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DIGOXIN
Digoxin is a marketed drug primarily indicated for the treatment of heart failure in adults, holding a significant position in the cardiovascular segment. Its key strength lies in its well-established use and long-standing efficacy in managing heart failure symptoms. The primary risk to consider is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | DIGOXIN |
|---|---|
| Drug class | Cardiac Glycoside [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1975 |
Approved indications
- Heart Failure in Adults
- Heart Failure in Pediatric Patients
- Atrial Fibrillation in Adults
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Headache
- Weakness
- Dizziness
- Apathy
- Confusion
- Anxiety
- Depression
- Delirium
- Hallucination
Serious adverse events
- Cardiac arrhythmias
- Digoxin toxicity
- Intestinal ischemia
- Hemorrhagic necrosis of the intestines
- Mental disturbances
- Thrombocytopenia
Key clinical trials
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults (PHASE1)
- Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation (NA)
- A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin (PHASE1)
- Digoxin Medulloblastoma Study (PHASE2)
- Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS) (PHASE3)
- Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DIGOXIN CI brief — competitive landscape report
- DIGOXIN updates RSS · CI watch RSS