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Digoxin Antibodies Fab Fragments
Digoxin Antibodies Fab Fragments is a Antidote; Digoxin-specific antibody fragment Small molecule drug developed by University of Maryland, Baltimore. It is currently FDA-approved for Digoxin toxicity or overdose, Life-threatening digoxin toxicity with arrhythmias or hyperkalemia.
Digoxin-specific antibody fragments bind to and neutralize circulating digoxin, preventing its toxic cardiac effects.
Digoxin-specific antibody fragments bind to and neutralize circulating digoxin, preventing its toxic cardiac effects. Used for Digoxin toxicity or overdose, Life-threatening digoxin toxicity with arrhythmias or hyperkalemia.
At a glance
| Generic name | Digoxin Antibodies Fab Fragments |
|---|---|
| Sponsor | University of Maryland, Baltimore |
| Drug class | Antidote; Digoxin-specific antibody fragment |
| Target | Digoxin |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
These monoclonal antibody fragments (Fab) are derived from sheep immunized against digoxin and act as a sequestering agent by binding digoxin with high affinity and specificity. The antibody-digoxin complex is then eliminated renally, rapidly reducing serum digoxin levels and reversing digoxin toxicity. This mechanism allows for rapid reversal of digoxin overdose or toxicity without removing the therapeutic drug already bound to cardiac Na+/K+-ATPase.
Approved indications
- Digoxin toxicity or overdose
- Life-threatening digoxin toxicity with arrhythmias or hyperkalemia
Common side effects
- Hypokalemia
- Allergic reactions
- Serum sickness
- Worsening heart failure (from loss of digoxin inotropic effect)
Key clinical trials
- Preop Digifab in CABG to Reduce Ouabain Levels and Prevent AKI (PHASE4)
- Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia (PHASE2, PHASE3)
- Marinobufagenin as a Target for DIGIBIND in Preeclampsia
- Efficacy Study of Digibind for Treatment of Severe Preeclampsia (PHASE2)
- Antibodies to Digoxin for Bipolar Disorder (PHASE2)
- Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease (PHASE4)
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 |
|---|---|
| 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 Antibodies Fab Fragments CI brief — competitive landscape report
- Digoxin Antibodies Fab Fragments updates RSS · CI watch RSS
- University of Maryland, Baltimore portfolio CI
Frequently asked questions about Digoxin Antibodies Fab Fragments
What is Digoxin Antibodies Fab Fragments?
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Related
- Drug class: All Antidote; Digoxin-specific antibody fragment drugs
- Target: All drugs targeting Digoxin
- Manufacturer: University of Maryland, Baltimore — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Digoxin toxicity or overdose
- Indication: Drugs for Life-threatening digoxin toxicity with arrhythmias or hyperkalemia
- Compare: Digoxin Antibodies Fab Fragments vs similar drugs
- Pricing: Digoxin Antibodies Fab Fragments cost, discount & access