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Digoxin (0.25mg)
Digoxin (0.25mg) is a Cardiac glycoside Small molecule drug developed by Advenchen Laboratories, LLC. It is currently in Phase 3 development for Heart failure with reduced ejection fraction, Atrial fibrillation with rapid ventricular response.
Digoxin inhibits the Na+/K+-ATPase pump, increasing intracellular calcium and enhancing cardiac contractility while slowing atrioventricular node conduction.
Digoxin (0.25mg) is a small molecule that inhibits the sodium/potassium-transporting ATPase, a mechanism that is consistent with its classification as an inhibitor. Digoxin is being studied in various clinical trials, including a phase I drug-drug interaction study, but its primary indications are not specified in the provided facts.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Digoxin (0.25mg) |
|---|---|
| Sponsor | Advenchen Laboratories, LLC |
| Drug class | Cardiac glycoside |
| Target | Na+/K+-ATPase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Digoxin binds to and inhibits the sodium-potassium pump (Na+/K+-ATPase) on cardiac myocyte membranes, leading to increased intracellular sodium and reduced activity of the Na+/Ca2+ exchanger. This results in increased intracellular calcium availability, which strengthens cardiac muscle contraction (positive inotropic effect). Additionally, digoxin enhances vagal tone and directly slows conduction through the atrioventricular node, reducing heart rate and providing antiarrhythmic effects.
Approved indications
- Heart failure with reduced ejection fraction
- Atrial fibrillation with rapid ventricular response
Common side effects
- Nausea and vomiting
- Arrhythmias (including ventricular ectopy and atrial fibrillation)
- Headache
- Visual disturbances
- Dizziness
- Digoxin toxicity (at supratherapeutic levels)
Key clinical trials
- Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS) (PHASE3)
- Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin (PHASE1)
- Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection (PHASE1)
- Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates (PHASE1)
- Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation (PHASE4)
- A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) (PHASE1)
- A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin (PHASE1)
- Bioequivalence Study of Digoxin Tablet in Healthy Subjects (PHASE1)
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 (0.25mg) CI brief — competitive landscape report
- Digoxin (0.25mg) updates RSS · CI watch RSS
- Advenchen Laboratories, LLC portfolio CI
Frequently asked questions about Digoxin (0.25mg)
What is Digoxin (0.25mg)?
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What is Digoxin (0.25mg) used for?
Who makes Digoxin (0.25mg)?
What drug class is Digoxin (0.25mg) in?
What development phase is Digoxin (0.25mg) in?
What are the side effects of Digoxin (0.25mg)?
What does Digoxin (0.25mg) target?
Related
- Drug class: All Cardiac glycoside drugs
- Target: All drugs targeting Na+/K+-ATPase
- Manufacturer: Advenchen Laboratories, LLC — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Heart failure with reduced ejection fraction
- Indication: Drugs for Atrial fibrillation with rapid ventricular response
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing