulatory2020-07-16FDA

Label change: DIGOXIN (ANDA040481)

Regulatory2016-11-02FDA

Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial.

Research2002-12-01JAMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Digoxin
Aliases & brands
CardoxinDigitekDigossinaLanoxicapsLanoxinDigoxDigoxinaDigoxineDigoxinum
RxNorm CUI
3407
ChEMBL ID
CHEMBL1751
ATC codes
C01AA05
UNII
73K4184T59
Primary mechanism
Sodium/potassium-transporting ATPase inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

8 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium/potassium-transporting ATPase subunit alpha-1
ATP1A1 · P05023
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit beta-2
ATP1B2 · P14415
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit beta-1
ATP1B1 · P05026
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit alpha-2
ATP1A2 · P50993
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit beta-3
ATP1B3 · P54709
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit alpha-3
ATP1A3 · P13637
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit alpha-4
ATP1A4 · Q13733
INHIBITORSodium/potassium-transporting ATPase inhibitor
Sodium/potassium-transporting ATPase subunit gamma
FXYD2 · P54710
INHIBITORSodium/potassium-transporting ATPase inhibitor

Regulatory timeline

8 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2003-08-21
Latest approval
2003-08-21
Authorities
FDA
Total events
8
fdaU.S. Food and Drug Administration· 8 events
2026-08-10Label change
Label change: DIGOXIN (ANDA040481)
Evidence ↗
2020-07-16Label change
Label change: DIGOXIN (ANDA040481)
Evidence ↗
2020-07-16Label change
Label change: DIGOXIN (ANDA040481)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

173 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
173
registered trials across all phases
LATEST COMPLETION 2026
12
Active studies
8
Recruiting
23
Late-stage (III+)
146
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 173
Early Phase 12Phase 1132Phase 1 / 23Phase 213Phase 38Phase 49Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Evaluation of Digoxin Therapy in Patients With Heart Failure After Acute Decompensation

RecruitingPH IVHospital General de Agudos "Dr. Cosme Argerich"n=1202028

Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands

CompletedPH IVUniversity Medical Center Groningenn=9822025

Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota

CompletedPH IVUniversity of Washingtonn=222025

Evaluating Different Rate Control Therapies in Permanent Atrial Fibrillation: A Prospective, Randomised, Open-label, Blinded Endpoint Feasibility Pilot Comparing Digoxin and Beta-blockers as Initial Rate Control Therapy

CompletedPH IVUniversity of Birminghamn=1612019

Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial

CompletedPH IVUniversity of California, San Franciscon=1782018

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in Healthy Participants

CompletedPH ICrinetics Pharmaceuticals Inc.n=462026

A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

CompletedPH IKaruna Therapeutics, Inc., a Bristol Myers Squibb companyn=622026

A Phase 2a Biomarker-Driven Trial of Oral Digoxin in Individuals With Amyotrophic Lateral Sclerosis (ALS) - The Acacia Trial, an ALS MyMatch Trial

CompletedPH IIMassachusetts General Hospitaln=412026

Phase 1, 2-Cohort, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of Repotrectinib on the Pharmacokinetics of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

CompletedPH IBristol-Myers Squibbn=302026

An Open, Fixed-sequence, Self-controlled Pharmacokinetic Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects

CompletedPH IShandong Suncadia Medicine Co., Ltd.n=402026

A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Multi-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PROT-001, the Effect of Food and Age on the Pharmacokinetics of PROT-001, and the Effect of PROT-001 on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Adult Participants.

CompletedPH IProtego Biopharma Pty Ltdn=1022025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022024
Major research themes5
Cardiac Pacing, Artificial1Defibrillators, Implantable1Drug Interactions1Glucagon-Like Peptide 11Pacemaker, Artificial1
Journals, researchers & institutions
Top journals
  • Drug safety1
  • JAMA1
Leading researchers
  • Calvarysky B1
  • Cohen TD1
  • Cook JR1
  • Dotan I1
  • Epstein AE1
  • Greene HL1
  • Hallstrom AP1
  • Hsia H1
Leading institutions
free-text, unnormalised
  • Institute of Endocrinology1
  • Institute of Hematology1
  • Rabin Medical Center1
  • Tel Aviv Medical Center1
  • Tel Aviv University1
  • The Cleveland Clinic Foundation1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Warfarin

Studied across 4 of the same disease areas as Digoxin in the shared literature.

4 shared diseases2 shared papers
Amiodarone

Studied across 4 of the same disease areas as Digoxin in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.